Pending: 32009L0023

January 16, 2026
16.5.2009 EN Official Journal of the European Union L 122/6
(1) Council Directive 90/384/EEC of 20 June 1990 on the harmonisation of the laws of the Member States relating to non-automatic weighing instruments(3)has been substantially amended(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications.
(3) In each Member State, mandatory provisions fix in particular the necessary performance requirements of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service. These mandatory provisions do not necessarily lead to different levels of protection from one Member State to another but do, by their disparity, impede trade within the Community.
(4) This Directive should set out mandatory and essential requirements as regards metrology and performance in relation to non-automatic weighing instruments. To facilitate proof of conformity with the essential requirements, it is necessary to have harmonised standards at European level, in particular as to the metrological, design and construction characteristics, so that instruments complying with those harmonised standards may be assumed to conform to the essential requirements. These standards, harmonised at European level, are drawn up by private bodies and must remain non-mandatory texts. For that purpose the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines(5)for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.
(5) A series of Directives designed to remove technical barriers to trade in accordance with the principles established in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(6)has been adopted; each of those Directives provides for the affixing of the ‘CE’ conformity marking. In its communication of 15 June 1989(7)on a global approach to certification and testing, the Commission proposed that common rules be drawn up concerning a ‘CE’ conformity marking with a single design. In its Resolution of 21 December 1989 on a global approach to conformity assessment(8), the Council approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the ‘CE’ conformity marking. The two basic elements of the new approach which should be applied are the essential requirements and the conformity assessment procedures.
(6) Assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties. The existing conformity assessment procedures differ from one Member State to another. To avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States. To facilitate the mutual recognition of conformity assessment procedures, Community procedures should be set up, together with criteria for the designation of the bodies responsible for carrying out tasks pertaining to the conformity assessment procedures.
(7) It is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community.
(8) The presence on a non-automatic weighing instrument of the ‘CE’ conformity marking or of the sticker bearing the letter ‘M’ should indicate that there is a presumption that it satisfies the provisions of this Directive and therefore make it unnecessary to repeat the assessments of conformity already carried out.
(9) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex VII, Part B,
(a) (i)determination of mass for commercial transactions;(ii)determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;(iii)determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;(iv)determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;(v)determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;(vi)determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages; (i) determination of mass for commercial transactions; (ii) determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment; (iii) determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings; (iv) determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment; (v) determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories; (vi) determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;
(i) determination of mass for commercial transactions;
(ii) determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(iii) determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;
(iv) determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(v) determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(vi) determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;
(i) determination of mass for commercial transactions;
(ii) determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(iii) determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;
(iv) determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(v) determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(vi) determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;
(b) all applications other than those listed in point (a).
(a) failure to meet the essential requirements set out in Annex I, where instruments do not meet the harmonised standards referred to in Article 6(1);
(b) incorrect application of the harmonised standards referred to in Article 6(1);
(c) shortcomings in the harmonised standards referred to in Article 6(1) themselves.
(a) EC type examination as referred to in Annex II, point 1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II, point 2, or by the EC verification as referred to in Annex II, point 3.However, EC type examination shall not be compulsory for instruments which do not use electronic devices and the load-measuring device of which does not use a spring to balance the load;
(b) EC unit verification as referred to in Annex II, point 4.
(a) where a Member State establishes that the ‘CE’ conformity marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the instrument conform as regards the provisions concerning the ‘CE’ conformity marking and to end the infringement under the conditions imposed by the Member State;
(b) where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.
— SI units: kilogram, microgram, milligram, gram, tonne,
— imperial unit: troy ounce, if weighing precious metals,
— other non-SI unit: metric carat, if weighing precious stones.
I special
II high
III medium
IIII ordinary
Class Verification scale interval (e) Minimum capacity (Min) Number of verification scale intervals
minimum value minimum value maximum value
I 0,001 g ≤ e 100 e 50 000 —
II 0,001 g ≤ e ≤ 0,05 g 20 e 100 100 000
0,1 g ≤ e 50 e 5 000 100 000
III 0,1 g ≤ e ≤ 2 g 20 e 100 10 000
5 g ≤ e 20 e 500 10 000
IIII 5 g ≤ e 10 e 100 1 000
2.2.1. The actual scale interval (d) and the verification scale interval (e) shall be in the form:1 × 10k, 2 × 10k, or 5 × 10kmass units,k being any integer or zero.
2.2.2. For all instruments other than those with auxiliary indicating devices:d = e.
2.2.3. For instruments with auxiliary indicating devices the following conditions apply:e = 1 × 10kg,d < e ≤ 10 d,except for instruments of class I with d < 10–4g, for which e = 10–3g.
3.3.1. Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments).Multi-interval instruments shall not be equipped with an auxiliary indicating device.
3.3.2. Each partial weighing range i of multi-interval instruments is defined by:—its verification scale interval eiwith e(i + 1)> ei—its maximum capacity Maxiwith Maxr= Max—its minimum capacity Miniwith Mini= Max(i – 1)and Min1= Minwhere:i=1, 2, … r,i=partial weighing range number,r=the total number of partial weighing ranges.All capacities are capacities of net load, irrespective of the value of any tare used. —its verification scale interval ei — its verification scale interval ei with e(i + 1)> ei —its maximum capacity Maxi — its maximum capacity Maxi with Maxr= Max —its minimum capacity Mini — its minimum capacity Mini with Mini= Max(i – 1)and Min1= Min i = 1, 2, … r, i = partial weighing range number, r = the total number of partial weighing ranges.
—its verification scale interval ei — its verification scale interval ei with e(i + 1)> ei
— its verification scale interval ei
—its maximum capacity Maxi — its maximum capacity Maxi with Maxr= Max
— its maximum capacity Maxi
—its minimum capacity Mini — its minimum capacity Mini with Mini= Max(i – 1)and Min1= Min
— its minimum capacity Mini
i = 1, 2, … r,
i = partial weighing range number,
r = the total number of partial weighing ranges.
—its verification scale interval ei — its verification scale interval ei with e(i + 1)> ei
— its verification scale interval ei
—its maximum capacity Maxi — its maximum capacity Maxi with Maxr= Max
— its maximum capacity Maxi
—its minimum capacity Mini — its minimum capacity Mini with Mini= Max(i – 1)and Min1= Min
— its minimum capacity Mini
— its verification scale interval ei
— its maximum capacity Maxi
— its minimum capacity Mini
i = 1, 2, … r,
i = partial weighing range number,
r = the total number of partial weighing ranges.
3.3.3. The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, that class being the instrument’s accuracy class.Table 2Multi-interval instrumentsi=1, 2, … ri=partial weighing range numberr=total number of partial weighing rangesClassVerification scale interval (e)Minimum capacity (Min)Number of verification scale intervalsMinimum valueMinimum value(2)Maximum valueI0,001g ≤ ei100 e150 000—II0,001g ≤ ei≤ 0,05 g20 e15 000100 0000,1g ≤ ei50 e15 000100 000III0,1g ≤ ei20 e150010 000IIII5g ≤ ei10 e1501 000 i = 1, 2, … r i = partial weighing range number r = total number of partial weighing ranges Class Verification scale interval (e) Minimum capacity (Min) Number of verification scale intervals Minimum value Minimum value(2) Maximum value I 0,001 g ≤ ei 100 e1 50 000 — II 0,001 g ≤ ei≤ 0,05 g 20 e1 5 000 100 000 0,1 g ≤ ei 50 e1 5 000 100 000 III 0,1 g ≤ ei 20 e1 500 10 000 IIII 5 g ≤ ei 10 e1 50 1 000
i = 1, 2, … r
i = partial weighing range number
r = total number of partial weighing ranges
Class Verification scale interval (e) Minimum capacity (Min) Number of verification scale intervals
Minimum value Minimum value(2) Maximum value
I 0,001 g ≤ ei 100 e1 50 000 —
II 0,001 g ≤ ei≤ 0,05 g 20 e1 5 000 100 000
0,1 g ≤ ei 50 e1 5 000 100 000
III 0,1 g ≤ ei 20 e1 500 10 000
IIII 5 g ≤ ei 10 e1 50 1 000
i = 1, 2, … r
i = partial weighing range number
r = total number of partial weighing ranges
Class Verification scale interval (e) Minimum capacity (Min) Number of verification scale intervals
Minimum value Minimum value(2) Maximum value
I 0,001 g ≤ ei 100 e1 50 000 —
II 0,001 g ≤ ei≤ 0,05 g 20 e1 5 000 100 000
0,1 g ≤ ei 50 e1 5 000 100 000
III 0,1 g ≤ ei 20 e1 500 10 000
IIII 5 g ≤ ei 10 e1 50 1 000
Load Maximum permissible error
Class I Class II Class III Class IIII
0 ≤ m ≤ 50 000 e 0 ≤ m ≤ 5 000 e 0 ≤ m ≤ 500 e 0 ≤ m ≤ 50 e ±0,5 e
50 000 e < m ≤ 200 000 e 5 000 e < m ≤ 20 000 e 500 e < m ≤ 2 000 e 50 e < m ≤ 200 e ±1,0 e
200 000 e < m 20 000 e < m ≤ 100 000 e 2 000 e < m ≤ 10 000 e 200 e < m ≤ 1 000 e ±1,5 e
— 5 °C for an instrument in class I,
— 15 °C for an instrument in class II,
— 30 °C for an instrument in class III or IIII.
— the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition,
— a written declaration that the application has not been lodged with any other notified body,
— the design documentation, as described in Annex III.
1.3.1. examine the design documentation and verify that the type has been manufactured in accordance with that documentation;
1.3.2. agree with the applicant on the location where the examinations and/or tests shall be carried out;
1.3.3. perform or have performed the appropriate examinations and/or tests to check whether the solutions adopted by the manufacturer meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied;
1.3.4. perform or have performed the appropriate examinations and/or tests to check whether, where the manufacturer has chosen to apply the relevant standards, these standards have been applied effectively, thereby assuring conformity with the essential requirements.
— applications received for EC type-examination,
— EC type-approval certificates issued,
— applications for type-certificates refused,
— additions and amendments relating to documents already issued.
2.3.1. The manufacturer shall lodge an application for approval of his quality system with a notified body.The application shall include:—an undertaking to carry out the obligations arising from the approved quality system,—an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.The manufacturer shall make available to the notified body all relevant information, in particular the quality system’s documentation and the design documentation of the instrument. — an undertaking to carry out the obligations arising from the approved quality system, — an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
— an undertaking to carry out the obligations arising from the approved quality system,
— an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
— an undertaking to carry out the obligations arising from the approved quality system,
— an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
2.3.2. The quality system shall ensure conformity of the instruments with the type as described in the EC type-approval certificate and with the requirement(s) of this Directive.All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written rules, procedures and instructions. This quality system documentation shall ensure a proper understanding of the quality programmes, plans, manuals and records.It shall contain in particular an adequate description of:—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,—the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,—the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,—the means to monitor the achievement of the required product quality and the effective operation of the quality system. — the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality, — the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used, — the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, — the means to monitor the achievement of the required product quality and the effective operation of the quality system.
— the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
— the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,
— the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
— the means to monitor the achievement of the required product quality and the effective operation of the quality system.
— the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
— the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,
— the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
— the means to monitor the achievement of the required product quality and the effective operation of the quality system.
2.3.3. The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 2.3.2. It shall presume conformity with these requirements in respect of quality systems that implement the corresponding harmonised standard.It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The notification to the manufacturer shall contain the conclusions of the examination and, in the event of refusal, the justification for the decision.
2.3.4. The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any updating of the quality assurance system in relation to changes brought about by, e.g. new technologies and new quality concepts.
2.3.5. Any notified body that withdraws approval of a quality system shall so inform the other notified bodies.
2.4.1. The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
2.4.2. The manufacturer shall grant the notified body access for inspection purposes to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular:—the quality system documentation,—the design documentation,—the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.In addition, the notified body may carry out unscheduled visits to the manufacturer. During such visits, the notified body may carry out full or partial audits. It shall provide the manufacturer with a report on the visit, and, where appropriate, an audit report. — the quality system documentation, — the design documentation, — the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
— the quality system documentation,
— the design documentation,
— the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
— the quality system documentation,
— the design documentation,
— the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
2.4.3. The notified body shall ensure that the manufacturer maintains and applies the approved quality system.
3.5.1. All instruments shall be individually examined and appropriate tests, as set out in the relevant harmonised standards referred to in Article 6(1), or equivalent tests, shall be carried out in order to verify their conformity, where applicable, with the type as described in the EC type-examination certificate and the requirements of this Directive.
3.5.2. The notified body shall affix, or cause to be affixed, its identification number on each instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity relating to the tests carried out.
3.5.3. The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
— a general description of the type,
— conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.,
— descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,
— a list of the harmonised standards referred to in Article 6(1), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied,
— results of design calculations made and of examinations, etc.,
— test reports,
— the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.
1.1. These instruments must bear:(a)—the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together;(b)a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;(c)the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. (a) —the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together; — the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI, — the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification. (b) a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black; (c) the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. — the number of the EC type-approval certificate, where appropriate, — the manufacturer’s mark or name, — the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles, — maximum capacity, in the form Max …, — minimum capacity, in the form Min …, — verification scale interval, in the forme= …, — the last two digits of the year in which the ‘CE’ conformity marking was affixed, — serial number, — for instruments consisting of separate but associated units: identification mark on each unit, — scale interval if it is different frome, in the formd= …, — maximum additive tare effect, in the formT= + …, — maximum subtractive tare effect if it is different from Max, in the formT= – …, — tare interval if it is different fromd, in the formdT= …, — maximum safe load if it is different from Max, in the form Lim …, — the special temperature limits, in the form … °C/… °C, — ratio between load receptor and load.
(a) —the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together; — the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI, — the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
— the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,
— the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
(b) a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;
(c) the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. — the number of the EC type-approval certificate, where appropriate, — the manufacturer’s mark or name, — the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles, — maximum capacity, in the form Max …, — minimum capacity, in the form Min …, — verification scale interval, in the forme= …, — the last two digits of the year in which the ‘CE’ conformity marking was affixed, — serial number, — for instruments consisting of separate but associated units: identification mark on each unit, — scale interval if it is different frome, in the formd= …, — maximum additive tare effect, in the formT= + …, — maximum subtractive tare effect if it is different from Max, in the formT= – …, — tare interval if it is different fromd, in the formdT= …, — maximum safe load if it is different from Max, in the form Lim …, — the special temperature limits, in the form … °C/… °C, — ratio between load receptor and load.
— the number of the EC type-approval certificate, where appropriate,
— the manufacturer’s mark or name,
— the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,
— maximum capacity, in the form Max …,
— minimum capacity, in the form Min …,
— verification scale interval, in the forme= …,
— the last two digits of the year in which the ‘CE’ conformity marking was affixed,
— serial number,
— for instruments consisting of separate but associated units: identification mark on each unit,
— scale interval if it is different frome, in the formd= …,
— maximum additive tare effect, in the formT= + …,
— maximum subtractive tare effect if it is different from Max, in the formT= – …,
— tare interval if it is different fromd, in the formdT= …,
— maximum safe load if it is different from Max, in the form Lim …,
— the special temperature limits, in the form … °C/… °C,
— ratio between load receptor and load.
(a) —the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together; — the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI, — the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
— the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,
— the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
— the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,
— the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
(b) a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;
(c) the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. — the number of the EC type-approval certificate, where appropriate, — the manufacturer’s mark or name, — the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles, — maximum capacity, in the form Max …, — minimum capacity, in the form Min …, — verification scale interval, in the forme= …, — the last two digits of the year in which the ‘CE’ conformity marking was affixed, — serial number, — for instruments consisting of separate but associated units: identification mark on each unit, — scale interval if it is different frome, in the formd= …, — maximum additive tare effect, in the formT= + …, — maximum subtractive tare effect if it is different from Max, in the formT= – …, — tare interval if it is different fromd, in the formdT= …, — maximum safe load if it is different from Max, in the form Lim …, — the special temperature limits, in the form … °C/… °C, — ratio between load receptor and load.
— the number of the EC type-approval certificate, where appropriate,
— the manufacturer’s mark or name,
— the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,
— maximum capacity, in the form Max …,
— minimum capacity, in the form Min …,
— verification scale interval, in the forme= …,
— the last two digits of the year in which the ‘CE’ conformity marking was affixed,
— serial number,
— for instruments consisting of separate but associated units: identification mark on each unit,
— scale interval if it is different frome, in the formd= …,
— maximum additive tare effect, in the formT= + …,
— maximum subtractive tare effect if it is different from Max, in the formT= – …,
— tare interval if it is different fromd, in the formdT= …,
— maximum safe load if it is different from Max, in the form Lim …,
— the special temperature limits, in the form … °C/… °C,
— ratio between load receptor and load.
— the number of the EC type-approval certificate, where appropriate,
— the manufacturer’s mark or name,
— the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,
— maximum capacity, in the form Max …,
— minimum capacity, in the form Min …,
— verification scale interval, in the forme= …,
— the last two digits of the year in which the ‘CE’ conformity marking was affixed,
— serial number,
— for instruments consisting of separate but associated units: identification mark on each unit,
— scale interval if it is different frome, in the formd= …,
— maximum additive tare effect, in the formT= + …,
— maximum subtractive tare effect if it is different from Max, in the formT= – …,
— tare interval if it is different fromd, in the formdT= …,
— maximum safe load if it is different from Max, in the form Lim …,
— the special temperature limits, in the form … °C/… °C,
— ratio between load receptor and load.
1.2. The instruments shall have adequate facilities for the affixing of the ‘CE’ conformity marking and/or inscriptions. These shall be such that it shall be impossible to remove the marking and inscriptions without damaging them, and that the marking and inscriptions shall be visible when the instrument is in its regular operating position.
1.3. Where a data plate is used it shall be possible to seal the plate unless it cannot be removed without being destroyed. If the data plate is sealable it shall be possible to apply a control mark to it.
1.4. The inscriptions Max, Min,e, andd, shall also be shown near the display of the result if they are not already located there.
1.5. Each load measuring device which is connected or can be connected to one or more load receptors shall bear the relevant inscriptions relating to the said load receptors.
— the manufacturer’s mark or name,
— maximum capacity, in the form Max ….
1. The bodies shall have at their disposal the necessary personnel, means and equipment.
2. The personnel of the bodies shall have technical competence and professional integrity.
3. The bodies shall work independently of all circles, groups or persons having a direct or indirect interest in non-automatic weighing instruments as regards the carrying-out of the tests, the preparation of the reports, the issuing of the certificates and the surveillance required by this Directive.
4. The personnel of the bodies shall respect professional confidentiality.
5. The bodies shall take out a civil liability insurance if their civil liability is not covered by the State under national law.
— The ‘CE’ conformity marking shall consist of the initials ‘CE’ taking the following form:
— If the ‘CE’ conformity marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
— The various components of the ‘CE’ conformity marking must have substantially the same vertical dimension, which may not be less than 5 mm.
Council Directive 90/384/EEC(OJ L 189, 20.7.1990, p. 1)
Council Directive 93/68/EEC(OJ L 220, 30.8.1993, p. 1) Article 1, point 7, and Article 8 only
Directive Time limit for transposition Date of application
90/384/EEC 30 June 1992 1 January 1993(1)
93/68/EEC 30 June 1994 1 January 1995(2)
Directive 90/384/EEC This Directive
Recital 5, last sentence Article 2, point (3)
Article 1(1), first subparagraph Article 2, point (1)
Article 1(1), second subparagraph Article 2, point (2)
Article 1(1), third subparagraph Article 1(1)
Article 1(2), introductory wording Article 1(2), introductory wording
Article 1(2), point (a)(1) Article 1(2), point (a)(i)
Article 1(2), point (a)(2) Article 1(2), point (a)(ii)
Article 1(2), point (a)(3) Article 1(2), point (a)(iii)
Article 1(2), point (a)(4) Article 1(2), point (a)(iv)
Article 1(2), point (a)(5) Article 1(2), point (a)(v)
Article 1(2), point (a)(6) Article 1(2), point (a)(vi)
Article 1(2), point (b) Article 1(2), point (b)
Article 2 Article 3
Article 3 Article 4
Article 4 Article 5
Article 5 Article 6
Article 6, first paragraph, first sentence Article 7, first paragraph
Article 6, first paragraph, second sentence Article 7, second paragraph
Article 6, second paragraph Article 7, third paragraph
Article 7 Article 8
Article 8(1) and (2) Article 9(1) and (2)
Article 8(3), point (a) Article 9(3), first subparagraph
Article 8(3), point (b) Article 9(3), second subparagraph
Article 9 Article 10
Article 10 Article 11
Article 11 Article 12
Article 12 Article 13
Article 13 Article 14
Article 14, first sentence Article 15, first paragraph
Article 14, second sentence Article 15, second paragraph
Article 15(1) to (3) —
Article 15(4) Article 16
Article 15(5) —
— Article 17
— Article 18
Article 16 Article 19
Annexes I to VI Annexes I to VI
— Annex VII
— Annex VIII
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
(1) Council Directive 90/384/EEC of 20 June 1990 on the harmonisation of the laws of the Member States relating to non-automatic weighing instruments(3)has been substantially amended(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications.
(3) In each Member State, mandatory provisions fix in particular the necessary performance requirements of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service. These mandatory provisions do not necessarily lead to different levels of protection from one Member State to another but do, by their disparity, impede trade within the Community.
(4) This Directive should set out mandatory and essential requirements as regards metrology and performance in relation to non-automatic weighing instruments. To facilitate proof of conformity with the essential requirements, it is necessary to have harmonised standards at European level, in particular as to the metrological, design and construction characteristics, so that instruments complying with those harmonised standards may be assumed to conform to the essential requirements. These standards, harmonised at European level, are drawn up by private bodies and must remain non-mandatory texts. For that purpose the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines(5)for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.
(5) A series of Directives designed to remove technical barriers to trade in accordance with the principles established in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(6)has been adopted; each of those Directives provides for the affixing of the ‘CE’ conformity marking. In its communication of 15 June 1989(7)on a global approach to certification and testing, the Commission proposed that common rules be drawn up concerning a ‘CE’ conformity marking with a single design. In its Resolution of 21 December 1989 on a global approach to conformity assessment(8), the Council approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the ‘CE’ conformity marking. The two basic elements of the new approach which should be applied are the essential requirements and the conformity assessment procedures.
(6) Assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties. The existing conformity assessment procedures differ from one Member State to another. To avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States. To facilitate the mutual recognition of conformity assessment procedures, Community procedures should be set up, together with criteria for the designation of the bodies responsible for carrying out tasks pertaining to the conformity assessment procedures.
(7) It is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community.
(8) The presence on a non-automatic weighing instrument of the ‘CE’ conformity marking or of the sticker bearing the letter ‘M’ should indicate that there is a presumption that it satisfies the provisions of this Directive and therefore make it unnecessary to repeat the assessments of conformity already carried out.
(9) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex VII, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Article 1
1. This Directive shall apply to all non-automatic weighing instruments.
2. For the purposes of this Directive, the following categories of use of non-automatic weighing instruments shall be distinguished:
(a)
(i)
determination of mass for commercial transactions;
(ii)
determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(iii)
determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;
(iv)
determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(v)
determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(vi)
determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;
(b)
all applications other than those listed in point (a).

Article 2
For the purposes of this Directive, the following definitions shall apply:
1.‘weighing instrument’: a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics;
2.‘non-automatic weighing instrument’ or ‘instrument’: a weighing instrument requiring the intervention of an operator during weighing;
3.‘harmonised standard’: a technical specification (European standard or harmonised document) adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec), or the European Telecommunications Standards Institute (ETSI), or by two or three of those bodies, upon a remit from the Commission in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations(9)and the general guidelines for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.

Article 3
1. Member States shall take all steps to ensure that only instruments that meet the requirements of this Directive may be placed on the market.
2. Member States shall take all steps to ensure that instruments may not be brought into service for the uses referred to in point (a) of Article 1(2) unless they meet the requirements of this Directive and accordingly bear the ‘CE’ conformity marking provided for in Article 11.

Article 4
Instruments used for the applications listed in point (a) of Article 1(2) must satisfy the essential requirements set out in Annex I.
In cases where the instrument includes, or is connected to, devices which are not used for the applications listed in point (a) of Article 1(2), such devices shall not be subject to those essential requirements.

Article 5
1. Member States shall not impede the placing on the market of instruments which meet the requirements of this Directive.
2. Member States shall not impede the putting into service, for the uses referred to in point (a) of Article 1(2), of instruments which meet the requirements of this Directive.

Article 6
1. Member States shall presume conformity with the essential requirements set out in Annex I in respect of instruments which comply with the relevant national standards implementing the harmonised standards that meet those requirements.
2. The Commission shall publish the references of the harmonised standards referred to in paragraph 1 in theOfficial Journal of the European Union.
Member States shall publish the references of the national standards referred to in paragraph 1.

Article 7
Where a Member State or the Commission considers that the harmonised standards referred to in Article 6(1) do not fully meet the essential requirements set out in Annex I, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the Committee’, giving its reasons for doing so.
The Committee shall deliver an opinion without delay.
In the light of the Committee’s opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 6(2).

Article 8
1. Where a Member State considers that instruments bearing the ‘CE’ conformity marking referred to in Annex II, points 2, 3 and 4, do not meet the requirements of this Directive when properly installed and used for the purposes for which they are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or restrict their being put into service and/or placed on the market.
The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-compliance is due to:
(a)
failure to meet the essential requirements set out in Annex I, where instruments do not meet the harmonised standards referred to in Article 6(1);
(b)
incorrect application of the harmonised standards referred to in Article 6(1);
(c)
shortcomings in the harmonised standards referred to in Article 6(1) themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible.
After such consultation the Commission shall immediately inform the Member State which took the action of the result. Should it find that the measure is justified it shall immediately inform the other Member States.
If the decision is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them, and shall subsequently initiate the procedures referred to in Article 7.
3. Where an instrument which does not comply bears the ‘CE’ conformity marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.

Article 9
1. The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant:
(a)
EC type examination as referred to in Annex II, point 1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II, point 2, or by the EC verification as referred to in Annex II, point 3.
However, EC type examination shall not be compulsory for instruments which do not use electronic devices and the load-measuring device of which does not use a spring to balance the load;
(b)
EC unit verification as referred to in Annex II, point 4.
2. The documents and correspondence relating to the procedures referred to in paragraph 1 shall be drafted in an official language of the Member State where the said procedures are carried out, or in a language accepted by the body notified in accordance with Article 10(1).
3. Where the instruments are subject to other Directives covering other aspects and which also provide for the affixing of the ‘CE’ conformity marking, that marking shall indicate that the instruments in question are also presumed to conform to the provisions of those other Directives.
However, where one or more of the Directives which apply to the instruments allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ conformity marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of publication in theOfficial Journal of the European Unionof the Directives applied must be given in the documents, notices or instructions required by the Directives and accompanying such instruments.

Article 10
1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in theOfficial Journal of the European Uniona list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the minimum criteria set out in Annex V for the designation of bodies. Bodies which satisfy the criteria fixed by the relevant harmonised standards shall be presumed to satisfy the criteria set out in that Annex.
3. A Member State which has designated a body shall cancel the designation if the body no longer meets the criteria for designation referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof and withdraw the notification.

Article 11
1. The ‘CE’ conformity marking and the required supplementary data as described in Annex IV, point 1, shall be affixed in a clearly visible, easily legible and indelible form to instruments for which EC conformity has been established.
2. The inscriptions referred to in Annex IV, point 2, shall be affixed in a clearly visible, easily legible and indelible form to all other instruments.
3. The affixing on the instruments of markings which are likely to deceive third parties as to the meaning and form of the ‘CE’ conformity marking shall be prohibited. Any other marking may be affixed to the instruments provided that the visibility and legibility of the ‘CE’ conformity marking is not thereby reduced.

Article 12
Without prejudice to Article 8:
(a)
where a Member State establishes that the ‘CE’ conformity marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the instrument conform as regards the provisions concerning the ‘CE’ conformity marking and to end the infringement under the conditions imposed by the Member State;
(b)
where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.

Article 13
Where an instrument which is used for any of the applications referred to in point (a) of Article 1(2) includes, or is connected to, devices that have not been subject to conformity assessment as referred to in Article 9, each of those devices shall bear the symbol restricting its use as defined by Annex IV, point 3. That symbol shall be affixed to the devices in a clearly visible and indelible form.

Article 14
Member States shall take all steps to ensure that instruments bearing the ‘CE’ conformity marking attesting conformity with the requirements of this Directive continue to conform to those requirements.

Article 15
Any decision taken pursuant to this Directive and resulting in restrictions on the putting into service of an instrument shall state the exact grounds on which it is based.
Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.

Article 16
Member States shall communicate to the Commission the texts of the main provisions of internal law which they adopt in the field covered by this Directive.

Article 17
Directive 90/384/EEC, as amended by the Directive listed in Annex VII, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex VII, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VIII.

Article 18
This Directive shall enter into force on the twentieth day following its publication in theOfficial Journal of the European Union.

Article 19
This Directive is addressed to the Member States.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
(1) Council Directive 90/384/EEC of 20 June 1990 on the harmonisation of the laws of the Member States relating to non-automatic weighing instruments(3)has been substantially amended(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Member States have the responsibility of protecting the public against incorrect results of weighing operations by means of non-automatic weighing instruments when used for certain categories of applications.
(3) In each Member State, mandatory provisions fix in particular the necessary performance requirements of non-automatic weighing instruments by specifying metrological and technical requirements, together with inspection procedures before and after going into service. These mandatory provisions do not necessarily lead to different levels of protection from one Member State to another but do, by their disparity, impede trade within the Community.
(4) This Directive should set out mandatory and essential requirements as regards metrology and performance in relation to non-automatic weighing instruments. To facilitate proof of conformity with the essential requirements, it is necessary to have harmonised standards at European level, in particular as to the metrological, design and construction characteristics, so that instruments complying with those harmonised standards may be assumed to conform to the essential requirements. These standards, harmonised at European level, are drawn up by private bodies and must remain non-mandatory texts. For that purpose the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec) and the European Telecommunications Standards Institute (ETSI) are recognised as the competent bodies for the adoption of harmonised standards in accordance with the general guidelines(5)for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.
(5) A series of Directives designed to remove technical barriers to trade in accordance with the principles established in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards(6)has been adopted; each of those Directives provides for the affixing of the ‘CE’ conformity marking. In its communication of 15 June 1989(7)on a global approach to certification and testing, the Commission proposed that common rules be drawn up concerning a ‘CE’ conformity marking with a single design. In its Resolution of 21 December 1989 on a global approach to conformity assessment(8), the Council approved as a guiding principle the adoption of a consistent approach such as this with regard to the use of the ‘CE’ conformity marking. The two basic elements of the new approach which should be applied are the essential requirements and the conformity assessment procedures.
(6) Assessment of conformity with the relevant metrological and technical provisions is necessary to provide effective protection for users and third parties. The existing conformity assessment procedures differ from one Member State to another. To avoid multiple assessments of conformity, which are in effect barriers to the free movement of the instruments, arrangements should be made for the mutual recognition of conformity assessment procedures by the Member States. To facilitate the mutual recognition of conformity assessment procedures, Community procedures should be set up, together with criteria for the designation of the bodies responsible for carrying out tasks pertaining to the conformity assessment procedures.
(7) It is therefore essential to ensure that such designated bodies ensure a high level of quality throughout the Community.
(8) The presence on a non-automatic weighing instrument of the ‘CE’ conformity marking or of the sticker bearing the letter ‘M’ should indicate that there is a presumption that it satisfies the provisions of this Directive and therefore make it unnecessary to repeat the assessments of conformity already carried out.
(9) This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex VII, Part B,
HAVE ADOPTED THIS DIRECTIVE:
1. This Directive shall apply to all non-automatic weighing instruments.
2. For the purposes of this Directive, the following categories of use of non-automatic weighing instruments shall be distinguished:
(a)
(i)
determination of mass for commercial transactions;
(ii)
determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment;
(iii)
determination of mass for the application of laws or regulations or for an expert opinion given in court proceedings;
(iv)
determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment;
(v)
determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories;
(vi)
determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages;
(b)
all applications other than those listed in point (a).
For the purposes of this Directive, the following definitions shall apply:
1.‘weighing instrument’: a measuring instrument serving to determine the mass of a body by using the action of gravity on that body. A weighing instrument may also serve to determine other mass-related magnitudes, quantities, parameters or characteristics;
2.‘non-automatic weighing instrument’ or ‘instrument’: a weighing instrument requiring the intervention of an operator during weighing;
3.‘harmonised standard’: a technical specification (European standard or harmonised document) adopted by the European Committee for Standardisation (CEN), the European Committee for Electrotechnical Standardisation (Cenelec), or the European Telecommunications Standards Institute (ETSI), or by two or three of those bodies, upon a remit from the Commission in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations(9)and the general guidelines for cooperation between the Commission, the European Free Trade Association (EFTA) and those three bodies, signed on 28 March 2003.
1. Member States shall take all steps to ensure that only instruments that meet the requirements of this Directive may be placed on the market.
2. Member States shall take all steps to ensure that instruments may not be brought into service for the uses referred to in point (a) of Article 1(2) unless they meet the requirements of this Directive and accordingly bear the ‘CE’ conformity marking provided for in Article 11.
Instruments used for the applications listed in point (a) of Article 1(2) must satisfy the essential requirements set out in Annex I.
In cases where the instrument includes, or is connected to, devices which are not used for the applications listed in point (a) of Article 1(2), such devices shall not be subject to those essential requirements.
1. Member States shall not impede the placing on the market of instruments which meet the requirements of this Directive.
2. Member States shall not impede the putting into service, for the uses referred to in point (a) of Article 1(2), of instruments which meet the requirements of this Directive.
1. Member States shall presume conformity with the essential requirements set out in Annex I in respect of instruments which comply with the relevant national standards implementing the harmonised standards that meet those requirements.
2. The Commission shall publish the references of the harmonised standards referred to in paragraph 1 in theOfficial Journal of the European Union.
Member States shall publish the references of the national standards referred to in paragraph 1.
Where a Member State or the Commission considers that the harmonised standards referred to in Article 6(1) do not fully meet the essential requirements set out in Annex I, the Commission or the Member State concerned shall bring the matter before the Standing Committee set up under Article 5 of Directive 98/34/EC, hereinafter referred to as ‘the Committee’, giving its reasons for doing so.
The Committee shall deliver an opinion without delay.
In the light of the Committee’s opinion, the Commission shall inform the Member States whether or not it is necessary to withdraw those standards from the publications referred to in Article 6(2).
1. Where a Member State considers that instruments bearing the ‘CE’ conformity marking referred to in Annex II, points 2, 3 and 4, do not meet the requirements of this Directive when properly installed and used for the purposes for which they are intended, it shall take all appropriate measures to withdraw those instruments from the market or to prohibit or restrict their being put into service and/or placed on the market.
The Member State concerned shall immediately inform the Commission of any such measure, indicating the reasons for its decision, and in particular whether non-compliance is due to:
(a)
failure to meet the essential requirements set out in Annex I, where instruments do not meet the harmonised standards referred to in Article 6(1);
(b)
incorrect application of the harmonised standards referred to in Article 6(1);
(c)
shortcomings in the harmonised standards referred to in Article 6(1) themselves.
2. The Commission shall enter into consultation with the parties concerned as soon as possible.
After such consultation the Commission shall immediately inform the Member State which took the action of the result. Should it find that the measure is justified it shall immediately inform the other Member States.
If the decision is attributed to shortcomings in the standards, the Commission, after consulting the parties concerned, shall bring the matter before the Committee within two months if the Member State which has taken the measures intends to maintain them, and shall subsequently initiate the procedures referred to in Article 7.
3. Where an instrument which does not comply bears the ‘CE’ conformity marking, the competent Member State shall take appropriate action against whomsoever has affixed the marking and shall inform the Commission and the other Member States thereof.
4. The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.
1. The conformity of instruments to the essential requirements set out in Annex I may be certified by either of the following procedures as selected by the applicant:
(a)
EC type examination as referred to in Annex II, point 1, followed either by the EC declaration of type conformity (guarantee of production quality) as referred to in Annex II, point 2, or by the EC verification as referred to in Annex II, point 3.
However, EC type examination shall not be compulsory for instruments which do not use electronic devices and the load-measuring device of which does not use a spring to balance the load;
(b)
EC unit verification as referred to in Annex II, point 4.
2. The documents and correspondence relating to the procedures referred to in paragraph 1 shall be drafted in an official language of the Member State where the said procedures are carried out, or in a language accepted by the body notified in accordance with Article 10(1).
3. Where the instruments are subject to other Directives covering other aspects and which also provide for the affixing of the ‘CE’ conformity marking, that marking shall indicate that the instruments in question are also presumed to conform to the provisions of those other Directives.
However, where one or more of the Directives which apply to the instruments allow the manufacturer, during a transitional period, to choose which arrangements to apply, the ‘CE’ conformity marking shall indicate conformity only to the Directives applied by the manufacturer. In this case, particulars of publication in theOfficial Journal of the European Unionof the Directives applied must be given in the documents, notices or instructions required by the Directives and accompanying such instruments.
1. Member States shall notify the Commission and the other Member States of the bodies which they have appointed to carry out the procedures referred to in Article 9 together with the specific tasks which these bodies have been appointed to carry out and the identification numbers assigned to them beforehand by the Commission.
The Commission shall publish in theOfficial Journal of the European Uniona list of the notified bodies and their identification numbers and the tasks for which they have been notified. The Commission shall ensure that this list is kept up to date.
2. Member States shall apply the minimum criteria set out in Annex V for the designation of bodies. Bodies which satisfy the criteria fixed by the relevant harmonised standards shall be presumed to satisfy the criteria set out in that Annex.
3. A Member State which has designated a body shall cancel the designation if the body no longer meets the criteria for designation referred to in paragraph 2. It shall immediately inform the other Member States and the Commission thereof and withdraw the notification.
1. The ‘CE’ conformity marking and the required supplementary data as described in Annex IV, point 1, shall be affixed in a clearly visible, easily legible and indelible form to instruments for which EC conformity has been established.
2. The inscriptions referred to in Annex IV, point 2, shall be affixed in a clearly visible, easily legible and indelible form to all other instruments.
3. The affixing on the instruments of markings which are likely to deceive third parties as to the meaning and form of the ‘CE’ conformity marking shall be prohibited. Any other marking may be affixed to the instruments provided that the visibility and legibility of the ‘CE’ conformity marking is not thereby reduced.
Without prejudice to Article 8:
(a)
where a Member State establishes that the ‘CE’ conformity marking has been affixed unduly, the manufacturer or his authorised representative established within the Community shall be obliged to make the instrument conform as regards the provisions concerning the ‘CE’ conformity marking and to end the infringement under the conditions imposed by the Member State;
(b)
where non-conformity continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the instrument in question or to ensure that it is withdrawn from the market in accordance with the procedures laid down in Article 8.
Where an instrument which is used for any of the applications referred to in point (a) of Article 1(2) includes, or is connected to, devices that have not been subject to conformity assessment as referred to in Article 9, each of those devices shall bear the symbol restricting its use as defined by Annex IV, point 3. That symbol shall be affixed to the devices in a clearly visible and indelible form.
Member States shall take all steps to ensure that instruments bearing the ‘CE’ conformity marking attesting conformity with the requirements of this Directive continue to conform to those requirements.
Any decision taken pursuant to this Directive and resulting in restrictions on the putting into service of an instrument shall state the exact grounds on which it is based.
Such a decision shall be notified without delay to the party concerned, who shall at the same time be informed of the judicial remedies available to him under the laws in force in the Member State in question and of the time limits to which such remedies are subject.
Member States shall communicate to the Commission the texts of the main provisions of internal law which they adopt in the field covered by this Directive.
Directive 90/384/EEC, as amended by the Directive listed in Annex VII, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex VII, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VIII.
This Directive shall enter into force on the twentieth day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.

ESSENTIAL REQUIREMENTS

ANNEX IThe terminology used is that of the International Organisation of Legal Metrology.

Preliminary observation
Where an instrument includes, or is connected to, more than one indicating or printing device used for the applications listed in point (a) of Article 1(2), those devices which repeat the results of the weighing operation and which cannot influence the correct functioning of the instrument shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and indelibly by a part of the instrument which meets the essential requirements and the results are accessible to both parties concerned by the measurement. However, in the case of instruments used for direct sales to the public, display and printing devices for the vendor and the customer must fulfil the essential requirements.

METROLOGICAL REQUIREMENTS
1. Units of massThe units of mass used shall be the legal units within the meaning of Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement(1).
Subject to compliance with this condition, the following units are permitted:

— | SI units: kilogram, microgram, milligram, gram, tonne,
— | imperial unit: troy ounce, if weighing precious metals,
— | other non-SI unit: metric carat, if weighing precious stones.For instruments that make use of the imperial unit of mass referred to above, the relevant essential requirements specified below shall be converted to that unit, using simple interpolation.
2. Accuracy classes2.1. The following accuracy classes have been defined:

I | special
II | high
III | medium
IIII | ordinaryThe specifications of these classes are given in Table 1.

Table 1

Accuracy classes

Class | Verification scale interval (e) | Minimum capacity (Min) | Number of verification scale intervals
minimum value | minimum value | maximum value
I | 0,001 | g ≤ e | 100 e | 50 000 | —
II | 0,001 | g ≤ e ≤ 0,05 g | 20 e | 100 | 100 000
0,1 | g ≤ e | 50 e | 5 000 | 100 000
III | 0,1 | g ≤ e ≤ 2 g | 20 e | 100 | 10 000
5 | g ≤ e | 20 e | 500 | 10 000
IIII | 5 | g ≤ e | 10 e | 100 | 1 000The minimum capacity is reduced to 5 e for instruments in classes II and III for determining a conveying tariff.
2.2. Scale intervals
| 2.2.1. | The actual scale interval (d) and the verification scale interval (e) shall be in the form:1 × 10k, 2 × 10k, or 5 × 10kmass units,k being any integer or zero.
| 2.2.2. | For all instruments other than those with auxiliary indicating devices:d = e.
| 2.2.3. | For instruments with auxiliary indicating devices the following conditions apply:e = 1 × 10kg,d < e ≤ 10 d,except for instruments of class I with d < 10–4g, for which e = 10–3g.3. Classification3.1. Instruments with one weighing rangeInstruments equipped with an auxiliary indicating device shall belong to class I or class II. For these instruments the minimum capacity lower limits for these two classes are obtained from Table 1 by replacement in column 3 of the verification scale interval (e) by the actual scale interval (d).
If d < 10–4g, the maximum capacity of class I may be less than 50 000 e.
3.2. Instruments with multiple weighing rangesMultiple weighing ranges are permitted, provided they are clearly indicated on the instrument. Each individual weighing range is classified according to point 3.1. If the weighing ranges fall into different accuracy classes the instrument shall comply with the severest of the requirements that apply for the accuracy classes in which the weighing ranges fall.
3.3. Multi-interval instruments
| 3.3.1. | Instruments with one weighing range may have several partial weighing ranges (multi-interval instruments).Multi-interval instruments shall not be equipped with an auxiliary indicating device.
| 3.3.2. | Each partial weighing range i of multi-interval instruments is defined by:—its verification scale interval eiwith e(i + 1)> ei—its maximum capacity Maxiwith Maxr= Max—its minimum capacity Miniwith Mini= Max(i – 1)and Min1= Minwhere:i=1, 2, … r,i=partial weighing range number,r=the total number of partial weighing ranges.All capacities are capacities of net load, irrespective of the value of any tare used. | —its verification scale interval ei | — | its verification scale interval ei | with e(i + 1)> ei | —its maximum capacity Maxi | — | its maximum capacity Maxi | with Maxr= Max | —its minimum capacity Mini | — | its minimum capacity Mini | with Mini= Max(i – 1)and Min1= Min | i | = | 1, 2, … r, | i | = | partial weighing range number, | r | = | the total number of partial weighing ranges.
—its verification scale interval ei | — | its verification scale interval ei | with e(i + 1)> ei
— | its verification scale interval ei
—its maximum capacity Maxi | — | its maximum capacity Maxi | with Maxr= Max
— | its maximum capacity Maxi
—its minimum capacity Mini | — | its minimum capacity Mini | with Mini= Max(i – 1)and Min1= Min
— | its minimum capacity Mini
i | = | 1, 2, … r,
i | = | partial weighing range number,
r | = | the total number of partial weighing ranges.
| 3.3.3. | The partial weighing ranges are classified according to Table 2. All partial weighing ranges shall fall into the same accuracy class, that class being the instrument’s accuracy class.Table 2Multi-interval instrumentsi=1, 2, … ri=partial weighing range numberr=total number of partial weighing rangesClassVerification scale interval (e)Minimum capacity (Min)Number of verification scale intervalsMinimum valueMinimum value(2)Maximum valueI0,001g ≤ ei100 e150 000—II0,001g ≤ ei≤ 0,05 g20 e15 000100 0000,1g ≤ ei50 e15 000100 000III0,1g ≤ ei20 e150010 000IIII5g ≤ ei10 e1501 000 | i | = | 1, 2, … r | i | = | partial weighing range number | r | = | total number of partial weighing ranges | Class | Verification scale interval (e) | Minimum capacity (Min) | Number of verification scale intervals | Minimum value | Minimum value(2) | Maximum value | I | 0,001 | g ≤ ei | 100 e1 | 50 000 | — | II | 0,001 | g ≤ ei≤ 0,05 g | 20 e1 | 5 000 | 100 000 | 0,1 | g ≤ ei | 50 e1 | 5 000 | 100 000 | III | 0,1 | g ≤ ei | 20 e1 | 500 | 10 000 | IIII | 5 | g ≤ ei | 10 e1 | 50 | 1 000
i | = | 1, 2, … r
i | = | partial weighing range number
r | = | total number of partial weighing ranges
Class | Verification scale interval (e) | Minimum capacity (Min) | Number of verification scale intervals
Minimum value | Minimum value(2) | Maximum value
I | 0,001 | g ≤ ei | 100 e1 | 50 000 | —
II | 0,001 | g ≤ ei≤ 0,05 g | 20 e1 | 5 000 | 100 000
0,1 | g ≤ ei | 50 e1 | 5 000 | 100 000
III | 0,1 | g ≤ ei | 20 e1 | 500 | 10 000
IIII | 5 | g ≤ ei | 10 e1 | 50 | 1 0004. Accuracy4.1. On implementation of the procedures laid down in Article 9, the error of indication shall not exceed the maximum permissible error of indication as shown in Table 3. In case of digital indication the error of indication shall be corrected for the rounding error.
The maximum permissible errors apply to the net value and tare value for all possible loads, excluding preset tare values.

Table 3

Maximum permissible errors

Load | Maximum permissible error
Class I | Class II | Class III | Class IIII
0 ≤ m ≤ 50 000 e | 0 ≤ m ≤ 5 000 e | 0 ≤ m ≤ 500 e | 0 ≤ m ≤ 50 e | ±0,5 e
50 000 e < m ≤ 200 000 e | 5 000 e < m ≤ 20 000 e | 500 e < m ≤ 2 000 e | 50 e < m ≤ 200 e | ±1,0 e
200 000 e < m | 20 000 e < m ≤ 100 000 e | 2 000 e < m ≤ 10 000 e | 200 e < m ≤ 1 000 e | ±1,5 e4.2. The maximum permissible errors in service are twice the maximum permissible errors fixed in Section 4.1.
5. Weighing results of an instrument shall be repeatable, and shall be reproducible by the other indicating devices used and in accordance with other methods of balancing used.
The weighing results shall be sufficiently insensitive to changes in the position of the load on the load receptor.
6. The instrument shall react to small variations in the load.
7. Influence quantities and time7.1. Instruments of classes II, III and IIII, liable to be used in a tilted position, shall be sufficiently insensitive to the degree of tilting that can occur in normal use.
7.2. The instruments shall meet the metrological requirements within the temperature range specified by the manufacturer. The value of this range shall be at least equal to:

— | 5 °C for an instrument in class I,
— | 15 °C for an instrument in class II,
— | 30 °C for an instrument in class III or IIII.In the absence of a manufacturer’s specification, the temperature range of – 10 °C to + 40 °C applies.
7.3. Instruments operated from a mains power supply shall meet the metrological requirements under conditions of power supply within the limits of normal fluctuation.
Instruments operated from battery power shall indicate whenever the voltage drops below the minimum required value and shall under those circumstances either continue to function correctly or be automatically put out of service.
7.4. Electronic instruments, except those in class I and in class II if e is less than 1 g, shall meet the metrological requirements under conditions of high relative humidity at the upper limit of their temperature range.
7.5. Loading an instrument in class II, III or IIII for a prolonged period of time shall have a negligible influence on the indication at load or on the zero indication immediately after removal of the load.
7.6. Under other conditions the instruments shall either continue to function correctly or be automatically put out of service.

Design and construction
8. General requirements8.1. Design and construction of the instruments shall be such that the instruments will preserve their metrological qualities when properly used and installed and when used in an environment for which they are intended. The value of the mass must be indicated.
8.2. When exposed to disturbances, electronic instruments shall not display the effects of significant faults, or shall automatically detect and indicate them.
Upon automatic detection of a significant fault, electronic instruments shall provide a visual or audible alarm that shall continue until the user takes corrective action or the fault disappears.
8.3. The requirements of points 8.1 and 8.2 shall be met on a lasting basis during a period of time that is normal in view of the intended use of such instruments.
Digital electronic devices shall always exercise adequate control of the correct operation of the measuring process, of the indicating device, and of all data storage and data transfer.
Upon automatic detection of a significant durability error, electronic instruments shall provide a visual or audible alarm that shall continue until the user takes corrective action or the error disappears.
8.4. When external equipment is connected to an electronic instrument through an appropriate interface the metrological qualities of the instrument shall not be adversely influenced.
8.5. The instruments shall have no characteristics likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal. Components that may not be dismantled or adjusted by the user shall be secured against such actions.
8.6. Instruments shall be designed to permit ready execution of the statutory controls laid down by this Directive.
9. Indication of weighing results and other weight valuesThe indication of the weighing results and other weight values shall be accurate, unambiguous and non-misleading and the indicating device shall permit easy reading of the indication under normal conditions of use.
The names and symbols of the units referred to in point 1 of this Annex shall comply with the provisions of Directive 80/181/EEC with the addition of the symbol for the metric carat which shall be the symbol ‘ct’.
Indication shall be impossible above the maximum capacity (Max), increased by 9 e.
An auxiliary indicating device is permitted only to the right of the decimal mark. An extended indicating device may be used only temporarily, and printing shall be inhibited during its functioning.
Secondary indications may be shown, provided that they cannot be mistaken for primary indications.
10. Printing of weighing results and other weight valuesPrinted results shall be correct, suitably identified and unambiguous. The printing shall be clear, legible, non-erasable and durable.
11. LevellingWhen appropriate, instruments shall be fitted with a levelling device and a level indicator, sufficiently sensitive to allow proper installation.
12. ZeroingInstruments may be equipped with zeroing devices. The operation of these devices shall result in accurate zeroing and shall not cause incorrect measuring results.
13. Tare devices and preset tare devicesThe instruments may have one or more tare devices and a preset tare device. The operation of the tare devices shall result in accurate zeroing and shall ensure correct net weighing. The operation of the preset tare device shall ensure correct determination of the calculated net value.
14. Instruments for direct sales to the public, with a maximum capacity not greater than 100 kg: additional requirements
Instruments for direct sale to the public shall show all essential information about the weighing operation and, in the case of price-indicating instruments, shall clearly show the customer the price calculation of the product to be purchased.
The price to pay, if indicated, shall be accurate.
Price-computing instruments shall display the essential indications long enough for the customer to read them properly.
Price-computing instruments may perform functions other than per-article weighing and price computation only if all indications related to all transactions are printed clearly and unambiguously and are conveniently arranged on a ticket or label for the customer.
Instruments shall bear no characteristics that can cause, directly or indirectly, indications the interpretation of which is not easy or straightforward.
Instruments shall safeguard customers against incorrect sales transactions due to their malfunctioning.
Auxiliary indicating devices and extended indicating devices are not permitted.
Supplementary devices are permitted only if they cannot lead to fraudulent use.
Instruments similar to those normally used for direct sales to the public which do not satisfy the requirements of this Section must carry near to the display the indelible marking ‘Not to be used for direct sale to the public’.
15. Price labelling instrumentsPrice labelling instruments shall meet the requirements of price indicating instruments for direct sale to the public, as far as applicable to the instrument in question. The printing of a price label shall be impossible below a minimum capacity.

(1)
OJ L 39, 15.2.1980, p. 40.
(2) For i = r, the corresponding column of Table 1 applies, with e replaced by er.

CONFORMITY ASSESSMENT PROCEDURES

ANNEX II1. EC type-examination1.1. EC type-examination is the procedure whereby a notified body verifies and certifies that an instrument, representative of the production envisaged, meets the requirements of this Directive.
1.2. The application for EC type-examination shall be lodged with a single notified body by the manufacturer or his authorised representative established within the Community.
The application shall include:

— | the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address in addition,
— | a written declaration that the application has not been lodged with any other notified body,
— | the design documentation, as described in Annex III.The applicant shall place at the disposal of the notified body an instrument, representative of the production envisaged, hereinafter the ‘type’.
1.3. The notified body shall:
| 1.3.1. | examine the design documentation and verify that the type has been manufactured in accordance with that documentation;
| 1.3.2. | agree with the applicant on the location where the examinations and/or tests shall be carried out;
| 1.3.3. | perform or have performed the appropriate examinations and/or tests to check whether the solutions adopted by the manufacturer meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied;
| 1.3.4. | perform or have performed the appropriate examinations and/or tests to check whether, where the manufacturer has chosen to apply the relevant standards, these standards have been applied effectively, thereby assuring conformity with the essential requirements.1.4. Where the type complies with the provisions of this Directive, the notified body shall issue an EC type-approval certificate to the applicant. The certificate shall contain the conclusions of the examination, conditions (if any) for its validity, the necessary data for identification of the approved instrument and, if relevant, a description of its functioning. All the relevant technical elements such as drawings and layouts shall be annexed to the EC type-approval certificate.
The certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.
In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of the certificate may be limited to two years and extended by three years.
1.5. Each notified body shall periodically make available to all Member States the list of:

— | applications received for EC type-examination,
— | EC type-approval certificates issued,
— | applications for type-certificates refused,
— | additions and amendments relating to documents already issued.Each notified body shall moreover inform all the Member States forthwith of withdrawals of EC type-approval certificates.
Each Member State shall make this information available to the bodies which it has notified.
1.6. The other notified bodies may receive a copy of the certificates together with the annexes to them.
1.7. The applicant shall keep the notified body that has issued the EC type-approval certificate informed of any modification to the approved type.
Modifications to the approved type must receive additional approval from the notified body that issued the EC type-approval certificate where such changes influence conformity with the essential requirements of this Directive or the prescribed conditions for use of the instrument. This additional approval is given in the form of an addition to the original EC type-approval certificate.
2. EC declaration of type conformity (guarantee of production quality)2.1. The EC declaration of type conformity (guarantee of production quality) is the procedure whereby the manufacturer who satisfies the obligations of point 2.2 declares that the instruments concerned are, where applicable, in conformity with the type as described in the EC type-approval certificate and that they satisfy the requirements of this Directive.
The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and the inscriptions provided for in Annex IV and shall draw up a written declaration of conformity.
The ‘CE’ conformity marking shall be accompanied by the identification number of the notified body responsible for the EC surveillance referred to in point 2.4.
2.2. The manufacturer shall have adequately implemented a quality system as specified in point 2.3 and shall be subject to EC surveillance as specified in point 2.4.
2.3. Quality system
| 2.3.1. | The manufacturer shall lodge an application for approval of his quality system with a notified body.The application shall include:—an undertaking to carry out the obligations arising from the approved quality system,—an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.The manufacturer shall make available to the notified body all relevant information, in particular the quality system’s documentation and the design documentation of the instrument. | — | an undertaking to carry out the obligations arising from the approved quality system, | — | an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
— | an undertaking to carry out the obligations arising from the approved quality system,
— | an undertaking to maintain the approved quality system to ensure its continuing suitability and effectiveness.
| 2.3.2. | The quality system shall ensure conformity of the instruments with the type as described in the EC type-approval certificate and with the requirement(s) of this Directive.All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written rules, procedures and instructions. This quality system documentation shall ensure a proper understanding of the quality programmes, plans, manuals and records.It shall contain in particular an adequate description of:—the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,—the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,—the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,—the means to monitor the achievement of the required product quality and the effective operation of the quality system. | — | the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality, | — | the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used, | — | the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out, | — | the means to monitor the achievement of the required product quality and the effective operation of the quality system.
— | the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,
— | the manufacturing process, the quality control and assurance techniques and the systematic measures that will be used,
— | the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
— | the means to monitor the achievement of the required product quality and the effective operation of the quality system.
| 2.3.3. | The notified body shall examine and evaluate the quality system to determine whether it satisfies the requirements referred to in point 2.3.2. It shall presume conformity with these requirements in respect of quality systems that implement the corresponding harmonised standard.It shall notify its decision to the manufacturer and inform the other notified bodies thereof. The notification to the manufacturer shall contain the conclusions of the examination and, in the event of refusal, the justification for the decision.
| 2.3.4. | The manufacturer or his authorised representative shall keep the notified body that has approved the quality system informed of any updating of the quality assurance system in relation to changes brought about by, e.g. new technologies and new quality concepts.
| 2.3.5. | Any notified body that withdraws approval of a quality system shall so inform the other notified bodies.2.4. EC surveillance
| 2.4.1. | The purpose of EC surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
| 2.4.2. | The manufacturer shall grant the notified body access for inspection purposes to the manufacture, inspection, testing and storage premises and shall provide it with all necessary information, in particular:—the quality system documentation,—the design documentation,—the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.The notified body shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system; it shall provide the manufacturer with an audit report.In addition, the notified body may carry out unscheduled visits to the manufacturer. During such visits, the notified body may carry out full or partial audits. It shall provide the manufacturer with a report on the visit, and, where appropriate, an audit report. | — | the quality system documentation, | — | the design documentation, | — | the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
— | the quality system documentation,
— | the design documentation,
— | the quality records, e.g. the inspection reports and tests and calibration data, reports on the qualifications of the personnel concerned, etc.
| 2.4.3. | The notified body shall ensure that the manufacturer maintains and applies the approved quality system.3. EC verification3.1. EC verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instruments which have been checked in accordance with point 3.3 are, where applicable, in conformity with the type described in the EC type-examination certificate and that they satisfy the requirements of this Directive.
3.2. The manufacturer shall take all necessary measures in order that the manufacturing process ensures conformity of the instruments, where applicable, with the type as described in the EC type-examination certificate and with the requirements of this Directive which apply to them. The manufacturer or his authorised representative established within the Community shall affix the ‘CE’ conformity marking to each instrument and draw up a written declaration of conformity.
3.3. The notified body shall carry out the appropriate examinations and tests in order to check the conformity of the product to the requirements of this Directive by examination and testing of every instrument, as specified in point 3.5.
3.4. For instruments not subject to EC type-approval, the documents relating to the design of the instrument, as set out in Annex III, must be accessible to the notified body should the latter so request.
3.5. Verification by checking and testing of each instrument
| 3.5.1. | All instruments shall be individually examined and appropriate tests, as set out in the relevant harmonised standards referred to in Article 6(1), or equivalent tests, shall be carried out in order to verify their conformity, where applicable, with the type as described in the EC type-examination certificate and the requirements of this Directive.
| 3.5.2. | The notified body shall affix, or cause to be affixed, its identification number on each instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity relating to the tests carried out.
| 3.5.3. | The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.4. EC unit verification4.1. EC unit verification is the procedure whereby the manufacturer or his authorised representative established within the Community ensures and declares that the instrument, generally designed for a specific application, which has been issued with the certificate referred to in point 4.2 conforms to the requirements of this Directive that apply to it. The manufacturer or his authorised representative shall affix the ‘CE’ conformity marking to the instrument and shall draw up a written declaration of conformity.
4.2. The notified body shall examine the instrument and carry out the appropriate tests, as set out in the relevant harmonised standard(s) referred to in Article 6(1), or equivalent tests, in order to ensure its conformity with the relevant requirements of this Directive.
The notified body shall affix, or cause to be affixed, its identification number to the instrument the conformity of which to requirements has been established, and shall draw up a written certificate of conformity concerning the tests carried out.
4.3. The aim of the technical documentation relating to the design of the instrument, as referred to in Annex III, is to enable conformity with the requirements of this Directive to be assessed and the design, manufacture and operation of the instrument to be understood. It must be accessible to the notified body.
4.4. The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
5. Common provisions5.1. The EC declaration of type conformity (guarantee of production quality), the EC verification, and the EC unit verification may be carried out at the manufacturer’s works or any other location if transport to the place of use does not require dismantling of the instrument, if the putting into service at the place of use does not require assembly of the instrument or other technical installation work likely to affect the instrument’s performance, and if the gravity value at the place of putting into service is taken into consideration or if the instrument’s performance is insensitive to gravity variations. In all other cases, they shall be carried out at the place of use of the instrument.
5.2. If the instrument’s performance is sensitive to gravity variations the procedures referred to in point 5.1 may be carried out in two stages, with the second stage comprising all examinations and tests of which the outcome is gravity-dependent, and the first stage all other examinations and tests. The second stage shall be carried out at the place of use of the instrument. If a Member State has established gravity zones on its territory the expression ‘at the place of use of the instrument’ may be read as ‘in the gravity zone of use of the instrument’.
5.2.1. Where a manufacturer has opted for execution in two stages of one of the procedures mentioned in point 5.1, and where these two stages will be carried out by different parties, an instrument which has undergone the first stage of the procedure shall bear the identification number of the notified body involved in that stage.
5.2.2. The party which has carried out the first stage of the procedure shall issue for each of the instruments a certificate containing the data necessary for identification of the instrument and specifying the examinations and tests that have been carried out.
The party which carries out the second stage of the procedure shall carry out those examinations and tests that have not yet been carried out.
The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.
5.2.3. A manufacturer who has opted for the EC declaration of type conformity (guarantee of production quality) in the first stage may either use this same procedure in the second stage or decide to continue in the second stage with EC verification.
5.2.4. The ‘CE’ conformity marking shall be affixed to the instrument on completion of the second stage, along with the identification number of the notified body which took part in the second stage.

DESIGN TECHNICAL DOCUMENTATION

ANNEX IIIThe technical documentation must render the design, manufacture and operation of the product intelligible and enable an assessment to be made of its conformity with the requirements of this Directive.
The documentation shall include in so far as relevant for assessment:

— | a general description of the type,
— | conceptual designs and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.,
— | descriptions and explanations necessary for the understanding of the above, including the operation of the instrument,
— | a list of the harmonised standards referred to in Article 6(1), applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where the harmonised standards referred to in Article 6(1) have not been applied,
— | results of design calculations made and of examinations, etc.,
— | test reports,
— | the EC type-approval certificates and the results of relevant tests on instruments containing parts identical to those in the design.

‘CE’ CONFORMITY MARKING AND INSCRIPTIONS

ANNEX IV1. Instruments subject to the EC conformity assessment procedure
| 1.1. | These instruments must bear:(a)—the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together;(b)a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;(c)the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. | (a) | —the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together; | — | the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI, | — | the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification. | (b) | a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black; | (c) | the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. | — | the number of the EC type-approval certificate, where appropriate, | — | the manufacturer’s mark or name, | — | the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles, | — | maximum capacity, in the form Max …, | — | minimum capacity, in the form Min …, | — | verification scale interval, in the forme= …, | — | the last two digits of the year in which the ‘CE’ conformity marking was affixed, | — | serial number, | — | for instruments consisting of separate but associated units: identification mark on each unit, | — | scale interval if it is different frome, in the formd= …, | — | maximum additive tare effect, in the formT= + …, | — | maximum subtractive tare effect if it is different from Max, in the formT= – …, | — | tare interval if it is different fromd, in the formdT= …, | — | maximum safe load if it is different from Max, in the form Lim …, | — | the special temperature limits, in the form … °C/… °C, | — | ratio between load receptor and load.
(a) | —the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,—the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.The abovementioned marking and inscriptions shall be affixed to the instrument and distinctly grouped together; | — | the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI, | — | the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
— | the ‘CE’ conformity marking comprising the ‘CE’ symbol as described in Annex VI,
— | the identification number(s) of the notified body/bodies that has/have carried out the EC surveillance or the EC verification.
(b) | a green sticker at least 12,5 mm × 12,5 mm square bearing a capital letter ‘M’ printed in black;
(c) | the following inscriptions:—the number of the EC type-approval certificate, where appropriate,—the manufacturer’s mark or name,—the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,—maximum capacity, in the form Max …,—minimum capacity, in the form Min …,—verification scale interval, in the forme= …,—the last two digits of the year in which the ‘CE’ conformity marking was affixed,plus, when applicable:—serial number,—for instruments consisting of separate but associated units: identification mark on each unit,—scale interval if it is different frome, in the formd= …,—maximum additive tare effect, in the formT= + …,—maximum subtractive tare effect if it is different from Max, in the formT= – …,—tare interval if it is different fromd, in the formdT= …,—maximum safe load if it is different from Max, in the form Lim …,—the special temperature limits, in the form … °C/… °C,—ratio between load receptor and load. | — | the number of the EC type-approval certificate, where appropriate, | — | the manufacturer’s mark or name, | — | the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles, | — | maximum capacity, in the form Max …, | — | minimum capacity, in the form Min …, | — | verification scale interval, in the forme= …, | — | the last two digits of the year in which the ‘CE’ conformity marking was affixed, | — | serial number, | — | for instruments consisting of separate but associated units: identification mark on each unit, | — | scale interval if it is different frome, in the formd= …, | — | maximum additive tare effect, in the formT= + …, | — | maximum subtractive tare effect if it is different from Max, in the formT= – …, | — | tare interval if it is different fromd, in the formdT= …, | — | maximum safe load if it is different from Max, in the form Lim …, | — | the special temperature limits, in the form … °C/… °C, | — | ratio between load receptor and load.
— | the number of the EC type-approval certificate, where appropriate,
— | the manufacturer’s mark or name,
— | the accuracy class, enclosed in an oval or in two horizontal lines joined by two half circles,
— | maximum capacity, in the form Max …,
— | minimum capacity, in the form Min …,
— | verification scale interval, in the forme= …,
— | the last two digits of the year in which the ‘CE’ conformity marking was affixed,
— | serial number,
— | for instruments consisting of separate but associated units: identification mark on each unit,
— | scale interval if it is different frome, in the formd= …,
— | maximum additive tare effect, in the formT= + …,
— | maximum subtractive tare effect if it is different from Max, in the formT= – …,
— | tare interval if it is different fromd, in the formdT= …,
— | maximum safe load if it is different from Max, in the form Lim …,
— | the special temperature limits, in the form … °C/… °C,
— | ratio between load receptor and load.
| 1.2. | The instruments shall have adequate facilities for the affixing of the ‘CE’ conformity marking and/or inscriptions. These shall be such that it shall be impossible to remove the marking and inscriptions without damaging them, and that the marking and inscriptions shall be visible when the instrument is in its regular operating position.
| 1.3. | Where a data plate is used it shall be possible to seal the plate unless it cannot be removed without being destroyed. If the data plate is sealable it shall be possible to apply a control mark to it.
| 1.4. | The inscriptions Max, Min,e, andd, shall also be shown near the display of the result if they are not already located there.
| 1.5. | Each load measuring device which is connected or can be connected to one or more load receptors shall bear the relevant inscriptions relating to the said load receptors.2. Other instrumentsThe other instruments must bear:

— | the manufacturer’s mark or name,
— | maximum capacity, in the form Max ….Those instruments may not bear the stickers provided for in point 1.1(b).
3. Restrictive use symbol specified in Article 13That symbol shall be constituted by a capital letter ‘M’ printed in black on a red background at least 25 mm × 25 mm square with two intersecting diagonals forming a cross.

The minimum criteria to be applied by member states when designating bodies for the carrying-out of tasks pertaining to the procedures referred to in article 9

ANNEX V
| 1. | The bodies shall have at their disposal the necessary personnel, means and equipment.
| 2. | The personnel of the bodies shall have technical competence and professional integrity.
| 3. | The bodies shall work independently of all circles, groups or persons having a direct or indirect interest in non-automatic weighing instruments as regards the carrying-out of the tests, the preparation of the reports, the issuing of the certificates and the surveillance required by this Directive.
| 4. | The personnel of the bodies shall respect professional confidentiality.
| 5. | The bodies shall take out a civil liability insurance if their civil liability is not covered by the State under national law.The fulfilment of the conditions under points 1 and 2 shall be periodically verified by the Member States.

‘CE’ CONFORMITY MARKING

ANNEX VI
— | The ‘CE’ conformity marking shall consist of the initials ‘CE’ taking the following form:
— | If the ‘CE’ conformity marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.
— | The various components of the ‘CE’ conformity marking must have substantially the same vertical dimension, which may not be less than 5 mm.

PART A

ANNEX VII
Repealed Directive with its amendment
(referred to in Article 17)
Council Directive 90/384/EEC(OJ L 189, 20.7.1990, p. 1) |
Council Directive 93/68/EEC(OJ L 220, 30.8.1993, p. 1) | Article 1, point 7, and Article 8 only
PART B

List of time limits for transposition into national law and application
(referred to in Article 17)
Directive | Time limit for transposition | Date of application
90/384/EEC | 30 June 1992 | 1 January 1993(1)
93/68/EEC | 30 June 1994 | 1 January 1995(2)
(1) In accordance with Article 15(3) of Directive 90/384/EEC Member States shall permit, during a period of 10 years from the date on which they apply the laws, regulations and administrative provisions adopted by the Member States in order to transpose that Directive into national law, the placing on the market and/or putting into service of instruments which conform to the rules in force before 1 January 1993.
(2) In accordance with Article 14(2) of Directive 93/68/EEC: ‘Until 1 January 1997, Member States shall allow the placing on the market and the bringing into service of products which comply with the marking arrangements in force before 1 January 1995
’.

ANNEX VIII
CORRELATION TABLE

Directive 90/384/EEC | This Directive
Recital 5, last sentence | Article 2, point (3)
Article 1(1), first subparagraph | Article 2, point (1)
Article 1(1), second subparagraph | Article 2, point (2)
Article 1(1), third subparagraph | Article 1(1)
Article 1(2), introductory wording | Article 1(2), introductory wording
Article 1(2), point (a)(1) | Article 1(2), point (a)(i)
Article 1(2), point (a)(2) | Article 1(2), point (a)(ii)
Article 1(2), point (a)(3) | Article 1(2), point (a)(iii)
Article 1(2), point (a)(4) | Article 1(2), point (a)(iv)
Article 1(2), point (a)(5) | Article 1(2), point (a)(v)
Article 1(2), point (a)(6) | Article 1(2), point (a)(vi)
Article 1(2), point (b) | Article 1(2), point (b)
Article 2 | Article 3
Article 3 | Article 4
Article 4 | Article 5
Article 5 | Article 6
Article 6, first paragraph, first sentence | Article 7, first paragraph
Article 6, first paragraph, second sentence | Article 7, second paragraph
Article 6, second paragraph | Article 7, third paragraph
Article 7 | Article 8
Article 8(1) and (2) | Article 9(1) and (2)
Article 8(3), point (a) | Article 9(3), first subparagraph
Article 8(3), point (b) | Article 9(3), second subparagraph
Article 9 | Article 10
Article 10 | Article 11
Article 11 | Article 12
Article 12 | Article 13
Article 13 | Article 14
Article 14, first sentence | Article 15, first paragraph
Article 14, second sentence | Article 15, second paragraph
Article 15(1) to (3) | —
Article 15(4) | Article 16
Article 15(5) | —
— | Article 17
— | Article 18
Article 16 | Article 19
Annexes I to VI | Annexes I to VI
— | Annex VII
— | Annex VIII

Pending: 32009L0022

January 16, 2026
1.5.2009 EN Official Journal of the European Union L 110/30
(1) Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers' interests(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Certain Directives, listed in Annex I to this Directive, lay down rules with regard to the protection of consumers' interests.
(3) Current mechanisms available for ensuring compliance with those Directives, both at national and at Community level, do not always allow infringements harmful to the collective interests of consumers to be terminated in good time. Collective interests means interests which do not include the cumulation of interests of individuals who have been harmed by an infringement. This is without prejudice to individual actions brought by individuals who have been harmed by an infringement.
(4) As far as the purpose of bringing about the cessation of practices that are unlawful under the national provisions applicable is concerned, the effectiveness of national measures transposing the Directives in question, including protective measures that go beyond the level required by those Directives, provided they are compatible with the Treaty and allowed by those Directives, may be thwarted where those practices produce effects in a Member State other than that in which they originate.
(5) Those difficulties can disrupt the smooth functioning of the internal market, their consequence being that it is sufficient to move the source of an unlawful practice to another country in order to place it out of reach of all forms of enforcement. This constitutes a distortion of competition.
(6) Those difficulties are likely to diminish consumer confidence in the internal market and may limit the scope for action by organisations representing the collective interests of consumers or independent public bodies responsible for protecting the collective interests of consumers, adversely affected by practices that infringe Community law.
(7) Those practices often extend beyond the frontiers between the Member States. There is an urgent need for some degree of approximation of national provisions designed to enjoin the cessation of the unlawful practices irrespective of the Member State in which the unlawful practice has produced its effects. With regard to jurisdiction, this is without prejudice to the rules of private international law and the Conventions in force between Member States, while respecting the general obligations of the Member States deriving from the Treaty, in particular those related to the smooth functioning of the internal market.
(8) The objective of the action envisaged can only be attained by the Community. It is therefore incumbent on the Community to act.
(9) The third paragraph of Article 5 of the Treaty makes it incumbent on the Community not to go beyond what is necessary to achieve the objectives of the Treaty. In accordance with that Article, the specific features of national legal systems must be taken into account to every extent possible by leaving Member States free to choose between different options having equivalent effect. The courts or administrative authorities competent to rule on the proceedings referred to in this Directive should have the right to examine the effects of previous decisions.
(10) One option should consist in requiring one or more independent public bodies, specifically responsible for the protection of the collective interests of consumers, to exercise the rights of action set out in this Directive. Another option should provide for the exercise of those rights by organisations whose purpose is to protect the collective interests of consumers, in accordance with criteria laid down by national law.
(11) Member States should be able to choose between or combine these two options in designating at national level the bodies and/or organisations qualified for the purposes of this Directive.
(12) For the purposes of intra-Community infringements the principle of mutual recognition should apply to these bodies and/or organisations. The Member States should, at the request of their national entities, communicate to the Commission the name and purpose of their national entities which are qualified to bring an action in their own country according to the provisions of this Directive.
(13) It is the business of the Commission to ensure the publication of a list of these qualified entities in theOfficial Journal of the European Union. Until a statement to the contrary is published, a qualified entity is assumed to have legal capacity if its name is included in that list.
(14) Member States should be able to require that a prior consultation be undertaken by the party that intends to bring an action for an injunction, in order to give the defendant an opportunity to bring the contested infringement to an end. Member States should be able to require that this prior consultation take place jointly with an independent public body designated by those Member States.
(15) Where the Member States have established that there should be prior consultation, a deadline of two weeks after the request for consultation is received should be set after which, should the cessation of the infringement not be achieved, the applicant shall be entitled to bring an action, without any further delay, before the competent court or administrative authority.
(16) It is appropriate that the Commission report on the functioning of this Directive and in particular on its scope and on the operation of prior consultation.
(17) The application of this Directive should not prejudice the application of Community competition rules.
(18) This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition and application in national law of the Directives set out in Annex II, Part B,
(a) an order with all due expediency, where appropriate by way of summary procedure, requiring the cessation or prohibition of any infringement;
(b) where appropriate, measures such as the publication of the decision, in full or in part, in such form as deemed adequate and/or the publication of a corrective statement with a view to eliminating the continuing effects of the infringement;
(c) in so far as the legal system of the Member State concerned so permits, an order against the losing defendant for payments into the public purse or to any beneficiary designated in or under national legislation, in the event of failure to comply with the decision within a time limit specified by the courts or administrative authorities, of a fixed amount for each day’s delay or any other amount provided for in national legislation, with a view to ensuring compliance with the decisions.
(a) one or more independent public bodies, specifically responsible for protecting the interests referred to in Article 1, in Member States in which such bodies exist; and/or
(b) organisations whose purpose is to protect the interests referred to in Article 1, in accordance with the criteria laid down by the national law.
(a) the scope of this Directive in relation to the protection of the collective interests of persons exercising a commercial, industrial, craft or professional activity;
(b) the scope of this Directive as determined by the Directives listed in Annex I;
(c) whether the prior consultation provided for in Article 5 has contributed to the effective protection of consumers.
1. Council Directive 85/577/EEC of 20 December 1985 to protect the consumer in respect of contracts negotiated away from business premises (OJ L 372, 31.12.1985, p. 31).
2. Council Directive 87/102/EEC of 22 December 1986 for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit (OJ L 42, 12.2.1987, p. 48)(2).
3. Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities: Articles 10 to 21 (OJ L 298, 17.10.1989, p. 23).
4. Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (OJ L 158, 23.6.1990, p. 59).
5. Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).
6. Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (OJ L 144, 4.6.1997, p. 19).
7. Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12).
8. Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects on information society services, in particular electronic commerce, in the internal market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1).
9. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use: Articles 86 to 100 (OJ L 311, 28.11.2001, p. 67).
10. Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services (OJ L 271, 9.10.2002, p. 16).
11. Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (OJ L 149, 11.6.2005, p. 22).
12. Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36).
13. Directive 2008/122/EC of the European Parliament and of the Council of 14 January 2009 on the protection of consumers in respect of certain aspects of timeshare, long-term holiday product, resale and exchange contracts (OJ L 33, 3.2.2009, p. 10).
Directive 98/27/EC of the European Parliament and of the Council(OJ L 166, 11.6.1998, p. 51).
Directive 1999/44/EC of the European Parliament and of the Council(OJ L 171, 7.7.1999, p. 12). Article 10 only
Directive 2000/31/EC of the European Parliament and of the Council(OJ L 178, 17.7.2000, p. 1). Article 18(2) only
Directive 2002/65/EC of the European Parliament and of the Council(OJ L 271, 9.10.2002, p. 16). Article 19 only
Directive 2005/29/EC of the European Parliament and of the Council(OJ L 149, 11.6.2005, p. 22). Article 16(1) only
Directive 2006/123/EC of the European Parliament and of the Council(OJ L 376, 27.12.2006, p. 36). Article 42 only
Directive Time limit for transposition Date of application
98/27/EC 1 January 2001 —
1999/44/EC 1 January 2002 —
2000/31/EC 16 January 2002 —
2002/65/EC 9 October 2004 —
2005/29/EC 12 June 2007 12 December 2007
2006/123/EC 28 December 2009 —
Directive 98/27/EC This Directive
Articles 1 to 5 Articles 1 to 5
Article 6(1) Article 6(1)
Article 6(2), first subparagraph, first indent Article 6(2), first subparagraph, point (a)
Article 6(2), first subparagraph, second indent Article 6(2), first subparagraph, point (b)
Article 6(2), first subparagraph, third indent Article 6(2), first subparagraph, point (c)
Article 6(2), second subparagraph Article 6(2), second subparagraph
Article 7 Article 7
Article 8(1) —
Article 8(2) Article 8
— Article 9
Article 9 Article 10
Article 10 Article 11
Annex Annex I
— Annex II
— Annex III
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
(1) Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers’ interests(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Certain Directives, listed in Annex I to this Directive, lay down rules with regard to the protection of consumers’ interests.
(3) Current mechanisms available for ensuring compliance with those Directives, both at national and at Community level, do not always allow infringements harmful to the collective interests of consumers to be terminated in good time. Collective interests means interests which do not include the cumulation of interests of individuals who have been harmed by an infringement. This is without prejudice to individual actions brought by individuals who have been harmed by an infringement.
(4) As far as the purpose of bringing about the cessation of practices that are unlawful under the national provisions applicable is concerned, the effectiveness of national measures transposing the Directives in question, including protective measures that go beyond the level required by those Directives, provided they are compatible with the Treaty and allowed by those Directives, may be thwarted where those practices produce effects in a Member State other than that in which they originate.
(5) Those difficulties can disrupt the smooth functioning of the internal market, their consequence being that it is sufficient to move the source of an unlawful practice to another country in order to place it out of reach of all forms of enforcement. This constitutes a distortion of competition.
(6) Those difficulties are likely to diminish consumer confidence in the internal market and may limit the scope for action by organisations representing the collective interests of consumers or independent public bodies responsible for protecting the collective interests of consumers, adversely affected by practices that infringe Community law.
(7) Those practices often extend beyond the frontiers between the Member States. There is an urgent need for some degree of approximation of national provisions designed to enjoin the cessation of the unlawful practices irrespective of the Member State in which the unlawful practice has produced its effects. With regard to jurisdiction, this is without prejudice to the rules of private international law and the Conventions in force between Member States, while respecting the general obligations of the Member States deriving from the Treaty, in particular those related to the smooth functioning of the internal market.
(8) The objective of the action envisaged can only be attained by the Community. It is therefore incumbent on the Community to act.
(9) The third paragraph of Article 5 of the Treaty makes it incumbent on the Community not to go beyond what is necessary to achieve the objectives of the Treaty. In accordance with that Article, the specific features of national legal systems must be taken into account to every extent possible by leaving Member States free to choose between different options having equivalent effect. The courts or administrative authorities competent to rule on the proceedings referred to in this Directive should have the right to examine the effects of previous decisions.
(10) One option should consist in requiring one or more independent public bodies, specifically responsible for the protection of the collective interests of consumers, to exercise the rights of action set out in this Directive. Another option should provide for the exercise of those rights by organisations whose purpose is to protect the collective interests of consumers, in accordance with criteria laid down by national law.
(11) Member States should be able to choose between or combine these two options in designating at national level the bodies and/or organisations qualified for the purposes of this Directive.
(12) For the purposes of intra-Community infringements the principle of mutual recognition should apply to these bodies and/or organisations. The Member States should, at the request of their national entities, communicate to the Commission the name and purpose of their national entities which are qualified to bring an action in their own country according to the provisions of this Directive.
(13) It is the business of the Commission to ensure the publication of a list of these qualified entities in theOfficial Journal of the European Union. Until a statement to the contrary is published, a qualified entity is assumed to have legal capacity if its name is included in that list.
(14) Member States should be able to require that a prior consultation be undertaken by the party that intends to bring an action for an injunction, in order to give the defendant an opportunity to bring the contested infringement to an end. Member States should be able to require that this prior consultation take place jointly with an independent public body designated by those Member States.
(15) Where the Member States have established that there should be prior consultation, a deadline of two weeks after the request for consultation is received should be set after which, should the cessation of the infringement not be achieved, the applicant shall be entitled to bring an action, without any further delay, before the competent court or administrative authority.
(16) It is appropriate that the Commission report on the functioning of this Directive and in particular on its scope and on the operation of prior consultation.
(17) The application of this Directive should not prejudice the application of Community competition rules.
(18) This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition and application in national law of the Directives set out in Annex II, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Scope
Article 1
1. The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to actions for an injunction referred to in Article 2 aimed at the protection of the collective interests of consumers included in the Directives listed in Annex I, with a view to ensuring the smooth functioning of the internal market.
2. For the purposes of this Directive, an infringement means any act contrary to the Directives listed in Annex I as transposed into the internal legal order of the Member States which harms the collective interests referred to in paragraph 1.

Actions for an injunction
Article 2
1. Member States shall designate the courts or administrative authorities competent to rule on proceedings commenced by qualified entities within the meaning of Article 3 seeking:
(a)
an order with all due expediency, where appropriate by way of summary procedure, requiring the cessation or prohibition of any infringement;
(b)
where appropriate, measures such as the publication of the decision, in full or in part, in such form as deemed adequate and/or the publication of a corrective statement with a view to eliminating the continuing effects of the infringement;
(c)
in so far as the legal system of the Member State concerned so permits, an order against the losing defendant for payments into the public purse or to any beneficiary designated in or under national legislation, in the event of failure to comply with the decision within a time limit specified by the courts or administrative authorities, of a fixed amount for each day’s delay or any other amount provided for in national legislation, with a view to ensuring compliance with the decisions.
2. This Directive shall be without prejudice to the rules of private international law with respect to the applicable law, that is, normally, either the law of the Member State where the infringement originated or the law of the Member State where the infringement has its effects.

Entities qualified to bring an action
Article 3
For the purposes of this Directive, a ‘qualified entity’ means any body or organisation which, being properly constituted according to the law of a Member State, has a legitimate interest in ensuring that the provisions referred to in Article 1 are complied with, in particular:
(a)
one or more independent public bodies, specifically responsible for protecting the interests referred to in Article 1, in Member States in which such bodies exist; and/or
(b)
organisations whose purpose is to protect the interests referred to in Article 1, in accordance with the criteria laid down by the national law.

Intra-Community infringements
Article 4
1. Each Member State shall take the measures necessary to ensure that, in the event of an infringement originating in that Member State, any qualified entity from another Member State where the interests protected by that qualified entity are affected by the infringement, may apply to the court or administrative authority referred to in Article 2, on presentation of the list provided for in paragraph 3 of this Article. The courts or administrative authorities shall accept this list as proof of the legal capacity of the qualified entity without prejudice to their right to examine whether the purpose of the qualified entity justifies its taking action in a specific case.
2. For the purposes of intra-Community infringements, and without prejudice to the rights granted to other entities under national legislation, the Member States shall, at the request of their qualified entities, communicate to the Commission that these entities are qualified to bring an action under Article 2. The Member States shall inform the Commission of the name and purpose of these qualified entities.
3. The Commission shall draw up a list of the qualified entities referred to in paragraph 2, with the specification of their purpose. This list shall be published in theOfficial Journal of the European Union; changes to this list shall be published without delay and the updated list shall be published every six months.

Prior consultation
Article 5
1. Member States may introduce or maintain in force provisions whereby the party that intends to seek an injunction can only start this procedure after it has tried to achieve the cessation of the infringement in consultation either with the defendant or with both the defendant and a qualified entity within the meaning of Article 3(a) of the Member State in which the injunction is sought. It shall be for the Member State to decide whether the party seeking the injunction must consult the qualified entity. If the cessation of the infringement is not achieved within two weeks after the request for consultation is received, the party concerned may bring an action for an injunction without any further delay.
2. The rules governing prior consultation adopted by Member States shall be notified to the Commission and shall be published in theOfficial Journal of the European Union.

Reports
Article 6
1. Every three years and for the first time no later than 2 July 2003 the Commission shall submit to the European Parliament and to the Council a report on the application of this Directive.
2. In its first report the Commission shall examine in particular:
(a)
the scope of this Directive in relation to the protection of the collective interests of persons exercising a commercial, industrial, craft or professional activity;
(b)
the scope of this Directive as determined by the Directives listed in Annex I;
(c)
whether the prior consultation provided for in Article 5 has contributed to the effective protection of consumers.
Where appropriate, this report shall be accompanied by proposals with a view to amending this Directive.

Provisions for wider action
Article 7
This Directive shall not prevent Member States from adopting or maintaining in force provisions designed to grant qualified entities and any other person concerned more extensive rights to bring action at national level.

Implementation
Article 8
Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.

Repeal
Article 9
Directive 98/27/EC, as amended by the Directives set out in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition into national law and application of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Entry into force
Article 10
This Directive shall enter into force on 29 December 2009.

Addressees
Article 11
This Directive is addressed to the Member States.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
(1) Directive 98/27/EC of the European Parliament and of the Council of 19 May 1998 on injunctions for the protection of consumers’ interests(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) Certain Directives, listed in Annex I to this Directive, lay down rules with regard to the protection of consumers’ interests.
(3) Current mechanisms available for ensuring compliance with those Directives, both at national and at Community level, do not always allow infringements harmful to the collective interests of consumers to be terminated in good time. Collective interests means interests which do not include the cumulation of interests of individuals who have been harmed by an infringement. This is without prejudice to individual actions brought by individuals who have been harmed by an infringement.
(4) As far as the purpose of bringing about the cessation of practices that are unlawful under the national provisions applicable is concerned, the effectiveness of national measures transposing the Directives in question, including protective measures that go beyond the level required by those Directives, provided they are compatible with the Treaty and allowed by those Directives, may be thwarted where those practices produce effects in a Member State other than that in which they originate.
(5) Those difficulties can disrupt the smooth functioning of the internal market, their consequence being that it is sufficient to move the source of an unlawful practice to another country in order to place it out of reach of all forms of enforcement. This constitutes a distortion of competition.
(6) Those difficulties are likely to diminish consumer confidence in the internal market and may limit the scope for action by organisations representing the collective interests of consumers or independent public bodies responsible for protecting the collective interests of consumers, adversely affected by practices that infringe Community law.
(7) Those practices often extend beyond the frontiers between the Member States. There is an urgent need for some degree of approximation of national provisions designed to enjoin the cessation of the unlawful practices irrespective of the Member State in which the unlawful practice has produced its effects. With regard to jurisdiction, this is without prejudice to the rules of private international law and the Conventions in force between Member States, while respecting the general obligations of the Member States deriving from the Treaty, in particular those related to the smooth functioning of the internal market.
(8) The objective of the action envisaged can only be attained by the Community. It is therefore incumbent on the Community to act.
(9) The third paragraph of Article 5 of the Treaty makes it incumbent on the Community not to go beyond what is necessary to achieve the objectives of the Treaty. In accordance with that Article, the specific features of national legal systems must be taken into account to every extent possible by leaving Member States free to choose between different options having equivalent effect. The courts or administrative authorities competent to rule on the proceedings referred to in this Directive should have the right to examine the effects of previous decisions.
(10) One option should consist in requiring one or more independent public bodies, specifically responsible for the protection of the collective interests of consumers, to exercise the rights of action set out in this Directive. Another option should provide for the exercise of those rights by organisations whose purpose is to protect the collective interests of consumers, in accordance with criteria laid down by national law.
(11) Member States should be able to choose between or combine these two options in designating at national level the bodies and/or organisations qualified for the purposes of this Directive.
(12) For the purposes of intra-Community infringements the principle of mutual recognition should apply to these bodies and/or organisations. The Member States should, at the request of their national entities, communicate to the Commission the name and purpose of their national entities which are qualified to bring an action in their own country according to the provisions of this Directive.
(13) It is the business of the Commission to ensure the publication of a list of these qualified entities in theOfficial Journal of the European Union. Until a statement to the contrary is published, a qualified entity is assumed to have legal capacity if its name is included in that list.
(14) Member States should be able to require that a prior consultation be undertaken by the party that intends to bring an action for an injunction, in order to give the defendant an opportunity to bring the contested infringement to an end. Member States should be able to require that this prior consultation take place jointly with an independent public body designated by those Member States.
(15) Where the Member States have established that there should be prior consultation, a deadline of two weeks after the request for consultation is received should be set after which, should the cessation of the infringement not be achieved, the applicant shall be entitled to bring an action, without any further delay, before the competent court or administrative authority.
(16) It is appropriate that the Commission report on the functioning of this Directive and in particular on its scope and on the operation of prior consultation.
(17) The application of this Directive should not prejudice the application of Community competition rules.
(18) This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition and application in national law of the Directives set out in Annex II, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Scope

1. The purpose of this Directive is to approximate the laws, regulations and administrative provisions of the Member States relating to actions for an injunction referred to in Article 2 aimed at the protection of the collective interests of consumers included in the Directives listed in Annex I, with a view to ensuring the smooth functioning of the internal market.
2. For the purposes of this Directive, an infringement means any act contrary to the Directives listed in Annex I as transposed into the internal legal order of the Member States which harms the collective interests referred to in paragraph 1.

Actions for an injunction

1. Member States shall designate the courts or administrative authorities competent to rule on proceedings commenced by qualified entities within the meaning of Article 3 seeking:
(a)
an order with all due expediency, where appropriate by way of summary procedure, requiring the cessation or prohibition of any infringement;
(b)
where appropriate, measures such as the publication of the decision, in full or in part, in such form as deemed adequate and/or the publication of a corrective statement with a view to eliminating the continuing effects of the infringement;
(c)
in so far as the legal system of the Member State concerned so permits, an order against the losing defendant for payments into the public purse or to any beneficiary designated in or under national legislation, in the event of failure to comply with the decision within a time limit specified by the courts or administrative authorities, of a fixed amount for each day’s delay or any other amount provided for in national legislation, with a view to ensuring compliance with the decisions.
2. This Directive shall be without prejudice to the rules of private international law with respect to the applicable law, that is, normally, either the law of the Member State where the infringement originated or the law of the Member State where the infringement has its effects.

Entities qualified to bring an action

For the purposes of this Directive, a ‘qualified entity’ means any body or organisation which, being properly constituted according to the law of a Member State, has a legitimate interest in ensuring that the provisions referred to in Article 1 are complied with, in particular:
(a)
one or more independent public bodies, specifically responsible for protecting the interests referred to in Article 1, in Member States in which such bodies exist; and/or
(b)
organisations whose purpose is to protect the interests referred to in Article 1, in accordance with the criteria laid down by the national law.

Intra-Community infringements

1. Each Member State shall take the measures necessary to ensure that, in the event of an infringement originating in that Member State, any qualified entity from another Member State where the interests protected by that qualified entity are affected by the infringement, may apply to the court or administrative authority referred to in Article 2, on presentation of the list provided for in paragraph 3 of this Article. The courts or administrative authorities shall accept this list as proof of the legal capacity of the qualified entity without prejudice to their right to examine whether the purpose of the qualified entity justifies its taking action in a specific case.
2. For the purposes of intra-Community infringements, and without prejudice to the rights granted to other entities under national legislation, the Member States shall, at the request of their qualified entities, communicate to the Commission that these entities are qualified to bring an action under Article 2. The Member States shall inform the Commission of the name and purpose of these qualified entities.
3. The Commission shall draw up a list of the qualified entities referred to in paragraph 2, with the specification of their purpose. This list shall be published in theOfficial Journal of the European Union; changes to this list shall be published without delay and the updated list shall be published every six months.

Prior consultation

1. Member States may introduce or maintain in force provisions whereby the party that intends to seek an injunction can only start this procedure after it has tried to achieve the cessation of the infringement in consultation either with the defendant or with both the defendant and a qualified entity within the meaning of Article 3(a) of the Member State in which the injunction is sought. It shall be for the Member State to decide whether the party seeking the injunction must consult the qualified entity. If the cessation of the infringement is not achieved within two weeks after the request for consultation is received, the party concerned may bring an action for an injunction without any further delay.
2. The rules governing prior consultation adopted by Member States shall be notified to the Commission and shall be published in theOfficial Journal of the European Union.

Reports

1. Every three years and for the first time no later than 2 July 2003 the Commission shall submit to the European Parliament and to the Council a report on the application of this Directive.
2. In its first report the Commission shall examine in particular:
(a)
the scope of this Directive in relation to the protection of the collective interests of persons exercising a commercial, industrial, craft or professional activity;
(b)
the scope of this Directive as determined by the Directives listed in Annex I;
(c)
whether the prior consultation provided for in Article 5 has contributed to the effective protection of consumers.
Where appropriate, this report shall be accompanied by proposals with a view to amending this Directive.

Provisions for wider action

This Directive shall not prevent Member States from adopting or maintaining in force provisions designed to grant qualified entities and any other person concerned more extensive rights to bring action at national level.

Implementation

Member States shall communicate to the Commission the provisions of national law which they adopt in the field covered by this Directive.

Repeal

Directive 98/27/EC, as amended by the Directives set out in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States concerning the time limits for transposition into national law and application of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Entry into force

This Directive shall enter into force on 29 December 2009.

Addressees

This Directive is addressed to the Member States.

LIST OF DIRECTIVES REFERRED TO IN ARTICLE 1
 (1)

ANNEX I
1. | Council Directive 85/577/EEC of 20 December 1985 to protect the consumer in respect of contracts negotiated away from business premises (OJ L 372, 31.12.1985, p. 31).
2. | Council Directive 87/102/EEC of 22 December 1986 for the approximation of the laws, regulations and administrative provisions of the Member States concerning consumer credit (OJ L 42, 12.2.1987, p. 48)(2).
3. | Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities: Articles 10 to 21 (OJ L 298, 17.10.1989, p. 23).
4. | Council Directive 90/314/EEC of 13 June 1990 on package travel, package holidays and package tours (OJ L 158, 23.6.1990, p. 59).
5. | Council Directive 93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ L 95, 21.4.1993, p. 29).
6. | Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (OJ L 144, 4.6.1997, p. 19).
7. | Directive 1999/44/EC of the European Parliament and of the Council of 25 May 1999 on certain aspects of the sale of consumer goods and associated guarantees (OJ L 171, 7.7.1999, p. 12).
8. | Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects on information society services, in particular electronic commerce, in the internal market (Directive on electronic commerce) (OJ L 178, 17.7.2000, p. 1).
9. | Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use: Articles 86 to 100 (OJ L 311, 28.11.2001, p. 67).
10. | Directive 2002/65/EC of the European Parliament and of the Council of 23 September 2002 concerning the distance marketing of consumer financial services (OJ L 271, 9.10.2002, p. 16).
11. | Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market (OJ L 149, 11.6.2005, p. 22).
12. | Directive 2006/123/EC of the European Parliament and of the Council of 12 December 2006 on services in the internal market (OJ L 376, 27.12.2006, p. 36).
13. | Directive 2008/122/EC of the European Parliament and of the Council of 14 January 2009 on the protection of consumers in respect of certain aspects of timeshare, long-term holiday product, resale and exchange contracts (OJ L 33, 3.2.2009, p. 10).
(1) The Directives referred to in points 5, 6, 9 and 11 contain specific provisions concerning injunctions.
(2) The said Directive was repealed and replaced, with effect from 12 May 2010, by Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers (OJ L 133, 22.5.2008, p. 66).

PART A

ANNEX II
Repealed Directive and its amendments
(referred to in Article 9)
Directive 98/27/EC of the European Parliament and of the Council(OJ L 166, 11.6.1998, p. 51). |
Directive 1999/44/EC of the European Parliament and of the Council(OJ L 171, 7.7.1999, p. 12). | Article 10 only
Directive 2000/31/EC of the European Parliament and of the Council(OJ L 178, 17.7.2000, p. 1). | Article 18(2) only
Directive 2002/65/EC of the European Parliament and of the Council(OJ L 271, 9.10.2002, p. 16). | Article 19 only
Directive 2005/29/EC of the European Parliament and of the Council(OJ L 149, 11.6.2005, p. 22). | Article 16(1) only
Directive 2006/123/EC of the European Parliament and of the Council(OJ L 376, 27.12.2006, p. 36). | Article 42 only
PART B

List of time limits for transposition into national law and application
(referred to in Article 9)
Directive | Time limit for transposition | Date of application
98/27/EC | 1 January 2001 | —
1999/44/EC | 1 January 2002 | —
2000/31/EC | 16 January 2002 | —
2002/65/EC | 9 October 2004 | —
2005/29/EC | 12 June 2007 | 12 December 2007
2006/123/EC | 28 December 2009 | —

ANNEX III
CORRELATION TABLE

Directive 98/27/EC | This Directive
Articles 1 to 5 | Articles 1 to 5
Article 6(1) | Article 6(1)
Article 6(2), first subparagraph, first indent | Article 6(2), first subparagraph, point (a)
Article 6(2), first subparagraph, second indent | Article 6(2), first subparagraph, point (b)
Article 6(2), first subparagraph, third indent | Article 6(2), first subparagraph, point (c)
Article 6(2), second subparagraph | Article 6(2), second subparagraph
Article 7 | Article 7
Article 8(1) | —
Article 8(2) | Article 8
— | Article 9
Article 9 | Article 10
Article 10 | Article 11
Annex | Annex I
— | Annex II
— | Annex III

Pending: 32008L0128

January 16, 2026
10.1.2009 EN Official Journal of the European Union L 6/20
(1) Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs(4).
(3) It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,
Definition Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.
HCl insoluble matter Not more than 0,5 %
Ether extractable matter Not more than 0,2 % (under neutral conditions)Specific purity criteria for the corresponding colours are applicable.
E 100 CURCUMIN
Synonyms CI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane
Definition Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of natural strains ofCurcuma longaL. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occuring in turmeric may be present.Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane.
Class Dicinnamoylmethane
Colour Index No 75300
Einecs 207-280-5
Chemical names I1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dioneII1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dioneIII1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione
II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione
III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
Chemical formula IC21H20O6IIC20H18O5IIIC19H16O4 I C21H20O6 II C20H18O5 III C19H16O4
I C21H20O6
II C20H18O5
III C19H16O4
Molecular weight I.368,39II.338,39III.308,39 I. 368,39 II. 338,39 III. 308,39
I. 368,39
II. 338,39
III. 308,39
Assay Content not less than 90 % total colouring mattersE1 cm1 %1 607 at ca 426 nm in ethanol
Description Orange-yellow crystalline powder
Identification
A.Spectrometry A. Spectrometry Maximum in ethanol at ca 426 nm
A. Spectrometry
B.Melting Range B. Melting Range 179 °C-182 °C
B. Melting Range
Purity
Solvent residues EthylacetateAcetonen-butanolMethanolEthanolHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 101 (i) RIBOFLAVIN
Synonyms Lactoflavin
Class Isoalloxazine
Einecs 201-507-1
Chemical names 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine
Chemical formula C17H20N4O6
Molecular weight 376,37
Assay Content not less than 98 % on the anhydrous basisE1 cm1 %328 at ca 444 nm in aqueous solution
Description Yellow to orange-yellow crystalline powder, with slight odour
Identification
A.Spectrometry A. Spectrometry The ratio A375/A267is between 0,31 and 0,33The ratio A444/A267is between 0,36 and 0,39 in aqueous solution
A. Spectrometry
Maximum in water at ca 444 nm
B.Specific rotation B. Specific rotation [α]D20between – 115° and – 140° in a 0,05 N sodium hydroxide solution
B. Specific rotation
Purity
Loss on drying Not more than 1,5 % after drying at 105 °C for 4 hrs
Sulfated ash Not more than 0,1 %
Primary aromatic amines Not more than 100 mg/kg (calculated as aniline)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE
Synonyms Riboflavin-5′-phosphate sodium
Definition These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate
Class Isoalloxazine
Einecs 204-988-6
Chemical names Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate;monosodium salt of 5′-monophosphate ester of riboflavin
Chemical formula For the dihydrate form:C17H20N4NaO9P·2H2OFor the anhydrous form:C17H20N4NaO9P For the dihydrate form : C17H20N4NaO9P·2H2O For the anhydrous form : C17H20N4NaO9P
For the dihydrate form : C17H20N4NaO9P·2H2O
For the anhydrous form : C17H20N4NaO9P
Molecular weight 541,36
Assay Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2OE1 cm1 %250 at ca 375 nm in aqueous solution
Description Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste
Identification
A.Spectrometry A. Spectrometry The ratio A375/A267is between 0,30 and 0,34The ratio A444/A267is between 0,35 and 0,40 in aqueous solution
A. Spectrometry
Maximum in water at ca 444 nm
B.Specific rotation B. Specific rotation [α]D20between + 38° and + 42° in a 5 molar HCl solution
B. Specific rotation
Purity
Loss on drying Not more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form
Sulfated ash Not more than 25 %
Inorganic phosphate Not more than 1,0 % (calculated as PO4on the anhydrous basis)
Subsidiary colouring matters Riboflavin (free):Not more than 6 %Riboflavine diphosphate:Not more than 6 % Riboflavin (free) : Not more than 6 % Riboflavine diphosphate : Not more than 6 %
Riboflavin (free) : Not more than 6 %
Riboflavine diphosphate : Not more than 6 %
Primary aromatic amines Not more than 70 mg/kg (calculated as aniline)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 102 TARTRAZINE
Synonyms CI Food Yellow 4
Definition Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 19140
Einecs 217-699-5
Chemical names Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate
Chemical formula C16H9N4Na3O9S2
Molecular weight 534,37
Assay Content not less than 85 % total colouring matters calculated as the sodium saltE1 cm1 %530 at ca 426 nm in aqueous solution
Description Light orange powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 426 nm
A. Spectrometry
B.Yellow solution in water B. Yellow solution in water
B. Yellow solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 1,0 %
Organic compounds other than colouring matters:
4-hydrazinobenzene sulfonic acid4-aminobenzene-1-sulfonic acid5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid4,4′-diazoaminodi(benzene sulfonic acid)Tetrahydroxysuccinic acid 4-hydrazinobenzene sulfonic acid 4-aminobenzene-1-sulfonic acid 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid 4,4′-diazoaminodi(benzene sulfonic acid) Tetrahydroxysuccinic acid Total not more than 0,5 %
4-hydrazinobenzene sulfonic acid
4-aminobenzene-1-sulfonic acid
5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid
4,4′-diazoaminodi(benzene sulfonic acid)
Tetrahydroxysuccinic acid
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 104 QUINOLINE YELLOW
Synonyms CI Food Yellow 13
Definition Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Chinophthalone
Colour Index No 47005
Einecs 305-897-5
Chemical name The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)
Chemical formula C18H9N Na2O8S2(principal component)
Molecular weight 477,38 (principal component)
Assay Content not less than 70 % total colouring matters calculated as the sodium saltQuinoline Yellow shall have the following composition:Of the total colouring matters present:—not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates—not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates—not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonateE1 cm1 %865 (principal component) at ca 411 nm in aqueous acetic acid solution — not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates — not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates — not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
— not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates
— not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates
— not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
Description Yellow powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm
A. Spectrometry
B.Yellow solution in water B. Yellow solution in water
B. Yellow solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 4,0 %
Organic compounds other than colouring matters:
2-methylquinoline2-methylquinoline-sulfonic acidPhthalic acid2,6-dimethyl quinoline2,6-dimethyl quinoline sulfonic acid 2-methylquinoline 2-methylquinoline-sulfonic acid Phthalic acid 2,6-dimethyl quinoline 2,6-dimethyl quinoline sulfonic acid Total not more than 0,5 %
2-methylquinoline
2-methylquinoline-sulfonic acid
Phthalic acid
2,6-dimethyl quinoline
2,6-dimethyl quinoline sulfonic acid
2-(2-quinolyl)indan-1,3-dione Not more than 4 mg/kg
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 110 SUNSET YELLOW FCF
Synonyms CI Food Yellow 3, Orange Yellow S
Definition Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 15985
Einecs 220-491-7
Chemical names Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate
Chemical formula C16H10N2Na2O7S2
Molecular weight 452,37
Assay Content not less than 85 % total colouring matters calculated as the sodium saltE1 cm1 %555 at ca 485 nm in aqueous solution at pH 7
Description Orange-red powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 485 nm at pH 7
A. Spectrometry
B.Orange solution in water B. Orange solution in water
B. Orange solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 5,0 %
1-(Phenylazo)-2-naphthalenol (Sudan I) Not more than 0,5 mg/kg
Organic compounds other than colouring matters:
4-aminobenzene-1-sulfonic acid3-hydroxynaphthalene-2,7-disulfonic acid6-hydroxynaphthalene-2-sulfonic acid7-hydroxynaphthalene-1,3-disulfonic acid4,4′-diazoaminodi(benzene sulfonic acid)6,6′-oxydi(naphthalene-2-sulfonic acid) 4-aminobenzene-1-sulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 4,4′-diazoaminodi(benzene sulfonic acid) 6,6′-oxydi(naphthalene-2-sulfonic acid) Total not more than 0,5 %
4-aminobenzene-1-sulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
4,4′-diazoaminodi(benzene sulfonic acid)
6,6′-oxydi(naphthalene-2-sulfonic acid)
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 120 COCHINEAL, CARMINIC ACID, CARMINES
Definition Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insectDactylopius coccusCosta.The colouring principle is carminic acid.Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.
Class Anthraquinone
Colour Index No 75470
Einecs Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4
Chemical names 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid
Chemical formula C22H20O13(carminic acid)
Molecular weight 492,39 (carminic acid)
Assay Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.
Description Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.
Identification
Spectrometry Maximum in aqueous ammonia solution at ca 518 nmMaximum in dilute hydrochloric solution at ca 494 nm for carminic acid
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 122 AZORUBINE, CARMOISINE
Synonyms CI Food Red 3
Definition Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 14720
Einecs 222-657-4
Chemical name Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate
Chemical formula C20H12N2Na2O7S2
Molecular weight 502,44
Assay Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %510 at ca 516 nm in aqueous solution
Description Red to maroon powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 516 nm
A. Spectrometry
B.Red solution in water B. Red solution in water
B. Red solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 2,0 %
Organic compounds other than colouring matters:
4-aminonaphthalene-1-sulfonic acid4-hydroxynaphthalene-1-sulfonic acid 4-aminonaphthalene-1-sulfonic acid 4-hydroxynaphthalene-1-sulfonic acid Total not more than 0,5 %
4-aminonaphthalene-1-sulfonic acid
4-hydroxynaphthalene-1-sulfonic acid
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 123 AMARANTH
Synonyms CI Food Red 9
Definition Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 16185
Einecs 213-022-2
Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate
Chemical formula C20H11N2Na3O10S3
Molecular weight 604,48
Assay Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %440 at ca 520 nm in aqueous solution
Description Reddish-brown powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 520 nm
A. Spectrometry
B.Red solution in water B. Red solution in water
B. Red solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 3,0 %
Organic compounds other than colouring matters:
4-aminonaphthalene-1-sulfonic acid3-hydroxynaphthalene-2,7-disulfonic acid6-hydroxynaphthalene-2-sulfonic acid7-hydroxynaphthalene-1,3-disulfonic acid7-hydroxynaphthalene-1,3-6-trisulfonic acid 4-aminonaphthalene-1-sulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Total not more than 0,5 %
4-aminonaphthalene-1-sulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
7-hydroxynaphthalene-1,3-6-trisulfonic acid
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 124 PONCEAU 4R, COCHINEAL RED A
Synonyms CI Food Red 7, New Coccine
Definition Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 16255
Einecs 220-036-2
Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate
Chemical formula C20H11N2Na3O10S3
Molecular weight 604,48
Assay Content not less than 80 % total colouring matters, calculated as the sodium salt.E1 cm1 %430 at ca 505 nm in aqueous solution
Description Reddish powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 505 nm
A. Spectrometry
B.Red solution in water B. Red solution in water
B. Red solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 1,0 %
Organic compounds other than colouring matters:
4-aminonaphthalene-1-sulfonic acid7-hydroxynaphthalene-1,3-disulfonic acid3-hydroxynaphthalene-2,7-disulfonic acid6-hydroxynaphthalene-2-sulfonic acid7-hydroxynaphthalene-1,3-6-trisulfonic acid 4-aminonaphthalene-1-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Total not more than 0,5 %
4-aminonaphthalene-1-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-6-trisulfonic acid
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 127 ERYTHROSINE
Synonyms CI Food Red 14
Definition Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Xanthen
Colour Index No 45430
Einecs 240-474-8
Chemical name Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate
Chemical formula C20H6I4Na2O5.H2O
Molecular weight 897,88
Assay Content not less than 87 % total colouring matters, calculated as the anhydrous sodium saltE1 cm1 %1 100 at ca 526 nm in aqueous solution at pH 7
Description Red powder or granules.
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 526 nm at pH 7
A. Spectrometry
B.Red solution in water B. Red solution in water
B. Red solution in water
Purity
Inorganic iodides calculated as sodium iodide Not more than 0,1 %
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters (except fluorescein) Not more than 4,0 %
Fluorescein Not more than 20 mg/kg
Organic compounds other than colouring matters:
Tri-iodoresorcinol Not more than 0,2 %
2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acid Not more than 0,2 %
Ether extractable matter From a solution of pH from 7 through 8, not more than 0,2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
Aluminium Lakes The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only.
E 128 RED 2G
Synonyms CI Food Red 10, Azogeranine
Definition Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 18050
Einecs 223-098-9
Chemical name Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate
Chemical formula C18H13N3Na2O8S2
Molecular weight 509,43
Assay Content not less than 80 % total colouring matters, calculated as the sodium saltE1 cm1 %620 at ca 532 nm in aqueous solution
Description Red powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 532 nm
A. Spectrometry
B.Red solution in water B. Red solution in water
B. Red solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 2,0 %
Organic compounds other than colouring matters:
5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid5-amino-4-hydroxynaphthalene-2,7-disulfonic acid 5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid 5-amino-4-hydroxynaphthalene-2,7-disulfonic acid Total not more than 0,5 %
5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid
5-amino-4-hydroxynaphthalene-2,7-disulfonic acid
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 129 ALLURA RED AC
Synonyms CI Food Red 17
Definition Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Monoazo
Colour Index No 16035
Einecs 247-368-0
Chemical name Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate
Chemical formula C18H14N2Na2O8S2
Molecular weight 496,42
Assay Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %540 at ca 504 nm in aqueous solution at pH 7
Description Dark red powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 504 nm
A. Spectrometry
B.Red solution in water B. Red solution in water
B. Red solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 3,0 %
Organic compounds other than colouring matters:
6-hydroxy-2-naphthalene sulfonic acid, sodium salt Not more than 0,3 %
4-amino-5-methoxy-2-methylbenezene sulfonic acid Not more than 0,2 %
6,6-oxybis (2-naphthalene sulfonic acid) disodium salt Not more than 1,0 %
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter From a solution of pH 7, not more than 0,2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 131 PATENT BLUE V
Synonyms CI Food Blue 5
Definition Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium sulfate as the principal uncoloured components.The potassium salt is also permitted.
Class Triarylmethane
Colour Index No 42051
Einecs 222-573-8
Chemical names The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt
Chemical formula Calcium compound: C27H31N2O7S2CaSodium compound: C27H31N2O7S2Na
Molecular weight Calcium compound: 579,72Sodium compound: 582,67
Assay Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %2 000 at ca 638 nm in aqueous solution at pH 5
Description Dark-blue powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at 638 nm at pH 5
A. Spectrometry
B.Blue solution in water B. Blue solution in water
B. Blue solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 2,0 %
Organic compounds other than colouring matters:
3-hydroxy benzaldehyde3-hydroxy benzoic acid3-hydroxy-4-sulfobenzoic acidN,N-diethylamino benzene sulfonic acid 3-hydroxy benzaldehyde 3-hydroxy benzoic acid 3-hydroxy-4-sulfobenzoic acid N,N-diethylamino benzene sulfonic acid Total not more than 0,5 %
3-hydroxy benzaldehyde
3-hydroxy benzoic acid
3-hydroxy-4-sulfobenzoic acid
N,N-diethylamino benzene sulfonic acid
Leuco base Not more than 4,0 %
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter From a solution of pH 5 not more than 0,2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 132 INDIGOTINE, INDIGO CARMINE
Synonyms CI Food Blue 1
Definition Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Indigoid
Colour Index No 73015
Einecs 212-728-8
Chemical names Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate
Chemical formula C16H8N2Na2O8S2
Molecular weight 466,36
Assay Content not less than 85 % total colouring matters, calculated as the sodium salt;disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 %E1 cm1 %480 at ca 610 nm in aqueous solution
Description Dark-blue powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 610 nm
A. Spectrometry
B.Blue solution in water B. Blue solution in water
B. Blue solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 %
Organic compounds other than colouring matters:
Isatin-5-sulfonic acid5-sulfoanthranilic acidAnthranilic acid Isatin-5-sulfonic acid 5-sulfoanthranilic acid Anthranilic acid Total not more than 0,5 %
Isatin-5-sulfonic acid
5-sulfoanthranilic acid
Anthranilic acid
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 133 BRILLIANT BLUE FCF
Synonyms CI Food Blue 2
Definition Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Triarylmethane
Colour Index No 42090
Einecs 223-339-8
Chemical names Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate
Chemical formula C37H34N2Na2O9S3
Molecular weight 792,84
Assay Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %1 630 at ca 630 nm in aqueous solution
Description Reddish-blue powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 630 nm
A. Spectrometry
B.Blue solution in water B. Blue solution in water
B. Blue solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 6,0 %
Organic compounds other than colouring matters:
Sum of 2-, 3- and 4-formyl benzene sulfonic acids Not more than 1,5 %
3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid Not more than 0,3 %
Leuco base Not more than 5,0 %
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % at pH 7
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 140 (i) CHLOROPHYLLS
Synonyms CI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin
Definition Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Class Porphyrin
Colour Index No 75810
Einecs Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4
Chemical names The major colouring principles are:Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b) Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a) Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)
Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
Chemical formula Chlorophyll a (magnesium complex): C55H72MgN4O5Chlorophyll a: C55H74N4O5Chlorophyll b (magnesium complex): C55H70MgN4O6Chlorophyll b: C55H72N4O6
Molecular weight Chlorophyll a (magnesium complex): 893,51Chlorophyll a: 871,22Chlorophyll b (magnesium complex): 907,49Chlorophyll b: 885,20
Assay Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %E1 cm1 %700 at ca 409 nm in chloroform
Description Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesium
Identification
Spectrometry Maximum in chloroform at ca 409 nm
Purity
Solvent residues AcetoneMethyl Ethyl ketoneMethanolEthanolPropan-2-olHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 140 (ii) CHLOROPHYLLINS
Synonyms CI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorophyllin
Definition The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium.Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Class Porphyrin
Colour Index No 75815
Einecs 287-483-3
Chemical names The major colouring principles in their acid forms are:—3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and—3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.Magnesium complexes may also be present. — 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and — 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)
— 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and
— 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)
Chemical formula Chlorophyllin a (acid form): C34H34N4O5Chlorophyllin b (acid form): C34H32N4O6
Molecular weight Chlorophyllin a: 578,68Chlorophyllin b: 592,66Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay Content of total chlorophyllins is not less than 95 % of the sample dried at ca 100 °C for 1 hour.E1 cm1 %700 at ca 405 nm in aqueous solution at pH 9E1 cm1 %140 at ca 653 nm in aqueous solution at pH 9
Description Dark green to blue/black powder
Identification
Spectrometry Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm
Purity
Solvent residues AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS
Synonyms CI Natural Green 3, Copper Chlorophyll, Copper Phaeophytin
Definition Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Class Porphyrin
Colour Index No 75815
Einecs Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
Chemical names [Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)[Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)
Chemical formula Copper chlorophyll a: C55H72Cu N4O5Copper chlorophyll b: C55H70Cu N4O6
Molecular weight Copper chlorophyll a: 932,75Copper chlorophyll b: 946,73
Assay Content of total copper chlorophylls is not less than 10 %.E1 cm1 %540 at ca 422 nm in chloroformE1 cm1 %300 at ca 652 nm in chloroform
Description Waxy solid ranging in colour from blue green to dark green depending on the source material
Identification
Spectrometry Maximum in chloroform at ca 422 nm and at ca 652 nm
Purity
Solvent residues AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Copper ions Not more than 200 mg/kg
Total copper Not more than 8,0 % of the total copper phaeophytins
E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS
Synonyms Sodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5
Definition The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralized to form the salts of potassium and/or sodium.Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.
Class Porphyrin
Colour Index No 75815
Einecs
Chemical names The major colouring principles in their acid forms are:3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a)and3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)
Chemical formula Copper chlorophyllin a (acid form): C34H32Cu N4O5Copper chlorophyllin b (acid form): C34H30Cu N4O6
Molecular weight Copper chlorophyllin a: 640,20Copper chlorophyllin b: 654,18Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.E1 cm1 %565 at ca 405 nm in aqueous phosphate buffer at pH 7,5E1 cm1 %145 at ca 630 nm in aqueous phosphate buffer at pH 7,5
Description Dark green to blue/black powder
Identification
Spectrometry Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nm
Purity
Solvent residues AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Copper ions Not more than 200 mg/kg
Total copper Not more than 8,0 % of the total copper chlorophyllins
E 142 GREEN S
Synonyms CI Food Green 4, Brilliant Green BS
Definition Green S consists essentially of sodium N-[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Triarylmethane
Colour Index No 44090
Einecs 221-409-2
Chemical names Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium;Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).
Chemical formula C27H25N2NaO7S2
Molecular Weight 576,63
Assay Content not less than 80 % total colouring matters calculated as the sodium saltE1 cm1 %1 720 at ca 632 nm in aqueous solution
Description Dark blue or dark green powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 632 nm
A. Spectrometry
B.Blue or green solution in water B. Blue or green solution in water
B. Blue or green solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 1,0 %
Organic compounds other than colouring matters:
4,4′-bis(dimethylamino)-benzhydryl alcohol Not more than 0,1 %
4,4′-bis(dimethylamino)-benzophenone Not more than 0,1 %
3-hydroxynaphthalene-2,7-disulfonic acid Not more than 0,2 %
Leuco base Not more than 5,0 %
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 150a PLAIN CARAMEL
Definition Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.
Einecs 232-435-9
Description Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose Not more than 50 %
Colour bound by phosphoryl cellulose Not more than 50 %
Colour intensity(1) 0,01-0,12
Total nitrogen Not more than 0,1 %
Total sulphur Not more than 0,2 %
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 25 mg/kg
E 150b CAUSTIC SULPHITE CARAMEL
Definition Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.
Einecs 232-435-9
Description Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose More than 50 %
Colour intensity(1) 0,05-0,13
Total nitrogen Not more than 0,3 %(2)
Sulphur dioxide Not more than 0,2 %(2)
Total sulphur 0,3-3,5 %(2)
Sulphur bound by DEAE cellulose More than 40 %
Absorbance ratio of colour bound by DEAE cellulose 19-34
Absorbance ratio(A 280/560) Greater than 50
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 25 mg/kg
E 150c AMMONIA CARAMEL
Definition Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.
Einecs 232-435-9
Description Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose Not more than 50 %
Colour bound by phosphoryl cellulose More than 50 %
Colour intensity(1) 0,08-0,36
Ammoniacal nitrogen Not more than 0,3 %(2)
4-methylimidazole Not more than 250 mg/kg(2)
2-acetyl-4-tetrahydroxy-butylimidazole Not more than 10 mg/kg(2)
Total sulphur Not more than 0,2 %(2)
Total nitrogen 0,7-3,3 %(2)
Absorbance ratio of colour bound by phosphoryl cellulose 13-35
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 25 mg/kg
E 150d SULPHITE AMMONIA CARAMEL
Definition Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).
Einecs 232-435-9
Description Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose More than 50 %
Colour intensity(1) 0,10-0,60
Ammoniacal nitrogen Not more than 0,6 %(2)
Sulphur dioxide Not more than 0,2 %(2)
4-methylimidazole Not more than 250 mg/kg(2)
Total nitrogen 0,3-1,7 %(2)
Total sulphur 0,8-2,5 %(2)
Nitrogen/sulphur ratio of alcohol precipitate 0,7-2,7
Absorbance ratio of alcohol precipitate(3) 8-14
Absorbance ratio (A280/560) Not more than 50
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 25 mg/kg
E 151 BRILLIANT BLACK BN, BLACK PN
Synonyms CI Food Black 1
Definition Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class Bisazo
Colour Index No 28440
Einecs 219-746-5
Chemical names Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate
Chemical formula C28H17N5Na4O14S4
Molecular weight 867,69
Assay Content not less than 80 % total colouring matters calculated as the sodium saltE1 cm1 %530 at ca 570 nm in solution
Description Black powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water at ca 570 nm
A. Spectrometry
B.Black-bluish solution in water B. Black-bluish solution in water
B. Black-bluish solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 10 % (expressed on the dye content)
Organic compounds other than colouring matters:
4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid4-amino-5-hydroxynaphthalene-1,7-disulfonic acid8-aminonaphthalene-2-sulfonic acid4,4′-diazoaminodi-(benzenesulfonic acid) 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid 8-aminonaphthalene-2-sulfonic acid 4,4′-diazoaminodi-(benzenesulfonic acid) Total not more than 0,8 %
4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid
4-amino-5-hydroxynaphthalene-1,7-disulfonic acid
8-aminonaphthalene-2-sulfonic acid
4,4′-diazoaminodi-(benzenesulfonic acid)
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % under neutral conditions
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 153 VEGETABLE CARBON
Synonyms Vegetable black
Definition Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonised at high temperatures. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.
Colour Index No 77266
Einecs 215-609-9
Chemical names Carbon
Chemical formula C
Molecular weight 12,01
Assay Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis
Description Black powder, odourless and tasteless
Identification
A.Solubility A. Solubility Insoluble in water and organic solvents
A. Solubility
B.Burning B. Burning When heated to redness it burns slowly without a flame
B. Burning
Purity
Ash (Total) Not more than 4,0 % (ignition temperature: 625 °C)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
Polyaromatic hydrocarbons The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1 000 ml of 0,01 M sulphuric acid.
Loss on drying Not more than 12 % (120 °C, 4 hrs)
Alkali soluble matter The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless
E 154 BROWN FK
Synonyms CI Food Brown 1
Definition Brown FK consists essentially of a mixture of:Isodium 4-(2,4-diaminophenylazo) benzenesulfonateIIsodium 4-(4,6-diamino-m-tolylazo) benzenesulfonateIIIdisodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)IVdisodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)Vdisodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)VItrisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted. I sodium 4-(2,4-diaminophenylazo) benzenesulfonate II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
I sodium 4-(2,4-diaminophenylazo) benzenesulfonate
II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate
III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)
VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
Class Azo (a mixture of mono-, bis- and trisazo colours)
Einecs
Chemical names A mixture of:Isodium 4-(2,4-diaminophenylazo) benzenesulfonateIIsodium 4-(4,6-diamino-m-tolylazo) benzenesulfonateIIIdisodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)IVdisodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)Vdisodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)VItrisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) I sodium 4-(2,4-diaminophenylazo) benzenesulfonate II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
I sodium 4-(2,4-diaminophenylazo) benzenesulfonate
II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate
III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)
VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
Chemical formula IC12H11N4NaO3SIIC13H13N4NaO3SIIIC18H14N6Na2O6S2IVC18H14N6Na2O6S2VC19H16N6Na2O6S2VIC24H17N8Na3O9S3 I C12H11N4NaO3S II C13H13N4NaO3S III C18H14N6Na2O6S2 IV C18H14N6Na2O6S2 V C19H16N6Na2O6S2 VI C24H17N8Na3O9S3
I C12H11N4NaO3S
II C13H13N4NaO3S
III C18H14N6Na2O6S2
IV C18H14N6Na2O6S2
V C19H16N6Na2O6S2
VI C24H17N8Na3O9S3
Molecular weight I314,30II328,33III520,46IV520,46V534,47VI726,59 I 314,30 II 328,33 III 520,46 IV 520,46 V 534,47 VI 726,59
I 314,30
II 328,33
III 520,46
IV 520,46
V 534,47
VI 726,59
Assay Content not less than 70 % total colouring mattersOf the total colouring matters present the proportions of the components shall not exceed:I26 %II17 %III17 %IV16 %V20 %VI16 % I 26 % II 17 % III 17 % IV 16 % V 20 % VI 16 %
I 26 %
II 17 %
III 17 %
IV 16 %
V 20 %
VI 16 %
Description Red-brown powder or granules
Identification
Orange to reddish solution
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 3,5 %
Organic compounds other than colouring matters:
4-aminobenzene-1-sulfonic acid Not more than 0,7 %
m-phenylenediamine and 4-methyl-m-phenylenediamine Not more than 0,35 %
Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamine Not more than 0,007 % (calculated as aniline)
Ether extractable matter From a solution of pH 7, not more than 0,2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 155 BROWN HT
Synonyms CI Food Brown 3
Definition Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulfate as the principal uncoloured components.Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.
Class Bisazo
Colour Index No 20285
Einecs 224-924-0
Chemical names Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)
Chemical formula C27H18N4Na2O9S2
Molecular Weight 652,57
Assay Content not less than 70 % total colouring matters calculated as the sodium salt.E1 cm1 %403 at ca 460 nm in aqueous solution at pH 7
Description Reddish-brown powder or granules
Identification
A.Spectrometry A. Spectrometry Maximum in water of pH 7 at ca 460 nm
A. Spectrometry
B.Brown solution in water B. Brown solution in water
B. Brown solution in water
Purity
Water insoluble matter Not more than 0,2 %
Subsidiary colouring matters Not more than 10 % (TLC method)
Organic compounds other than colouring matters:
4-aminonaphthalene-1-sulfonic acid Not more than 0,7 %
Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline)
Ether extractable matter Not more than 0,2 % in a solution of pH 7
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 160a (i) MIXED CAROTENES
1.Plant carotenes
Synonyms CI Food Orange 5
Definition Mixed carotenes are obtained by solvent extraction of natural strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane(4), dichloromethane and carbon dioxide.
Class Carotenoid
Colour Index No 75130
Einecs 230-636-6
Chemical formula Beta-carotene: C40H56
Molecular weight Beta-carotene: 536,88
Assay Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats.E1 cm1 %2 500 at approximately 440 nm to 457 nm in cyclohexane
Identification
Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm
Purity
Solvent residues AcetoneMethyl ethyl ketoneMethanolPropan-2-olHexaneEthanol Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
Lead Not more than 5 mg/kg
2.Algal carotenes
Synonyms CI Food Orange 5
Definition Mixed carotenes may also be produced from natural strains of the algaeDunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
Class Carotenoid
Colour Index No 75130
Chemical formula Beta-Carotene: C40H56
Molecular weight Beta-Carotene: 536,88
Assay Content of carotenes (calculated as beta-carotene) is not less than 20 %E1 cm1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane
Identification
Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm
Purity
Natural tocopherols in edible oil Not more than 0,3 %
Lead Not more than 5 mg/kg
E 160a (ii) BETA-CAROTENE
1.Beta-carotene
Synonyms CI Food Orange 5
Definition These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.
Class Carotenoid
Colour Index No 40800
Einecs 230-636-6
Chemical names Beta-carotene, beta, beta-carotene
Chemical formula C40H56
Molecular weight 536,88
Assay Not less than 96 % total colouring matters (expressed as beta-carotene)E1 cm1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane
Description Red to brownish-red crystals or crystalline powder
Identification
Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
Purity
Sulfated ash Not more than 0,2 %
Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
Lead Not more than 2 mg/kg
2.Beta-carotene fromBlakeslea trispora
Synonyms CI Food Orange 5
Definition Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of natural strains of the fungusBlakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.
Class Carotenoid
Colour Index No 40800
Einecs 230-636-6
Chemical names Beta-carotene, beta,beta-carotene
Chemical formula C40H56
Molecular weight 536,88
Assay Not less than 96 % total colouring matters (expressed as beta-carotene)E1 cm1 %2 500 at approximately 440 nm to 457 nm in cyclohexane
Description Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)
Identification
Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
Purity
Solvent residues Ethyl acetateEthanol Not more than 0,8 %, singly or in combination
Isobutyl acetate: Not more than 1,0 %
Isopropyl alcohol: Not more than 0,1 %
Sulfated ash Not more than 0,2 %
Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
Lead Not more than 2 mg/kg
Mycotoxins:
Aflatoxin B1 Absent
Trichothecene (T2) Absent
Ochratoxin Absent
Zearalenone Absent
Microbiology:
Moulds Not more than 100/g
Yeasts Not more than 100/g
Salmonella Absent in 25 g
Escherichia coli Absent in 5 g
E 160b ANNATTO, BIXIN, NORBIXIN
Synonyms CI Natural Orange 4
Definition
Class Carotenoid
Colour Index No 75120
Einecs Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
Chemical names Bixin:6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioateNorbixin:9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid Bixin : 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate Norbixin : 9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid
Bixin : 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
Norbixin : 9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid
Chemical formula Bixin:C25H30O4Norbixin:C24H28O4 Bixin : C25H30O4 Norbixin : C24H28O4
Bixin : C25H30O4
Norbixin : C24H28O4
Molecular weight Bixin:394,51Norbixin:380,48 Bixin : 394,51 Norbixin : 380,48
Bixin : 394,51
Norbixin : 380,48
Description Reddish-brown powder, suspension or solution
Identification
Spectrometry Bixin:maximum in chloroform at ca 502 nmNorbixin:maximum in dilute KOH solution at ca 482 nm Bixin : maximum in chloroform at ca 502 nm Norbixin : maximum in dilute KOH solution at ca 482 nm
Bixin : maximum in chloroform at ca 502 nm
Norbixin : maximum in dilute KOH solution at ca 482 nm
(i)Solvent extracted bixin and norbixin
Definition Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellanaL.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.Bixin and norbixin may contain other materials extracted from the annatto seed.The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.
Assay Content of bixin powders not less than 75 % total carotenoids calculated as bixin.Content of norbixin powders not less than 25 % total carotenoids calculated as norbixinBixin:E1 cm1 %2 870 at ca 502 nm in chloroformNorbixin:E1 cm1 %2 870 at ca 482 nm in KOH solution Bixin : E1 cm1 %2 870 at ca 502 nm in chloroform Norbixin : E1 cm1 %2 870 at ca 482 nm in KOH solution
Bixin : E1 cm1 %2 870 at ca 502 nm in chloroform
Norbixin : E1 cm1 %2 870 at ca 482 nm in KOH solution
Purity
Solvent residues AcetoneMethanolHexane not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
(ii)Alkali extracted annatto
Definition Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellanaL.)Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.
Assay Contains not less than 0,1 % of total carotenoids expressed as norbixinNorbixin:E1 cm1 %2 870 at ca 482 nm in KOH solution Norbixin : E1 cm1 %2 870 at ca 482 nm in KOH solution
Norbixin : E1 cm1 %2 870 at ca 482 nm in KOH solution
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
(iii)Oil extracted annatto
Definition Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellanaL.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present.
Assay Contains not less than 0,1 % of total carotenoids expressed as bixinBixin:E1 cm1 %2 870 at ca 502 nm in chloroform Bixin : E1 cm1 %2 870 at ca 502 nm in chloroform
Bixin : E1 cm1 %2 870 at ca 502 nm in chloroform
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN
Synonyms Paprika Oleoresin
Definition Paprika extract is obtained by solvent extraction of the natural strains of paprika, which consists of the ground fruits pods, with or without seeds, ofCapsicum annuumL., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate and carbon dioxide.
Class Carotenoid
Einecs Capsanthin: 207-364-1, capsorubin: 207-425-2
Chemical names Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-oneCapsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-carotene-6,6′-dione
Chemical formula Capsanthin: C40H56O3Capsorubin: C40H56O4
Molecular weight Capsanthin: 584,85Capsorubin: 600,85
Assay Paprika extract: content not less than 7,0 % carotenoidsCapsanthin/capsorubin: not less than 30 % of total carotenoidsE1 cm1 %2 100 at ca 462 nm in acetone
Description Dark-red viscous liquid
Identification
A.Spectrometry A. Spectrometry Maximum in acetone at ca 462 nm
A. Spectrometry
B.Colour reaction B. Colour reaction A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform
B. Colour reaction
Purity
Solvent residues Ethyl acetateMethanolEthanolAcetoneHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Capsaicin Not more than 250 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 160d LYCOPENE
Synonyms Natural Yellow 27
Definition Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentumL.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes.
Class Carotenoid
Colour Index No 75125
Chemical names Lycopene, ψ,ψ-carotene
Chemical formula C40H56
Molecular weight 536,85
Assay Content not less than 5 % total colouring mattersE1 cm1 %3 450 at ca 472 nm in hexane
Description Dark red viscous liquid
Identification
Spectrometry Maximum in hexane at ca 472 nm
Purity
Solvent residues Ethyl acetateMethanolEthanolAcetoneHexanePropan-2-ol Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Sulfated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 160e BETA-APO-8′-CAROTENAL (C30)
Synonyms CI Food Orange 6
Definition These specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Class Carotinoid
Colour Index No 40820
Einecs 214-171-6
Chemical names β-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehyde
Chemical formula C30H40O
Molecular weight 416,65
Assay Not less than 96 % of total colouring mattersE1 cm1 %2 640 at ca 460-462 nm in cyclohexane
Description Dark violet crystals with metallic lustre or crystalline powder
Identification
Spectrometry Maximum in cyclohexane at 460-462 nm
Purity
Sulfated ash Not more than 0,1 %
Subsidiary colouring matters Carotenoids other than β-apo-8′-carotenal:not more than 3,0 % of total colouring matters
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30)
Synonyms CI Food Orange 7, β-apo-8′-carotenoic ester
Definition These specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Class Carotenoid
Colour Index No 40825
Einecs 214-173-7
Chemical names β-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate
Chemical formula C32H44O2
Molecular weight 460,70
Assay Not less than 96 % of total colouring mattersE1 cm1 %2 550 at ca 449 nm in cyclohexane
Description Red to violet-red crystals or crystalline powder
Identification
Spectrometry Maximum in cyclohexane at ca 449 nm
Purity
Sulfated ash Not more than 0,1 %
Subsidiary colouring matters Carotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring matters
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 161b LUTEIN
Synonyms Mixed Carotenoids, Xanthophylls
Definition Lutein is obtained by solvent extraction of the natural strains of edible fruits and plants, grass, lucerne (alfalfa) andtagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material.Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone, dichloromethane and carbon dioxide
Class Carotenoid
Einecs 204-840-0
Chemical names 3,3′-dihydroxy-d-carotene
Chemical formula C40H56O2
Molecular weight 568,88
Assay Content of total colouring matter not less than 4 % calculated as luteinE1 cm1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)
Description Dark, yellowish brown liquid
Identification
Spectrometry Maximum in chloroform/ethanol (10 + 90) at ca 445 nm
Purity
Solvent residues AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 161g CANTHAXANTHIN
Synonyms CI Food Orange 8
Definition These specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Class Carotinoid
Colour Index No 40850
Einecs 208-187-2
Chemical names β-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-carotene
Chemical formula C40H52O2
Molecular weight 564,86
Assay Not less than 96 % of total colouring matters (expressed as canthaxanthin)E1 cm1 %2 200at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether E1 cm1 %2 200 at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether
E1 cm1 %2 200 at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether
Description Deep violet crystals or crystalline powder
Identification
Spectrometry Maximum in chloroform at ca 485 nmMaximum in cyclohexane at 468-472 nmMaximum in petroleum ether at 464-467 nm
Purity
Sulfated ash Not more than 0,1 %
Subsidiary colouring matters Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 162 BEETROOT RED, BETANIN
Synonyms Beet Red
Definition Beet red is obtained from the roots of natural strains of red beets (Beta vulgarisL. var.rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.
Class Betalaine
Einecs 231-628-5
Chemical names (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate
Chemical formula Betanin: C24H26N2O13
Molecular weight 550,48
Assay Content of red colour (expressed as betanine) is not less than 0,4 %E1 cm1 %1 120 at ca 535 nm in aqueous solution at pH 5
Description Red or dark red liquid, paste, powder or solid
Identification
Spectrometry Maximum in water of pH 5 at ca 535 nm
Purity
Nitrate Not more than 2 g nitrate anion/g of red colour (as calculated from assay).
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 163 ANTHOCYANINS
Definition Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material.
Class Anthocyanin
Einecs 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)
Chemical names 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin)3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)
Chemical formula Cyanidin: C15H11O6ClPeonidin: C16H13O6ClMalvidin: C17H15O7ClDelphinidin: C15H11O7ClPetunidin: C16H13O7ClPelargonidin: C15H11O5Cl
Molecular weight Cyanidin: 322,6Peonidin: 336,7Malvidin: 366,7Delphinidin: 340,6Petunidin: 352,7Pelargonidin: 306,7
Assay E1 cm1 %300 for the pure pigment at 515-535 nm at pH 3,0
Description Purplish-red liquid, powder or paste, having a slight characteristic odour
Identification
Spectrometry Maximum in methanol with 0,01 % conc. HClCyanidin: 535 nmPeonidin: 532 nmMalvidin: 542 nmDelphinidin: 546 nmPetunidin: 543 nmPelargonidin: 530 nm
Purity
Solvent residues MethanolEthanol Not more than 50 mg/kg, singly or in combination
Sulfur dioxide Not more than 1 000 mg/kg per percent pigment
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 170 CALCIUM CARBONATE
Synonyms CI Pigment White 18, Chalk
Definition Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
Class Inorganic
Colour Index No 77220
Einecs Calcium carbonate: 207-439-9Limestone: 215-279-6
Chemical names Calcium carbonate
Chemical formula CaCO3
Molecular weight 100,1
Assay Content not less than 98 % on the anhydrous basis
Description White crystalline or amorphous, odourless and tasteless powder
Identification
Solubility Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
Purity
Loss on drying Not more than 2,0 % (200 °C, 4 hours)
Acid-insoluble substances Not more than 0,2 %
Magnesium and alkali salts Not more than 1,5 %
Fluoride Not more than 50 mg/kg
Antimony (as Sb)Copper (as Cu)Chromium (as Cr)Zinc (as Zn)Barium (as Ba) Not more than 100 mg/kg, singly or in combination
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Cadmium Not more than 1 mg/kg
E 171 TITANIUM DIOXIDE
Synonyms CI Pigment White 6
Definition Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.
Class Inorganic
Colour Index No 77891
Einecs 236-675-5
Chemical names Titanium dioxide
Chemical formula TiO2
Molecular weight 79,88
Assay Content not less than 99 % on an alumina and silica-free basis
Description White to slightly coloured powder
Identification
Solubility Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.
Purity
Loss on drying Not more than 0,5 % (105 °C, 3 hours)
Loss on ignition Not more than 1,0 % on a volatile matter free basis (800 °C)
Aluminium oxide and/or silicon dioxide Total not more than 2,0 %
Matter soluble in 0,5 N HCl Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.
Water soluble matter Not more than 0,5 %
Cadmium Not more than 1 mg/kg
Antimony Not more than 50 mg/kg by total dissolution
Arsenic Not more than 3 mg/kg by total dissolution
Lead Not more than 10 mg/kg by total dissolution
Mercury Not more than 1 mg/kg by total dissolution
Zink Not more than 50 mg/kg by total dissolution
E 172 IRON OXIDES AND IRON HYDROXIDES
Synonyms Iron Oxide Yellow:CI Pigment Yellow 42 and 43Iron Oxide Red:CI Pigment Red 101 and 102Iron Oxide Black:CI Pigment Black 11 Iron Oxide Yellow : CI Pigment Yellow 42 and 43 Iron Oxide Red : CI Pigment Red 101 and 102 Iron Oxide Black : CI Pigment Black 11
Iron Oxide Yellow : CI Pigment Yellow 42 and 43
Iron Oxide Red : CI Pigment Red 101 and 102
Iron Oxide Black : CI Pigment Black 11
Definition Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.
Class Inorganic
Colour Index No Iron Oxide Yellow:77492Iron Oxide Red:77491Iron Oxide Black:77499 Iron Oxide Yellow : 77492 Iron Oxide Red : 77491 Iron Oxide Black : 77499
Iron Oxide Yellow : 77492
Iron Oxide Red : 77491
Iron Oxide Black : 77499
Einecs Iron Oxide Yellow:257-098-5Iron Oxide Red:215-168-2Iron Oxide Black:235-442-5 Iron Oxide Yellow : 257-098-5 Iron Oxide Red : 215-168-2 Iron Oxide Black : 235-442-5
Iron Oxide Yellow : 257-098-5
Iron Oxide Red : 215-168-2
Iron Oxide Black : 235-442-5
Chemical names Iron Oxide Yellow:hydrated ferric oxide, hydrated iron (III) oxideIron Oxide Red:anhydrous ferric oxide, anhydrous iron (III) oxideIron Oxide Black:ferroso ferric oxide, iron (II, III) oxide Iron Oxide Yellow : hydrated ferric oxide, hydrated iron (III) oxide Iron Oxide Red : anhydrous ferric oxide, anhydrous iron (III) oxide Iron Oxide Black : ferroso ferric oxide, iron (II, III) oxide
Iron Oxide Yellow : hydrated ferric oxide, hydrated iron (III) oxide
Iron Oxide Red : anhydrous ferric oxide, anhydrous iron (III) oxide
Iron Oxide Black : ferroso ferric oxide, iron (II, III) oxide
Chemical formula Iron Oxide Yellow:FeO(OH)·H2OIron Oxide Red:Fe2O3Iron Oxide Black:FeO·Fe2O3 Iron Oxide Yellow : FeO(OH)·H2O Iron Oxide Red : Fe2O3 Iron Oxide Black : FeO·Fe2O3
Iron Oxide Yellow : FeO(OH)·H2O
Iron Oxide Red : Fe2O3
Iron Oxide Black : FeO·Fe2O3
Molecular weight 88,85:FeO(OH)159,70:Fe2O3231,55:FeO·Fe2O3 88,85 : FeO(OH) 159,70 : Fe2O3 231,55 : FeO·Fe2O3
88,85 : FeO(OH)
159,70 : Fe2O3
231,55 : FeO·Fe2O3
Assay Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron
Description Powder; yellow, red, brown or black in hue
Identification
Solubility Insoluble in water and in organic solventsSoluble in concentrated mineral acids
Purity
Water soluble matter Not more than 1,0 % By total dissolution
Arsenic Not more than 5 mg/kg
Barium Not more than 50 mg/kg
Cadmium Not more than 5 mg/kg
Chromium Not more than 100 mg/kg
Copper Not more than 50 mg/kg
Lead Not more than 20 mg/kg
Mercury Not more than 1 mg/kg
Nickel Not more than 200 mg/kg
Zinc Not more than 100 mg/kg
E 173 ALUMINIUM
Synonyms CI Pigment Metal, Al
Definition Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.
Colour Index No 77000
Einecs 231-072-3
Chemical names Aluminium
Chemical formula Al
Atomic weight 26,98
Assay Not less than 99 % calculated as Al on an oil-free basis
Description A silvery-grey powder or tiny sheets
Identification
Solubility Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium.
Purity
Loss on drying Not more than 0,5 % (105 °C, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
E 174 SILVER
Synonyms Argentum, Ag
Class Inorganic
Colour Index No 77820
Einecs 231-131-3
Chemical names Silver
Chemical formula Ag
Atomic weight 107,87
Assay Content not less than 99,5 % Ag
Description Silver-coloured powder or tiny sheets
E 175 GOLD
Synonyms Pigment Metal 3, Aurum, Au
Class Inorganic
Colour Index No 77480
Einecs 231-165-9
Chemical names Gold
Chemical formula Au
Atomic weight 197,0
Assay Content not less than 90 % Au
Description Gold-coloured powder or tiny sheets
Purity
Silver Not more than 7,0 % After complete dissolution
Copper Not more than 4,0 %
E 180 LITHOLRUBINE BK
Synonyms CI Pigment Red 57, Rubinpigment, Carmine 6B
Definition Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulfate as the principal uncoloured components.
Class Monoazo
Colour Index No 15850:1
Einecs 226-109-5
Chemical names Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate
Chemical formula C18H12CaN2O6S
Molecular weight 424,45
Assay Content not less than 90 % total colouring mattersE1 cm1 %200 at ca 442 nm in dimethylformamide
Description Red powder
Identification
Spectrometry Maximum in dimethylformamide at ca 442 nm
Purity
Subsidiary colouring matters Not more than 0,5 %
Organic compounds other than colouring matters:
2-Amino-5-methylbenzenesulfonic acid, calcium salt Not more than 0,2 %
3-hydroxy-2-naphthalenecarboxylic acid, calcium salt Not more than 0,4 %
Unsulfonated primary aromatic amines Not more than 0,01 % (expressed as aniline)
Ether extractable matter From a solution of pH 7, not more than 0,2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 40 mg/kg
I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione
II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione
III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
I C21H20O6
II C20H18O5
III C19H16O4
I. 368,39
II. 338,39
III. 308,39
A. Spectrometry
B. Melting Range
A. Spectrometry
B. Specific rotation
For the dihydrate form : C17H20N4NaO9P·2H2O
For the anhydrous form : C17H20N4NaO9P
A. Spectrometry
B. Specific rotation
Riboflavin (free) : Not more than 6 %
Riboflavine diphosphate : Not more than 6 %
A. Spectrometry
B. Yellow solution in water
4-hydrazinobenzene sulfonic acid
4-aminobenzene-1-sulfonic acid
5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid
4,4′-diazoaminodi(benzene sulfonic acid)
Tetrahydroxysuccinic acid
— not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates
— not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates
— not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
A. Spectrometry
B. Yellow solution in water
2-methylquinoline
2-methylquinoline-sulfonic acid
Phthalic acid
2,6-dimethyl quinoline
2,6-dimethyl quinoline sulfonic acid
A. Spectrometry
B. Orange solution in water
4-aminobenzene-1-sulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
4,4′-diazoaminodi(benzene sulfonic acid)
6,6′-oxydi(naphthalene-2-sulfonic acid)
A. Spectrometry
B. Red solution in water
4-aminonaphthalene-1-sulfonic acid
4-hydroxynaphthalene-1-sulfonic acid
A. Spectrometry
B. Red solution in water
4-aminonaphthalene-1-sulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
7-hydroxynaphthalene-1,3-6-trisulfonic acid
A. Spectrometry
B. Red solution in water
4-aminonaphthalene-1-sulfonic acid
7-hydroxynaphthalene-1,3-disulfonic acid
3-hydroxynaphthalene-2,7-disulfonic acid
6-hydroxynaphthalene-2-sulfonic acid
7-hydroxynaphthalene-1,3-6-trisulfonic acid
A. Spectrometry
B. Red solution in water
A. Spectrometry
B. Red solution in water
5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid
5-amino-4-hydroxynaphthalene-2,7-disulfonic acid
A. Spectrometry
B. Red solution in water
A. Spectrometry
B. Blue solution in water
3-hydroxy benzaldehyde
3-hydroxy benzoic acid
3-hydroxy-4-sulfobenzoic acid
N,N-diethylamino benzene sulfonic acid
A. Spectrometry
B. Blue solution in water
Isatin-5-sulfonic acid
5-sulfoanthranilic acid
Anthranilic acid
A. Spectrometry
B. Blue solution in water
Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)
Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
— 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and
— 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)
A. Spectrometry
B. Blue or green solution in water
A. Spectrometry
B. Black-bluish solution in water
4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid
4-amino-5-hydroxynaphthalene-1,7-disulfonic acid
8-aminonaphthalene-2-sulfonic acid
4,4′-diazoaminodi-(benzenesulfonic acid)
A. Solubility
B. Burning
I sodium 4-(2,4-diaminophenylazo) benzenesulfonate
II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate
III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)
VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
I sodium 4-(2,4-diaminophenylazo) benzenesulfonate
II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate
III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)
VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
I C12H11N4NaO3S
II C13H13N4NaO3S
III C18H14N6Na2O6S2
IV C18H14N6Na2O6S2
V C19H16N6Na2O6S2
VI C24H17N8Na3O9S3
I 314,30
II 328,33
III 520,46
IV 520,46
V 534,47
VI 726,59
I 26 %
II 17 %
III 17 %
IV 16 %
V 20 %
VI 16 %
A. Spectrometry
B. Brown solution in water
Bixin : 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
Norbixin : 9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid
Bixin : C25H30O4
Norbixin : C24H28O4
Bixin : 394,51
Norbixin : 380,48
Bixin : maximum in chloroform at ca 502 nm
Norbixin : maximum in dilute KOH solution at ca 482 nm
Bixin : E1 cm1 %2 870 at ca 502 nm in chloroform
Norbixin : E1 cm1 %2 870 at ca 482 nm in KOH solution
Norbixin : E1 cm1 %2 870 at ca 482 nm in KOH solution
Bixin : E1 cm1 %2 870 at ca 502 nm in chloroform
A. Spectrometry
B. Colour reaction
E1 cm1 %2 200 at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether
Iron Oxide Yellow : CI Pigment Yellow 42 and 43
Iron Oxide Red : CI Pigment Red 101 and 102
Iron Oxide Black : CI Pigment Black 11
Iron Oxide Yellow : 77492
Iron Oxide Red : 77491
Iron Oxide Black : 77499
Iron Oxide Yellow : 257-098-5
Iron Oxide Red : 215-168-2
Iron Oxide Black : 235-442-5
Iron Oxide Yellow : hydrated ferric oxide, hydrated iron (III) oxide
Iron Oxide Red : anhydrous ferric oxide, anhydrous iron (III) oxide
Iron Oxide Black : ferroso ferric oxide, iron (II, III) oxide
Iron Oxide Yellow : FeO(OH)·H2O
Iron Oxide Red : Fe2O3
Iron Oxide Black : FeO·Fe2O3
88,85 : FeO(OH)
159,70 : Fe2O3
231,55 : FeO·Fe2O3
Commission Directive 95/45/EC (OJ L 226, 22.9.1995, p. 1)
Commission Directive 1999/75/EC (OJ L 206, 5.8.1999, p. 19)
Commission Directive 2001/50/EC (OJ L 190, 12.7.2001, p. 14)
Commission Directive 2004/47/EC (OJ L 113, 20.4.2004, p. 24)
Commission Directive 2006/33/EC (OJ L 82, 21.3.2006, p. 10)
Directive Time-limit for transposition
95/45/EC 1 July 1996(1)
1999/75/EC 1 July 2000
2001/50/EC 29 June 2002
2004/47/EC 1 April 2005(2)
2006/33/EC 10 April 2007
Directive 95/45/EC This Directive
Article 1, first paragraph Article 1
Article 1, second paragraph —
Article 2 —
— Article 2
Article 3 Article 3
Article 4 Article 4
Annex Annex I
— Annex II
— Annex III
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof,
(1) Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs(4).
(3) It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,
HAS ADOPTED THIS DIRECTIVE:

Article 1
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in Annex I hereto.

Article 2
Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3
This Directive shall enter into force on the 20th day following that of its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof,
(1) Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs(4).
(3) It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,
HAS ADOPTED THIS DIRECTIVE:
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in Annex I hereto.
Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
This Directive shall enter into force on the 20th day following that of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.

A.   GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS

ANNEX I
Definition | Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulfate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.
HCl insoluble matter | Not more than 0,5 %
Ether extractable matter | Not more than 0,2 % (under neutral conditions)Specific purity criteria for the corresponding colours are applicable.B. SPECIFIC CRITERIA OF PURITY
E 100 CURCUMIN
Synonyms | CI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane
Definition | Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of natural strains ofCurcuma longaL. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occuring in turmeric may be present.Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane.
Class | Dicinnamoylmethane
Colour Index No | 75300
Einecs | 207-280-5
Chemical names | I1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dioneII1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dioneIII1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione | I | 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione | II | 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione | III | 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
I | 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione
II | 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione
III | 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
Chemical formula | IC21H20O6IIC20H18O5IIIC19H16O4 | I | C21H20O6 | II | C20H18O5 | III | C19H16O4
I | C21H20O6
II | C20H18O5
III | C19H16O4
Molecular weight | I.368,39II.338,39III.308,39 | I. | 368,39 | II. | 338,39 | III. | 308,39
I. | 368,39
II. | 338,39
III. | 308,39
Assay | Content not less than 90 % total colouring mattersE1 cm1 %1 607 at ca 426 nm in ethanol
Description | Orange-yellow crystalline powder
Identification
A.Spectrometry | A. | Spectrometry | Maximum in ethanol at ca 426 nm
A. | Spectrometry
B.Melting Range | B. | Melting Range | 179 °C-182 °C
B. | Melting Range
Purity
Solvent residues | EthylacetateAcetonen-butanolMethanolEthanolHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 101 (i) RIBOFLAVIN
Synonyms | Lactoflavin
Class | Isoalloxazine
Einecs | 201-507-1
Chemical names | 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine
Chemical formula | C17H20N4O6
Molecular weight | 376,37
Assay | Content not less than 98 % on the anhydrous basisE1 cm1 %328 at ca 444 nm in aqueous solution
Description | Yellow to orange-yellow crystalline powder, with slight odour
Identification
A.Spectrometry | A. | Spectrometry | The ratio A375/A267is between 0,31 and 0,33The ratio A444/A267is between 0,36 and 0,39 | in aqueous solution
A. | Spectrometry
Maximum in water at ca 444 nm
B.Specific rotation | B. | Specific rotation | [α]D20between – 115° and – 140° in a 0,05 N sodium hydroxide solution
B. | Specific rotation
Purity
Loss on drying | Not more than 1,5 % after drying at 105 °C for 4 hrs
Sulfated ash | Not more than 0,1 %
Primary aromatic amines | Not more than 100 mg/kg (calculated as aniline)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE
Synonyms | Riboflavin-5′-phosphate sodium
Definition | These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate
Class | Isoalloxazine
Einecs | 204-988-6
Chemical names | Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate;monosodium salt of 5′-monophosphate ester of riboflavin
Chemical formula | For the dihydrate form:C17H20N4NaO9P·2H2OFor the anhydrous form:C17H20N4NaO9P | For the dihydrate form | : | C17H20N4NaO9P·2H2O | For the anhydrous form | : | C17H20N4NaO9P
For the dihydrate form | : | C17H20N4NaO9P·2H2O
For the anhydrous form | : | C17H20N4NaO9P
Molecular weight | 541,36
Assay | Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2OE1 cm1 %250 at ca 375 nm in aqueous solution
Description | Yellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste
Identification
A.Spectrometry | A. | Spectrometry | The ratio A375/A267is between 0,30 and 0,34The ratio A444/A267is between 0,35 and 0,40 | in aqueous solution
A. | Spectrometry
Maximum in water at ca 444 nm
B.Specific rotation | B. | Specific rotation | [α]D20between + 38° and + 42° in a 5 molar HCl solution
B. | Specific rotation
Purity
Loss on drying | Not more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form
Sulfated ash | Not more than 25 %
Inorganic phosphate | Not more than 1,0 % (calculated as PO4on the anhydrous basis)
Subsidiary colouring matters | Riboflavin (free):Not more than 6 %Riboflavine diphosphate:Not more than 6 % | Riboflavin (free) | : | Not more than 6 % | Riboflavine diphosphate | : | Not more than 6 %
Riboflavin (free) | : | Not more than 6 %
Riboflavine diphosphate | : | Not more than 6 %
Primary aromatic amines | Not more than 70 mg/kg (calculated as aniline)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 102 TARTRAZINE
Synonyms | CI Food Yellow 4
Definition | Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 19140
Einecs | 217-699-5
Chemical names | Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate
Chemical formula | C16H9N4Na3O9S2
Molecular weight | 534,37
Assay | Content not less than 85 % total colouring matters calculated as the sodium saltE1 cm1 %530 at ca 426 nm in aqueous solution
Description | Light orange powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 426 nm
A. | Spectrometry
B.Yellow solution in water | B. | Yellow solution in water |
B. | Yellow solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 1,0 %
Organic compounds other than colouring matters: |
4-hydrazinobenzene sulfonic acid4-aminobenzene-1-sulfonic acid5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid4,4′-diazoaminodi(benzene sulfonic acid)Tetrahydroxysuccinic acid | | 4-hydrazinobenzene sulfonic acid | | 4-aminobenzene-1-sulfonic acid | | 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid | | 4,4′-diazoaminodi(benzene sulfonic acid) | | Tetrahydroxysuccinic acid | Total not more than 0,5 %
| 4-hydrazinobenzene sulfonic acid
| 4-aminobenzene-1-sulfonic acid
| 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid
| 4,4′-diazoaminodi(benzene sulfonic acid)
| Tetrahydroxysuccinic acid
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 104 QUINOLINE YELLOW
Synonyms | CI Food Yellow 13
Definition | Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Chinophthalone
Colour Index No | 47005
Einecs | 305-897-5
Chemical name | The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)
Chemical formula | C18H9N Na2O8S2(principal component)
Molecular weight | 477,38 (principal component)
Assay | Content not less than 70 % total colouring matters calculated as the sodium saltQuinoline Yellow shall have the following composition:Of the total colouring matters present:—not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates—not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates—not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonateE1 cm1 %865 (principal component) at ca 411 nm in aqueous acetic acid solution | — | not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates | — | not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates | — | not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
— | not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates
— | not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates
— | not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
Description | Yellow powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm
A. | Spectrometry
B.Yellow solution in water | B. | Yellow solution in water |
B. | Yellow solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 4,0 %
Organic compounds other than colouring matters: |
2-methylquinoline2-methylquinoline-sulfonic acidPhthalic acid2,6-dimethyl quinoline2,6-dimethyl quinoline sulfonic acid | | 2-methylquinoline | | 2-methylquinoline-sulfonic acid | | Phthalic acid | | 2,6-dimethyl quinoline | | 2,6-dimethyl quinoline sulfonic acid | Total not more than 0,5 %
| 2-methylquinoline
| 2-methylquinoline-sulfonic acid
| Phthalic acid
| 2,6-dimethyl quinoline
| 2,6-dimethyl quinoline sulfonic acid
2-(2-quinolyl)indan-1,3-dione | Not more than 4 mg/kg
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 110 SUNSET YELLOW FCF
Synonyms | CI Food Yellow 3, Orange Yellow S
Definition | Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 15985
Einecs | 220-491-7
Chemical names | Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate
Chemical formula | C16H10N2Na2O7S2
Molecular weight | 452,37
Assay | Content not less than 85 % total colouring matters calculated as the sodium saltE1 cm1 %555 at ca 485 nm in aqueous solution at pH 7
Description | Orange-red powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 485 nm at pH 7
A. | Spectrometry
B.Orange solution in water | B. | Orange solution in water |
B. | Orange solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 5,0 %
1-(Phenylazo)-2-naphthalenol (Sudan I) | Not more than 0,5 mg/kg
Organic compounds other than colouring matters: |
4-aminobenzene-1-sulfonic acid3-hydroxynaphthalene-2,7-disulfonic acid6-hydroxynaphthalene-2-sulfonic acid7-hydroxynaphthalene-1,3-disulfonic acid4,4′-diazoaminodi(benzene sulfonic acid)6,6′-oxydi(naphthalene-2-sulfonic acid) | | 4-aminobenzene-1-sulfonic acid | | 3-hydroxynaphthalene-2,7-disulfonic acid | | 6-hydroxynaphthalene-2-sulfonic acid | | 7-hydroxynaphthalene-1,3-disulfonic acid | | 4,4′-diazoaminodi(benzene sulfonic acid) | | 6,6′-oxydi(naphthalene-2-sulfonic acid) | Total not more than 0,5 %
| 4-aminobenzene-1-sulfonic acid
| 3-hydroxynaphthalene-2,7-disulfonic acid
| 6-hydroxynaphthalene-2-sulfonic acid
| 7-hydroxynaphthalene-1,3-disulfonic acid
| 4,4′-diazoaminodi(benzene sulfonic acid)
| 6,6′-oxydi(naphthalene-2-sulfonic acid)
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
E 120 COCHINEAL, CARMINIC ACID, CARMINES
Definition | Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insectDactylopius coccusCosta.The colouring principle is carminic acid.Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.
Class | Anthraquinone
Colour Index No | 75470
Einecs | Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4
Chemical names | 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid
Chemical formula | C22H20O13(carminic acid)
Molecular weight | 492,39 (carminic acid)
Assay | Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.
Description | Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.
Identification
Spectrometry | Maximum in aqueous ammonia solution at ca 518 nmMaximum in dilute hydrochloric solution at ca 494 nm for carminic acid
Purity
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 122 AZORUBINE, CARMOISINE
Synonyms | CI Food Red 3
Definition | Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 14720
Einecs | 222-657-4
Chemical name | Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate
Chemical formula | C20H12N2Na2O7S2
Molecular weight | 502,44
Assay | Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %510 at ca 516 nm in aqueous solution
Description | Red to maroon powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 516 nm
A. | Spectrometry
B.Red solution in water | B. | Red solution in water |
B. | Red solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 2,0 %
Organic compounds other than colouring matters: |
4-aminonaphthalene-1-sulfonic acid4-hydroxynaphthalene-1-sulfonic acid | | 4-aminonaphthalene-1-sulfonic acid | | 4-hydroxynaphthalene-1-sulfonic acid | Total not more than 0,5 %
| 4-aminonaphthalene-1-sulfonic acid
| 4-hydroxynaphthalene-1-sulfonic acid
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 123 AMARANTH
Synonyms | CI Food Red 9
Definition | Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 16185
Einecs | 213-022-2
Chemical name | Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate
Chemical formula | C20H11N2Na3O10S3
Molecular weight | 604,48
Assay | Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %440 at ca 520 nm in aqueous solution
Description | Reddish-brown powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 520 nm
A. | Spectrometry
B.Red solution in water | B. | Red solution in water |
B. | Red solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 3,0 %
Organic compounds other than colouring matters: |
4-aminonaphthalene-1-sulfonic acid3-hydroxynaphthalene-2,7-disulfonic acid6-hydroxynaphthalene-2-sulfonic acid7-hydroxynaphthalene-1,3-disulfonic acid7-hydroxynaphthalene-1,3-6-trisulfonic acid | | 4-aminonaphthalene-1-sulfonic acid | | 3-hydroxynaphthalene-2,7-disulfonic acid | | 6-hydroxynaphthalene-2-sulfonic acid | | 7-hydroxynaphthalene-1,3-disulfonic acid | | 7-hydroxynaphthalene-1,3-6-trisulfonic acid | Total not more than 0,5 %
| 4-aminonaphthalene-1-sulfonic acid
| 3-hydroxynaphthalene-2,7-disulfonic acid
| 6-hydroxynaphthalene-2-sulfonic acid
| 7-hydroxynaphthalene-1,3-disulfonic acid
| 7-hydroxynaphthalene-1,3-6-trisulfonic acid
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 124 PONCEAU 4R, COCHINEAL RED A
Synonyms | CI Food Red 7, New Coccine
Definition | Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 16255
Einecs | 220-036-2
Chemical name | Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate
Chemical formula | C20H11N2Na3O10S3
Molecular weight | 604,48
Assay | Content not less than 80 % total colouring matters, calculated as the sodium salt.E1 cm1 %430 at ca 505 nm in aqueous solution
Description | Reddish powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 505 nm
A. | Spectrometry
B.Red solution in water | B. | Red solution in water |
B. | Red solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 1,0 %
Organic compounds other than colouring matters: |
4-aminonaphthalene-1-sulfonic acid7-hydroxynaphthalene-1,3-disulfonic acid3-hydroxynaphthalene-2,7-disulfonic acid6-hydroxynaphthalene-2-sulfonic acid7-hydroxynaphthalene-1,3-6-trisulfonic acid | | 4-aminonaphthalene-1-sulfonic acid | | 7-hydroxynaphthalene-1,3-disulfonic acid | | 3-hydroxynaphthalene-2,7-disulfonic acid | | 6-hydroxynaphthalene-2-sulfonic acid | | 7-hydroxynaphthalene-1,3-6-trisulfonic acid | Total not more than 0,5 %
| 4-aminonaphthalene-1-sulfonic acid
| 7-hydroxynaphthalene-1,3-disulfonic acid
| 3-hydroxynaphthalene-2,7-disulfonic acid
| 6-hydroxynaphthalene-2-sulfonic acid
| 7-hydroxynaphthalene-1,3-6-trisulfonic acid
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 127 ERYTHROSINE
Synonyms | CI Food Red 14
Definition | Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Xanthen
Colour Index No | 45430
Einecs | 240-474-8
Chemical name | Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate
Chemical formula | C20H6I4Na2O5.H2O
Molecular weight | 897,88
Assay | Content not less than 87 % total colouring matters, calculated as the anhydrous sodium saltE1 cm1 %1 100 at ca 526 nm in aqueous solution at pH 7
Description | Red powder or granules.
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 526 nm at pH 7
A. | Spectrometry
B.Red solution in water | B. | Red solution in water |
B. | Red solution in water
Purity
Inorganic iodides calculated as sodium iodide | Not more than 0,1 %
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters (except fluorescein) | Not more than 4,0 %
Fluorescein | Not more than 20 mg/kg
Organic compounds other than colouring matters: |
Tri-iodoresorcinol | Not more than 0,2 %
2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acid | Not more than 0,2 %
Ether extractable matter | From a solution of pH from 7 through 8, not more than 0,2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
Aluminium Lakes | The hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only.
E 128 RED 2G
Synonyms | CI Food Red 10, Azogeranine
Definition | Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 18050
Einecs | 223-098-9
Chemical name | Disodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate
Chemical formula | C18H13N3Na2O8S2
Molecular weight | 509,43
Assay | Content not less than 80 % total colouring matters, calculated as the sodium saltE1 cm1 %620 at ca 532 nm in aqueous solution
Description | Red powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 532 nm
A. | Spectrometry
B.Red solution in water | B. | Red solution in water |
B. | Red solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 2,0 %
Organic compounds other than colouring matters: |
5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid5-amino-4-hydroxynaphthalene-2,7-disulfonic acid | | 5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid | | 5-amino-4-hydroxynaphthalene-2,7-disulfonic acid | Total not more than 0,5 %
| 5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid
| 5-amino-4-hydroxynaphthalene-2,7-disulfonic acid
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 129 ALLURA RED AC
Synonyms | CI Food Red 17
Definition | Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Monoazo
Colour Index No | 16035
Einecs | 247-368-0
Chemical name | Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate
Chemical formula | C18H14N2Na2O8S2
Molecular weight | 496,42
Assay | Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %540 at ca 504 nm in aqueous solution at pH 7
Description | Dark red powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 504 nm
A. | Spectrometry
B.Red solution in water | B. | Red solution in water |
B. | Red solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 3,0 %
Organic compounds other than colouring matters: |
6-hydroxy-2-naphthalene sulfonic acid, sodium salt | Not more than 0,3 %
4-amino-5-methoxy-2-methylbenezene sulfonic acid | Not more than 0,2 %
6,6-oxybis (2-naphthalene sulfonic acid) disodium salt | Not more than 1,0 %
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | From a solution of pH 7, not more than 0,2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 131 PATENT BLUE V
Synonyms | CI Food Blue 5
Definition | Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium sulfate as the principal uncoloured components.The potassium salt is also permitted.
Class | Triarylmethane
Colour Index No | 42051
Einecs | 222-573-8
Chemical names | The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt
Chemical formula | Calcium compound: C27H31N2O7S2CaSodium compound: C27H31N2O7S2Na
Molecular weight | Calcium compound: 579,72Sodium compound: 582,67
Assay | Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %2 000 at ca 638 nm in aqueous solution at pH 5
Description | Dark-blue powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at 638 nm at pH 5
A. | Spectrometry
B.Blue solution in water | B. | Blue solution in water |
B. | Blue solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 2,0 %
Organic compounds other than colouring matters: |
3-hydroxy benzaldehyde3-hydroxy benzoic acid3-hydroxy-4-sulfobenzoic acidN,N-diethylamino benzene sulfonic acid | | 3-hydroxy benzaldehyde | | 3-hydroxy benzoic acid | | 3-hydroxy-4-sulfobenzoic acid | | N,N-diethylamino benzene sulfonic acid | Total not more than 0,5 %
| 3-hydroxy benzaldehyde
| 3-hydroxy benzoic acid
| 3-hydroxy-4-sulfobenzoic acid
| N,N-diethylamino benzene sulfonic acid
Leuco base | Not more than 4,0 %
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | From a solution of pH 5 not more than 0,2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 132 INDIGOTINE, INDIGO CARMINE
Synonyms | CI Food Blue 1
Definition | Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Indigoid
Colour Index No | 73015
Einecs | 212-728-8
Chemical names | Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate
Chemical formula | C16H8N2Na2O8S2
Molecular weight | 466,36
Assay | Content not less than 85 % total colouring matters, calculated as the sodium salt;disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 %E1 cm1 %480 at ca 610 nm in aqueous solution
Description | Dark-blue powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 610 nm
A. | Spectrometry
B.Blue solution in water | B. | Blue solution in water |
B. | Blue solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 %
Organic compounds other than colouring matters: |
Isatin-5-sulfonic acid5-sulfoanthranilic acidAnthranilic acid | | Isatin-5-sulfonic acid | | 5-sulfoanthranilic acid | | Anthranilic acid | Total not more than 0,5 %
| Isatin-5-sulfonic acid
| 5-sulfoanthranilic acid
| Anthranilic acid
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 133 BRILLIANT BLUE FCF
Synonyms | CI Food Blue 2
Definition | Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Triarylmethane
Colour Index No | 42090
Einecs | 223-339-8
Chemical names | Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate
Chemical formula | C37H34N2Na2O9S3
Molecular weight | 792,84
Assay | Content not less than 85 % total colouring matters, calculated as the sodium saltE1 cm1 %1 630 at ca 630 nm in aqueous solution
Description | Reddish-blue powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 630 nm
A. | Spectrometry
B.Blue solution in water | B. | Blue solution in water |
B. | Blue solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 6,0 %
Organic compounds other than colouring matters: |
Sum of 2-, 3- and 4-formyl benzene sulfonic acids | Not more than 1,5 %
3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid | Not more than 0,3 %
Leuco base | Not more than 5,0 %
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % at pH 7
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 140 (i) CHLOROPHYLLS
Synonyms | CI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin
Definition | Chlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Class | Porphyrin
Colour Index No | 75810
Einecs | Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4
Chemical names | The major colouring principles are:Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b) | | Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a) | | Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
| Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Pheophytin a), or as the magnesium complex (Chlorophyll a)
| Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
Chemical formula | Chlorophyll a (magnesium complex): C55H72MgN4O5Chlorophyll a: C55H74N4O5Chlorophyll b (magnesium complex): C55H70MgN4O6Chlorophyll b: C55H72N4O6
Molecular weight | Chlorophyll a (magnesium complex): 893,51Chlorophyll a: 871,22Chlorophyll b (magnesium complex): 907,49Chlorophyll b: 885,20
Assay | Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %E1 cm1 %700 at ca 409 nm in chloroform
Description | Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesium
Identification
Spectrometry | Maximum in chloroform at ca 409 nm
Purity
Solvent residues | AcetoneMethyl Ethyl ketoneMethanolEthanolPropan-2-olHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 140 (ii) CHLOROPHYLLINS
Synonyms | CI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorophyllin
Definition | The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium.Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Class | Porphyrin
Colour Index No | 75815
Einecs | 287-483-3
Chemical names | The major colouring principles in their acid forms are:—3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and—3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.Magnesium complexes may also be present. | — | 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and | — | 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)
— | 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)and
— | 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)
Chemical formula | Chlorophyllin a (acid form): C34H34N4O5Chlorophyllin b (acid form): C34H32N4O6
Molecular weight | Chlorophyllin a: 578,68Chlorophyllin b: 592,66Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay | Content of total chlorophyllins is not less than 95 % of the sample dried at ca 100 °C for 1 hour.E1 cm1 %700 at ca 405 nm in aqueous solution at pH 9E1 cm1 %140 at ca 653 nm in aqueous solution at pH 9
Description | Dark green to blue/black powder
Identification
Spectrometry | Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm
Purity
Solvent residues | AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS
Synonyms | CI Natural Green 3, Copper Chlorophyll, Copper Phaeophytin
Definition | Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Class | Porphyrin
Colour Index No | 75815
Einecs | Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
Chemical names | [Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)[Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)
Chemical formula | Copper chlorophyll a: C55H72Cu N4O5Copper chlorophyll b: C55H70Cu N4O6
Molecular weight | Copper chlorophyll a: 932,75Copper chlorophyll b: 946,73
Assay | Content of total copper chlorophylls is not less than 10 %.E1 cm1 %540 at ca 422 nm in chloroformE1 cm1 %300 at ca 652 nm in chloroform
Description | Waxy solid ranging in colour from blue green to dark green depending on the source material
Identification
Spectrometry | Maximum in chloroform at ca 422 nm and at ca 652 nm
Purity
Solvent residues | AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Copper ions | Not more than 200 mg/kg
Total copper | Not more than 8,0 % of the total copper phaeophytins
E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS
Synonyms | Sodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5
Definition | The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of natural strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralized to form the salts of potassium and/or sodium.Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.
Class | Porphyrin
Colour Index No | 75815
Einecs |
Chemical names | The major colouring principles in their acid forms are:3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a)and3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)
Chemical formula | Copper chlorophyllin a (acid form): C34H32Cu N4O5Copper chlorophyllin b (acid form): C34H30Cu N4O6
Molecular weight | Copper chlorophyllin a: 640,20Copper chlorophyllin b: 654,18Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay | Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.E1 cm1 %565 at ca 405 nm in aqueous phosphate buffer at pH 7,5E1 cm1 %145 at ca 630 nm in aqueous phosphate buffer at pH 7,5
Description | Dark green to blue/black powder
Identification
Spectrometry | Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nm
Purity
Solvent residues | AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Copper ions | Not more than 200 mg/kg
Total copper | Not more than 8,0 % of the total copper chlorophyllins
E 142 GREEN S
Synonyms | CI Food Green 4, Brilliant Green BS
Definition | Green S consists essentially of sodium N-[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Triarylmethane
Colour Index No | 44090
Einecs | 221-409-2
Chemical names | Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium;Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).
Chemical formula | C27H25N2NaO7S2
Molecular Weight | 576,63
Assay | Content not less than 80 % total colouring matters calculated as the sodium saltE1 cm1 %1 720 at ca 632 nm in aqueous solution
Description | Dark blue or dark green powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 632 nm
A. | Spectrometry
B.Blue or green solution in water | B. | Blue or green solution in water |
B. | Blue or green solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 1,0 %
Organic compounds other than colouring matters: |
4,4′-bis(dimethylamino)-benzhydryl alcohol | Not more than 0,1 %
4,4′-bis(dimethylamino)-benzophenone | Not more than 0,1 %
3-hydroxynaphthalene-2,7-disulfonic acid | Not more than 0,2 %
Leuco base | Not more than 5,0 %
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 150a PLAIN CARAMEL
Definition | Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.
Einecs | 232-435-9
Description | Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose | Not more than 50 %
Colour bound by phosphoryl cellulose | Not more than 50 %
Colour intensity(1) | 0,01-0,12
Total nitrogen | Not more than 0,1 %
Total sulphur | Not more than 0,2 %
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 25 mg/kg
E 150b CAUSTIC SULPHITE CARAMEL
Definition | Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.
Einecs | 232-435-9
Description | Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose | More than 50 %
Colour intensity(1) | 0,05-0,13
Total nitrogen | Not more than 0,3 %(2)
Sulphur dioxide | Not more than 0,2 %(2)
Total sulphur | 0,3-3,5 %(2)
Sulphur bound by DEAE cellulose | More than 40 %
Absorbance ratio of colour bound by DEAE cellulose | 19-34
Absorbance ratio(A 280/560) | Greater than 50
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 25 mg/kg
E 150c AMMONIA CARAMEL
Definition | Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.
Einecs | 232-435-9
Description | Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose | Not more than 50 %
Colour bound by phosphoryl cellulose | More than 50 %
Colour intensity(1) | 0,08-0,36
Ammoniacal nitrogen | Not more than 0,3 %(2)
4-methylimidazole | Not more than 250 mg/kg(2)
2-acetyl-4-tetrahydroxy-butylimidazole | Not more than 10 mg/kg(2)
Total sulphur | Not more than 0,2 %(2)
Total nitrogen | 0,7-3,3 %(2)
Absorbance ratio of colour bound by phosphoryl cellulose | 13-35
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 25 mg/kg
E 150d SULPHITE AMMONIA CARAMEL
Definition | Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).
Einecs | 232-435-9
Description | Dark brown to black liquids or solids
Purity
Colour bound by DEAE cellulose | More than 50 %
Colour intensity(1) | 0,10-0,60
Ammoniacal nitrogen | Not more than 0,6 %(2)
Sulphur dioxide | Not more than 0,2 %(2)
4-methylimidazole | Not more than 250 mg/kg(2)
Total nitrogen | 0,3-1,7 %(2)
Total sulphur | 0,8-2,5 %(2)
Nitrogen/sulphur ratio of alcohol precipitate | 0,7-2,7
Absorbance ratio of alcohol precipitate(3) | 8-14
Absorbance ratio (A280/560) | Not more than 50
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 25 mg/kg
E 151 BRILLIANT BLACK BN, BLACK PN
Synonyms | CI Food Black 1
Definition | Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components.Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.
Class | Bisazo
Colour Index No | 28440
Einecs | 219-746-5
Chemical names | Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate
Chemical formula | C28H17N5Na4O14S4
Molecular weight | 867,69
Assay | Content not less than 80 % total colouring matters calculated as the sodium saltE1 cm1 %530 at ca 570 nm in solution
Description | Black powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water at ca 570 nm
A. | Spectrometry
B.Black-bluish solution in water | B. | Black-bluish solution in water |
B. | Black-bluish solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 10 % (expressed on the dye content)
Organic compounds other than colouring matters: |
4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid4-amino-5-hydroxynaphthalene-1,7-disulfonic acid8-aminonaphthalene-2-sulfonic acid4,4′-diazoaminodi-(benzenesulfonic acid) | | 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid | | 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid | | 8-aminonaphthalene-2-sulfonic acid | | 4,4′-diazoaminodi-(benzenesulfonic acid) | Total not more than 0,8 %
| 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid
| 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid
| 8-aminonaphthalene-2-sulfonic acid
| 4,4′-diazoaminodi-(benzenesulfonic acid)
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % under neutral conditions
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 153 VEGETABLE CARBON
Synonyms | Vegetable black
Definition | Vegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonised at high temperatures. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.
Colour Index No | 77266
Einecs | 215-609-9
Chemical names | Carbon
Chemical formula | C
Molecular weight | 12,01
Assay | Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis
Description | Black powder, odourless and tasteless
Identification
A.Solubility | A. | Solubility | Insoluble in water and organic solvents
A. | Solubility
B.Burning | B. | Burning | When heated to redness it burns slowly without a flame
B. | Burning
Purity
Ash (Total) | Not more than 4,0 % (ignition temperature: 625 °C)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
Polyaromatic hydrocarbons | The extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1 000 ml of 0,01 M sulphuric acid.
Loss on drying | Not more than 12 % (120 °C, 4 hrs)
Alkali soluble matter | The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless
E 154 BROWN FK
Synonyms | CI Food Brown 1
Definition | Brown FK consists essentially of a mixture of:Isodium 4-(2,4-diaminophenylazo) benzenesulfonateIIsodium 4-(4,6-diamino-m-tolylazo) benzenesulfonateIIIdisodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)IVdisodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)Vdisodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)VItrisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components.Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted. | I | sodium 4-(2,4-diaminophenylazo) benzenesulfonate | II | sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate | III | disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) | IV | disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) | V | disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) | VI | trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
I | sodium 4-(2,4-diaminophenylazo) benzenesulfonate
II | sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate
III | disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
IV | disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
V | disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)
VI | trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
Class | Azo (a mixture of mono-, bis- and trisazo colours)
Einecs |
Chemical names | A mixture of:Isodium 4-(2,4-diaminophenylazo) benzenesulfonateIIsodium 4-(4,6-diamino-m-tolylazo) benzenesulfonateIIIdisodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)IVdisodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)Vdisodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)VItrisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) | I | sodium 4-(2,4-diaminophenylazo) benzenesulfonate | II | sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate | III | disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) | IV | disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) | V | disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) | VI | trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
I | sodium 4-(2,4-diaminophenylazo) benzenesulfonate
II | sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate
III | disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
IV | disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate)
V | disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate)
VI | trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate)
Chemical formula | IC12H11N4NaO3SIIC13H13N4NaO3SIIIC18H14N6Na2O6S2IVC18H14N6Na2O6S2VC19H16N6Na2O6S2VIC24H17N8Na3O9S3 | I | C12H11N4NaO3S | II | C13H13N4NaO3S | III | C18H14N6Na2O6S2 | IV | C18H14N6Na2O6S2 | V | C19H16N6Na2O6S2 | VI | C24H17N8Na3O9S3
I | C12H11N4NaO3S
II | C13H13N4NaO3S
III | C18H14N6Na2O6S2
IV | C18H14N6Na2O6S2
V | C19H16N6Na2O6S2
VI | C24H17N8Na3O9S3
Molecular weight | I314,30II328,33III520,46IV520,46V534,47VI726,59 | I | 314,30 | II | 328,33 | III | 520,46 | IV | 520,46 | V | 534,47 | VI | 726,59
I | 314,30
II | 328,33
III | 520,46
IV | 520,46
V | 534,47
VI | 726,59
Assay | Content not less than 70 % total colouring mattersOf the total colouring matters present the proportions of the components shall not exceed:I26 %II17 %III17 %IV16 %V20 %VI16 % | I | 26 % | II | 17 % | III | 17 % | IV | 16 % | V | 20 % | VI | 16 %
I | 26 %
II | 17 %
III | 17 %
IV | 16 %
V | 20 %
VI | 16 %
Description | Red-brown powder or granules
Identification
Orange to reddish solution |
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 3,5 %
Organic compounds other than colouring matters: |
4-aminobenzene-1-sulfonic acid | Not more than 0,7 %
m-phenylenediamine and 4-methyl-m-phenylenediamine | Not more than 0,35 %
Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamine | Not more than 0,007 % (calculated as aniline)
Ether extractable matter | From a solution of pH 7, not more than 0,2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 155 BROWN HT
Synonyms | CI Food Brown 3
Definition | Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulfate as the principal uncoloured components.Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.
Class | Bisazo
Colour Index No | 20285
Einecs | 224-924-0
Chemical names | Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)
Chemical formula | C27H18N4Na2O9S2
Molecular Weight | 652,57
Assay | Content not less than 70 % total colouring matters calculated as the sodium salt.E1 cm1 %403 at ca 460 nm in aqueous solution at pH 7
Description | Reddish-brown powder or granules
Identification
A.Spectrometry | A. | Spectrometry | Maximum in water of pH 7 at ca 460 nm
A. | Spectrometry
B.Brown solution in water | B. | Brown solution in water |
B. | Brown solution in water
Purity
Water insoluble matter | Not more than 0,2 %
Subsidiary colouring matters | Not more than 10 % (TLC method)
Organic compounds other than colouring matters: |
4-aminonaphthalene-1-sulfonic acid | Not more than 0,7 %
Unsulfonated primary aromatic amines | Not more than 0,01 % (calculated as aniline)
Ether extractable matter | Not more than 0,2 % in a solution of pH 7
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 160a (i) MIXED CAROTENES
1.Plant carotenes
Synonyms | CI Food Orange 5
Definition | Mixed carotenes are obtained by solvent extraction of natural strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane(4), dichloromethane and carbon dioxide.
Class | Carotenoid
Colour Index No | 75130
Einecs | 230-636-6
Chemical formula | Beta-carotene: C40H56
Molecular weight | Beta-carotene: 536,88
Assay | Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats.E1 cm1 %2 500 at approximately 440 nm to 457 nm in cyclohexane
Identification
Spectrometry | Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm
Purity
Solvent residues | AcetoneMethyl ethyl ketoneMethanolPropan-2-olHexaneEthanol | Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
Lead | Not more than 5 mg/kg
2.Algal carotenes
Synonyms | CI Food Orange 5
Definition | Mixed carotenes may also be produced from natural strains of the algaeDunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
Class | Carotenoid
Colour Index No | 75130
Chemical formula | Beta-Carotene: C40H56
Molecular weight | Beta-Carotene: 536,88
Assay | Content of carotenes (calculated as beta-carotene) is not less than 20 %E1 cm1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane
Identification
Spectrometry | Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm
Purity
Natural tocopherols in edible oil | Not more than 0,3 %
Lead | Not more than 5 mg/kg
E 160a (ii) BETA-CAROTENE
1.Beta-carotene
Synonyms | CI Food Orange 5
Definition | These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.
Class | Carotenoid
Colour Index No | 40800
Einecs | 230-636-6
Chemical names | Beta-carotene, beta, beta-carotene
Chemical formula | C40H56
Molecular weight | 536,88
Assay | Not less than 96 % total colouring matters (expressed as beta-carotene)E1 cm1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane
Description | Red to brownish-red crystals or crystalline powder
Identification
Spectrometry | Maximum in cyclohexane at 453 nm to 456 nm
Purity
Sulfated ash | Not more than 0,2 %
Subsidiary colouring matters | Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
Lead | Not more than 2 mg/kg
2.Beta-carotene fromBlakeslea trispora
Synonyms | CI Food Orange 5
Definition | Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of natural strains of the fungusBlakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.
Class | Carotenoid
Colour Index No | 40800
Einecs | 230-636-6
Chemical names | Beta-carotene, beta,beta-carotene
Chemical formula | C40H56
Molecular weight | 536,88
Assay | Not less than 96 % total colouring matters (expressed as beta-carotene)E1 cm1 %2 500 at approximately 440 nm to 457 nm in cyclohexane
Description | Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)
Identification
Spectrometry | Maximum in cyclohexane at 453 nm to 456 nm
Purity
Solvent residues | Ethyl acetateEthanol | Not more than 0,8 %, singly or in combination
Isobutyl acetate: Not more than 1,0 %
Isopropyl alcohol: Not more than 0,1 %
Sulfated ash | Not more than 0,2 %
Subsidiary colouring matters | Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
Lead | Not more than 2 mg/kg
Mycotoxins:
Aflatoxin B1 | Absent
Trichothecene (T2) | Absent
Ochratoxin | Absent
Zearalenone | Absent
Microbiology:
Moulds | Not more than 100/g
Yeasts | Not more than 100/g
Salmonella | Absent in 25 g
Escherichia coli | Absent in 5 g
E 160b ANNATTO, BIXIN, NORBIXIN
Synonyms | CI Natural Orange 4
Definition
Class | Carotenoid
Colour Index No | 75120
Einecs | Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
Chemical names | Bixin:6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioateNorbixin:9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid | Bixin | : | 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate | Norbixin | : | 9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid
Bixin | : | 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
Norbixin | : | 9′Cis-6,6′-diapocarotene-6,6′-dioic acid9′-Trans-6,6′-diapocarotene-6,6′-dioic acid
Chemical formula | Bixin:C25H30O4Norbixin:C24H28O4 | Bixin | : | C25H30O4 | Norbixin | : | C24H28O4
Bixin | : | C25H30O4
Norbixin | : | C24H28O4
Molecular weight | Bixin:394,51Norbixin:380,48 | Bixin | : | 394,51 | Norbixin | : | 380,48
Bixin | : | 394,51
Norbixin | : | 380,48
Description | Reddish-brown powder, suspension or solution
Identification
Spectrometry | Bixin:maximum in chloroform at ca 502 nmNorbixin:maximum in dilute KOH solution at ca 482 nm | Bixin | : | maximum in chloroform at ca 502 nm | Norbixin | : | maximum in dilute KOH solution at ca 482 nm
Bixin | : | maximum in chloroform at ca 502 nm
Norbixin | : | maximum in dilute KOH solution at ca 482 nm
(i)Solvent extracted bixin and norbixin
Definition | Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellanaL.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.Bixin and norbixin may contain other materials extracted from the annatto seed.The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.
Assay | Content of bixin powders not less than 75 % total carotenoids calculated as bixin.Content of norbixin powders not less than 25 % total carotenoids calculated as norbixinBixin:E1 cm1 %2 870 at ca 502 nm in chloroformNorbixin:E1 cm1 %2 870 at ca 482 nm in KOH solution | Bixin | : | E1 cm1 %2 870 at ca 502 nm in chloroform | Norbixin | : | E1 cm1 %2 870 at ca 482 nm in KOH solution
Bixin | : | E1 cm1 %2 870 at ca 502 nm in chloroform
Norbixin | : | E1 cm1 %2 870 at ca 482 nm in KOH solution
Purity
Solvent residues | AcetoneMethanolHexane | not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
(ii)Alkali extracted annatto
Definition | Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellanaL.)Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.
Assay | Contains not less than 0,1 % of total carotenoids expressed as norbixinNorbixin:E1 cm1 %2 870 at ca 482 nm in KOH solution | Norbixin | : | E1 cm1 %2 870 at ca 482 nm in KOH solution
Norbixin | : | E1 cm1 %2 870 at ca 482 nm in KOH solution
Purity
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
(iii)Oil extracted annatto
Definition | Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellanaL.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present.
Assay | Contains not less than 0,1 % of total carotenoids expressed as bixinBixin:E1 cm1 %2 870 at ca 502 nm in chloroform | Bixin | : | E1 cm1 %2 870 at ca 502 nm in chloroform
Bixin | : | E1 cm1 %2 870 at ca 502 nm in chloroform
Purity
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN
Synonyms | Paprika Oleoresin
Definition | Paprika extract is obtained by solvent extraction of the natural strains of paprika, which consists of the ground fruits pods, with or without seeds, ofCapsicum annuumL., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate and carbon dioxide.
Class | Carotenoid
Einecs | Capsanthin: 207-364-1, capsorubin: 207-425-2
Chemical names | Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-oneCapsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-carotene-6,6′-dione
Chemical formula | Capsanthin: C40H56O3Capsorubin: C40H56O4
Molecular weight | Capsanthin: 584,85Capsorubin: 600,85
Assay | Paprika extract: content not less than 7,0 % carotenoidsCapsanthin/capsorubin: not less than 30 % of total carotenoidsE1 cm1 %2 100 at ca 462 nm in acetone
Description | Dark-red viscous liquid
Identification
A.Spectrometry | A. | Spectrometry | Maximum in acetone at ca 462 nm
A. | Spectrometry
B.Colour reaction | B. | Colour reaction | A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroform
B. | Colour reaction
Purity
Solvent residues | Ethyl acetateMethanolEthanolAcetoneHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Capsaicin | Not more than 250 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 160d LYCOPENE
Synonyms | Natural Yellow 27
Definition | Lycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentumL.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes.
Class | Carotenoid
Colour Index No | 75125
Chemical names | Lycopene, ψ,ψ-carotene
Chemical formula | C40H56
Molecular weight | 536,85
Assay | Content not less than 5 % total colouring mattersE1 cm1 %3 450 at ca 472 nm in hexane
Description | Dark red viscous liquid
Identification
Spectrometry | Maximum in hexane at ca 472 nm
Purity
Solvent residues | Ethyl acetateMethanolEthanolAcetoneHexanePropan-2-ol | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Sulfated ash | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 160e BETA-APO-8′-CAROTENAL (C30)
Synonyms | CI Food Orange 6
Definition | These specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Class | Carotinoid
Colour Index No | 40820
Einecs | 214-171-6
Chemical names | β-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehyde
Chemical formula | C30H40O
Molecular weight | 416,65
Assay | Not less than 96 % of total colouring mattersE1 cm1 %2 640 at ca 460-462 nm in cyclohexane
Description | Dark violet crystals with metallic lustre or crystalline powder
Identification
Spectrometry | Maximum in cyclohexane at 460-462 nm
Purity
Sulfated ash | Not more than 0,1 %
Subsidiary colouring matters | Carotenoids other than β-apo-8′-carotenal:not more than 3,0 % of total colouring matters
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30)
Synonyms | CI Food Orange 7, β-apo-8′-carotenoic ester
Definition | These specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Class | Carotenoid
Colour Index No | 40825
Einecs | 214-173-7
Chemical names | β-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate
Chemical formula | C32H44O2
Molecular weight | 460,70
Assay | Not less than 96 % of total colouring mattersE1 cm1 %2 550 at ca 449 nm in cyclohexane
Description | Red to violet-red crystals or crystalline powder
Identification
Spectrometry | Maximum in cyclohexane at ca 449 nm
Purity
Sulfated ash | Not more than 0,1 %
Subsidiary colouring matters | Carotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring matters
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 161b LUTEIN
Synonyms | Mixed Carotenoids, Xanthophylls
Definition | Lutein is obtained by solvent extraction of the natural strains of edible fruits and plants, grass, lucerne (alfalfa) andtagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material.Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone, dichloromethane and carbon dioxide
Class | Carotenoid
Einecs | 204-840-0
Chemical names | 3,3′-dihydroxy-d-carotene
Chemical formula | C40H56O2
Molecular weight | 568,88
Assay | Content of total colouring matter not less than 4 % calculated as luteinE1 cm1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)
Description | Dark, yellowish brown liquid
Identification
Spectrometry | Maximum in chloroform/ethanol (10 + 90) at ca 445 nm
Purity
Solvent residues | AcetoneMethyl ethyl ketoneMethanolEthanolPropan-2-olHexane | Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 161g CANTHAXANTHIN
Synonyms | CI Food Orange 8
Definition | These specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Class | Carotinoid
Colour Index No | 40850
Einecs | 208-187-2
Chemical names | β-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-carotene
Chemical formula | C40H52O2
Molecular weight | 564,86
Assay | Not less than 96 % of total colouring matters (expressed as canthaxanthin)E1 cm1 %2 200at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether | E1 cm1 %2 200 | at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether
E1 cm1 %2 200 | at ca 485 nm in chloroformat 468-472 nm in cyclohexaneat 464-467 nm in petroleum ether
Description | Deep violet crystals or crystalline powder
Identification
Spectrometry | Maximum in chloroform at ca 485 nmMaximum in cyclohexane at 468-472 nmMaximum in petroleum ether at 464-467 nm
Purity
Sulfated ash | Not more than 0,1 %
Subsidiary colouring matters | Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 162 BEETROOT RED, BETANIN
Synonyms | Beet Red
Definition | Beet red is obtained from the roots of natural strains of red beets (Beta vulgarisL. var.rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.
Class | Betalaine
Einecs | 231-628-5
Chemical names | (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate
Chemical formula | Betanin: C24H26N2O13
Molecular weight | 550,48
Assay | Content of red colour (expressed as betanine) is not less than 0,4 %E1 cm1 %1 120 at ca 535 nm in aqueous solution at pH 5
Description | Red or dark red liquid, paste, powder or solid
Identification
Spectrometry | Maximum in water of pH 5 at ca 535 nm
Purity
Nitrate | Not more than 2 g nitrate anion/g of red colour (as calculated from assay).
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 163 ANTHOCYANINS
Definition | Anthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material.
Class | Anthocyanin
Einecs | 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)
Chemical names | 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin)3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)
Chemical formula | Cyanidin: C15H11O6ClPeonidin: C16H13O6ClMalvidin: C17H15O7ClDelphinidin: C15H11O7ClPetunidin: C16H13O7ClPelargonidin: C15H11O5Cl
Molecular weight | Cyanidin: 322,6Peonidin: 336,7Malvidin: 366,7Delphinidin: 340,6Petunidin: 352,7Pelargonidin: 306,7
Assay | E1 cm1 %300 for the pure pigment at 515-535 nm at pH 3,0
Description | Purplish-red liquid, powder or paste, having a slight characteristic odour
Identification
Spectrometry | Maximum in methanol with 0,01 % conc. HClCyanidin: 535 nmPeonidin: 532 nmMalvidin: 542 nmDelphinidin: 546 nmPetunidin: 543 nmPelargonidin: 530 nm
Purity
Solvent residues | MethanolEthanol | Not more than 50 mg/kg, singly or in combination
Sulfur dioxide | Not more than 1 000 mg/kg per percent pigment
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 170 CALCIUM CARBONATE
Synonyms | CI Pigment White 18, Chalk
Definition | Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
Class | Inorganic
Colour Index No | 77220
Einecs | Calcium carbonate: 207-439-9Limestone: 215-279-6
Chemical names | Calcium carbonate
Chemical formula | CaCO3
Molecular weight | 100,1
Assay | Content not less than 98 % on the anhydrous basis
Description | White crystalline or amorphous, odourless and tasteless powder
Identification
Solubility | Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
Purity
Loss on drying | Not more than 2,0 % (200 °C, 4 hours)
Acid-insoluble substances | Not more than 0,2 %
Magnesium and alkali salts | Not more than 1,5 %
Fluoride | Not more than 50 mg/kg
Antimony (as Sb)Copper (as Cu)Chromium (as Cr)Zinc (as Zn)Barium (as Ba) | Not more than 100 mg/kg, singly or in combination
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Cadmium | Not more than 1 mg/kg
E 171 TITANIUM DIOXIDE
Synonyms | CI Pigment White 6
Definition | Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.
Class | Inorganic
Colour Index No | 77891
Einecs | 236-675-5
Chemical names | Titanium dioxide
Chemical formula | TiO2
Molecular weight | 79,88
Assay | Content not less than 99 % on an alumina and silica-free basis
Description | White to slightly coloured powder
Identification
Solubility | Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.
Purity
Loss on drying | Not more than 0,5 % (105 °C, 3 hours)
Loss on ignition | Not more than 1,0 % on a volatile matter free basis (800 °C)
Aluminium oxide and/or silicon dioxide | Total not more than 2,0 %
Matter soluble in 0,5 N HCl | Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.
Water soluble matter | Not more than 0,5 %
Cadmium | Not more than 1 mg/kg
Antimony | Not more than 50 mg/kg by total dissolution
Arsenic | Not more than 3 mg/kg by total dissolution
Lead | Not more than 10 mg/kg by total dissolution
Mercury | Not more than 1 mg/kg by total dissolution
Zink | Not more than 50 mg/kg by total dissolution
E 172 IRON OXIDES AND IRON HYDROXIDES
Synonyms | Iron Oxide Yellow:CI Pigment Yellow 42 and 43Iron Oxide Red:CI Pigment Red 101 and 102Iron Oxide Black:CI Pigment Black 11 | Iron Oxide Yellow | : | CI Pigment Yellow 42 and 43 | Iron Oxide Red | : | CI Pigment Red 101 and 102 | Iron Oxide Black | : | CI Pigment Black 11
Iron Oxide Yellow | : | CI Pigment Yellow 42 and 43
Iron Oxide Red | : | CI Pigment Red 101 and 102
Iron Oxide Black | : | CI Pigment Black 11
Definition | Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.
Class | Inorganic
Colour Index No | Iron Oxide Yellow:77492Iron Oxide Red:77491Iron Oxide Black:77499 | Iron Oxide Yellow | : | 77492 | Iron Oxide Red | : | 77491 | Iron Oxide Black | : | 77499
Iron Oxide Yellow | : | 77492
Iron Oxide Red | : | 77491
Iron Oxide Black | : | 77499
Einecs | Iron Oxide Yellow:257-098-5Iron Oxide Red:215-168-2Iron Oxide Black:235-442-5 | Iron Oxide Yellow | : | 257-098-5 | Iron Oxide Red | : | 215-168-2 | Iron Oxide Black | : | 235-442-5
Iron Oxide Yellow | : | 257-098-5
Iron Oxide Red | : | 215-168-2
Iron Oxide Black | : | 235-442-5
Chemical names | Iron Oxide Yellow:hydrated ferric oxide, hydrated iron (III) oxideIron Oxide Red:anhydrous ferric oxide, anhydrous iron (III) oxideIron Oxide Black:ferroso ferric oxide, iron (II, III) oxide | Iron Oxide Yellow | : | hydrated ferric oxide, hydrated iron (III) oxide | Iron Oxide Red | : | anhydrous ferric oxide, anhydrous iron (III) oxide | Iron Oxide Black | : | ferroso ferric oxide, iron (II, III) oxide
Iron Oxide Yellow | : | hydrated ferric oxide, hydrated iron (III) oxide
Iron Oxide Red | : | anhydrous ferric oxide, anhydrous iron (III) oxide
Iron Oxide Black | : | ferroso ferric oxide, iron (II, III) oxide
Chemical formula | Iron Oxide Yellow:FeO(OH)·H2OIron Oxide Red:Fe2O3Iron Oxide Black:FeO·Fe2O3 | Iron Oxide Yellow | : | FeO(OH)·H2O | Iron Oxide Red | : | Fe2O3 | Iron Oxide Black | : | FeO·Fe2O3
Iron Oxide Yellow | : | FeO(OH)·H2O
Iron Oxide Red | : | Fe2O3
Iron Oxide Black | : | FeO·Fe2O3
Molecular weight | 88,85:FeO(OH)159,70:Fe2O3231,55:FeO·Fe2O3 | 88,85 | : | FeO(OH) | 159,70 | : | Fe2O3 | 231,55 | : | FeO·Fe2O3
88,85 | : | FeO(OH)
159,70 | : | Fe2O3
231,55 | : | FeO·Fe2O3
Assay | Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron
Description | Powder; yellow, red, brown or black in hue
Identification
Solubility | Insoluble in water and in organic solventsSoluble in concentrated mineral acids
Purity
Water soluble matter | Not more than 1,0 % | By total dissolution
Arsenic | Not more than 5 mg/kg
Barium | Not more than 50 mg/kg
Cadmium | Not more than 5 mg/kg
Chromium | Not more than 100 mg/kg
Copper | Not more than 50 mg/kg
Lead | Not more than 20 mg/kg
Mercury | Not more than 1 mg/kg
Nickel | Not more than 200 mg/kg
Zinc | Not more than 100 mg/kg
E 173 ALUMINIUM
Synonyms | CI Pigment Metal, Al
Definition | Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.
Colour Index No | 77000
Einecs | 231-072-3
Chemical names | Aluminium
Chemical formula | Al
Atomic weight | 26,98
Assay | Not less than 99 % calculated as Al on an oil-free basis
Description | A silvery-grey powder or tiny sheets
Identification
Solubility | Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium.
Purity
Loss on drying | Not more than 0,5 % (105 °C, to constant weight)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
E 174 SILVER
Synonyms | Argentum, Ag
Class | Inorganic
Colour Index No | 77820
Einecs | 231-131-3
Chemical names | Silver
Chemical formula | Ag
Atomic weight | 107,87
Assay | Content not less than 99,5 % Ag
Description | Silver-coloured powder or tiny sheets
E 175 GOLD
Synonyms | Pigment Metal 3, Aurum, Au
Class | Inorganic
Colour Index No | 77480
Einecs | 231-165-9
Chemical names | Gold
Chemical formula | Au
Atomic weight | 197,0
Assay | Content not less than 90 % Au
Description | Gold-coloured powder or tiny sheets
Purity
Silver | Not more than 7,0 % | After complete dissolution
Copper | Not more than 4,0 %
E 180 LITHOLRUBINE BK
Synonyms | CI Pigment Red 57, Rubinpigment, Carmine 6B
Definition | Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulfate as the principal uncoloured components.
Class | Monoazo
Colour Index No | 15850:1
Einecs | 226-109-5
Chemical names | Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate
Chemical formula | C18H12CaN2O6S
Molecular weight | 424,45
Assay | Content not less than 90 % total colouring mattersE1 cm1 %200 at ca 442 nm in dimethylformamide
Description | Red powder
Identification
Spectrometry | Maximum in dimethylformamide at ca 442 nm
Purity
Subsidiary colouring matters | Not more than 0,5 %
Organic compounds other than colouring matters: |
2-Amino-5-methylbenzenesulfonic acid, calcium salt | Not more than 0,2 %
3-hydroxy-2-naphthalenecarboxylic acid, calcium salt | Not more than 0,4 %
Unsulfonated primary aromatic amines | Not more than 0,01 % (expressed as aniline)
Ether extractable matter | From a solution of pH 7, not more than 0,2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 40 mg/kg
(1) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
(2) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
(3) Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).
(4) Benzene not more than 0,05 % v/v.

PART A

ANNEX IIRepealed Directive with list of its successive amendments(referred to in Article 2)
Commission Directive 95/45/EC | (OJ L 226, 22.9.1995, p. 1)
Commission Directive 1999/75/EC | (OJ L 206, 5.8.1999, p. 19)
Commission Directive 2001/50/EC | (OJ L 190, 12.7.2001, p. 14)
Commission Directive 2004/47/EC | (OJ L 113, 20.4.2004, p. 24)
Commission Directive 2006/33/EC | (OJ L 82, 21.3.2006, p. 10)PART BList of time-limits for transposition into national law(referred to in Article 2)
Directive | Time-limit for transposition
95/45/EC | 1 July 1996(1)
1999/75/EC | 1 July 2000
2001/50/EC | 29 June 2002
2004/47/EC | 1 April 2005(2)
2006/33/EC | 10 April 2007
(1) According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted.
(2) According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted.
ANNEX IIICorrelation table
Directive 95/45/EC | This Directive
Article 1, first paragraph | Article 1
Article 1, second paragraph | —
Article 2 | —
— | Article 2
Article 3 | Article 3
Article 4 | Article 4
Annex | Annex I
— | Annex II
— | Annex III

Pending: 32008L0127

January 16, 2026
20.12.2008 EN Official Journal of the European Union L 344/89
(1) Commission Regulations (EC) No 1112/2002(2)and (EC) No 2229/2004(3)lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the active substances listed in the Annex to this Directive.
(2) By Regulation (EC) No 1095/2007(4)a new Article 24b was inserted into Regulation (EC) No 2229/2004 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.
(3) For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 24a of Regulation (EC) No 2229/2004 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 24b of Regulation (EC) No 2229/2004.
(4) In accordance with Article 25(1) of Regulation (EC) No 2229/2004 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2008 in the format of the Commission review reports. In accordance with Article 25a of Regulation (EC) No 2229/2004 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.
(5) It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
(6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
(7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing the active substances listed in the Annex to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives that have been adopted until now amending Annex I.
(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
(a) in the case of a product containing one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 31 August 2015 at the latest; or
(b) in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 31 August 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
No Common Name, Identification Numbers IUPAC Name Purity(1) Entry into force Expiration of inclusion Specific provisions
‘224 Acetic acidCAS No: 64-19-7CIPAC No: not allocated Acetic acid ≥ 980 g/kg 1 September 2009 31 August 2019 PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
225 Aluminium ammonium sulphateCAS No: 7784-26-1CIPAC No: not allocated Aluminium ammonium sulphate ≥ 960 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
226 Aluminium silicateCAS No: 1332-58-7CIPAC No: not allocated Not availableChemical name: Kaolin ≥ 999,8 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium silicate (SANCO/2603/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
227 Ammonium acetateCAS No: 631-61-8CIPAC No: not allocated Ammonium acetate ≥ 970 g/kgRelevant impurity: Heavy metals as Pb maximum 10 ppm 1 September 2009 31 August 2019 PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
228 Blood mealCAS No: not allocatedCIPAC No: not allocated Not available ≥ 990 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1774/2002.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
229 Calcium carbideCAS No: 75-20-7CIPAC No: not allocated Calcium carbideCalcium acetylide ≥ 765 g/kgContaining 0,08-0,52 g/kg Calcium Phosphide 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
230 Calcium carbonateCAS No: 471-34-1CIPAC No: not allocated Calcium carbonate ≥ 995 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
231 Carbon dioxideCAS No: 124-38-9 Carbon dioxide ≥ 99,9 % 1 September 2009 31 August 2019 PART AOnly uses as fumigant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
232 Denathonium benzoateCAS No: 3734-33-6CIPAC No: not allocated Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate ≥ 995 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
233 EthyleneCAS No: 74-85-1CIPAC No: not allocated Ethene ≥ 99 % 1 September 2009 31 August 2019 PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
234 Extract from tea treeCAS No: Tee Tree Oil 68647-73-4Main components:terpinen-4-ol 562-74-3γ-terpinene 99-85-4α-terpinene 99-86-51,8-cineol 470-82-6CIPAC No: not allocated terpinen-4-ol 562-74-3 γ-terpinene 99-85-4 α-terpinene 99-86-5 1,8-cineol 470-82-6 Tee Tree Oil is a complex mixture of chemical substances. Main components:terpinen-4-ol ≥ 300 g/kgγ-terpinene ≥ 100 g/kgα-terpinene ≥ 50 g/kg1,8-cineol trace terpinen-4-ol ≥ 300 g/kg γ-terpinene ≥ 100 g/kg α-terpinene ≥ 50 g/kg 1,8-cineol trace 1 September 2009 31 August 2019 PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on extract from tea tree (SANCO/2609/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
terpinen-4-ol 562-74-3
γ-terpinene 99-85-4
α-terpinene 99-86-5
1,8-cineol 470-82-6
terpinen-4-ol ≥ 300 g/kg
γ-terpinene ≥ 100 g/kg
α-terpinene ≥ 50 g/kg
1,8-cineol trace
235 Fat destilation residuesCAS No: not allocatedCIPAC No: not allocated Not available ≥ 40 % of cleaved fatty acidsRelevant impurity: Ni maximum 200 mg/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised. Fat destilation residues of animal origin must be in compliance with Regulation (EC) No 1774/2002.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fat destilation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
236 Fatty acids C7to C20CAS No: 112-05-0 (Pelargonic Acid)67701-09-1 (Fatty acids C7-C18and C18unsaturated potassium salts)124-07-2 (Caprylic Acid)334-48-5 (Capric Acid)143-07-7 (Lauric Acid)112-80-1 (Oleic Acid)85566-26-3 (Fatty acids C8-C10Me esters)111-11-5 (Methyl octanoate)110-42-9 (Methyl decanoate)CIPAC No: not allocated Nonanoic acidCaprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)Fatty acids, C7-C10, Me esters ≥ 889 g/kg (Pelargonic Acid)≥ 838 g/kg fatty acids≥ 99 % fatty acid methyl esters 1 September 2009 31 August 2019 PART AOnly uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
237 Garlic extractCAS No: 8008-99-9CIPAC No: not allocated Food grade garlic juice concentrate ≥ 99,9 % 1 September 2009 31 August 2019 PART AOnly uses as repellent, insecticide and nematicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
238 Gibberellic acidCAS No: 77-06-5CIPAC No: 307 (3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acidAlt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid ≥ 850 g/kg 1 September 2009 31 August 2019 PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
239 GibberellinsCAS No: GA4: 468-44-0GA7: 510-75-8GA4A7 mixture: 8030-53-3CIPAC No: not allocated GA4:(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acidGA7:(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid Review report (SANCO/2614/2008). 1 September 2009 31 August 2019 PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
240 Hydrolised proteinsBeet molasses urea hydrolysateCollagen protein hydrolysateCAS No: not allocatedCIPAC No: not allocated Not available Beet molasses urea hydrolysate: minimum Crude Protein Equivalent: 360 g/kg (36 % w/w)Collagen protein hydrolysate: organic nitrogen content > 240 g/kg 1 September 2009 31 August 2019 PART AOnly uses as attractant may be authorised. Hydrolised proteins of animal origin must be in compliance with Regulation (EC) No 1774/2002PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on hydrolised proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
241 Iron sulphateIron(II)sulphate anhydrous: CAS No: 7720-78-7Iron(II)sulphate monohydrate: CAS No: 17375-41-6Iron(II)sulphate heptahydrate: CAS No: 7782-63-0CIPAC No: not allocated Iron (II) sulfate Iron(II)sulphate anhydrous ≥ 367,5 g/kgIron(II)sulphate monohydrate ≥ 300 g/kgIron(II)sulphate heptahydrate ≥ 180 g/kg 1 September 2009 31 August 2019 PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
242 Kieselgur (Diatomaceous earth)CAS No: 61790-53-2CIPAC No: 647 Kieselgur (diatomaceous earth) 920 ± 20 g SiO2/kg DEMaximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) 1 September 2009 31 August 2019 PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on kieselgur (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
243 LimestoneCAS No: 1317-65-3CIPAC No: not allocated not available ≥ 980 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
244 Methyl nonyl ketoneCAS No: 112-12-9CIPAC No: not allocated Undecan-2-one ≥ 975g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on methylnonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
245 PepperCAS No: not allocatedCIPAC No: not allocated Black pepper — Piper nigrum It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 % 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
246 Plant oils/citronella oilCAS No: 8000-29-1CIPAC No: not allocated Citronella Oil is a complex mixture of chemical substances.The main components are:Citronellal (3,7-dimethyl-6-octenal).Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).Citronellol (3,7-dimethyl-6-octan-2-ol).Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate). Citronellal (3,7-dimethyl-6-octenal). Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol). Citronellol (3,7-dimethyl-6-octan-2-ol). Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate). Relevant impurities methyl eugenol and methyl-isoeugenol maximum 0,1 %. 1 September 2009 31 August 2019 PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
Citronellal (3,7-dimethyl-6-octenal).
Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).
Citronellol (3,7-dimethyl-6-octan-2-ol).
Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).
247 Plant oils/clove oilCAS No: 94961-50-2 (clove oil)97-53-0 (Eugenol — main component)CIPAC No: not allocated Clove Oil is a complex mixture of chemical substances.The main component is eugenol. ≥ 800 g/kg 1 September 2009 31 August 2019 PART AOnly uses as fungicide and bactericide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
248 Plant oils/rape seed oilCAS No: 8002-13-9CIPAC No: not allocated Rape seed oil Rape seed oil is a complex mixture of fatty acids 1 September 2009 31 August 2019 PART AOnly uses as insecticide and acaricide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
249 Plant oils/spear mint oilCAS No: 8008-79-5CIPAC No: not allocated Spearmint oil ≥ 550 g/kg as L-Carvone 1 September 2009 31 August 2019 PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
250 Potassium hydrogen carbonateCAS No: 298-14-6CIPAC No: not allocated Potassium hydrogen carbonate ≥ 99,5 % 1 September 2009 31 August 2019 PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
251 Putrescin (1,4-Diaminobutane)CAS No: 110-60-1CIPAC No: not allocated Butane-1,4-diamine ≥ 990 g/kg 1 September 2009 31 August 2019 PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on putrescin (SANCO/2626/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
252 PyrethrinsCAS No: (A) and (B):Pyrethrins: 8003-34-7Extract A: extractives of Chrysanthemum cinerariaefolium: 89997-63-7pyrethrin 1: CAS 121-21-1pyrethrin 2: CAS 121-29-9cinerin 1: CAS 25402-06-6cinerin 2: CAS 121-20-0jasmolin 1: CAS 4466-14-2jasmolin 2: CAS 1172-63-0Extract B: pyrethrin 1: CAS 121-21-1pyrethrin 2: CAS 121-29-9cinerin 1: CAS 25402-06-6cinerin 2: CAS 121-20-0jasmolin 1: CAS 4466-14-2jasmolin 2: CAS 1172-63-0CIPAC No 32 Pyrethrins are a complex mixture of chemical substances. Extract A: ≥ 500 g/kg PyrethrinsExtract B: ≥ 480 g/kg Pyrethrins 1 September 2009 31 August 2019 PART AOnly uses as insecticide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
253 Quartz sandCAS No: 14808-60-7CIPAC No: not allocated Quarz, Quartz, Siliciumdioxid, Silica, Silicon dioxide, SiO2 ≥ 915 g/kgMaximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.) 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
254 Repellents by smell of animal or plant origin/fish oilCAS No: 100085-40-3CIPAC No: not allocated Fish Oil ≥ 99 % 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1774/2002PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
255 Repellents by smell of animal or plant origin/sheep fatCAS No: 98999-15-6CIPAC No: not allocated Sheep Fat Pure sheep fat containing a maximum of 0,18 % w/w/water. 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1774/2002PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
256 Repellents by smell of animal or plant origin/tall oil crude CAS No: 8002-26-4CIPAC No: not allocated Tall Oil Crude Tall oil crude is a complex mixture of tall rosin and fatty acids 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
257 Repellents by smell of animal or plant origin/tall oil pitch CAS No: 8016-81-7CIPAC No: not allocated Tall Oil Pitch Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids. 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
258 Sea-algae extract (formerly sea algae extract and sea weeds)CAS No: not allocatedCIPAC No: not allocated See algae extract See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008 1 September 2009 31 August 2019 PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
259 Sodium aluminium silicateCAS No: 1344-00-9CIPAC No: not allocated Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O 1 000 g/kg 1 September 2009 31 August 2019 PART AOnly uses as repellent may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
260 Sodium HypochloriteCAS No: 7681-52-9CIPAC No: not allocated Sodium Hypochlorite 10 % (w/w) expressed as chlorine 1 September 2009 31 August 2019 PART AOnly uses as disinfectant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
261 Straight Chain Lepidopteran Pheromones Acetate group: Review report (SANCO/2633/2008) 1 September 2009 31 August 2019 PART AOnly uses as attractants may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
(E)-5-decen-1-yl acetateCAS No: 38421-90-8CIPAC No: not allocated (E)-5-decen-1-yl acetate
(E)-8-dodecen-1-yl acetateCAS No: 38363-29-0CIPAC No:not allocated (E)-8-dodecen-1-yl acetate
(E/Z)-8-dodecen-1-yl acetateCAS No: not availableCIPAC No: not avaiable (E/Z)-8-dodecen-1-yl acetate as individual isomers
(Z)-8-dodecen-1-yl acetateCAS No: 28079-04-1CIPAC No: not allocated (Z)-8-dodecen-1-yl acetate
(Z)-9-dodecen-1-yl acetateCAS No: 16974-11-1CIPAC No: 422 (Z)-9-dodecen-1-yl acetate
(E,Z)-7,9-dodecadien-1-yl acetateCAS No: 54364-62-4CIPAC No: not allocated (E,Z)-7,9-dodecadien-1-yl acetate
(E)-11-tetradecen-1-yl acetateCAS No: 33189-72-9CIPAC No: not allocated (E)-11-tetradecen-1-yl acetate
(Z)-9-tetradecen-1-yl acetateCAS No: 16725-53-4CIPAC No: not allocated (Z)-9-tetradecen-1-yl acetate
(Z)-11-tetradecen-1-yl acetateCAS No: 20711-10-8CIPAC No: not allocated (Z)-11-tetradecen-1-yl acetate
(Z, E)-9, 12-tetradecadien-1-yl acetateCAS No: 31654-77-0CIPAC No: not allocated (Z, E)-9, 12-tetradecadien-1-yl acetate
Z-11-hexadecen-1-yl acetateCAS No: 34010-21-4CIPAC No: not allocated Z-11-hexadecen-1-yl acetate
(Z, E)-7, 11-hexadecadien-1-yl acetateCAS No: 51606-94-4CIPAC No: not allocated Z, E)-7, 11-hexadecadien-1-yl acetate
(E, Z)-2, 13-octadecadien-1-yl acetate.CAS No: 86252-65-5CIPAC No: not allocated (E, Z)-2, 13-octadecadien-1-yl acetate.
Alcohol group: Alcohol group:
(E)-5-decen-1-olCAS No: 56578-18-8CIPAC No: not allocated (E)-5-decen-1-ol
(Z)-8-dodecen-1-olCAS No: 40642-40-8CIPAC No: not allocated (Z)-8-dodecen-1-ol
(E,E)-8,10-dodecadien-1-olCAS No: 33956-49-9CIPAC No: not allocated (E,E)-8,10-dodecadien-1-ol
tetradecan-1-olCAS No: 112-72-1CIPAC No: not allocated tetradecan-1-ol
(Z)-11-hexadecen-1-olCAS No: 56683-54-6CIPAC No: not allocated (Z)-11-hexadecen-1-ol
Aldehyde group: Aldehyde group:
(Z)-7-tetradecenalCAS No: 65128-96-3CIPAC No: not allocated (Z)-7-tetradecenal
(Z)-9-hexadecenalCAS No: 56219-04-6CIPAC No: not allocated (Z)-9-hexadecenal
(Z)-11-hexadecenalCAS No: 53939-28-9CIPAC No: not allocated (Z)-11-hexadecenal
(Z)-13-octadecenalCAS No: 58594-45-9CIPAC No: not allocated (Z)-13-octadecenal
Blends acetates: Blends acetates:
i)(Z)-8-dodecen-1-yl acetateCAS No: 28079-04-1CIPAC No: not allocated i) (Z)-8-dodecen-1-yl acetateCAS No: 28079-04-1CIPAC No: not allocated i)(Z)-8-dodecen-1-yl acetate i) (Z)-8-dodecen-1-yl acetate
i) (Z)-8-dodecen-1-yl acetateCAS No: 28079-04-1CIPAC No: not allocated
i) (Z)-8-dodecen-1-yl acetate
and ii) Dodecyl acetateCAS No: 112-66-3CIPAC No: not allocated; and ii) Dodecyl acetate;
i)(Z)-9-dodecen-1-yl acetateCAS No: 16974-11-1CIPAC No: 422and i) (Z)-9-dodecen-1-yl acetateCAS No: 16974-11-1CIPAC No: 422and i)(Z)-9-dodecen-1-yl acetateand i) (Z)-9-dodecen-1-yl acetateand
i) (Z)-9-dodecen-1-yl acetateCAS No: 16974-11-1CIPAC No: 422and
i) (Z)-9-dodecen-1-yl acetateand
ii)Dodecyl acetateCAS No: 112-66-3CIPAC No: 422; ii) Dodecyl acetateCAS No: 112-66-3CIPAC No: 422; ii)Dodecyl acetate; ii) Dodecyl acetate;
ii) Dodecyl acetateCAS No: 112-66-3CIPAC No: 422;
ii) Dodecyl acetate;
i)(E,Z)-7,9-dodecadien-1-yl acetateCAS No: 55774-32-8CIPAC No: not allocatedand i) (E,Z)-7,9-dodecadien-1-yl acetateCAS No: 55774-32-8CIPAC No: not allocatedand i)(E,Z)-7,9-dodecadien-1-yl acetate,and i) (E,Z)-7,9-dodecadien-1-yl acetate,and
i) (E,Z)-7,9-dodecadien-1-yl acetateCAS No: 55774-32-8CIPAC No: not allocatedand
i) (E,Z)-7,9-dodecadien-1-yl acetate,and
ii)(E,E)-7,9-dodecadien-1-yl acetateCAS No: 54364-63-5CIPAC No: not allocated; ii) (E,E)-7,9-dodecadien-1-yl acetateCAS No: 54364-63-5CIPAC No: not allocated; ii)(E,E)-7,9-dodecadien-1-yl acetate; ii) (E,E)-7,9-dodecadien-1-yl acetate;
ii) (E,E)-7,9-dodecadien-1-yl acetateCAS No: 54364-63-5CIPAC No: not allocated;
ii) (E,E)-7,9-dodecadien-1-yl acetate;
i)(Z,Z)-7,11-hexadecadien-1-yl acetateand i) (Z,Z)-7,11-hexadecadien-1-yl acetateand i)(Z,Z)-7,11-hexadecadien-1-yl acetateand i) (Z,Z)-7,11-hexadecadien-1-yl acetateand
i) (Z,Z)-7,11-hexadecadien-1-yl acetateand
i) (Z,Z)-7,11-hexadecadien-1-yl acetateand
ii)(Z,E)-7,11-hexadecadien-1-yl acetateCAS No: i) & ii) 53042-79-8CAS No: i) 52207-99-5CAS No: ii) 51606-94-4CIPAC No: not allocated; ii) (Z,E)-7,11-hexadecadien-1-yl acetateCAS No: i) & ii) 53042-79-8CAS No: i) 52207-99-5CAS No: ii) 51606-94-4CIPAC No: not allocated; ii)(Z,E)-7,11-hexadecadien-1-yl acetate; ii) (Z,E)-7,11-hexadecadien-1-yl acetate;
ii) (Z,E)-7,11-hexadecadien-1-yl acetateCAS No: i) & ii) 53042-79-8CAS No: i) 52207-99-5CAS No: ii) 51606-94-4CIPAC No: not allocated;
ii) (Z,E)-7,11-hexadecadien-1-yl acetate;
Blends aldehydes: Blends aldehydes:
i)(Z)-9-hexadecenalCAS No: 56219-04-6CIPAC No: not allocatedand i) (Z)-9-hexadecenalCAS No: 56219-04-6CIPAC No: not allocatedand i)(Z)-9-hexadecenaland i) (Z)-9-hexadecenaland
i) (Z)-9-hexadecenalCAS No: 56219-04-6CIPAC No: not allocatedand
i) (Z)-9-hexadecenaland
ii)(Z)-11-hexadecenalCAS No: 53939-28-9CIPAC: not allocatedand ii) (Z)-11-hexadecenalCAS No: 53939-28-9CIPAC: not allocatedand ii)(Z)-11-hexadecenaland ii) (Z)-11-hexadecenaland
ii) (Z)-11-hexadecenalCAS No: 53939-28-9CIPAC: not allocatedand
ii) (Z)-11-hexadecenaland
iii)(Z)-13-octadecenalCAS No: 58594-45-9CIPAC No: not allocated; iii) (Z)-13-octadecenalCAS No: 58594-45-9CIPAC No: not allocated; iii)(Z)-13-octadecenal; iii) (Z)-13-octadecenal;
iii) (Z)-13-octadecenalCAS No: 58594-45-9CIPAC No: not allocated;
iii) (Z)-13-octadecenal;
Blends mixtures: Blends mixtures:
i)(E)-5-decen-1-yl acetateCAS No: 38421-90-8CIPAC No: not allocatedand i) (E)-5-decen-1-yl acetateCAS No: 38421-90-8CIPAC No: not allocatedand i)(E)-5-decen-1-yl acetate and i) (E)-5-decen-1-yl acetate and
i) (E)-5-decen-1-yl acetateCAS No: 38421-90-8CIPAC No: not allocatedand
i) (E)-5-decen-1-yl acetate and
ii)(E)-5-decen-1-olCAS No: 56578-18-8CIPAC No: not allocated; ii) (E)-5-decen-1-olCAS No: 56578-18-8CIPAC No: not allocated; ii)(E)-5-decen-1-ol; ii) (E)-5-decen-1-ol;
ii) (E)-5-decen-1-olCAS No: 56578-18-8CIPAC No: not allocated;
ii) (E)-5-decen-1-ol;
i)(E/Z)-8-dodecen-1-yl acetateCAS No: as individual isomersCIPAC No: not allocated;and i) (E/Z)-8-dodecen-1-yl acetateCAS No: as individual isomersCIPAC No: not allocated;and i)(E/Z)-8-dodecen-1-yl acetateand i) (E/Z)-8-dodecen-1-yl acetateand
i) (E/Z)-8-dodecen-1-yl acetateCAS No: as individual isomersCIPAC No: not allocated;and
i) (E/Z)-8-dodecen-1-yl acetateand
i)(E)-8-dodecen-1-yl acetateCAS No: (E) 38363-29-0CIPAC No: not allocatedand i) (E)-8-dodecen-1-yl acetateCAS No: (E) 38363-29-0CIPAC No: not allocatedand i)(E)-8-dodecen-1-yl acetateand i) (E)-8-dodecen-1-yl acetateand
i) (E)-8-dodecen-1-yl acetateCAS No: (E) 38363-29-0CIPAC No: not allocatedand
i) (E)-8-dodecen-1-yl acetateand
i)(Z)-8-dodecen-1-yl acetateCAS No: (Z) 28079-04-1CIPAC No: not allocatedand i) (Z)-8-dodecen-1-yl acetateCAS No: (Z) 28079-04-1CIPAC No: not allocatedand i)(Z)-8-dodecen-1-yl acetateand i) (Z)-8-dodecen-1-yl acetateand
i) (Z)-8-dodecen-1-yl acetateCAS No: (Z) 28079-04-1CIPAC No: not allocatedand
i) (Z)-8-dodecen-1-yl acetateand
ii)(Z)-8-dodecen-1-olCAS No: ii) 40642-40-8CIPAC No: not allocated; ii) (Z)-8-dodecen-1-olCAS No: ii) 40642-40-8CIPAC No: not allocated; ii)(Z)-8-dodecen-1-ol; ii) (Z)-8-dodecen-1-ol;
ii) (Z)-8-dodecen-1-olCAS No: ii) 40642-40-8CIPAC No: not allocated;
ii) (Z)-8-dodecen-1-ol;
i)(Z)-11-hexadecenalCAS No: 53939-28-9CIPAC No: not allocatedand i) (Z)-11-hexadecenalCAS No: 53939-28-9CIPAC No: not allocatedand i)(Z)-11-hexadecenaland i) (Z)-11-hexadecenaland
i) (Z)-11-hexadecenalCAS No: 53939-28-9CIPAC No: not allocatedand
i) (Z)-11-hexadecenaland
ii)(Z)-11-hexadecen-1-yl acetateCAS No: 34010-21-4CIPAC No: not allocated ii) (Z)-11-hexadecen-1-yl acetateCAS No: 34010-21-4CIPAC No: not allocated ii)(Z)-11-hexadecen-1-yl acetate ii) (Z)-11-hexadecen-1-yl acetate
ii) (Z)-11-hexadecen-1-yl acetateCAS No: 34010-21-4CIPAC No: not allocated
ii) (Z)-11-hexadecen-1-yl acetate
262 Trimethylamine hydrochlorideCAS No: 593-81-7CIPAC No: not allocated Trimethylamine hydrochloride ≥ 988 g/kg 1 September 2009 31 August 2019 PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
263 UreaCAS No: 57-13-6CIPAC No: 8352 Urea ≥ 98 % w/w 1 September 2009 31 August 2019 PART AOnly uses as attractant and fungicide may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
264 Z-13-hexadecen-11-yn-1-yl acetateCAS No: 78617-58-0CIPAC: not allocated Z-13-hexadecen-11-yn-1-yl acetate ≥ 75 % 1 September 2009 31 August 2019 PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on Z-13-hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.
265 Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrateCAS No: 135459-81-3CIPAC: not allocated Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate ≥ 90 % 1 September 2009 31 August 2019 PART AOnly uses as attractant may be authorised.PART BFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.Conditions of use shall include, where appropriate, risk mitigation measures.’
terpinen-4-ol 562-74-3
γ-terpinene 99-85-4
α-terpinene 99-86-5
1,8-cineol 470-82-6
terpinen-4-ol ≥ 300 g/kg
γ-terpinene ≥ 100 g/kg
α-terpinene ≥ 50 g/kg
1,8-cineol trace
Citronellal (3,7-dimethyl-6-octenal).
Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).
Citronellol (3,7-dimethyl-6-octan-2-ol).
Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).
i) (Z)-8-dodecen-1-yl acetateCAS No: 28079-04-1CIPAC No: not allocated
i) (Z)-8-dodecen-1-yl acetate
i) (Z)-9-dodecen-1-yl acetateCAS No: 16974-11-1CIPAC No: 422and
i) (Z)-9-dodecen-1-yl acetateand
ii) Dodecyl acetateCAS No: 112-66-3CIPAC No: 422;
ii) Dodecyl acetate;
i) (E,Z)-7,9-dodecadien-1-yl acetateCAS No: 55774-32-8CIPAC No: not allocatedand
i) (E,Z)-7,9-dodecadien-1-yl acetate,and
ii) (E,E)-7,9-dodecadien-1-yl acetateCAS No: 54364-63-5CIPAC No: not allocated;
ii) (E,E)-7,9-dodecadien-1-yl acetate;
i) (Z,Z)-7,11-hexadecadien-1-yl acetateand
i) (Z,Z)-7,11-hexadecadien-1-yl acetateand
ii) (Z,E)-7,11-hexadecadien-1-yl acetateCAS No: i) & ii) 53042-79-8CAS No: i) 52207-99-5CAS No: ii) 51606-94-4CIPAC No: not allocated;
ii) (Z,E)-7,11-hexadecadien-1-yl acetate;
i) (Z)-9-hexadecenalCAS No: 56219-04-6CIPAC No: not allocatedand
i) (Z)-9-hexadecenaland
ii) (Z)-11-hexadecenalCAS No: 53939-28-9CIPAC: not allocatedand
ii) (Z)-11-hexadecenaland
iii) (Z)-13-octadecenalCAS No: 58594-45-9CIPAC No: not allocated;
iii) (Z)-13-octadecenal;
i) (E)-5-decen-1-yl acetateCAS No: 38421-90-8CIPAC No: not allocatedand
i) (E)-5-decen-1-yl acetate and
ii) (E)-5-decen-1-olCAS No: 56578-18-8CIPAC No: not allocated;
ii) (E)-5-decen-1-ol;
i) (E/Z)-8-dodecen-1-yl acetateCAS No: as individual isomersCIPAC No: not allocated;and
i) (E/Z)-8-dodecen-1-yl acetateand
i) (E)-8-dodecen-1-yl acetateCAS No: (E) 38363-29-0CIPAC No: not allocatedand
i) (E)-8-dodecen-1-yl acetateand
i) (Z)-8-dodecen-1-yl acetateCAS No: (Z) 28079-04-1CIPAC No: not allocatedand
i) (Z)-8-dodecen-1-yl acetateand
ii) (Z)-8-dodecen-1-olCAS No: ii) 40642-40-8CIPAC No: not allocated;
ii) (Z)-8-dodecen-1-ol;
i) (Z)-11-hexadecenalCAS No: 53939-28-9CIPAC No: not allocatedand
i) (Z)-11-hexadecenaland
ii) (Z)-11-hexadecen-1-yl acetateCAS No: 34010-21-4CIPAC No: not allocated
ii) (Z)-11-hexadecen-1-yl acetate
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) Commission Regulations (EC) No 1112/2002(2)and (EC) No 2229/2004(3)lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the active substances listed in the Annex to this Directive.
(2) By Regulation (EC) No 1095/2007(4)a new Article 24b was inserted into Regulation (EC) No 2229/2004 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.
(3) For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 24a of Regulation (EC) No 2229/2004 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 24b of Regulation (EC) No 2229/2004.
(4) In accordance with Article 25(1) of Regulation (EC) No 2229/2004 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2008 in the format of the Commission review reports. In accordance with Article 25a of Regulation (EC) No 2229/2004 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.
(5) It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
(6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
(7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing the active substances listed in the Annex to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives that have been adopted until now amending Annex I.
(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2
Member States shall adopt and publish by 28 February 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 March 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing the active substances listed in the Annex as active substances by 28 February 2010.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to the active substances listed in the Annex are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holders of the authorisations have, or have access to, dossiers satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing one of the active substances listed in the Annex as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning the active substances listed in the Annex. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(a)
in the case of a product containing one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 31 August 2015 at the latest; or
(b)
in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 31 August 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4
This Directive shall enter into force on 1 September 2009.

Article 5
This Directive is addressed to the Member States.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), and in particular Article 6(1) thereof,
(1) Commission Regulations (EC) No 1112/2002(2)and (EC) No 2229/2004(3)lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the active substances listed in the Annex to this Directive.
(2) By Regulation (EC) No 1095/2007(4)a new Article 24b was inserted into Regulation (EC) No 2229/2004 to allow active substances for which there are clear indications that it may be expected that they do not have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment, to be included in Annex I to Directive 91/414/EEC without detailed scientific advice from the European Food Safety Authority (EFSA) having been sought.
(3) For the active substances listed in the Annex to this Directive the Commission examined in accordance with Article 24a of Regulation (EC) No 2229/2004 the effects on human, animal health, groundwater and the environment for a range of uses proposed by the notifiers, with the conclusion that those active substances satisfy the requirements of Article 24b of Regulation (EC) No 2229/2004.
(4) In accordance with Article 25(1) of Regulation (EC) No 2229/2004 the Commission has submitted draft review reports for the active substances listed in the Annex to this Directive to the Standing Committee on the Food Chain and Animal Health, for examination. Those reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2008 in the format of the Commission review reports. In accordance with Article 25a of Regulation (EC) No 2229/2004 the Commission is to request the EFSA to deliver its view on the draft review reports by 31 December 2010 at the latest.
(5) It has appeared from the various examinations made that plant protection products containing the active substances listed in the Annex to this Directive may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include in Annex I to that Directive the active substances listed in the Annex to this Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.
(6) A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.
(7) Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing the active substances listed in the Annex to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.
(8) The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives that have been adopted until now amending Annex I.
(9) It is therefore appropriate to amend Directive 91/414/EEC accordingly.
(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Member States shall adopt and publish by 28 February 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 1 March 2010.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
1. Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing the active substances listed in the Annex as active substances by 28 February 2010.
By that date they shall in particular verify that the conditions in Annex I to that Directive relating to the active substances listed in the Annex are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holders of the authorisations have, or have access to, dossiers satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
2. By way of derogation from paragraph 1, for each authorised plant protection product containing one of the active substances listed in the Annex as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning the active substances listed in the Annex. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
Following that determination Member States shall:
(a)
in the case of a product containing one of the active substances listed in the Annex as the only active substance, where necessary, amend or withdraw the authorisation by 31 August 2015 at the latest; or
(b)
in the case of a product containing one of the active substances listed in the Annex as one of several active substances, where necessary, amend or withdraw the authorisation by 31 August 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.
This Directive shall enter into force on 1 September 2009.
This Directive is addressed to the Member States.
ANNEXThe following entry shall be added at the end of the table in Annex I to Directive 91/414/EC:

No
Common Name, Identification Numbers
IUPAC Name
Purity (1) Entry into force
Expiration of inclusion
Specific provisions
‘224
Acetic acid
CAS No: 64-19-7
CIPAC No: not allocated
Acetic acid
≥ 980 g/kg
1 September 2009
31 August 2019
PART A
Only uses as herbicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on acetic acid (SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
225
Aluminium ammonium sulphate
CAS No: 7784-26-1
CIPAC No: not allocated
Aluminium ammonium sulphate
≥ 960 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
226
Aluminium silicate
CAS No: 1332-58-7
CIPAC No: not allocated
Not available
Chemical name: Kaolin
≥ 999,8 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium silicate (SANCO/2603/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
227
Ammonium acetate
CAS No: 631-61-8
CIPAC No: not allocated
Ammonium acetate
≥ 970 g/kg
Relevant impurity: Heavy metals as Pb maximum 10 ppm
1 September 2009
31 August 2019
PART A
Only uses as attractant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ammonium acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
228
Blood meal
CAS No: not allocated
CIPAC No: not allocated
Not available
≥ 990 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised. Blood meal must be in compliance with Regulation (EC) No 1774/2002. PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on blood meal (SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
229
Calcium carbide
CAS No: 75-20-7
CIPAC No: not allocated
Calcium carbide
Calcium acetylide
≥ 765 g/kg
Containing 0,08-0,52 g/kg Calcium Phosphide
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
230
Calcium carbonate
CAS No: 471-34-1
CIPAC No: not allocated
Calcium carbonate
≥ 995 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
231
Carbon dioxide
CAS No: 124-38-9
Carbon dioxide
≥ 99,9 %
1 September 2009
31 August 2019
PART A
Only uses as fumigant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carbon dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
232
Denathonium benzoate
CAS No: 3734-33-6
CIPAC No: not allocated
Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate
≥ 995 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
233
Ethylene
CAS No: 74-85-1
CIPAC No: not allocated
Ethene
≥ 99 %
1 September 2009
31 August 2019
PART A
Only uses as plant growth regulator may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethylene (SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
234
Extract from tea tree
CAS No: Tee Tree Oil 68647-73-4
Main components:

terpinen-4-ol 562-74-3

γ-terpinene 99-85-4

α-terpinene 99-86-5

1,8-cineol 470-82-6
CIPAC No: not allocated
Tee Tree Oil is a complex mixture of chemical substances.
Main components:

terpinen-4-ol ≥ 300 g/kg

γ-terpinene ≥ 100 g/kg

α-terpinene ≥ 50 g/kg

1,8-cineol trace
1 September 2009
31 August 2019
PART A
Only uses as fungicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on extract from tea tree (SANCO/2609/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
235
Fat destilation residues
CAS No: not allocated
CIPAC No: not allocated
Not available
≥ 40 % of cleaved fatty acids
Relevant impurity: Ni maximum 200 mg/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised. Fat destilation residues of animal origin must be in compliance with Regulation (EC) No 1774/2002. PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fat destilation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
236
Fatty acids C7 to C20
CAS No: 112-05-0 (Pelargonic Acid)
67701-09-1 (Fatty acids C7-C18 and C18 unsaturated potassium salts)
124-07-2 (Caprylic Acid)
334-48-5 (Capric Acid)
143-07-7 (Lauric Acid)
112-80-1 (Oleic Acid)
85566-26-3 (Fatty acids C8-C10 Me esters)
111-11-5 (Methyl octanoate)
110-42-9 (Methyl decanoate)
CIPAC No: not allocated
Nonanoic acid
Caprylic Acid, Pelargonic Acid, Capric Acid, Lauric Acid, Oleic Acid (ISO in each case)
Octanoic Acid, Nonanoic Acid, Decanoic Acid, Dodecanoic Acid, cis-9-Octadecenoic Acid (IUPAC in each case)
Fatty acids, C7-C10, Me esters
≥ 889 g/kg (Pelargonic Acid)
≥ 838 g/kg fatty acids
≥ 99 % fatty acid methyl esters
1 September 2009
31 August 2019
PART A
Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fatty acids (SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
237
Garlic extract
CAS No: 8008-99-9
CIPAC No: not allocated
Food grade garlic juice concentrate
≥ 99,9 %
1 September 2009
31 August 2019
PART A
Only uses as repellent, insecticide and nematicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on garlic extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
238
Gibberellic acid
CAS No: 77-06-5
CIPAC No: 307
(3S,3aS,4S,4aS,7S,9aR,9bR,12S)-7,12-dihydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenol(1,2-b)furan-4-carboxylic acid
Alt: (3S,3aR,4S,4aS,6S,8aR,8bR,11S)-6,11-dihydroxy-3-methyl-12-methylene-2-oxo-4a,6-methano-3,8b-prop-lenoperhydroindenol (1,2-b) furan-4-carboxylic acid
≥ 850 g/kg
1 September 2009
31 August 2019
PART A
Only uses as plant growth regulator may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on gibberellic acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
239
Gibberellins
CAS No: GA4: 468-44-0
GA7: 510-75-8
GA4A7 mixture: 8030-53-3
CIPAC No: not allocated
GA4:
(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-3,9b-propanoazuleno[1,2-b]furan-4-carboxylic acid
GA7:
(3S,3aR,4S,4aR,7R,9aR,9bR,12S)-12-hydroxy-3-methyl-6-methylene-2-oxoperhydro-4a,7-methano-9b,3-propenoazuleno[1,2-b]furan-4-carboxylic acid
Review report (SANCO/2614/2008).
1 September 2009
31 August 2019
PART A
Only uses as plant growth regulator may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on gibberellins (SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
240
Hydrolised proteins
Beet molasses urea hydrolysate
Collagen protein hydrolysate
CAS No: not allocated
CIPAC No: not allocated
Not available
Beet molasses urea hydrolysate: minimum Crude Protein Equivalent: 360 g/kg (36 % w/w)
Collagen protein hydrolysate: organic nitrogen content > 240 g/kg
1 September 2009
31 August 2019
PART A
Only uses as attractant may be authorised. Hydrolised proteins of animal origin must be in compliance with Regulation (EC) No 1774/2002
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on hydrolised proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
241
Iron sulphate
Iron(II)sulphate anhydrous: CAS No: 7720-78-7
Iron(II)sulphate monohydrate: CAS No: 17375-41-6
Iron(II)sulphate heptahydrate: CAS No: 7782-63-0
CIPAC No: not allocated
Iron (II) sulfate
Iron(II)sulphate anhydrous ≥ 367,5 g/kg
Iron(II)sulphate monohydrate ≥ 300 g/kg
Iron(II)sulphate heptahydrate ≥ 180 g/kg
1 September 2009
31 August 2019
PART A
Only uses as herbicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iron sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
242
Kieselgur (Diatomaceous earth)
CAS No: 61790-53-2
CIPAC No: 647
Kieselgur (diatomaceous earth)
920 ± 20 g SiO2/kg DE
Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)
1 September 2009
31 August 2019
PART A
Only uses as insecticide and acaricide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on kieselgur (SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
243
Limestone
CAS No: 1317-65-3
CIPAC No: not allocated
not available
≥ 980 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on limestone (SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
244
Methyl nonyl ketone
CAS No: 112-12-9
CIPAC No: not allocated
Undecan-2-one
≥ 975g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on methylnonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
245
Pepper
CAS No: not allocated
CIPAC No: not allocated
Black pepper — Piper nigrum
It is a complex mixture of chemical substances, the component piperine as marker should be minimum 4 %
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pepper (SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
246
Plant oils/citronella oil
CAS No: 8000-29-1
CIPAC No: not allocated
Citronella Oil is a complex mixture of chemical substances.
The main components are:

Citronellal (3,7-dimethyl-6-octenal).

Geraniol ((E)-3,7-dimethyl-2,6-octadien-1-ol).

Citronellol (3,7-dimethyl-6-octan-2-ol).

Geranyl acetate (3,7-dimethyl-6-octen-1yl acetate).
Relevant impurities methyl eugenol and methyl-isoeugenol maximum 0,1 %.
1 September 2009
31 August 2019
PART A
Only uses as herbicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on citronella oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
247
Plant oils/clove oil
CAS No: 94961-50-2 (clove oil)
97-53-0 (Eugenol — main component)
CIPAC No: not allocated
Clove Oil is a complex mixture of chemical substances.
The main component is eugenol.
≥ 800 g/kg
1 September 2009
31 August 2019
PART A
Only uses as fungicide and bactericide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on clove oil (SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
248
Plant oils/rape seed oil
CAS No: 8002-13-9
CIPAC No: not allocated
Rape seed oil
Rape seed oil is a complex mixture of fatty acids
1 September 2009
31 August 2019
PART A
Only uses as insecticide and acaricide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
249
Plant oils/spear mint oil
CAS No: 8008-79-5
CIPAC No: not allocated
Spearmint oil
≥ 550 g/kg as L-Carvone
1 September 2009
31 August 2019
PART A
Only uses as plant growth regulator may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
250
Potassium hydrogen carbonate
CAS No: 298-14-6
CIPAC No: not allocated
Potassium hydrogen carbonate
≥ 99,5 %
1 September 2009
31 August 2019
PART A
Only uses as fungicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on potassium hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
251
Putrescin (1,4-Diaminobutane)
CAS No: 110-60-1
CIPAC No: not allocated
Butane-1,4-diamine
≥ 990 g/kg
1 September 2009
31 August 2019
PART A
Only uses as attractant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on putrescin (SANCO/2626/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
252
Pyrethrins
CAS No: (A) and (B):
Pyrethrins: 8003-34-7
Extract A: extractives of Chrysanthemum cinerariaefolium: 89997-63-7
pyrethrin 1: CAS 121-21-1
pyrethrin 2: CAS 121-29-9
cinerin 1: CAS 25402-06-6
cinerin 2: CAS 121-20-0
jasmolin 1: CAS 4466-14-2
jasmolin 2: CAS 1172-63-0
Extract B: pyrethrin 1: CAS 121-21-1
pyrethrin 2: CAS 121-29-9
cinerin 1: CAS 25402-06-6
cinerin 2: CAS 121-20-0
jasmolin 1: CAS 4466-14-2
jasmolin 2: CAS 1172-63-0
CIPAC No 32
Pyrethrins are a complex mixture of chemical substances.
Extract A: ≥ 500 g/kg Pyrethrins
Extract B: ≥ 480 g/kg Pyrethrins
1 September 2009
31 August 2019
PART A
Only uses as insecticide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
253
Quartz sand
CAS No: 14808-60-7
CIPAC No: not allocated
Quarz, Quartz, Siliciumdioxid, Silica, Silicon dioxide, SiO2
≥ 915 g/kg
Maximum 0,1 % of particles of Crystalline Silica (with diameter below 50 um.)
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quartz sand (SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
254
Repellents by smell of animal or plant origin/fish oil
CAS No: 100085-40-3
CIPAC No: not allocated
Fish Oil
≥ 99 %
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised. Fish oil must be in compliance with Regulation (EC) No 1774/2002
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fish oil (SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
255
Repellents by smell of animal or plant origin/sheep fat
CAS No: 98999-15-6
CIPAC No: not allocated
Sheep Fat
Pure sheep fat containing a maximum of 0,18 % w/w/water.
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised. Sheep fat must be in compliance with Regulation (EC) No 1774/2002
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sheep fat (SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
256
Repellents by smell of animal or plant origin/tall oil crude CAS No: 8002-26-4
CIPAC No: not allocated
Tall Oil Crude
Tall oil crude is a complex mixture of tall rosin and fatty acids
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tall oil crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
257
Repellents by smell of animal or plant origin/tall oil pitch CAS No: 8016-81-7
CIPAC No: not allocated
Tall Oil Pitch
Complex mixture of esters of fatty acids, rosin and small amounts of dimers and trimers of resin acids and fatty acids.
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tall oil pitch (SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
258
Sea-algae extract (formerly sea algae extract and sea weeds)
CAS No: not allocated
CIPAC No: not allocated
See algae extract
See algae extract is a complex mixture. Main components as markers: mannitol, fucoidans and alginates. Review report SANCO/2634/2008
1 September 2009
31 August 2019
PART A
Only uses as plant growth regulator may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sea algae extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
259
Sodium aluminium silicate
CAS No: 1344-00-9
CIPAC No: not allocated
Sodium aluminium silicate: Nax[(AlO2)x(SiO2)y] × zH2O
1 000 g/kg
1 September 2009
31 August 2019
PART A
Only uses as repellent may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sodium aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
260
Sodium Hypochlorite
CAS No: 7681-52-9
CIPAC No: not allocated
Sodium Hypochlorite
10 % (w/w) expressed as chlorine
1 September 2009
31 August 2019
PART A
Only uses as disinfectant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sodium hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
261
Straight Chain Lepidopteran Pheromones
Acetate group:
Review report (SANCO/2633/2008)
1 September 2009
31 August 2019
PART A
Only uses as attractants may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
(E)-5-decen-1-yl acetate
CAS No: 38421-90-8
CIPAC No: not allocated
(E)-5-decen-1-yl acetate
(E)-8-dodecen-1-yl acetate
CAS No: 38363-29-0
CIPAC No:
not allocated
(E)-8-dodecen-1-yl acetate
(E/Z)-8-dodecen-1-yl acetate
CAS No: not available
CIPAC No: not avaiable
(E/Z)-8-dodecen-1-yl acetate as individual isomers
(Z)-8-dodecen-1-yl acetate
CAS No: 28079-04-1
CIPAC No: not allocated
(Z)-8-dodecen-1-yl acetate
(Z)-9-dodecen-1-yl acetate
CAS No: 16974-11-1
CIPAC No: 422
(Z)-9-dodecen-1-yl acetate
(E,Z)-7,9-dodecadien-1-yl acetate
CAS No: 54364-62-4
CIPAC No: not allocated
(E,Z)-7,9-dodecadien-1-yl acetate
(E)-11-tetradecen-1-yl acetate
CAS No: 33189-72-9
CIPAC No: not allocated
(E)-11-tetradecen-1-yl acetate
(Z)-9-tetradecen-1-yl acetate
CAS No: 16725-53-4
CIPAC No: not allocated
(Z)-9-tetradecen-1-yl acetate
(Z)-11-tetradecen-1-yl acetate
CAS No: 20711-10-8
CIPAC No: not allocated
(Z)-11-tetradecen-1-yl acetate
(Z, E)-9, 12-tetradecadien-1-yl acetate
CAS No: 31654-77-0
CIPAC No: not allocated
(Z, E)-9, 12-tetradecadien-1-yl acetate
Z-11-hexadecen-1-yl acetate
CAS No: 34010-21-4
CIPAC No: not allocated
Z-11-hexadecen-1-yl acetate
(Z, E)-7, 11-hexadecadien-1-yl acetate
CAS No: 51606-94-4
CIPAC No: not allocated
Z, E)-7, 11-hexadecadien-1-yl acetate
(E, Z)-2, 13-octadecadien-1-yl acetate.
CAS No: 86252-65-5
CIPAC No: not allocated
(E, Z)-2, 13-octadecadien-1-yl acetate.
Alcohol group:
Alcohol group:
(E)-5-decen-1-ol
CAS No: 56578-18-8
CIPAC No: not allocated
(E)-5-decen-1-ol
(Z)-8-dodecen-1-ol
CAS No: 40642-40-8
CIPAC No: not allocated
(Z)-8-dodecen-1-ol
(E,E)-8,10-dodecadien-1-ol
CAS No: 33956-49-9
CIPAC No: not allocated
(E,E)-8,10-dodecadien-1-ol
tetradecan-1-ol
CAS No: 112-72-1
CIPAC No: not allocated
tetradecan-1-ol
(Z)-11-hexadecen-1-ol
CAS No: 56683-54-6
CIPAC No: not allocated
(Z)-11-hexadecen-1-ol
Aldehyde group:
Aldehyde group:
(Z)-7-tetradecenal
CAS No: 65128-96-3
CIPAC No: not allocated
(Z)-7-tetradecenal
(Z)-9-hexadecenal
CAS No: 56219-04-6
CIPAC No: not allocated
(Z)-9-hexadecenal
(Z)-11-hexadecenal
CAS No: 53939-28-9
CIPAC No: not allocated
(Z)-11-hexadecenal
(Z)-13-octadecenal
CAS No: 58594-45-9
CIPAC No: not allocated
(Z)-13-octadecenal
Blends acetates:
Blends acetates: i)
(Z)-8-dodecen-1-yl acetate
CAS No: 28079-04-1
CIPAC No: not allocated i)
(Z)-8-dodecen-1-yl acetate
and ii) Dodecyl acetate
CAS No: 112-66-3
CIPAC No: not allocated;
and ii) Dodecyl acetate; i)
(Z)-9-dodecen-1-yl acetate
CAS No: 16974-11-1
CIPAC No: 422
and i)
(Z)-9-dodecen-1-yl acetate
and
ii)
Dodecyl acetate
CAS No: 112-66-3
CIPAC No: 422;
ii)
Dodecyl acetate; i)
(E,Z)-7,9-dodecadien-1-yl acetate
CAS No: 55774-32-8
CIPAC No: not allocated
and i)
(E,Z)-7,9-dodecadien-1-yl acetate,
and
ii)
(E,E)-7,9-dodecadien-1-yl acetate
CAS No: 54364-63-5
CIPAC No: not allocated;
ii)
(E,E)-7,9-dodecadien-1-yl acetate; i)
(Z,Z)-7,11-hexadecadien-1-yl acetate
and i)
(Z,Z)-7,11-hexadecadien-1-yl acetate
and
ii)
(Z,E)-7,11-hexadecadien-1-yl acetate
CAS No: i) & ii) 53042-79-8
CAS No: i) 52207-99-5
CAS No: ii) 51606-94-4
CIPAC No: not allocated;
ii)
(Z,E)-7,11-hexadecadien-1-yl acetate;
Blends aldehydes:
Blends aldehydes: i)
(Z)-9-hexadecenal
CAS No: 56219-04-6
CIPAC No: not allocated
and i)
(Z)-9-hexadecenal
and
ii)
(Z)-11-hexadecenal
CAS No: 53939-28-9
CIPAC: not allocated
and
ii)
(Z)-11-hexadecenal
and
iii)
(Z)-13-octadecenal
CAS No: 58594-45-9
CIPAC No: not allocated;
iii)
(Z)-13-octadecenal;
Blends mixtures:
Blends mixtures: i)
(E)-5-decen-1-yl acetate
CAS No: 38421-90-8
CIPAC No: not allocated
and i)
(E)-5-decen-1-yl acetate and
ii)
(E)-5-decen-1-ol
CAS No: 56578-18-8
CIPAC No: not allocated;
ii)
(E)-5-decen-1-ol; i)
(E/Z)-8-dodecen-1-yl acetate
CAS No: as individual isomers
CIPAC No: not allocated;
and i)
(E/Z)-8-dodecen-1-yl acetate
and i)
(E)-8-dodecen-1-yl acetate
CAS No: (E) 38363-29-0
CIPAC No: not allocated
and i)
(E)-8-dodecen-1-yl acetate
and i)
(Z)-8-dodecen-1-yl acetate
CAS No: (Z) 28079-04-1
CIPAC No: not allocated
and i)
(Z)-8-dodecen-1-yl acetate
and
ii)
(Z)-8-dodecen-1-ol
CAS No: ii) 40642-40-8
CIPAC No: not allocated;
ii)
(Z)-8-dodecen-1-ol; i)
(Z)-11-hexadecenal
CAS No: 53939-28-9
CIPAC No: not allocated
and i)
(Z)-11-hexadecenal
and
ii)
(Z)-11-hexadecen-1-yl acetate
CAS No: 34010-21-4
CIPAC No: not allocated
ii)
(Z)-11-hexadecen-1-yl acetate
262
Trimethylamine hydrochloride
CAS No: 593-81-7
CIPAC No: not allocated
Trimethylamine hydrochloride
≥ 988 g/kg
1 September 2009
31 August 2019
PART A
Only uses as attractant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
263
Urea
CAS No: 57-13-6
CIPAC No: 8352
Urea
≥ 98 % w/w
1 September 2009
31 August 2019
PART A
Only uses as attractant and fungicide may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on urea (SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
264
Z-13-hexadecen-11-yn-1-yl acetate
CAS No: 78617-58-0
CIPAC: not allocated
Z-13-hexadecen-11-yn-1-yl acetate
≥ 75 %
1 September 2009
31 August 2019
PART A
Only uses as attractant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Z-13-hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
265
Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate
CAS No: 135459-81-3
CIPAC: not allocated
Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate
≥ 90 %
1 September 2009
31 August 2019
PART A
Only uses as attractant may be authorised.
PART B
For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Z,Z,Z,Z-7,13,16,19-docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.’

(1) Further details on identity and specification of active substance are provided in the review report.

Pending: 32008L0126

January 16, 2026
31.1.2009 EN Official Journal of the European Union L 32/1
(1) Binding administrative instructions for the inspection have been adopted pursuant to Article 22 of the Revised Convention for Rhine Navigation. It is therefore necessary to amend Directive 2006/87/EC accordingly.
(2) It should be ensured that the Community vessel certificate and the vessel certificate delivered in accordance with the Rhine Vessel Inspection Regulation are issued on the basis of technical requirements which guarantee an equivalent level of safety.
(3) In order to avoid distortions of competition as well as different levels of safety, the amendments to Directive 2006/87/EC should be implemented as quickly as possible.
(4) The measure provided for in this Directive are in accordance with the opinion of the Committee established under Article 7 of Council Directive 91/672/EEC of 16 December 1991 on the reciprocal recognition of national boatmasters’ certificates for the carriage of goods and passengers by inland waterway(2),
No 1 : Requirements relating to the capacity for taking evasive action and turning capacity
No 2 : Requirements concerning prescribed (forward) speed, stopping capacity and capacity for going astern
No 3 : Requirements for coupling systems and coupling devices for craft suitable for propelling or being propelled in a rigid assembly
No 4 : Left void
No 5 : Noise measurements
No 6 : Left void
No 7 : Special anchors with reduced mass
No 8 : Strength of watertight windows
No 9 : Requirements for automatic pressurised water sprinklers
No 10 : Left void
No 11 : Completion of the Community Certificate
No 12 : Fuel tanks on floating equipment
No 13 : Minimum hull thickness of barges
No 14 : Left void
No 15 : Steerageway under vessel's own power
No 16 : Left void
No 17 : Appropriate fire alarm system
No 18 : Proof of buoyancy, trim and stability of the separated parts of a vessel
No 19 : Left void
No 20 : Equipment for vessels to be operated according to standards S1 and S2
No 21 : Requirements for low-location lighting
No 22 : Specific safety needs of persons with reduced mobility
No 23 : Left void
No 24 : Suitable gas warning equipment
No 25 : Electrical cables
Dimensions of vessels or convoysL × B Required turning speedr1= r3(°/min) Limit values for the time t4(s) in shallow and deep water
δ = 20° δ = 45° 1,2 ≤ h/T ≤ 1,4 1,4 < h/T < 2 h/T > 2
1 All motor vessels; single-in-line convoys ≤ 110 × 11,45 20°/min 28°/min 150 s 110 s 110 s
2 Single-in-line convoys up to 193 × 11,45 or two-abreast convoys up to 110 × 22,90 12°/min 18°/min 180 s 130 s 110 s
3 Two-abreast convoys ≤ 193 × 22,90 8°/min 12°/min 180 s 130 s 110 s
4 Two-abreast convoys up to 270 × 22,90 or three-abreast convoys up to 193 × 34,35 6°/min 8°/min (*1) (*1) (*1)
— one to starboard with a rudder angle δ = 20°
— one to port with a rudder angle δ = 20°
— one to starboard with a rudder angle δ = 45°
— one to port with a rudder angle δ = 45°.
(a) for manually controlled steering systems, a single turn of the wheel shall correspond to a rudder angle of at least 3°;
(b) for powered steering systems, when the rudder is at maximum immersion, it shall be possible to achieve an average angular velocity of 4°/s over the rudder’s entire turning range.
t0 = Start of evasive action manoeuvre
t1 = Time to reach turning speed r1
t2 = Time to reach turning speed r2= 0
t3 = Time to reach turning speed r3
t4 = Time to reach turning speed r4= 0 (end of evasive action manoeuvre)
δ = Rudder angle [°]
r = Turning speed [°/min]
Type of craft: … Test area: …
or convoy: … Relevant water level [m]: …
L × B [m × m]: … Depth of water h [m]: …
Ttest[m]: … h/T: …
Timet1to t4required for the evasive action Rudder angle δ or δa(*3)at which evasive action commencesand turning speed to be complied with r1= r3 Comments
δ = 20° STAR(*3) δ = 20° PORT(*3) δ = 45° STAR(*3) δ = 45° PORT(*3)
δa= … STAR(*3) δa= … PORT(*3) δa= … STAR(*3) δa= … PORT(*3)
r1= r3= … °/min r1= r3= … °/min
t1[s]
t2[s]
t3[s]
t4[s]
Limit value t4according to 2.2 Limit value t4= … [s]
(a) the keel clearance set out in point 2.1 shall be complied with;
(b) the measuring, recording, registration and evaluation of test data shall be carried out.
(a) In flowing water (current velocity of 1,5 m/s), stopping in relation to the water shall be demonstrated over a maximum distance measured in relation to the ground of:550 m for vessels and convoys of:—length L > 110 m or—width B > 11,45 m,or480 m for vessels and convoys of:—length L ≤ 110 m and—width B ≤ 11,45 m.The stopping manoeuvre is completed on coming to a stop in relation to the ground. — length L > 110 m or — width B > 11,45 m, — length L ≤ 110 m and — width B ≤ 11,45 m.
— length L > 110 m or
— width B > 11,45 m,
— length L ≤ 110 m and
— width B ≤ 11,45 m.
— length L > 110 m or
— width B > 11,45 m,
— length L ≤ 110 m and
— width B ≤ 11,45 m.
(b) In standing water (current velocity of less than 0,2 m/s), stopping in relation to the water shall be demonstrated over a maximum distance, measured in relation to the ground of:350 m for vessels and convoys of:—length L > 110 m or—width B > 11,45 m,or305 m for vessels and convoys of:—length L ≤ 110 m and—width B ≤ 11,45 m.In standing water, a test shall also be performed to demonstrate that a speed of not less than 6,5 km/h can be reached when going astern. — length L > 110 m or — width B > 11,45 m, — length L ≤ 110 m and — width B ≤ 11,45 m.
— length L > 110 m or
— width B > 11,45 m,
— length L ≤ 110 m and
— width B ≤ 11,45 m.
— length L > 110 m or
— width B > 11,45 m,
— length L ≤ 110 m and
— width B ≤ 11,45 m.
A “stop” order
B propeller stopped
C propeller in reverse
D v = 0 in relation to the water
E v = 0 in relation to the ground
v speed of vessel
vL v in relation to the ground
s distance covered in relation to the ground
t measured time
Inspection Body: … Type of vessel or convoy: … Test area: …
L × B [m]: … Water level gauge reading [m]: …
Date: … T at test [m]: … Water depth [m]: …
Name: … Load at Test [t]: … Gradient [m/km]: …
Test run No: … % of maximum deadweight … VSTR [km/h]: …
Power of propulsion engines PB[kW] … [m/s]: …
Propulsion system according to Annex 2, table 2: … Max. displacement [m3]: …
Position[river-km] Time[sec.] Δs[m] Δt[sec.] vIL[km/h] Engine speed n[min–1] Observations
— Phase I (“Full ahead” reversed to “full astern”):SIand
— Phase II (End of reversal until vessel stops in relation to the water):SII
Calculation Formulae: with the following coefficients
4.1. —k1according to table 1 — k1according to table 1
— k1according to table 1
4.2. —k2, k3, k4according to table 1 — k2, k3, k4according to table 1
— k2, k3, k4according to table 1
4.3. —k6, k7according to table 1—RT/v2according to table 3 — k6, k7according to table 1 — RT/v2according to table 3
— k6, k7according to table 1
— RT/v2according to table 3
4.4.
4.5. —k6according to table 1 — k6according to table 1
— k6according to table 1
4.6. —f according to table 2 — f according to table 2
— f according to table 2
4.7. —k4according to table 1 — k4according to table 1
— k4according to table 1
— k1according to table 1
— k2, k3, k4according to table 1
— k6, k7according to table 1
— RT/v2according to table 3
— k6according to table 1
— f according to table 2
— k4according to table 1
vL Speed in relation to the ground at the start of reversal (m/s)
tI Reversal time (s)
vII Speed in relation to the water at the end of reversal (m/s)
D Displacement (m3)
FPOR Bollard pull in reverse (kN)
PB Power of propulsion engine (kW)
RTmII Average resistance during phase II, to be determined using the diagram for determining RT/v2 (kN)
RG Gradient resistance (kN)
i Gradient in m/km (if missing to be taken as 0,16) (m/km)
vSTR Average current velocity (m/s)
g Acceleration due to gravity (9,81) (m/s2)
ρ Density of water, ρ fresh water = 1 000 (kg/m3)
T Maximum draught (of vessel or convoy) (m)
h Water depth (m)
B Width (m)
L Length (m)
(a) Motor vessels and single file convoys
(b) Two-abreast convoys
(c) Three-abreast convoys
a b c Units
k1 0,95 0,95 0,95 —
k2 0,115 0,120 0,125
k3 1,20 1,15 1,10 —
k4 0,48 0,48 0,48 —
k6 0,90 0,85 0,80 —
k7 0,58 0,55 0,52 —
Propulsion system f Units
Modern nozzles with rounded rear edge 0,118 kN/kW
Old nozzles with sharp rear edge 0,112 kN/kW
Propellers without nozzle 0,096 kN/kW
Rudder propellers with nozzles (generally sharp rear edge) 0,157 kN/kW
Rudder propellers without nozzles 0,113 kN/kW
L [m] B [m] Tmax[m] Dwt(*4)max[t] Dmax[m3] PB[kW]
Motor vessel 110 11,4 3,5 2 900 3 731 1 500
Lighter 76,5 11,4 3,7 2 600 2 743 —
Convoy 110 22,8 3,7 5 500 6 474 1 500
Propulsion system of the motor vessel: modern nozzles with rounded rear edge
Current velocity: vSTRactual = 1,4m/s ≈ 5,1km/h
Speed of vessel (in relation to the water): VSactual = 3,5m/s ≈ 12,5km/h
Speed of vessel (in relation to the ground): VLactual = 4,9m/s ≈ 17,6km/h
Reversal time (measured) (pointAtoC): tI = 16s
Stopping distance in relation to the water (pointAtoD): SMEASURED = 340m
Load condition (possibly estimated): Dactual = 5 179m3 ≈ 0,8Dmax
Actual draught of convoy: Tactual = 2,96m ≈ 0,8Tmax
— Measured valueaccording to Appendix 1 (see point 2)smeasured= 340m
— to be calculated:sactualas the sum ofsIactual(according to formula 4.1 of Appendix 2 with vLactual)andsIIactual(according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with actual speedsvIIactual, vSTRactual, Dactual)sreferenceas the sum ofsIreference(according to formula 4.1 of Appendix 2 with vLreference)andsIIreference(according to formulae 4.2 to 4.6 of Appendix 2 with the reference speeds according to 2.1 of the Administrative instruction and given that the load condition is greater than 70 % of the maximum load (≈ 80 %):Dreference= DactualandTreference= Tactual) sIactual (according to formula 4.1 of Appendix 2 with vLactual) sIIactual (according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with actual speedsvIIactual, vSTRactual, Dactual) sIreference (according to formula 4.1 of Appendix 2 with vLreference) sIIreference (according to formulae 4.2 to 4.6 of Appendix 2 with the reference speeds according to 2.1 of the Administrative instruction and given that the load condition is greater than 70 % of the maximum load (≈ 80 %):Dreference= DactualandTreference= Tactual)
sIactual (according to formula 4.1 of Appendix 2 with vLactual)
sIIactual (according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with actual speedsvIIactual, vSTRactual, Dactual)
sIreference (according to formula 4.1 of Appendix 2 with vLreference)
sIIreference (according to formulae 4.2 to 4.6 of Appendix 2 with the reference speeds according to 2.1 of the Administrative instruction and given that the load condition is greater than 70 % of the maximum load (≈ 80 %):Dreference= DactualandTreference= Tactual)
sIactual (according to formula 4.1 of Appendix 2 with vLactual)
sIIactual (according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with actual speedsvIIactual, vSTRactual, Dactual)
sIreference (according to formula 4.1 of Appendix 2 with vLreference)
sIIreference (according to formulae 4.2 to 4.6 of Appendix 2 with the reference speeds according to 2.1 of the Administrative instruction and given that the load condition is greater than 70 % of the maximum load (≈ 80 %):Dreference= DactualandTreference= Tactual)
— to be checked:
for sIactualand sIreference k1 = 0,95
for sIIactualand sIIreference k2 = 0,12
k3 = 1,15
k4 = 0,48
k6 = 0,85
k7 = 0,55
(a) sIactualwith the values measured during the stopping manoeuvre (formula 4.1)
(b) Formula forsIIactual
(c) Calculation ofRTmIIactualaccording to table 3 and formula 4.3 of Appendix 2according to table 3
(d) Calculation of resistance to gradientaccording to formula 4.4
(e) Calculation of vIIactualaccording to formula 4.5
(f) Calculation ofFPORaccording to formula 4.6 and table 2
(g) Calculation ofsIIactualusing formula (b) and the results of (c), (d), (e) and (f)
(h) Calculation of total distance according to formula 3.1Note:The term (RtmII—RG), which is a function of D, with an actual value of 20,67 kN is obviously relatively small compared tok3·FPORwith an actual value of 203,55 kN, so for simplification purposes,sIIcan be taken as proportional toD, i.e.sII= Constant ·D.
(a)
(b)
(c) calculation ofRTmIIreferenceas in point 4.2, sinceB, DandTare unchanged.
(d) Resistance due to gradientRGas in point 4.2
(e) Calculation ofvIIreference
(f) FPORas in point 4.2.
(g) Calculation ofsIIreferenceusing formula (b) and the result from (c) to (f)=0,0472· 5 179 =244,5m = 0,0472 · 5 179 =244,5m
= 0,0472 · 5 179 =244,5m
= 0,0472 · 5 179 =244,5m
(h) Calculation of total distance
— admission to downstream navigation is possible without problems for the actual load condition (0,8 · Dmax),
— a higher load condition is possible and may be calculated according to point 5 below.
L [m] B [m] Tmax[m] Dwt(*5)max[t] Dmax[m3] PB[kW]
Motor vessel 110 11,4 3,5 2 900 3 731 1 500
Each lighter 76,5 11,4 3,7 2 600 2 743 —
Convoy 186,5 22,8 3,7 10 700 11 960 1 500
Propulsion system of the self-propelled vessel: modern nozzles with rounded rear edge.
Current velocity: vSTRactual = 1,4m/s ≈ 5,1km/h
Speed of vessel (in relation to the water): VSactual = 3,5m/s ≈ 12,5km/h
Speed of vessel (in relation to the bank): VLactual = 4,9m/s ≈ 17,6km/h
Reversal time (measured) (pointAtoC): tI = 16 sec
Stopping distance in relation to the water (pointAtoD): smeasured = 580m
Load condition (possibly estimated): Dactual = 9 568m3 ≈ 0,8Dmax
Actual draught of convoy: Tactual = 2,96 m ≈ 0,8Tmax
— Measured value:smeasured= 340m
— calculations to be made:sactualas the sum ofsIactual(according to formula 4.1 of Appendix 2 withVLactual)andsIIactual(according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with real speedsvLactual(see under 2 above) and Dactual)sreference:sum sIreference+sIIreference(according to formulae 4.1 to 4.6 of Appendix 2 with reference speeds and in conformity of Appendix 2, because the load condition > 70 % of maximum, whereDreference= Dactualand Treference=Tactual) sIactual (according to formula 4.1 of Appendix 2 withVLactual) sIIactual (according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with real speedsvLactual(see under 2 above) and Dactual) sreference:sum sIreference+sIIreference (according to formulae 4.1 to 4.6 of Appendix 2 with reference speeds and in conformity of Appendix 2, because the load condition > 70 % of maximum, whereDreference= Dactualand Treference=Tactual)
sIactual (according to formula 4.1 of Appendix 2 withVLactual)
sIIactual (according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with real speedsvLactual(see under 2 above) and Dactual)
sreference:sum sIreference+sIIreference (according to formulae 4.1 to 4.6 of Appendix 2 with reference speeds and in conformity of Appendix 2, because the load condition > 70 % of maximum, whereDreference= Dactualand Treference=Tactual)
sIactual (according to formula 4.1 of Appendix 2 withVLactual)
sIIactual (according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with real speedsvLactual(see under 2 above) and Dactual)
sreference:sum sIreference+sIIreference (according to formulae 4.1 to 4.6 of Appendix 2 with reference speeds and in conformity of Appendix 2, because the load condition > 70 % of maximum, whereDreference= Dactualand Treference=Tactual)
— to be verified:, otherwise
— calculate:s*standard= 550m by reduction of Dactualto D*
forsIactualandsIreference k1 = 0,95
forsIactualandsIreference k2 = 0,12
k3 = 1,15
k4 = 0,48
k5 = 0,85
k7 = 0,55
(a) sIactualUsing the values measured during the stopping manoeuvressIactual=k1·vLactual·tIactualsIactual= 0,95 · 4,8 · 16 =73m
(b) formula forsIIactual
(c) Calculation of RTmIIactualaccording to table 3 and formula 4.3 of Appendix 2from table 3
(d) Calculation of resistance due to gradientaccording to formula 4.4 of Appendix 2.
(e) Calculation of vIIactualaccording to formula 4.5 of Appendix 2
(f) Calculation ofFPORacording to formula 4.6 and table 2
(g) Calculation of sIIactualusing formula (b) and the result of (c), (d), (e) and (f)SIIactual=402m
(h) Calculation of the total distance according to formula 3.1sactual= 73 + 402 =475m
(a)
(b)
(c) Calculation ofas under point 4.2 since B, D and T and unchanged
(d) Resistance due to gradientas under point 4.2
(e) Calculation of,
(f) as under point 4.2
(g) Calculation ofusing formula (b) and the result of (c) to (f)SIIreference=0,04684· 9 568 =448 m SIIreference= 0,04684 · 9 568 =448 m
SIIreference= 0,04684 · 9 568 =448 m
SIIreference= 0,04684 · 9 568 =448 m
(h) Calculation of the total distance
FSB, FSF, FSL[kN] Coupling force of the longitudinal connection;
PB[kW] Installed power of the propulsion engine;
LS[m] Distance from the stern of the pusher or pushing craft to the coupling point;
L'S[m] Distance from the stern of the pushing craft to the coupling point between the first pushed craft and the craft coupled ahead of it;
hK, h'K[m] Respective lever arm of the longitudinal connection;
BS[m] Width of the pushing craft;
270 and 80 Empirically established values for the conversion of installed power to thrust while ensuring adequate levels of safety.
— on board craft in accordance with ISO 2923:2003
— air noise emitted from craft in accordance with EN ISO 2922:2000(*6)
Number Manufacturer Type Year of construction Power (kW) Engine speed(min–1) Two-stroke/four-stroke Turbo-chargedyes/no
1
2
Number Propulsion of Manufacturer Type Year of construction Power (kW) Engine speed (min–1)
1
2
3
4
5
Number Measurement point Doors Windows Measured valuein dB(A) Observations
open closed open closed
Number Measurement point Measured valuesin dB(A) Observations
Anchor No Authorised reduction of anchor mass(%) Competent authority
1.HA-DU 1. HA-DU 30 % Germany
1. HA-DU
2.D'Hone Spezial 2. D'Hone Spezial 30 % Germany
2. D'Hone Spezial
3.Pool 1 (hollow) 3. Pool 1 (hollow) 35 % Germany
3. Pool 1 (hollow)
4.Pool 2 (solid) 4. Pool 2 (solid) 40 % Germany
4. Pool 2 (solid)
5.De Biesbosch-Danforth 5. De Biesbosch-Danforth 50 % Germany
5. De Biesbosch-Danforth
6.Vicinay-Danforth 6. Vicinay-Danforth 50 % France
6. Vicinay-Danforth
7.Vicinay AC 14 7. Vicinay AC 14 25 % France
7. Vicinay AC 14
8.Vicinay Type 1 8. Vicinay Type 1 45 % France
8. Vicinay Type 1
9.Vicinay Type 2 9. Vicinay Type 2 45 % France
9. Vicinay Type 2
10.Vicinay Type 3 10. Vicinay Type 3 40 % France
10. Vicinay Type 3
11.Stockes 11. Stockes 35 % France
11. Stockes
12.D'Hone-Danforth 12. D'Hone-Danforth 50 % Germany
12. D'Hone-Danforth
13.Schmitt high holding anchor 13. Schmitt high holding anchor 40 % Netherlands
13. Schmitt high holding anchor
1. HA-DU
2. D'Hone Spezial
3. Pool 1 (hollow)
4. Pool 2 (solid)
5. De Biesbosch-Danforth
6. Vicinay-Danforth
7. Vicinay AC 14
8. Vicinay Type 1
9. Vicinay Type 2
10. Vicinay Type 3
11. Stockes
12. D'Hone-Danforth
13. Schmitt high holding anchor
(a) an outline of the dimensions and mass of the special anchor, giving the main dimensions and type designation for each available anchor size;
(b) a braking force diagram for the reference anchor A (in accordance with point 2.2) and the special anchor B to be authorised which has been prepared and assessed by an institution designated by the competent authority.
r the percentage of reduction of anchor mass of special anchor B in relation to reference anchor A;
PA the mass of reference anchor A;
PB the mass of special anchor B;
FA holding force of reference anchor A at v = 0,5 km/h;
FB holding force of special anchor B at v = 0,5 km/h;
AA the surface area on the braking force diagram defined by:—the line parallel to the y-axis at v = 0,—the line parallel to the y-axis at v = 5 km/h,—the line parallel to the x-axis at holding force F = 0,—the braking force curve for reference anchor A,Model braking force diagram(Determining the surface areas AA and AB) — the line parallel to the y-axis at v = 0, — the line parallel to the y-axis at v = 5 km/h, — the line parallel to the x-axis at holding force F = 0, — the braking force curve for reference anchor A,Model braking force diagram(Determining the surface areas AA and AB)
— the line parallel to the y-axis at v = 0,
— the line parallel to the y-axis at v = 5 km/h,
— the line parallel to the x-axis at holding force F = 0,
— the braking force curve for reference anchor A,Model braking force diagram(Determining the surface areas AA and AB)
AB same definition as for AA except that the braking force curve for special anchor B is used.
— the line parallel to the y-axis at v = 0,
— the line parallel to the y-axis at v = 5 km/h,
— the line parallel to the x-axis at holding force F = 0,
— the braking force curve for reference anchor A,Model braking force diagram(Determining the surface areas AA and AB)
1. The automatic pressurised water sprinkler shall be ready for service at all times when there are persons on board. No additional action by crew members shall be required to trigger operation.
2. The system shall be permanently maintained at the necessary pressure. The pipes shall be filled with water up to the spray nozzles at all times. The system shall have a continuously working water supply. It shall not be possible for impurities harmful to operation to enter the system. Appropriate display instruments and test systems (e.g. pressure gauges, pressure-tank water level indicators, pump test piping) shall be installed for monitoring and checking the system.
3. The pump for the water supply to the spray nozzles shall be activated automatically by a pressure drop in the system. The pump shall be dimensioned so that it can continuously provide a sufficient water supply at the necessary pressure if all the spray nozzles necessary for covering the area of the largest room to be protected are activated simultaneously. The pump shall supply the automatic pressurised water sprinkler exclusively. In the event of pump failure, it shall be possible to provide the spray nozzles with a sufficient water supply from another on-board pump.
4. The system shall be divided into sections, each with no more than 50 spray nozzles.
5. The number and the layout of spray nozzles shall ensure effective distribution of water in the rooms to be protected.
6. Spray nozzles shall be triggered at a temperature between 68 °C and 79 °C.
7. The installation of components of automatic pressurised water sprinklers within the rooms to be protected shall be limited to the necessary minimum. No such system components shall be installed in main engine rooms.
8. Visual and acoustic indicators shall be provided in one or more suitable locations, at least one of which must be permanently manned, displaying activation of automatic pressurised water sprinklers for each section.
9. The energy supply of the installation of automatic pressurised water sprinklers shall be provided by two independent energy sources that shall not be installed in the same location. Each energy source shall be capable of supplying the entire system unassisted.
10. An installation plan of the automatic pressurised water sprinkler shall be presented to the inspection body for examination before installation of the system. The plan shall indicate the types and performance data of the machines and equipment used. An installation tested and certified by an approved classification society which complies at least with the above prescriptions can be authorised without further testing.
11. The presence of an automatic pressurised water sprinkler shall be entered in the Community Certificate under item 43.
2. If applicable, insert terms as per Article 1.01. Other vessel types shall be entered with their commonly accepted designation.
15. This section shall only be completed for craft for which at least one of the properties 1.1 or 1.2 or 3 in item 14 is not deleted, otherwise the entire table shall be deleted.
15.1. In the column “formation figure” of the table the number(s) of the formations depicted shall be entered. Lines without entry shall be struck through.Further formations may be drawn under “Other formations” and shall be designated 18, 19, 20, etc.If it is not apparent from the property “fit to push” in the previous ship certificate which formations are authorised, the entry from the previous ship certificate may be transferred to item 52. “See item 52” shall be entered in line 1 of the table “Authorised formations”.
15.2. CouplingsOnly the details of the coupling between the pushing craft and the pushed section of the convoy shall be entered.
17-20. Details according to the tonnage certificate items 17-19 to two decimal places and item 20 without decimal places. Length overall and breadth overall give the maximum dimensions of the craft, including all projecting fixed parts. Length L and Breadth B give the maximum hull dimensions (see also Article 1.01 Definitions).
21. Dead weight tonnage for cargo vessels in t according to the tonnage certificate for the maximum draught according to item 19.Displacement for all other craft in m3. If no tonnage certificate is available, calculate the displacement from the product of the block coefficient and length LWL, breadth BWLand mean draught at maximum immersion.
23. Number of passenger berths available (including folding beds and similar).
24. Only watertight transverse bulkheads extending from one side of the vessel to the other shall be taken into consideration.
26. If applicable, the following terms shall be used:—manually operated hatch covers,—manually operated rolling hatch covers,—manually operated sliding hatch covers,—mechanically operated sliding hatch covers,—mechanically operated hatch covers.Other types of hatch covers shall be entered with their commonly accepted designation.Any holds which do not have a hatch cover shall be listed, e.g. under item 52. — manually operated hatch covers, — manually operated rolling hatch covers, — manually operated sliding hatch covers, — mechanically operated sliding hatch covers, — mechanically operated hatch covers.
— manually operated hatch covers,
— manually operated rolling hatch covers,
— manually operated sliding hatch covers,
— mechanically operated sliding hatch covers,
— mechanically operated hatch covers.
— manually operated hatch covers,
— manually operated rolling hatch covers,
— manually operated sliding hatch covers,
— mechanically operated sliding hatch covers,
— mechanically operated hatch covers.
28. Figure without decimal place.
30, 31 and 33. Every winch housing shall be counted as one winch, regardless of the number of anchors or towing cables connected to it.
34. Under “Other installations” systems which do not use rudder blades (e.g. rudder-propeller, cycloidal-propeller, bow-thruster systems) shall be entered.Enter also any electrical auxiliary engines for manual actuation.With bow-thruster systems, “remote-controlled” refers only to remote controls operated from the steering position in the wheelhouse.
35. Only the theoretical values according to Article 8.08(2) and (3), Article 15.01(1)(c), and Article 15.08(5) shall be entered, and then only for craft whose keels were laid down after 31 December 1984.
36. A sketch may be necessary for clarification.
37. Only the theoretical values without reduction according to Article 10.01(1)-(4) shall be entered.
38. Only the minimum lengths according to Article 10.01(10) and the minimum tensile strength according to Article 10.01(11) shall be entered.
39 and 40. Only the minimum lengths and minimum tensile strength values recalculated according to Article 10.02(2) shall be entered.
42. The inspection body may add items to the list of necessary equipment. These shall be justified as essential to ship safety for the respective vessel type or its operational area. Additions shall be entered under item 52.Left column, row 3 and 4: for passenger vessels the first mentioned item shall be crossed out and under the second mentioned item the length of the gangway as established by the inspection body shall be entered. For all other vessels the second mentioned item shall be crossed out completely respectively, if the inspection body has allowed a shorter length than what is foreseen by Article 10.02(2)(d), only the first half shall be crossed out and the length of the gangway entered.Left column, row 6: here the number of the prescribed first aid kits according to Article 10.02(2)(f) and Article 15.08(9) shall be entered.Left column, row 10: here the number of the prescribed fire proof receptacles according to Article 10.02(1)(d) to (f) shall be entered.
43. Portable fire extinguishers required by other safety regulations, e.g. the regulation for the carriage of dangerous substances on the Rhine (ADNR), are not included here.
44. Row 3: in Community Certificates to be extended before 1.1.2010, or 1.1.2025 where Chapter 24a is applicable, the item “according to EN 395:1998 or 396:1998” shall be crossed if no life vests according to this standard are onboard.Row 4: when Community Certificates are extended after 1.1.2015, or 1.1.2030 where Chapter 24a is applicable, or if a new dinghy is taken onboard, the item “with a set of oars, one mooring line and a baler” shall be crossed. The item “according to EN 1914:1997” shall be crossed if no dinghy according to this standard is onboard.
46. As a general rule, continuous operation shall not be inserted if there is a lack of berths or if there are excessive noise levels.
50. The expert shall sign only if he has completed page 11 himself.
52. Here any additional restrictions, exemptions and explanations, or similar, applying to entries under individual items can be given.
1. The capacity of these tanks shall not exceed 1 000 litres.
2. It shall be possible to attach the tanks sufficiently firmly and to earth them.
3. The tanks shall be made from steel of a sufficient wall thickness and shall be installed in a drip tray. The latter shall be designed to prevent leaking fuel contaminating the waterways. The drip tray may be dispensed with if double-skin tanks with a leak protection or leakage warning system are used and which are filled only via an automatic delivery valve. The provisions of point 3 shall be deemed to be fulfilled if the construction of a tank has been certified and approved according to the regulations of a Member State.
(a) fire detection system,
(b) fire indicator system,
(c) control panel,
(a) heat detectors;
(b) smoke detectors;
(c) ion detectors;
(d) flame detectors;
(e) combination detectors (fire detectors combining two or more of the detectors listed in (a) to (d)).
(a) with or
(b) without
Type of fire detector Maximum floor surface area per fire detector Maximum distance between fire detectors Maximum distance of fire detectors from bulkheads
Heat 37 m2 9 m 4,5 m
Smoke 74 m2 11 m 5,5 m
(a) after installation;
(b) regularly, but at least every two years.
— metacentric height MG shall be not less than 0,50 m,
— there shall be a residual safety clearance of 100 mm,
— the speed to be taken into account shall be 7 km/h,
— the wind pressure shall be taken to be 0,01 t/m2.
(a) be kept permanently pressurised by an automatically adjusting compressor; or
(b) when an alarm is triggered in the wheelhouse be pressurised by means of an auxiliary engine which can be started from the steering position. If the auxiliary engine has its own fuel tank, there shall — in accordance with Article 8.05(13) — be a warning device in the wheelhouse to indicate if the level of filling is not sufficient to ensure further safe operation.
(a) its contents shall be sufficient to ensure an operation period of the propulsion system of 24 hours, assuming a consumption of 0,25 litres per kW per hour;
(b) the fuel supply pump for refilling the daily-supply tank shall be operated continuously; or
(c) the fuel supply pump shall be fitted with:—a switch that automatically switches on the fuel supply pump when the daily-supply tank reaches a certain low level, and—a switch that automatically switches off the fuel supply pump when the daily-supply tank is full. — a switch that automatically switches on the fuel supply pump when the daily-supply tank reaches a certain low level, and — a switch that automatically switches off the fuel supply pump when the daily-supply tank is full.
— a switch that automatically switches on the fuel supply pump when the daily-supply tank reaches a certain low level, and
— a switch that automatically switches off the fuel supply pump when the daily-supply tank is full.
— a switch that automatically switches on the fuel supply pump when the daily-supply tank reaches a certain low level, and
— a switch that automatically switches off the fuel supply pump when the daily-supply tank is full.
(a) direct visual contact is possible between the wheelhouse and the control positions for the winches and bollards on the fore section or the stern of the vessel and in addition the distance from the wheelhouse to these control positions is not more than 35 m; and
(b) the accommodation is directly accessible from the wheelhouse.
(a) manually operated anchor winches (the maximum force required shall be deemed to be that when the anchors are hanging freely);
(b) cranks for lifting hatches;
(c) cranks on mast and funnel winches.
(a) warping and coupling winches;
(b) cranks on cranes, unless intended for ship’s boats.
(a) the wheelhouse is arranged in accordance with European Standard EN 1864:2008; or
(b) the wheelhouse is designed for radar navigation by one person; or
(c) the wheelhouse meets the following requirements:(aa)the control units and monitoring instruments are in the forward field of vision and within an arc of not more than 180° (90° to starboard and 90° to port), including the floor and ceiling. They shall be clearly legible and visible from the normal position of the helmsman;(bb)the main control units such as the steering wheel or steering lever, the engine controls, the radio controls, and the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, shall be arranged in such a way that the distance between the controls on the starboard side and those on the port side is not more than 3 m. The helmsman shall be able to operate the engines without letting go of the controls for the steering system and while still being able to operate the other controls such as the radio system, the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate;(cc)the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, are operated electrically, pneumatically, hydraulically or mechanically. By way of derogation, it may be operated by means of a tension wire only if safe operation from the steering position is possible in this way. (aa) the control units and monitoring instruments are in the forward field of vision and within an arc of not more than 180° (90° to starboard and 90° to port), including the floor and ceiling. They shall be clearly legible and visible from the normal position of the helmsman; (bb) the main control units such as the steering wheel or steering lever, the engine controls, the radio controls, and the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, shall be arranged in such a way that the distance between the controls on the starboard side and those on the port side is not more than 3 m. The helmsman shall be able to operate the engines without letting go of the controls for the steering system and while still being able to operate the other controls such as the radio system, the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate; (cc) the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, are operated electrically, pneumatically, hydraulically or mechanically. By way of derogation, it may be operated by means of a tension wire only if safe operation from the steering position is possible in this way.
(aa) the control units and monitoring instruments are in the forward field of vision and within an arc of not more than 180° (90° to starboard and 90° to port), including the floor and ceiling. They shall be clearly legible and visible from the normal position of the helmsman;
(bb) the main control units such as the steering wheel or steering lever, the engine controls, the radio controls, and the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, shall be arranged in such a way that the distance between the controls on the starboard side and those on the port side is not more than 3 m. The helmsman shall be able to operate the engines without letting go of the controls for the steering system and while still being able to operate the other controls such as the radio system, the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate;
(cc) the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, are operated electrically, pneumatically, hydraulically or mechanically. By way of derogation, it may be operated by means of a tension wire only if safe operation from the steering position is possible in this way.
(aa) the control units and monitoring instruments are in the forward field of vision and within an arc of not more than 180° (90° to starboard and 90° to port), including the floor and ceiling. They shall be clearly legible and visible from the normal position of the helmsman;
(bb) the main control units such as the steering wheel or steering lever, the engine controls, the radio controls, and the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, shall be arranged in such a way that the distance between the controls on the starboard side and those on the port side is not more than 3 m. The helmsman shall be able to operate the engines without letting go of the controls for the steering system and while still being able to operate the other controls such as the radio system, the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate;
(cc) the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, are operated electrically, pneumatically, hydraulically or mechanically. By way of derogation, it may be operated by means of a tension wire only if safe operation from the steering position is possible in this way.
(a) do not have hydraulically or electrically operated coupling winches; or
(b) whose hydraulically or electrically operated coupling winches do not meet the requirements of point 3.3 of this Administrative instruction,
(a) the device shall provide the tensioning force required for the coupling only by mechanical means;
(b) the controls for the device shall be located on the device itself. By way of derogation, remote control is permitted provided that:—the person operating the device has an unobstructed direct view of the device from the control position,—there is a device at the control position to prevent unintentional operation,—the device has an emergency stop; — the person operating the device has an unobstructed direct view of the device from the control position, — there is a device at the control position to prevent unintentional operation, — the device has an emergency stop;
— the person operating the device has an unobstructed direct view of the device from the control position,
— there is a device at the control position to prevent unintentional operation,
— the device has an emergency stop;
— the person operating the device has an unobstructed direct view of the device from the control position,
— there is a device at the control position to prevent unintentional operation,
— the device has an emergency stop;
(c) the device shall have a braking device which acts immediately if the controls are released or the motive force fails;
(d) it shall be possible for the coupling cable to be released manually if the motive force fails.
(a) a multi-propeller drive and at least two independent propulsion systems with similar power output;
(b) at least one cycloidal propeller;
(c) at least one rudder propeller; or
(d) at least one 360° water-jet propulsion system.
1. the active parts of electrically powered systems shall have a minimum luminance of 10 cd/m2;
2. the point sources of miniature incandescent lamps shall provide not less than 150 mcd mean spherical intensity with a spacing of not more than 0,1 m between lamps;
3. the point sources of light-emitting-diode systems shall have a minimum peak intensity of 35 mcd. The angle of half-intensity cone shall be appropriate to the likely track directions of approach and viewing. Spacing between lamps shall be no more than 0,3 m; and
4. for electroluminescent systems, these shall function for 30 minutes from the instant when the main power supply to which it was required to be connected by Section 7.1 fails.
— Directive 2003/24/EC of the European Parliament and of the Council of 14 April 2003 amending Council Directive 98/18/EC on safety rules and standards for passenger ships, and
— the guide for the adaptation of inland waterway passenger vessels to people with disabilities in accordance with Resolution No 25 of the United Nations Economic Commission for Europe.
— a place where life-saving equipment is stowed or issued in an emergency,
— seats,
— a suitably-adapted toilet (No 10 of these guidelines), and
— connecting corridors.
(a) 10 % lower explosion limit (LEL) of a propane-air mixture; and
(b) 30 ppm CO (carbon monoxide).
(a) local ventilation systems;
(b) structural arrangements (design of walls, partitions etc.) facilitating or complicating the accumulation of gases; and
(c) prevention of adverse effects due to mechanical damage, water or heat damage.
(a) name and address of the manufacturer;
(b) legal marking;
(c) designation of series and type;
(d) if possible, serial number;
(e) if required, any advice indispensable for safe use; and
(f) for each sensor the indication of the calibration gas.
(a) complete instructions, drawings and diagrams concerning the safe and proper operation as well as the installation, starting-up and maintenance of the gas warning equipment;
(b) operating instructions containing at least:(aa)measures to be taken in the case of an alarm or error indication;(bb)safety measures in the case of non-availability (e.g. calibration, inspection, interruption); and(cc)persons responsible for installation and maintenance; (aa) measures to be taken in the case of an alarm or error indication; (bb) safety measures in the case of non-availability (e.g. calibration, inspection, interruption); and (cc) persons responsible for installation and maintenance;
(aa) measures to be taken in the case of an alarm or error indication;
(bb) safety measures in the case of non-availability (e.g. calibration, inspection, interruption); and
(cc) persons responsible for installation and maintenance;
(aa) measures to be taken in the case of an alarm or error indication;
(bb) safety measures in the case of non-availability (e.g. calibration, inspection, interruption); and
(cc) persons responsible for installation and maintenance;
(c) instructions for calibration before the starting-up, and for routine calibration, including time intervals to be followed;
(d) supply voltage;
(e) type and meaning of the alarms and displays (e.g. special status);
(f) information concerning the detection of operating difficulties and the removal of faults;
(g) type and scope of the replacement of components with limited lifespan; and
(h) type, scope and time interval of the inspections.
(a) the cables are run in such a manner as to avoid being rendered unserviceable by heating of the bulkheads and decks that may be caused by a fire in an adjacent space;
(b) where the cables supply equipment located within high fire risk areas, the cable runs within such areas must avoid routes which pass over or near the top of diesel engines and oil-fired equipment, or near to hot surfaces e.g. diesel engine exhaust systems. Where there is no alternative route, cables must be protected from heat and fire damage. Such fire protection could be in the form of a steel plate or trunk;
(c) the cables and associated equipment supplied from the emergency source of power should, as far as practicable, be kept within the safe area;
(d) cable systems are arranged so that fire in any area bounded by Type A partitions as shown in Article 15.11, Section 2 will not interfere with services essential for safety in any other such area. This requirement will be met if main and emergency cables do not pass through the same area. If they pass through the same area, the requirement will be met if:(aa)they are separated as wide as is practicable; or(bb)the emergency cable is of the fire resistant type. (aa) they are separated as wide as is practicable; or (bb) the emergency cable is of the fire resistant type.
(aa) they are separated as wide as is practicable; or
(bb) the emergency cable is of the fire resistant type.
(aa) they are separated as wide as is practicable; or
(bb) the emergency cable is of the fire resistant type.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2006/87/EC of the European Parliament and of the Council of 12 December 2006 laying down technical requirements for inland waterway vessels and repealing Council Directive 82/714/EEC(1), and in particular Article 20(1) thereof,
(1) Binding administrative instructions for the inspection have been adopted pursuant to Article 22 of the Revised Convention for Rhine Navigation. It is therefore necessary to amend Directive 2006/87/EC accordingly.
(2) It should be ensured that the Community vessel certificate and the vessel certificate delivered in accordance with the Rhine Vessel Inspection Regulation are issued on the basis of technical requirements which guarantee an equivalent level of safety.
(3) In order to avoid distortions of competition as well as different levels of safety, the amendments to Directive 2006/87/EC should be implemented as quickly as possible.
(4) The measure provided for in this Directive are in accordance with the opinion of the Committee established under Article 7 of Council Directive 91/672/EEC of 16 December 1991 on the reciprocal recognition of national boatmasters’ certificates for the carriage of goods and passengers by inland waterway(2),
HAS ADOPTED THIS DIRECTIVE:

Article 1
Appendix II to Annex II to Directive 2006/87/EC is amended as set out in the Annex to this Directive.

Article 2
Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 30 December 2008. They shall forthwith communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3
This Directive shall enter into force on the day of its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2006/87/EC of the European Parliament and of the Council of 12 December 2006 laying down technical requirements for inland waterway vessels and repealing Council Directive 82/714/EEC(1), and in particular Article 20(1) thereof,
(1) Binding administrative instructions for the inspection have been adopted pursuant to Article 22 of the Revised Convention for Rhine Navigation. It is therefore necessary to amend Directive 2006/87/EC accordingly.
(2) It should be ensured that the Community vessel certificate and the vessel certificate delivered in accordance with the Rhine Vessel Inspection Regulation are issued on the basis of technical requirements which guarantee an equivalent level of safety.
(3) In order to avoid distortions of competition as well as different levels of safety, the amendments to Directive 2006/87/EC should be implemented as quickly as possible.
(4) The measure provided for in this Directive are in accordance with the opinion of the Committee established under Article 7 of Council Directive 91/672/EEC of 16 December 1991 on the reciprocal recognition of national boatmasters’ certificates for the carriage of goods and passengers by inland waterway(2),
HAS ADOPTED THIS DIRECTIVE:
Appendix II to Annex II to Directive 2006/87/EC is amended as set out in the Annex to this Directive.
Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 30 December 2008. They shall forthwith communicate to the Commission the text of those provisions.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
This Directive shall enter into force on the day of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States which have inland waterways as referred to in Article 1(1) of Directive 2006/87/EC.
ANNEXAppendix II to Annex II to Directive 2006/87/EC is replaced by the following:

‘Appendix II
Administrative instructions
No 1
:
Requirements relating to the capacity for taking evasive action and turning capacity
No 2
:
Requirements concerning prescribed (forward) speed, stopping capacity and capacity for going astern
No 3
:
Requirements for coupling systems and coupling devices for craft suitable for propelling or being propelled in a rigid assembly
No 4
:
Left void
No 5
:
Noise measurements
No 6
:
Left void
No 7
:
Special anchors with reduced mass
No 8
:
Strength of watertight windows
No 9
:
Requirements for automatic pressurised water sprinklers
No 10
:
Left void
No 11
:
Completion of the Community Certificate
No 12
:
Fuel tanks on floating equipment
No 13
:
Minimum hull thickness of barges
No 14
:
Left void
No 15
:
Steerageway under vessel’s own power
No 16
:
Left void
No 17
:
Appropriate fire alarm system
No 18
:
Proof of buoyancy, trim and stability of the separated parts of a vessel
No 19
:
Left void
No 20
:
Equipment for vessels to be operated according to standards S1 and S2
No 21
:
Requirements for low-location lighting
No 22
:
Specific safety needs of persons with reduced mobility
No 23
:
Left void
No 24
:
Suitable gas warning equipment
No 25
:
Electrical cables
Note:
In accordance with Article 5(7) of the Directive, for subjects covered by Annex IV, each Member State may allow less stringent requirements for the respective values indicated in the following Administrative instructions for craft operating exclusively on Zone 3 and Zone 4 waterways within its territory.
In accordance with Article 5(1) and (3) of the Directive, for subjects covered by Annex III, each Member State may adopt more stringent requirements for the respective values indicated in the following Administrative instructions for craft operating on Zone 1 and Zone 2 waterways within its territory.
‘ADMINISTRATIVE INSTRUCTION No 1
Requirements relating to the capacity for taking evasive action and turning capacity
(Articles 5.09 and 5.10 in conjunction with Articles 5.02(1), 5.03(1), 5.04 and 16.06 of Annex II) 1. General conditions and boundary conditions relating to the evasive action test
1.1. According to Article 5.09, vessels and convoys shall be able to take evasive action in good time and the capacity for such action shall be proved by evasive action manoeuvres in the test area in accordance with Article 5.03. This shall be proved by simulated evasive action manoeuvres to port and starboard with prescribed values whereby for specific turning speeds of the vessel in response to putting across and then checking the helm a certain time limit shall be complied with.
During tests the requirements of Section 2 shall be complied with keeping a keel clearance of at least 20 % of the draught, but not less than 0,50 m. 2. Evasive action test procedure and recording of data
(Diagram in Annex 1)
2.1. Evasive action manoeuvres shall be performed as follows:
With the vessel or convoy under way at a constant speed of V0 = 13 km/h in relation to the water, at the start of the manoeuvre (time t0 = 0 s, turning speed r = 0°/min, rudder angle δ0 = 0°, engine speed kept constant), evasive action to port or starboard is to be initiated by putting across the helm. The rudder shall be set to an angle δ, or the steering unit to an angle δa in the case of an active steering device, at the start of the manoeuvre, in accordance with the indications given in point 2.3. The rudder angle δ (e.g. 20° to starboard) shall be maintained until the value r1 of the turning speed referred to in point 2.2 for the corresponding dimensions of the vessel or convoy is reached. When the turning speed r1 is reached, the time t1 shall be recorded and the rudder set to the same angle on the opposite side (e.g. 20° to port) so as to stop the turn and commence turning in the opposite direction, i.e., to reduce the turning speed to r2 = 0 and let it to rise again to the value given in point 2.2. When the turning speed r2 = 0 is reached, the time t2 shall be recorded. When the turning speed r3 given in point 2.2 is reached, the rudder shall be set in the opposite direction to the same angle δ, so as to stop the turning movement. The time t3 shall be recorded. When the turning speed r4 = 0 is reached, the time t4 shall be recorded and the vessel or convoy shall be returned to its original course.
2.2. The following limit values shall be complied with to reach turning speed r4 depending on the dimensions of the vessels or the convoys and on the water depth h:

Dimensions of vessels or convoys
L × B
Required turning speed
r1 = r3 (°/min)
Limit values for the time t4 (s) in shallow and deep water
δ = 20°
δ = 45°
1,2 ≤ h/T ≤ 1,4
1,4 < h/T < 2
h/T > 2
1
All motor vessels; single-in-line convoys ≤ 110 × 11,45
20°/min
28°/min
150 s
110 s
110 s
2
Single-in-line convoys up to 193 × 11,45 or two-abreast convoys up to 110 × 22,90
12°/min
18°/min
180 s
130 s
110 s
3
Two-abreast convoys ≤ 193 × 22,90
8°/min
12°/min
180 s
130 s
110 s
4
Two-abreast convoys up to 270 × 22,90 or three-abreast convoys up to 193 × 34,35
6°/min
8°/min
(*1)
(*1)
(*1)
The times t1, t2, t3 and t4 required to reach turning speeds r1, r2, r3 and r4 shall be recorded in the measurements report in Annex 2. The t4 values shall not exceed the limits given in the table.
2.3. At least four evasive action manoeuvres shall be carried out, namely:
—
one to starboard with a rudder angle δ = 20°
—
one to port with a rudder angle δ = 20°
—
one to starboard with a rudder angle δ = 45°
—
one to port with a rudder angle δ = 45°.
If necessary (e.g. in the case of uncertainty about the values measured or of unsatisfactory manoeuvres), the evasive action manoeuvres shall be repeated. The turning speeds given in point 2.2 and the time limits shall be complied with. For active steering devices or special types of rudder, a position δa of the steering unit or rudder angle δa other than δ = 20° and δ = 45° may be selected, according to the expert’s assessment, depending on the type of steering system.
2.4. In order to determine the turning speed, a rate-of-turn indicator in accordance with Annex IX to the Directive shall be on board.
2.5. In accordance with Article 5.04, the load condition during the evasive action manoeuvre shall be between 70 % and 100 % of the maximum deadweight. If the test is carried out with a smaller load, approval for downstream and upstream navigation shall be restricted to that load limit.
The procedure for evasive action manoeuvres and the terms used are shown in a diagram in Annex 1. 3. Turning capacity
The turning capacity of vessels and convoys whose length (L) does not exceed 86 m and width (B) does not exceed 22,90 m shall be considered sufficient under Article 5.10, in conjunction with Article 5.02(1) when during an upstream turning manoeuvre with an initial speed in relation to the water of 13 km/h, the limit values for stopping facing downstream established in Administrative instruction No 2 are complied with. The keel clearance conditions according to Section 1.1 shall be complied with. 4. Other requirements
4.1. Notwithstanding points 1 to 3, the following requirements shall be met:
(a) for manually controlled steering systems, a single turn of the wheel shall correspond to a rudder angle of at least 3°;
(b) for powered steering systems, when the rudder is at maximum immersion, it shall be possible to achieve an average angular velocity of 4°/s over the rudder’s entire turning range.
This requirement shall also be checked, with the vessel at full speed, for moving the rudder over a range from 35° port to 35° starboard. In addition, it shall be checked whether the rudder keeps the position of maximum angle at maximum propulsion power. For active steering systems or special types of rudder, this provision applies mutatis mutandis.
4.2. If any of the additional equipment referred to in Article 5.05 is needed in order to reach the required manoeuvring capacities, it shall comply with the requirements of chapter 6, and the following particulars shall be entered under item 52 of the Community Certificate:
“Flanking rudders (*2)/bow steering systems (*2)/other equipment (*2) referred to under item 34 is (*2)/are (*2) necessary to comply with the manoeuvrability requirements of chapter 5. 5. Recording of data and reports
The measurements, reports and recording of data shall be carried out according to the procedure set out in Annex 2. ‘ANNEX 1
to Administrative instruction No 1
Diagram of the evasive action manoeuvre
t0
=
Start of evasive action manoeuvre
t1
=
Time to reach turning speed r1
t2
=
Time to reach turning speed r2 = 0
t3
=
Time to reach turning speed r3
t4
=
Time to reach turning speed r4 = 0 (end of evasive action manoeuvre)
δ
=
Rudder angle [°]
r
=
Turning speed [°/min]
‘ANNEX 2
to Administrative instruction No 1
Report on evasive action manoeuvre and turning capacity
Inspection body: …
Date: …
Name: …
Name of craft: …
Owner: …
Type of craft: …
Test area: …
or convoy: …
Relevant water level [m]: …
L × B [m × m]: …
Depth of water h [m]: …
Ttest [m]: …
h/T: …
Speed of the current [m/s]:
Load: … % of maximum …
(during test) [t]: … deadweight: …
Rate-of turn indicator
Type: …
Type of rudder construction: normal construction/special construction (*3)
Active steering system: yes/no (*3)
Results of evasive action manoeuvres:
Time
t1 to t4 required for the evasive action
Rudder angle δ or δa
(*3) at which evasive action commences
and turning speed to be complied with r1 = r3
Comments
δ = 20° STAR (*3)
δ = 20° PORT (*3)
δ = 45° STAR (*3)
δ = 45° PORT (*3)
δa = … STAR (*3)
δa = … PORT (*3)
δa = … STAR (*3)
δa = … PORT (*3)
r1 = r3 = … °/min
r1 = r3 = … °/min
t1 [s]

t2 [s]

t3 [s]

t4 [s]

Limit value t4 according to 2.2
Limit value t4 = … [s]
Turning capacity (*3)
Geographic position at start of turning manoeuvre … km
Geographic position at end of turning manoeuvre … km
Steering apparatus
Type of operation: manual/powered (*3)
Rudder angle for each turn of the wheel (*3): … °
Angular velocity of the rudder over the whole range (*3): … °/s
Angular velocity of the rudder over the range 35° Port to 35° Starboard (*3): … °/s
‘ADMINISTRATIVE INSTRUCTION No 2
Requirements concerning prescribed (forward) speed, stopping capacity and capacity for going astern
(Articles 5.06, 5.07 and 5.08 in conjunction with Articles 5.02(1), 5.03(1), 5.04 and 16.06 of Annex II) 1. Maximum prescribed (forward) speed in accordance with Article 5.06
The speed in relation to the water is satisfactory in accordance with Article 5.06(1) when it reaches at least 13 km/h. During tests, the following conditions shall be met in the same way as for the stopping test:
(a) the keel clearance set out in point 2.1 shall be complied with;
(b) the measuring, recording, registration and evaluation of test data shall be carried out. 2. Stopping capacity and capacity for going astern prescribed in accordance with Articles 5.07 and 5.08
2.1. Vessels and convoys are deemed able to stop facing downstream in good time in accordance with Article 5.07(1) when this is proved during a test of stopping in relation to the ground facing downstream at an initial speed in relation to the water of 13 km/h, with a keel clearance equal to at least 20 % of the draught but not less than 0,50 m.
(a) In flowing water (current velocity of 1,5 m/s), stopping in relation to the water shall be demonstrated over a maximum distance measured in relation to the ground of:
550 m for vessels and convoys of:
—
length L > 110 m or
—
width B > 11,45 m,
or
480 m for vessels and convoys of:
—
length L ≤ 110 m and
—
width B ≤ 11,45 m.
The stopping manoeuvre is completed on coming to a stop in relation to the ground.
(b) In standing water (current velocity of less than 0,2 m/s), stopping in relation to the water shall be demonstrated over a maximum distance, measured in relation to the ground of:
350 m for vessels and convoys of:
—
length L > 110 m or
—
width B > 11,45 m,
or
305 m for vessels and convoys of:
—
length L ≤ 110 m and
—
width B ≤ 11,45 m.
In standing water, a test shall also be performed to demonstrate that a speed of not less than 6,5 km/h can be reached when going astern.
The measuring, recording and registration of the test data referred to in (a) or (b) shall be carried out in accordance with the procedure set out in Appendix 1. Throughout the entire test, the vessel or the convoy shall have adequate manoeuvrability.
2.2. In accordance with Article 5.04, during the test, vessels shall be loaded as far as possible to 70-100 % of their deadweight. This load condition shall be evaluated in accordance with Appendix 2. When the vessel or the convoy is loaded to less than 70 % at the time of the test, the permitted maximum displacement in downstream navigation shall be set in accordance with the actual load, provided that the limit values of point 2.1 are complied with.
2.3. If the actual values of the initial speed and current velocity at the time of the test do not meet the conditions set out in point 2.1, the results obtained shall be evaluated according to the procedure described in Appendix 2. The permitted deviation of the initial speed of 13 km/h shall be not more than +1 km/h, and the current velocity in flowing water shall be between 1,3 and 2,2 m/s, otherwise the tests shall be repeated.
2.4. The permitted maximum displacement or the respective maximum load or the maximum immersed cross-section for vessels and convoys in downstream navigation shall be determined on the basis of the tests and entered in the Community Certificate.
‘Appendix 1
to Administrative instruction No 2
MEASURING, RECORDING AND REGISTRATION OF DATA COLLECTED DURING STOPPING MANOEUVRE TESTS 1. Stopping manoeuvre
The vessels and convoys referred to in Chapter 5 shall carry out a test in flowing water or in standing water, in a test area, to prove that they are capable of stopping facing downstream only with their propulsion system without the use of anchors. The stopping manoeuvre shall, in principle, be carried out in accordance with figure 1. It begins when the vessel is travelling at a constant speed of as near as possible to 13 km/h in relation to the water by reversing the engines from “ahead” to “astern” (point A of the order “stop”) and is completed when the vessel is stationary in relation to the ground (point E: v = 0 in relation to the ground or point D: = point E: v = 0 in relation to the water and in relation to the ground if the stopping manoeuvre is carried out in standing water).
When stopping manoeuvres are carried out in flowing water, the position and the moment of stopping in relation to the water shall also be recorded (the vessel moves at the speed of the current; point D: v = 0 in relation to the water).
The data measured shall be entered in a report as shown in the diagram of table 1. Before the stopping manoeuvre is carried out, the unchanging data shall be entered at the top of the form.
The average current velocity (vSTR
) in the fairway shall be determined, if available, based on the reading of an established water level gauge, or by measuring the movement of a floating body and shall be entered in the report.
In principle, the use of current metres is permitted to determine the speed of the vessel in relation to the water during the stopping manoeuvre, if it is possible to record the movement and the required data in accordance with the procedure above. 2. Registration of the data measured and recording them in the report (table 1)
For the stopping manoeuvre, first of all the initial speed in relation to the water shall be determined. This can be done by measuring the time taken to travel between two markers on land. In flowing water, the average current velocity shall be taken into account.
The stopping manoeuvre is initiated by the order “stop”
A, given on passing a marker on land. Passing the land marker shall be recorded perpendicularly to the axis of the vessel and shall be entered in the report. Passing all other land markers during the stopping manoeuvre shall be similarly recorded and each marker (e.g. kilometre post) and the time of passing shall be noted in the report.
The values measured shall, if possible, be recorded at intervals of 50 m. In each case, note should be taken of the time when points B and C — if possible — as well as when points D and E are reached and the respective position shall be estimated. The data concerning the engine speed need not be recorded in the report, but should be noted to permit more accurate control of the initial speed. 3. Description of the stopping manoeuvre
The stopping manoeuvre according to figure 1 shall be presented in the form of a diagram. First of all, the time-traverse diagram shall be plotted using the measurements entered in the test report and points A to E shall be indicated. It will then be possible to determine the average speed between two measurement points and to plot the speed/time diagram.
This is done as follows (see figure 1):
By determining the quotient of the difference of position over the difference in time Δs/Δt, the average speed of the vessel for this period can be calculated.
Example:
During the interval between 0 sec. and 10 sec., the distance from 0 m to 50 m is covered.
Δs/Δt = 50 m/10 s = 5,0 m/s = 18,0 km/h
This value is entered as the average speed at the 5 sec. abscissa-position. During the second interval, from 10 sec. to 20 sec., a distance of 45 m is covered.
Δs/Δt = 45 m/10 s = 4,5 m/s = 16,2 km/h
At marker D, the vessel has stopped in relation to the water i.e. current velocity is approximately 5 km/h.
Figure 1
Stopping manoeuvre
Key to symbols in figure 1
A
“stop” order
B
propeller stopped
C
propeller in reverse
D
v = 0 in relation to the water
E
v = 0 in relation to the ground
v
speed of vessel
vL
v in relation to the ground
s
distance covered in relation to the ground
t
measured time
Table 1
Report of the stopping manoeuvre
Inspection Body:
…
Type of vessel or convoy:
…
Test area:
…
L × B [m]:
…
Water level gauge reading
[m]:
…
Date:
…
T at test [m]:
…
Water depth
[m]:
…
Name:
…
Load at Test [t]:
…
Gradient
[m/km]:
…
Test run No:
…
% of maximum deadweight
…
VSTR
[km/h]:
…

Power of propulsion engines PB[kW]
…
[m/s]:
…

Propulsion system according to Annex 2, table 2:
…
Max. displacement
[m3]:
…
Position
[river-km]
Time
[sec.]
Δs
[m]
Δt
[sec.]
vIL
[km/h]
Engine speed n
[min–1]
Observations

‘Appendix 2
to Administrative instruction No 2
EVALUATION OF THE RESULTS OF THE STOPPING MANOEUVRE 1. On the basis of the values recorded compliance with the limit values in accordance with Appendix 1 shall be verified. If the conditions for the stopping manoeuvre deviate substantially from the standard conditions, or if there are doubts as to the compliance with the limit values, the results shall be evaluated. To that end the following procedure may be applied for calculating stopping manoeuvres. 2. Theoretical stopping distances are determined under the standard conditions (Sreference) of point 2.1 of Administrative instruction No 2 and under stopping manoeuvre conditions (Sactual) and are compared with the stopping distance measured (Smeasured). The corrected stopping distance of the stopping manoeuvre under standard conditions (Sstandard) is calculated as follows:
Formula 2.1:
Limit value in accordance with point 2.1(a) or (b) of Administrative instruction No 2
When the stopping manoeuvre has been carried out with a load of 70-100 % of the maximum deadweight in accordance with point 2.2 of Administrative instruction No 2 in order to calculate Sstandard
the displacement (Dreference
= Dactual
) corresponding to the load at the time of the test shall be used for the determination of Sreference
and Sactual
.
When in determining Sstandard
according to formula 2.1, the limit value in question is exceeded or not reached, the value of Sreference
shall be reduced or increased by variation of Dreference
so that the limit value is complied with (Sstandard
= limit value in question). The maximum displacement permitted in downstream navigation shall be set accordingly. 3. According to the limit values given in point 2.1(a) and (b) of Administrative instruction No 2, only the stopping distances measured in
—
Phase I (“Full ahead” reversed to “full astern”): SI
and
—
Phase II (End of reversal until vessel stops in relation to the water): SII
shall be calculated (see figure 1). The total stopping distance is then:
Formula 3.1:
The particular stopping distances shall be calculated as follows:
CALCULATION OF THE STOPPING MANOEUVRE
Figure 2
Diagram

Calculation Formulae:
with the following coefficients
4.1. —
k1 according to table 1
4.2. —
k2, k3, k4 according to table 1
4.3. —
k6, k7 according to table 1
—
RT/v2 according to table 3
4.4.
4.5. —
k6 according to table 1
4.6. —
f according to table 2
4.7. —
k4 according to table 1
In formulae 4.1 to 4.7:
vL
Speed in relation to the ground at the start of reversal
(m/s)
tI
Reversal time
(s) vII
Speed in relation to the water at the end of reversal
(m/s)
D
Displacement
(m3)
FPOR
Bollard pull in reverse
(kN)
PB
Power of propulsion engine
(kW)
RTmII
Average resistance during phase II, to be determined using the diagram for determining RT/v2
(kN)
RG
Gradient resistance
(kN)
i
Gradient in m/km (if missing to be taken as 0,16)
(m/km)
vSTR
Average current velocity
(m/s)
g
Acceleration due to gravity (9,81)
(m/s2)
ρ
Density of water, ρ fresh water = 1 000
(kg/m3)
T
Maximum draught (of vessel or convoy)
(m) h
Water depth
(m) B
Width
(m) L
Length
(m) The coefficients for the formulae 4.1, 4.2, 4.3, 4.4, 4.5, 4.6 and 4.7 can be taken from the tables below.
Table 1
k factors for:
(a) Motor vessels and single file convoys
(b) Two-abreast convoys
(c) Three-abreast convoys

a
b
c
Units
k1
0,95
0,95
0,95
—
k2
0,115
0,120
0,125
k3
1,20
1,15
1,10
—
k4
0,48
0,48
0,48
—
k6
0,90
0,85
0,80
—
k7
0,58
0,55
0,52
—
Table 2
Coefficient f for ratio between bollard pull in reverse and the power of the propulsion engines
Propulsion system
f
Units
Modern nozzles with rounded rear edge
0,118
kN/kW
Old nozzles with sharp rear edge
0,112
kN/kW
Propellers without nozzle
0,096
kN/kW
Rudder propellers with nozzles (generally sharp rear edge)
0,157
kN/kW
Rudder propellers without nozzles
0,113
kN/kW
Table 3
Diagram concerning the calculation of resistance
To determine the value of RT/v2
in relation to D1/3
[B + 2T]:
‘Annex to Appendix 2
to Administrative instruction No 2
Examples on the application of Appendix 2
(Evaluation of the results of the stopping manoeuvre)
EXAMPLE I 1. Data of vessels and convoy
Formation: ordinary motor vessel with a (Europa IIa) lighter coupled abreast

L [m]
B [m]
T max [m]
Dwt (*4)
max [t]
D max [m3]
PB [kW]
Motor vessel
110
11,4
3,5
2 900
3 731
1 500
Lighter
76,5
11,4
3,7
2 600
2 743
—
Convoy
110
22,8
3,7
5 500
6 474
1 500
Propulsion system of the motor vessel: modern nozzles with rounded rear edge 2. Values measured during the stopping manoeuvre
Current velocity:
vSTRactual
=
1,4 m/s
≈
5,1 km/h
Speed of vessel (in relation to the water):
VSactual
=
3,5 m/s
≈
12,5 km/h
Speed of vessel (in relation to the ground):
VLactual
=
4,9 m/s
≈
17,6 km/h
Reversal time (measured) (point A to C):
tI
=
16 s

Stopping distance in relation to the water (point A to D):
SMEASURED
=
340 m

Load condition (possibly estimated):
Dactual
=
5 179 m3
≈
0,8 D
max
Actual draught of convoy:
Tactual
=
2,96 m
≈
0,8 T
max 3. Limit value according to point 2.1(a) or (b) to be compared with Sstandard
Since B > 11,45 m and since the convoy is in flowing water, the following is applicable for this convoy under 2.1(a):
Sstandard
< 550 m 4. Determination of corrected stopping distance compared to standard conditions
—
Measured value according to Appendix 1 (see point 2)
smeasured
= 340 m
—
to be calculated:
sactual
as the sum of
sIactual
(according to formula 4.1 of Appendix 2 with vLactual
)
and
sIIactual
(according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with actual speeds vIIactual
, vSTRactual
, Dactual
)
sreference
as the sum of
sIreference
(according to formula 4.1 of Appendix 2 with vLreference
)
and
sIIreference
(according to formulae 4.2 to 4.6 of Appendix 2 with the reference speeds according to 2.1 of the Administrative instruction and given that the load condition is greater than 70 % of the maximum load (≈ 80 %): Dreference = Dactual
and Treference = Tactual
)
—
to be checked:
4.1. Coefficients for the calculation taken from Appendix 2
Table 1
for sIactual
and sIreference
k1
=
0,95
for sIIactual
and sIIreference
k2
=
0,12

k3
=
1,15

k4
=
0,48

k6
=
0,85

k7
=
0,55
Table 2 (for modern nozzles with rounded rear edge)
f = 0,118
4.2. Calculation of Sactual
(a) sIactual
with the values measured during the stopping manoeuvre (formula 4.1)
(b) Formula for sIIactual
(c) Calculation of RTmIIactual
according to table 3 and formula 4.3 of Appendix 2
according to table 3
(d) Calculation of resistance to gradient
according to formula 4.4
(e) Calculation of vIIactual
according to formula 4.5
(f) Calculation of F
POR
according to formula 4.6 and table 2
(g) Calculation of sIIactual
using formula (b) and the results of (c), (d), (e) and (f) (h) Calculation of total distance according to formula 3.1
Note: The term (RtmII
— RG
), which is a function of D, with an actual value of 20,67 kN is obviously relatively small compared to k3
· FPOR
with an actual value of 203,55 kN, so for simplification purposes, sII
can be taken as proportional to D, i.e. sII
= Constant · D.
4.3. Calculation of sreference
Initial values

(a) (b) (c) calculation of RTmIIreference
as in point 4.2, since B, D and T are unchanged.
(d) Resistance due to gradient RG
as in point 4.2
(e) Calculation of vIIreference
(f) FPOR
as in point 4.2. (g) Calculation of sIIreference
using formula (b) and the result from (c) to (f) =
0,0472
· 5 179 = 244,5 m
(h) Calculation of total distance
4.4. Verification of compliance with permissible stopping distance under standard conditions sstandard
according to formula 2.1 of Appendix 2
Conclusion:
The permissible limit value is far from being reached, i.e.:
—
admission to downstream navigation is possible without problems for the actual load condition (0,8 · D
max
),
—
a higher load condition is possible and may be calculated according to point 5 below. 5. Possible increase of D
actual
in downstream navigation
With s
IIreference
= Constant
reference
· D according to the note under point 4.2
Hence
From this follows that:
Since (D
reference
)
Limit
> D
max (8 756 > 6 474) this formation (see point 1) may be permitted in downstream navigation with full load.
EXAMPLE II 1. Data of vessels and convoy
Formation: large motor vessel propelling
2 lighters side-by-side in front and
1 lighter coupled side-by-side

L [m]
B [m]
T max [m]
Dwt (*5)
max [t]
D max [m3]
PB [kW]
Motor vessel
110
11,4
3,5
2 900
3 731
1 500
Each lighter
76,5
11,4
3,7
2 600
2 743
—
Convoy
186,5
22,8
3,7
10 700
11 960
1 500
Propulsion system of the self-propelled vessel: modern nozzles with rounded rear edge. 2. Values measured during the stopping manoeuvre
Current velocity:
vSTRactual
=
1,4 m/s
≈
5,1 km/h
Speed of vessel (in relation to the water):
VSactual
=
3,5 m/s
≈
12,5 km/h
Speed of vessel (in relation to the bank):
VLactual
=
4,9 m/s
≈
17,6 km/h
Reversal time (measured) (point A to C):
tI
=
16 sec

Stopping distance in relation to the water (point A to D):
smeasured
=
580 m

Load condition (possibly estimated):
Dactual
=
9 568 m
3
≈
0,8 D
max
Actual draught of convoy:
Tactual
=
2,96 m
≈
0,8 T
max 3. Limit value according to paragraph 2.1(a) or (b) of the Administrative instruction to be compared with sstandard
Since B > 11,45 and the convoy is in flowing water, the following applies for this convoy under point 2.1(a):
sstandard
≤ 550 m 4. Determination of the corrected stopping distance compared with standard conditions
—
Measured value:
smeasured
= 340 m
—
calculations to be made:
sactual as the sum of
sIactual
(according to formula 4.1 of Appendix 2 with VLactual
)
and
sIIactual
(according to formulae 4.2, 4.3, 4.4, 4.5 and 4.6 of Appendix 2 with real speeds vLactual
(see under 2 above) and Dactual
)
sreference
: sum sIreference
+ sIIreference
(according to formulae 4.1 to 4.6 of Appendix 2 with reference speeds and in conformity of Appendix 2, because the load condition > 70 % of maximum, where Dreference = Dactual and Treference
= Tactual
)
—
to be verified:
, otherwise
—
calculate:
s* standard
= 550 m by reduction of Dactual to D*
4.1. Coefficients for the calculation according to Appendix 2
Table 1
for sIactual
and sIreference
k1
=
0,95
for sIactual
and sIreference
k2
=
0,12

k3
=
1,15

k4
=
0,48

k5
=
0,85

k7
=
0,55
Table 2 (for modern nozzles with rounded rear edge)
f = 0,118
4.2. Calculation of sIactual
(a) sIactual
Using the values measured during the stopping manoeuvres
sIactual
= k1
· vLactual
· tIactual
sIactual
= 0,95 · 4,8 · 16 = 73 m
(b) formula for sIIactual
(c) Calculation of R
TmIIactual
according to table 3 and formula 4.3 of Appendix 2
from table 3
(d) Calculation of resistance due to gradient
according to formula 4.4 of Appendix 2. (e) Calculation of vIIactual
according to formula 4.5 of Appendix 2
(f) Calculation of FPOR
acording to formula 4.6 and table 2
(g) Calculation of sIIactual
using formula (b) and the result of (c), (d), (e) and (f) SIIactual
= 402 m
(h) Calculation of the total distance according to formula 3.1
sactual
= 73 + 402 = 475 m
4.3. Calculation of sreference
Initial values:

(a) (b) (c) Calculation of
as under point 4.2 since B, D and T and unchanged
(d) Resistance due to gradient
as under point 4.2
(e) Calculation of
,
(f) as under point 4.2
(g) Calculation of
using formula (b) and the result of (c) to (f) SIIreference
=
0,04684
· 9 568 = 448 m
(h) Calculation of the total distance
4.4. Verification of compliance with permissible stopping distance under standard conditions
according to formula 2.1 of Appendix 2
Conclusion: The limit value has clearly been exceeded; admission to downstream navigation is possible only with a load restriction. This restricted load can be determined in conformity with No 5 below. 5. D* permissible in downstream navigation according to formula 2.1 of Appendix 2
Therefore:
Consequence: Since in downstream navigation the permissible displacement
is only 7 950 m3, the permissible deadweight (perm. Dwt.) in this formation is approximately:
Permissible deadweight (see point 1)
‘ADMINISTRATIVE INSTRUCTION No 3
Requirements for coupling systems and coupling devices for craft suitable for propelling or being propelled in a rigid assembly
(Articles 16.01, 16.02, 16.06, 16.07 of Annex II)
In addition to the requirements of Chapter 16 of Annex II, the relevant provisions of the navigational authority regulations in force in the Member States shall be observed. 1. General requirements
1.1. Every coupling system shall guarantee the rigid coupling of all the craft in a convoy, i.e. under foreseen operating conditions the coupling device shall prevent longitudinal or transversal movement between the vessels, so that the assembly can be seen as a “nautical unit”.
1.2. The coupling system and its components shall be safe and easy to use, enabling craft to be coupled rapidly without endangering personnel.
1.3. The forces arising from foreseen operating conditions shall be properly absorbed and safely transmitted into the vessel’s structure by the coupling system and its components.
1.4. A sufficient number of coupling points shall be available. 2. Coupling forces and dimensioning of coupling devices
The coupling devices of convoys and formations of vessels to be authorised shall be dimensioned so as to guarantee sufficient safety levels. This condition is deemed to be fulfilled if the coupling forces determined according to points 2.1, 2.2 and 2.3 are assumed to be the tensile strength for the dimensioning of the longitudinal coupling components.
2.1. Coupling points between pusher and pushed lighters or other craft:
2.2. Coupling points between pushing motor vessel and pushed craft:
2.3. Coupling points between pushed craft:
A value of 1 200 kN is deemed to be sufficient for the maximum coupling force for a pushing craft at the coupling point between the first pushed craft and the craft coupled ahead of it, even if formula in point 2.3 produces a higher value.
For the coupling points of all other longitudinal connections between pushed craft, the dimensioning of the coupling devices shall be based on the coupling force determined according to formula in point 2.3. Pushing
craft
Pushed
craft
Pushing
craft
Pushed
craft
Where:
FSB, FSF, FSL [kN]
Coupling force of the longitudinal connection;
PB [kW]
Installed power of the propulsion engine;
LS [m]
Distance from the stern of the pusher or pushing craft to the coupling point;
L’S [m]
Distance from the stern of the pushing craft to the coupling point between the first pushed craft and the craft coupled ahead of it;
hK, h’K [m]
Respective lever arm of the longitudinal connection;
BS [m]
Width of the pushing craft;
270 and 80
Empirically established values for the conversion of installed power to thrust while ensuring adequate levels of safety.
2.4.1. For the longitudinal coupling of individual craft at least two coupling points shall be used. Each coupling point shall be dimensioned for the coupling force determined according to points 2.1, 2.2 or 2.3. If rigid coupling components are used, a single coupling point may be authorised if that point ensures secure connection of the craft.
The tensile strength of the cables shall be selected according to the foreseen number of windings. There shall be no more than three windings at the coupling point. Cables shall be selected according to their intended use.
2.4.2. In the case of pushers with a single pushed lighter, formula in point 2.2 can be used to determine the coupling force if such pushers have been authorised to propel several such lighters.
2.4.3. Sufficient numbers of bollards or equivalent devices shall be available and be capable of absorbing the coupling forces arising. 3. Special requirements for articulated couplings
Articulated couplings shall be designed so as to also ensure a rigid coupling between craft. Compliance with the requirements of Chapter 5 shall be checked during navigation tests with a rigid convoy in accordance with Article 16.06. The drive unit of the articulated coupling shall enable a satisfactory return from the articulated position. The requirements of Articles 6.02 to 6.04 shall be applied mutatis mutandis, hence when a powered drive unit is used, a second independent drive unit and energy source shall be available in the event of failure.
It shall be possible to operate and monitor the articulated coupling (its articulated movement, at least) from the wheelhouse, the requirements of Articles 7.03 and 7.05 shall be applied mutatis mutandis.
‘ADMINISTRATIVE INSTRUCTION No 4
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 5
Noise measurements
(Article 3.04(7), Article 7.01(2), Article 7.03(6), Article 7.09(3), Article 8.10, Article 11.09(3), Article 12.02(5), Article 17.02(3)(b), and Article 17.03(1) of Annex II) 1. General
In order to check the maximum sound pressure levels given in Annex II, measured values, measurement procedures and conditions for the quantitative, reproducible recording of sound pressure levels in accordance with points 2 and 3 shall be established. 2. Measuring instruments
The measuring instrument shall meet the requirements of class 1 according to EN 60651:1994. Before and after each set of measurements, a class 1 calibrator according to EN 60942:1998 shall be placed on the microphone in order to calibrate the measurement system. The compliance of the calibrator with the requirements of EN 60942:1998 shall be checked once per year. The compliance of the measuring equipment with the requirements of EN 60651:1994 shall be checked every two years. 3. Noise measurements
3.1. On board craft
Measurements shall be carried out in accordance with ISO 2923:2003 Sections 5 to 8 measuring only A-weighted sound pressure levels.
3.2. Air noise emitted from craft
Noise emissions from craft on inland waterways and in ports are determined by means of measurements in accordance with EN ISO 22922:2000, Sections 7 to 11. Doors and windows of engine rooms shall be closed during measurements 4. Documentation
Measurements shall be recorded according to the “Noise Measurement Report” (Annex).
Noise Measurement Report
—
on board craft in accordance with ISO 2923:2003
—
air noise emitted from craft in accordance with EN ISO 2922:2000 (*6)
A. Craft data 1. Craft type and name:
Unique European vessel identification number: 2. Owner:
Main propulsion system:
3.1. Main engines:
Number
Manufacturer
Type
Year of construction
Power (kW)
Engine speed
(min–1)
Two-stroke/four-stroke
Turbo-charged
yes/no
1

2

3.2. Transmission
Manufacturer: … Type: … Gear reduction: 1: …
3.3. Propellers
Number: … Number of blades: … Diameter: … mm … Nozzle: yes/no (*6)
3.4. Steering system
Type: 4. Auxiliaries:
Number
Propulsion of
Manufacturer
Type
Year of construction
Power (kW)
Engine speed (min–1)
1

2

3

4

5

5. Noise reduction measures implemented: 6. Observations:
B. Measuring instruments used 1. Sound pressure level meter:
Manufacturer: … Type: … Latest check: … 2. Octave/Third octave band analyser:
Manufacturer: … Type: … Latest check: … 3. Calibrator:
Manufacturer: … Type: … Latest check: … 4. Accessories: 5. Observations:
C. Measurement conditions — craft 1. Formation during the measurements: 2. Load/displacement: … t/m3
(*6) (approximately … % of maximum value) 3. Speed of main engine: … min–1 (approximately … % of maximum value) 4. Auxiliaries in service No: 5. Observations:
D. Measurement conditions — surroundings 1. Area of measurement: … Upstream/downstream (*6) 2. Water depth: … m (Relevant water level = … m) 3. Weather: … Temperature: … °C; Wind strength: … BF 4. External noise interference: yes/no (*6), if yes, specify: … 5. Observations:
E. Recording of measurement 1. Measurement carried out by: 2. Date: 3. Observations: 4. Signature:
F.1. Measurement results
Noise measurements on board craft:
Number
Measurement point
Doors
Windows
Measured value
in dB(A)
Observations
open
closed
open
closed

F.2. Measurement results
Measurement of air noise emitted from craft:
Number
Measurement point
Measured values
in dB(A)
Observations

‘ADMINISTRATIVE INSTRUCTION No 6
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 7
Special anchors with reduced mass
(Article 10.01(5) of Annex II)
PART 1
Authorised special anchors
Special anchors with reduced mass authorised by the competent authorities in accordance with Article 10.01(5) are presented in the following table.
Anchor No
Authorised reduction of anchor mass
(%)
Competent authority 1. HA-DU
30 %
Germany 2. D’Hone Spezial
30 %
Germany 3. Pool 1 (hollow)
35 %
Germany 4. Pool 2 (solid)
40 %
Germany 5. De Biesbosch-Danforth
50 %
Germany 6. Vicinay-Danforth
50 %
France 7. Vicinay AC 14
25 %
France 8. Vicinay Type 1
45 %
France 9. Vicinay Type 2
45 %
France 10. Vicinay Type 3
40 %
France 11. Stockes
35 %
France 12. D’Hone-Danforth
50 %
Germany 13. Schmitt high holding anchor
40 %
Netherlands
PART 2
Authorisation and test procedure of special anchors with reduced mass
(Reduction of the anchor mass values determined in accordance with Article 10.01(1) to (4) of Annex II) 1. Chapter 1 — Authorisation procedure
1.1. Special anchors with reduced mass in accordance with Article 10.01(5) of Annex II shall be authorised by the competent authorities. The competent authority determines the authorised reduction of anchor mass for special anchors in accordance with the procedure outlined below.
1.2. Authorisation as special anchor is only possible if the reduction of anchor mass established is at least 15 %.
1.3. Applications for the authorisation of a special anchor in accordance with point 1.1 shall be submitted to the competent authority of a Member State. Ten copies of the following documents shall be forwarded with each application:
(a) an outline of the dimensions and mass of the special anchor, giving the main dimensions and type designation for each available anchor size;
(b) a braking force diagram for the reference anchor A (in accordance with point 2.2) and the special anchor B to be authorised which has been prepared and assessed by an institution designated by the competent authority.
1.4. The competent authority notifies the Commission of any applications to reduce anchor mass which it considers to authorise after testing. The competent authority consequently notifies the Commission of any authorised special anchor, giving its type designation and authorised reduction of anchor mass. The competent authority grants authorisation to the applicant at the earliest 3 months after notifying the Commission provided that the latter does not raise objections. 2. Chapter 2 — Test Procedure
2.1. The braking force diagrams in accordance with point 1.3 shall show the braking forces as a function of speed for the reference anchor A and the special anchor B to be authorised on the basis of tests in accordance with points 2.2 to 2.5 below. Annex I shows one possible braking force test.
2.2. The reference anchor A used in the tests shall be a conventional folding stockless anchor corresponding to the sketch and details given below, with a mass of at least 400 kg.
A tolerance of ±5 % applies to the dimensions and mass given. However, the surface area of each fluke must be at least 0,15 m2. 2.3. The mass of the special anchor B used in the tests shall not deviate by more than 10 % from the mass of the reference anchor A. If the tolerances are greater, the forces shall be recalculated proportional to mass.
2.4. Braking force diagrams shall give a linear representation of speed (v) in the range 0 to 5 km/h (speed over ground). To this end, three tests shall be carried out in an upstream direction for the reference anchor A and the special anchor B on an alternating basis over each of two stretches of river determined by the competent authority, one with coarse gravel and one with fine sand. On the River Rhine the stretch between 401-402 km can serve as a reference stretch for the coarse gravel tests and the stretch between 480-481 km for the fine sand tests.
2.5. For each test, the anchor being tested shall be towed with a steel wire cable whose length between the points of connection on the anchor and on the towing craft or device is 10 times the height of the connection point on the craft above the anchorage ground.
2.6. The percentage of reduction of anchor mass is calculated by the following formula:
Where
r
the percentage of reduction of anchor mass of special anchor B in relation to reference anchor A;
PA
the mass of reference anchor A;
PB
the mass of special anchor B;
FA
holding force of reference anchor A at v = 0,5 km/h;
FB
holding force of special anchor B at v = 0,5 km/h;
AA
the surface area on the braking force diagram defined by:
—
the line parallel to the y-axis at v = 0,
—
the line parallel to the y-axis at v = 5 km/h,
—
the line parallel to the x-axis at holding force F = 0,
—
the braking force curve for reference anchor A,
Model braking force diagram
(Determining the surface areas AA and AB)
AB
same definition as for AA except that the braking force curve for special anchor B is used.
2.7. The acceptable percentage is the average of six values of r calculated in accordance with point 2.6. ‘Annex I to the regulations on the inspection and authorisation of special anchors
Example of an anchor test method with a single-file two-part pushed convoy
Pusher
2nd lighter
1st lighter
Anchor
Crane
Hawser
Tow line
Tensile force dynamometer
anchorage
500 kg
750 kg
12 mm Ø
24 mm Ø
20 t
sand/gravel
Towing speed: 0 → 5 km/h
Tow line inclination angle ≤ 1:10
‘ADMINISTRATIVE INSTRUCTION No 8
Strength of watertight windows
(Article 15.02(16) of Annex II) 1. General
According to Article 15.02(16) of Annex II, watertight windows may be situated below the margin line if they are watertight, cannot be opened, possess sufficient strength and conform to Article 15.06(14). 2. Construction of watertight windows
The requirements of Article 15.02(16) of Annex II are deemed to be fulfilled if the construction of watertight windows complies with the following provisions.
2.1. Only pre-stressed glass complying with ISO 614, published 04/94, shall be used.
2.2. Round windows shall comply with ISO 1751, published 04/94, Series B: medium heavy-duty windows Type: non-opening window.
2.3. Angular windows shall comply with ISO 3903, published 04/94, Series E: heavy-duty windows Type: non-opening window
2.4. ISO standard windows may be replaced by windows whose construction is at least equivalent to the requirements of points 2.1 to 2.3. ‘ADMINISTRATIVE INSTRUCTION No 9
Requirements for automatic pressurised water sprinklers
(Article 10.03a(1) of Annex II)
Suitable automatic pressurised water sprinklers as in Article 10.03a(1) shall meet the following requirements: 1. The automatic pressurised water sprinkler shall be ready for service at all times when there are persons on board. No additional action by crew members shall be required to trigger operation. 2. The system shall be permanently maintained at the necessary pressure. The pipes shall be filled with water up to the spray nozzles at all times. The system shall have a continuously working water supply. It shall not be possible for impurities harmful to operation to enter the system. Appropriate display instruments and test systems (e.g. pressure gauges, pressure-tank water level indicators, pump test piping) shall be installed for monitoring and checking the system. 3. The pump for the water supply to the spray nozzles shall be activated automatically by a pressure drop in the system. The pump shall be dimensioned so that it can continuously provide a sufficient water supply at the necessary pressure if all the spray nozzles necessary for covering the area of the largest room to be protected are activated simultaneously. The pump shall supply the automatic pressurised water sprinkler exclusively. In the event of pump failure, it shall be possible to provide the spray nozzles with a sufficient water supply from another on-board pump. 4. The system shall be divided into sections, each with no more than 50 spray nozzles. 5. The number and the layout of spray nozzles shall ensure effective distribution of water in the rooms to be protected. 6. Spray nozzles shall be triggered at a temperature between 68 °C and 79 °C. 7. The installation of components of automatic pressurised water sprinklers within the rooms to be protected shall be limited to the necessary minimum. No such system components shall be installed in main engine rooms. 8. Visual and acoustic indicators shall be provided in one or more suitable locations, at least one of which must be permanently manned, displaying activation of automatic pressurised water sprinklers for each section. 9. The energy supply of the installation of automatic pressurised water sprinklers shall be provided by two independent energy sources that shall not be installed in the same location. Each energy source shall be capable of supplying the entire system unassisted. 10. An installation plan of the automatic pressurised water sprinkler shall be presented to the inspection body for examination before installation of the system. The plan shall indicate the types and performance data of the machines and equipment used. An installation tested and certified by an approved classification society which complies at least with the above prescriptions can be authorised without further testing. 11. The presence of an automatic pressurised water sprinkler shall be entered in the Community Certificate under item 43. ‘ADMINISTRATIVE INSTRUCTION No 10
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 11
Completion of the Community Certificate 1. GENERAL
1.1. Forms
For completion of the Community Certificate only forms authorised by the competent authority shall be used. Forms shall be filled in on one side only.
When issuing a new Community Certificate, all pages 1 to 13 shall be included, even if some pages have no entries.
1.2. Method of entry
Entries on the Community Certificate shall be typewritten or computer-printed. Hand written entries may only be made in exceptional cases. The entries shall be indelible. Font colours shall be black or blue only. Deletions shall be made in red. 2. ENTRIES
2.1. Deletion of alternatives
Where entries are marked with (*7) those which are not appropriate shall be deleted.
2.2. Items without entry
If, for any of the items 1 to 48, no entry is either necessary or possible, a line shall be drawn across the entire field.
2.3. Final page of the Community Certificate
If no additional pages are required after page 13 (see point 3.2.3), the words “continued on page”
(*7) at the bottom of page 13 shall be deleted.
2.4. Amendments
2.4.1. First handwritten amendment on a page
A page can be amended once only, however, several amendments may be made at that time. A red line shall be drawn through any details to be amended. A previously deleted alternative (see point 2.1) or an item previously without entry (see point 2.3) shall be underlined in red. The new details shall not be entered in the amended field, but on the same page under the heading “Amendments”, the line “This page has been replaced” shall be deleted.
2.4.2. Further handwritten amendments on a page
For further amendments the page shall be replaced and the necessary amendments as well as any earlier amendments shall be entered directly under the appropriate items. Under the heading “Amendments” the line “amendments to item(s)” shall be deleted.
The old page shall be retained by the inspection body which originally issued the Community Certificate.
2.4.3. Amendments by electronic data processing
In case of amendments by electronic data processing, the page shall be replaced and the necessary amendments as well as any earlier amendments shall be entered directly under the appropriate items. Under the heading “Amendments” the line “amendments to item(s)” shall be deleted.
The old page shall be retained by the inspection body which originally issued the Community Certificate.
2.5. Corrections by pasting over
Pasting over of entries or pasting in further details added to an item is not allowed. 3. REPLACING AND ADDING PAGES
3.1. Replacing pages
Page 1 of the Community Certificate shall never be replaced. For replacing other pages the procedures outlined in point 2.4.2 or point 2.4.3 shall be applied.
3.2. Adding pages
If there is insufficient space for further entries on pages 10, 12 or 13 of the Community Certificate, additional pages may be attached.
3.2.1. Extension/Confirmation of validity
If further extension is necessary when the certificate has already been extended six times, the words “Continued on page 10a” shall be added at the bottom of page 10, and a further page 10 shall be marked as page 10a and inserted after page 10. The respective entry is then made under item 49 at the top of page 10a. At the bottom of page 10a the entry “Continued on page 11” shall be made.
3.2.2. Extension of the liquefied gas installation certificate
A similar procedure to point 3.2.1 shall be applied, with page 12a inserted after page 12. 3.2.3. Annex to the Community Certificate
At the bottom of page 13 the words “End of the Community Certificate” shall be deleted in red, the deleted words “Continued on page (*7)
” shall be underlined in red and behind that the page number 13a shall be entered. This amendment shall carry an official stamp. A further page 13 shall be marked as page 13a and inserted after page 13. The provisions of points 2.2 and 2.3 apply to page 13a mutatis mutandis.
The same procedure shall be applied for any further annexes (pages 13b, 13c, etc.). 4. EXPLANATIONS OF INDIVIDUAL ITEMS
Self-explanatory items are not mentioned below. 2. If applicable, insert terms as per Article 1.01. Other vessel types shall be entered with their commonly accepted designation. 15. This section shall only be completed for craft for which at least one of the properties 1.1 or 1.2 or 3 in item 14 is not deleted, otherwise the entire table shall be deleted.
15.1. In the column “formation figure” of the table the number(s) of the formations depicted shall be entered. Lines without entry shall be struck through.
Further formations may be drawn under “Other formations” and shall be designated 18, 19, 20, etc.
If it is not apparent from the property “fit to push” in the previous ship certificate which formations are authorised, the entry from the previous ship certificate may be transferred to item 52. “See item 52” shall be entered in line 1 of the table “Authorised formations”.
15.2. Couplings
Only the details of the coupling between the pushing craft and the pushed section of the convoy shall be entered.
17-20. Details according to the tonnage certificate items 17-19 to two decimal places and item 20 without decimal places. Length overall and breadth overall give the maximum dimensions of the craft, including all projecting fixed parts. Length L and Breadth B give the maximum hull dimensions (see also Article 1.01 Definitions). 21. Dead weight tonnage for cargo vessels in t according to the tonnage certificate for the maximum draught according to item 19. Displacement for all other craft in m3. If no tonnage certificate is available, calculate the displacement from the product of the block coefficient and length LWL, breadth BWL and mean draught at maximum immersion. 23. Number of passenger berths available (including folding beds and similar). 24. Only watertight transverse bulkheads extending from one side of the vessel to the other shall be taken into consideration. 26. If applicable, the following terms shall be used:
—
manually operated hatch covers,
—
manually operated rolling hatch covers,
—
manually operated sliding hatch covers,
—
mechanically operated sliding hatch covers,
—
mechanically operated hatch covers.
Other types of hatch covers shall be entered with their commonly accepted designation.
Any holds which do not have a hatch cover shall be listed, e.g. under item 52. 28. Figure without decimal place.
30, 31 and 33. Every winch housing shall be counted as one winch, regardless of the number of anchors or towing cables connected to it. 34. Under “Other installations” systems which do not use rudder blades (e.g. rudder-propeller, cycloidal-propeller, bow-thruster systems) shall be entered.
Enter also any electrical auxiliary engines for manual actuation.
With bow-thruster systems, “remote-controlled” refers only to remote controls operated from the steering position in the wheelhouse. 35. Only the theoretical values according to Article 8.08(2) and (3), Article 15.01(1)(c), and Article 15.08(5) shall be entered, and then only for craft whose keels were laid down after 31 December 1984. 36. A sketch may be necessary for clarification. 37. Only the theoretical values without reduction according to Article 10.01(1)-(4) shall be entered. 38. Only the minimum lengths according to Article 10.01(10) and the minimum tensile strength according to Article 10.01(11) shall be entered.
39 and 40. Only the minimum lengths and minimum tensile strength values recalculated according to Article 10.02(2) shall be entered. 42. The inspection body may add items to the list of necessary equipment. These shall be justified as essential to ship safety for the respective vessel type or its operational area. Additions shall be entered under item 52. Left column, row 3 and 4: for passenger vessels the first mentioned item shall be crossed out and under the second mentioned item the length of the gangway as established by the inspection body shall be entered. For all other vessels the second mentioned item shall be crossed out completely respectively, if the inspection body has allowed a shorter length than what is foreseen by Article 10.02(2)(d), only the first half shall be crossed out and the length of the gangway entered.
Left column, row 6: here the number of the prescribed first aid kits according to Article 10.02(2)(f) and Article 15.08(9) shall be entered.
Left column, row 10: here the number of the prescribed fire proof receptacles according to Article 10.02(1)(d) to (f) shall be entered. 43. Portable fire extinguishers required by other safety regulations, e.g. the regulation for the carriage of dangerous substances on the Rhine (ADNR), are not included here. 44. Row 3: in Community Certificates to be extended before 1.1.2010, or 1.1.2025 where Chapter 24a is applicable, the item “according to EN 395:1998 or 396:1998” shall be crossed if no life vests according to this standard are onboard.
Row 4: when Community Certificates are extended after 1.1.2015, or 1.1.2030 where Chapter 24a is applicable, or if a new dinghy is taken onboard, the item “with a set of oars, one mooring line and a baler” shall be crossed. The item “according to EN 1914:1997” shall be crossed if no dinghy according to this standard is onboard. 46. As a general rule, continuous operation shall not be inserted if there is a lack of berths or if there are excessive noise levels. 50. The expert shall sign only if he has completed page 11 himself. 52. Here any additional restrictions, exemptions and explanations, or similar, applying to entries under individual items can be given. 5. TRANSITIONAL PROVISIONS
5.1. Existing Community Certificates
With the exception of Article 2.09(2), no further extensions to existing Community Certificates shall be granted.
5.2. Replacement after a periodical inspection
After a periodical inspection of a vessel which does not yet have a Community Certificate in line with the model in Annex V Part 1, a Community Certificate shall be issued. Article 2.09(4) and Article 2.17 shall apply.
‘ADMINISTRATIVE INSTRUCTION No 12
Fuel tanks on floating equipment
(Article 8.05(1) and Article 17.02(1)(d) of Annex II)
According to Article 8.05(1), fuel tanks shall form an integral part of the hull or shall be firmly attached to it.
Fuel tanks for engines of working gear on floating equipment do not have to form an integral part of the hull or be firmly attached to it. Mobile tanks may be used, provided that they comply with the following conditions: 1. The capacity of these tanks shall not exceed 1 000 litres. 2. It shall be possible to attach the tanks sufficiently firmly and to earth them. 3. The tanks shall be made from steel of a sufficient wall thickness and shall be installed in a drip tray. The latter shall be designed to prevent leaking fuel contaminating the waterways. The drip tray may be dispensed with if double-skin tanks with a leak protection or leakage warning system are used and which are filled only via an automatic delivery valve. The provisions of point 3 shall be deemed to be fulfilled if the construction of a tank has been certified and approved according to the regulations of a Member State.
An appropriate entry shall be made in the Community Certificate.
‘ADMINISTRATIVE INSTRUCTION No 13
Minimum hull thickness of barges
(Article 3.02(1) of Annex II)
During periodical inspections in accordance with Article 2.09 of barges which are exclusively towed, the inspection body may allow minor deviations from Article 3.02(1)(b) with respect to the minimum thickness of the shell plating of the hull. The deviation shall not be more than 10 %, and the minimum hull thickness shall not be less than 3 mm.
The deviations shall be entered in the Community Certificate.
Under item 14 of the Community Certificate, only property No 6.2 “Towed as a craft with no motive power of its own” shall apply.
Properties No 1 to 5.3 and 6.1 shall be deleted.
‘ADMINISTRATIVE INSTRUCTION No 14
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 15
Steerageway under vessel’s own power
(Article 10.03b(2)(a), Article 15.07(1), Article 22a.05(1)(a) of Annex II) 1. Minimum requirements for vessel’s steerageway
Steerageway under a vessel’s own power in accordance with Articles 10.03b(2)(a), 15.07(1) and 22a.05(1)(a) is deemed to be sufficient if — when using the bow thruster — the vessel or the formation propelled by the vessel attains a speed of 6,5 km/h in relation to the water and a rate-of-turn of 20°/min can be induced and maintained while under way at a speed of 6,5 km/h in relation to the water. 2. Navigation tests
On verifying the minimum requirements Articles 5.03 and 5.04 shall be complied with.
‘ADMINISTRATIVE INSTRUCTION No 16
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 17
Appropriate fire alarm system
(Article 10.03b(3), Article 15.11(17), Article 22b.11(1) of Annex II)
Fire alarm systems are considered to be appropriate if they meet the following conditions. 0. COMPONENTS
0.1. Fire alarm systems consist of:
(a) fire detection system,
(b) fire indicator system,
(c) control panel,
as well as the external power supply.
0.2. The fire detection system may be divided into one or more fire zones.
0.3. The fire indicator system may have one or more indicator devices.
0.4. The control panel is the central control unit of the fire alarm system. It also includes parts of the fire indicator system (i.e. an indicator device).
0.5. A fire detection zone may have one or more fire detectors.
0.6. Fire detectors may be:
(a) heat detectors;
(b) smoke detectors;
(c) ion detectors;
(d) flame detectors;
(e) combination detectors (fire detectors combining two or more of the detectors listed in (a) to (d)).
Fire detectors which respond to other factors indicating the onset of a fire may be approved by the inspection body provided that they are no less sensitive than the detectors referred to under (a) to (e).
0.7. Fire detectors may be installed:
(a) with or
(b) without
individual identification. 1. CONSTRUCTION REQUIREMENTS
1.1. General
1.1.1. Compulsory fire alarm systems shall be operational at all times.
1.1.2. Fire detectors required in accordance with point 2.2 shall be automatic. Additional manually operated fire detectors may be installed.
1.1.3. The system and its components shall be able to withstand voltage fluctuations and surges, changes in ambient temperature, vibrations, humidity, shocks, impacts and corrosion such as commonly occur on vessels.
1.2. Energy supply
1.2.1. Energy sources and electric circuits necessary for the operation of the fire alarm system shall be self monitoring. Any fault occurring shall activate a visual and acoustic alarm signal on the control panel which can be distinguished from a fire alarm signal.
1.2.2. There shall be at least two power sources for the electrical part of the fire alarm system, one of which shall be an emergency power system (i.e. emergency power source and emergency switchboard). There shall be two separate power-feeds solely for this purpose. These shall lead to an automatic switch in or near the control panel of the fire alarm system. On day-trip vessels up to 25 m LWL and on motor vessels a separate emergency power supply is sufficient.
1.3. Fire detection system
1.3.1. Fire detectors shall be grouped in fire detection zones
1.3.2. Fire detection systems shall not be used for any other purpose. By way of derogation the closing of the doors in accordance with Article 15.11(8) and similar functions may be activated and indicated on the control panel.
1.3.3. Fire detection systems shall be designed in such a way that the first indicated fire alarm does not prevent fire alarms set off by other detectors.
1.4 Fire detection zones
1.4.1. Where the fire detectors cannot be remotely identified individually, a fire detection zone shall not monitor more than one deck. This does not apply to a fire detection zone which monitors an encapsulated stairwell.
In order to avoid delays in detecting the origin of the fire, the number of enclosed spaces included in each fire detection zone shall be limited. There shall not be more than fifty enclosed spaces in one fire detection zone.
Where the fire detection system has remote identification of individual fire detectors, the fire detection zones may monitor several decks and any number of enclosed spaces.
1.4.2. On passenger vessels which do not have a fire detection system with remote identification of individual fire detectors, a fire detection zone shall not comprise more than the area constituted in accordance with Article 15.11(10). The activation of a fire detector in an individual cabin in this fire detection zone shall set off a visual and acoustic signal in the passageway outside that cabin.
1.4.3. Galleys, engine rooms and boiler rooms shall constitute separate fire detection zones.
1.5. Fire detectors
1.5.1. Only heat, smoke or ion detectors shall be used as fire detectors. Other types may only be used as additional detectors.
1.5.2. Fire detectors shall be type-approved.
1.5.3. All automatic fire detectors shall be designed in such a way that they can be tested to ensure that they are working properly and brought back into service without having to replace any components.
1.5.4. Smoke detectors shall be set so that they respond to a reduction in visibility per metre caused by smoke of more than 2 % to 12,5 %. Smoke detectors fitted in galleys, engine rooms and boiler rooms shall respond within sensitivity limits meeting the requirements of the inspection body, whereby under-sensitivity or over-sensitivity of the detectors shall be avoided.
1.5.5. Heat detectors shall be set so that with temperature increase rates of less than 1 °C/min they respond at temperatures of between 54 °C and 78 °C.
With higher rates of temperature increase, the heat detector shall respond within temperature limits where under- or over-sensitivity of the heat detector is avoided.
1.5.6. With the agreement of the inspection body, the permissible operating temperature of heat detectors may be increased to 30 °C above the maximum temperature in the upper part of engine and boiler rooms.
1.5.7. The sensitivity of flame detectors shall be sufficient to detect flames against an illuminated background. Flame detectors shall also be equipped with a system for identifying false alarms.
1.6. Fire detection system and control panel
1.6.1. Activation of a fire detector shall set off a visual and acoustic fire alarm signal at the control panel and the indicator devices.
1.6.2. The control panel and the indicator devices shall be at a location which is permanently manned by crew or shipboard personnel. One indicator shall be at the steering position.
1.6.3. The indicator devices shall indicate at least the fire detection zone in which a fire detector has been activated.
1.6.4. On or near each indicator device there shall be clear information on the areas monitored and the location of the fire detection zones. 2. INSTALLATION REQUIREMENTS
2.1. Fire detectors shall be installed in such a manner as to ensure the best possible operation of the system. Locations in the vicinity of deck girders and ventilation shafts or other locations where air currents could adversely affect system operation and locations where impacts or mechanical damage are likely shall be avoided.
2.2. In general, fire detectors located on the ceiling shall be at least 0,5 metres away from bulkheads. The maximum distance between fire detectors and bulkheads shall conform to the following table:
Type of fire detector
Maximum floor surface area per fire detector
Maximum distance between fire detectors
Maximum distance of fire detectors from bulkheads
Heat
37 m2
9 m
4,5 m
Smoke
74 m2
11 m
5,5 m
The inspection body may stipulate or approve other distances on the basis of tests which prove the characteristics of the detectors.
2.3. The routing of electric cables for the fire alarm system through engine rooms and boiler rooms or other high fire risk areas is not permitted unless this is necessary for fire detection in those areas or connection to the corresponding power supply. 3. TESTING
3.1. Fire alarm systems shall be tested by an expert:
(a) after installation;
(b) regularly, but at least every two years.
In the case of engine rooms and boiler rooms these tests shall be carried out under varying operational and ventilation conditions.
3.2. A test certificate shall be signed by the expert, indicating the date of the test.
‘ADMINISTRATIVE INSTRUCTION No 18
Proof of buoyancy, trim and stability of the separated parts of a vessel
(Article22a.05(2), in conjunction with Article 22.02 and Article 22.03 of Annex II) 1. When proving the buoyancy, trim and stability of the parts of a vessel which have been separated in accordance with Article 22a.05(2)(a), it shall be assumed that both parts were partly or fully unloaded beforehand or That containers extending beyond the hatch coaming were suitably protected from slipping. 2. For each of the two parts, the following requirements shall therefore be met when calculating stability in accordance with Article 22.03 (Limit conditions and method of calculation for confirmation of stability for the transport of secured containers):
—
metacentric height MG shall be not less than 0,50 m,
—
there shall be a residual safety clearance of 100 mm,
—
the speed to be taken into account shall be 7 km/h,
—
the wind pressure shall be taken to be 0,01 t/m2. 3. The heeling angle (≤ 5°) does not have to be complied with for the parts of the vessel separated in accordance with Article 22a.05(2) since this angle — derived from the coefficient of friction — was specified for non-secured containers.
The heeling lever resulting from the free surfaces of liquids shall be taken into account in accordance with the formula given in Article 22.02(1)(e). 4. The requirements set out in points 2 and 3 shall also be deemed to have been met if, for each of the two parts, the stability requirements set out in Section 9.1.0.95.2 of the Ordinance on the transportation of hazardous goods on the Rhine (ADNR) are met. 5. Confirmation of the stability of the separated parts of the vessel may be obtained on the assumption that the load is evenly distributed, as an even distribution of the load — as far as it is not already the case — can be done prior to separation, or else the vessel can be largely unloaded.
‘ADMINISTRATIVE INSTRUCTION No 19
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 20
Equipment for vessels to be operated according to standards S1 and S2
(Article 23.09 of Annex II) 1. GENERAL INTRODUCTION
According to Article 23.09(1) of Annex II, vessels which are intended to be operated according to standards S1 and S2 shall comply with the provisions of this Article. According to Article 23.09(1) the inspection body shall confirm in the Community Certificate that the vessel complies with these provisions.
These provisions are supplementary equipment requirements which apply in addition to the requirements with which a vessel has to comply for the Community Certificate to be issued. Provisions of Article 23.09 which might be interpreted in different ways will be clarified in this Administrative instruction. Accordingly, the provisions of Article 23.09(1) of Annex II shall be interpreted as follows: 2. ARTICLE 23.09
2.1. (1.1)(a) — Arrangement of the propulsion system
If a vessel is fitted with a directly reversible main engine, the compressed air system which is required to reverse the direction of thrust shall:
(a) be kept permanently pressurised by an automatically adjusting compressor; or
(b) when an alarm is triggered in the wheelhouse be pressurised by means of an auxiliary engine which can be started from the steering position. If the auxiliary engine has its own fuel tank, there shall — in accordance with Article 8.05(13) — be a warning device in the wheelhouse to indicate if the level of filling is not sufficient to ensure further safe operation.
2.2. (1.1)(b) — Bilge levels in the main engine room
If a bow steering system is necessary to comply with the manoeuvring requirements of Chapter 5, the room containing the bow steering system shall be deemed to be a main engine room.
2.3. (1.1)(c) — Automatic fuel supply
2.3.1. If the propulsion system has a daily-supply tank,
(a) its contents shall be sufficient to ensure an operation period of the propulsion system of 24 hours, assuming a consumption of 0,25 litres per kW per hour;
(b) the fuel supply pump for refilling the daily-supply tank shall be operated continuously; or
(c) the fuel supply pump shall be fitted with:
—
a switch that automatically switches on the fuel supply pump when the daily-supply tank reaches a certain low level, and
—
a switch that automatically switches off the fuel supply pump when the daily-supply tank is full.
2.3.2. The daily-supply tank shall have a level alarm device which meets the requirements of Article 8.05(13).
2.4. (1.1)(d) — No particular force required for the steering system
Hydraulically operated steering systems fulfil this requirement. Manually operated steering systems shall not require a force of more than 160 N in order to be operated.
2.5. (1.1)(e) — Visual and acoustic signals required under way
Visual signs do not include cylinders, balls, cones or double cones required under navigational authority regulations of the Member States.
2.6. (1.1)(f) — Direct communication and communication with the engine room
2.6.1. Direct communication shall be deemed to be ensured if:
(a) direct visual contact is possible between the wheelhouse and the control positions for the winches and bollards on the fore section or the stern of the vessel and in addition the distance from the wheelhouse to these control positions is not more than 35 m; and
(b) the accommodation is directly accessible from the wheelhouse.
2.6.2. Communication with the engine room shall be deemed to be ensured if the signal referred to in Article 7.09(3) second sentence, can be operated independently from the switch referred to in Article 7.09(2).
2.7. (1.1)(i) — Cranks and similar rotating means of operation
These include:
(a) manually operated anchor winches (the maximum force required shall be deemed to be that when the anchors are hanging freely);
(b) cranks for lifting hatches;
(c) cranks on mast and funnel winches.
These do not include:
(a) warping and coupling winches;
(b) cranks on cranes, unless intended for ship’s boats.
2.8. (1.1)(m) — Ergonomic arrangement
The provisions are deemed to be fulfilled if:
(a) the wheelhouse is arranged in accordance with European Standard EN 1864:2008; or
(b) the wheelhouse is designed for radar navigation by one person; or
(c) the wheelhouse meets the following requirements:
(aa)
the control units and monitoring instruments are in the forward field of vision and within an arc of not more than 180° (90° to starboard and 90° to port), including the floor and ceiling. They shall be clearly legible and visible from the normal position of the helmsman;
(bb)
the main control units such as the steering wheel or steering lever, the engine controls, the radio controls, and the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, shall be arranged in such a way that the distance between the controls on the starboard side and those on the port side is not more than 3 m. The helmsman shall be able to operate the engines without letting go of the controls for the steering system and while still being able to operate the other controls such as the radio system, the controls for the acoustic signals and the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate;
(cc) the warning and manoeuvring signals required under national or international navigational authority regulations, as appropriate, are operated electrically, pneumatically, hydraulically or mechanically. By way of derogation, it may be operated by means of a tension wire only if safe operation from the steering position is possible in this way. 3. ARTICLE 23.09
3.1. (1.2)(a) — Motor vessel operating separately
Motor vessels which according to the Community Certificate are also suitable for pushing but which:
(a) do not have hydraulically or electrically operated coupling winches; or
(b) whose hydraulically or electrically operated coupling winches do not meet the requirements of point 3.3 of this Administrative instruction,
shall be given the standard S2 as motor vessel operating separately.
The entry “Standard S2 does not apply to the motor vessel when pushing” shall be entered under item 47 of the Community Certificate.
3.2. (1.2)(c) — Pushed convoys
Motor vessels which according to their Community Certificate are suitable for pushing and are fitted with hydraulically or electrically operated coupling winches that fulfil the requirements of point 3.3 of this Administrative instruction but which do not have their own bow thruster shall be given the standard S2 as motor vessel pushing a convoy. The entry “Standard S2 does not apply to the motor vessel when operating separately” shall be entered under item 47 of the Community Certificate.
3.3. (1.2)(c), first sentence, and (1.2)(d), first sentence — Special winches or equivalent devices for tensioning the cables (coupling devices)
The coupling devices required are the minimum equipment specified in accordance with Article 16.01(2) which, according to points 2.1 and 2.2 of Administrative instruction No 3 (longitudinal connections), serve to take up the coupling forces and which meet the following requirements:
(a) the device shall provide the tensioning force required for the coupling only by mechanical means;
(b) the controls for the device shall be located on the device itself. By way of derogation, remote control is permitted provided that:
—
the person operating the device has an unobstructed direct view of the device from the control position,
—
there is a device at the control position to prevent unintentional operation,
—
the device has an emergency stop;
(c) the device shall have a braking device which acts immediately if the controls are released or the motive force fails;
(d) it shall be possible for the coupling cable to be released manually if the motive force fails.
3.4. (1.2)(c), second sentence, and (1.2)(d), second sentence — Operating the bow thruster
The control for operating the bow thruster shall be permanently installed in the wheelhouse. The requirements of Article 7.04(8) shall be complied with. The electric cabling to operate the bow thruster shall be permanently installed up to the fore section of the pushing motor vessel or the pusher.
3.5. (1.2)(e) — Equivalent manoeuvrability
Equivalent manoeuvrability is ensured by a propulsion system consisting of:
(a) a multi-propeller drive and at least two independent propulsion systems with similar power output;
(b) at least one cycloidal propeller;
(c) at least one rudder propeller; or
(d) at least one 360° water-jet propulsion system.
‘ADMINISTRATIVE INSTRUCTION No 21
Requirements for low-location lighting
(Article 15.06(7); Article 22b.10(d) of Annex II) 1. General
1.1. According to the abovementioned provisions, passenger vessels and high-speed vessels shall have suitable systems to clearly identify the escape routes and emergency exits when the normal emergency lighting is less effective due to smoke. Such systems shall take the form of low-location lighting (LLL). This Administrative instruction covers the approval, installation and maintenance of such systems.
1.2. In addition to the emergency lighting required by Article 15.10(3) the escape routes, including stairways, exits and emergency exits, shall be marked by low-location lighting (LLL) throughout the whole of the escape route, particularly at corners and intersections.
1.3. The LLL system shall function for at least 30 minutes after its activation.
1.4. LLL products shall be neither radioactive nor toxic.
1.5. Instructions on the LLL system shall be displayed with the safety plan in accordance with Article 15.13(2) and in every cabin. 2. Definitions
2.1. Low-location lighting (LLL) — Electrically powered lighting or photoluminescent indicators placed along the escape routes so as to ensure that all such routes can be easily identified.
2.2. Photoluminescent (PL) system — An LLL system which uses PL material. Photoluminescent material contains a chemical (example: zinc sulphide) that has the quality of storing energy when illuminated by visible light. The PL material emits light which becomes visible when the ambient light source is less effective. Without the light source to re-energise it, the PL material gives off the stored energy for a period of time with diminishing luminance.
2.3. Electrically powered (EP) system — An LLL system which requires electrical power for its operation, such as systems using incandescent bulbs, light-emitting diodes, electroluminescent strips or lamps, electrofluorescent lamps, etc. 3. Passageways and stairways
3.1. In all passageways, the LLL shall be continuous, except where interrupted by corridors and cabin doors, in order to provide a visible delineation along the escape route. LLL systems in compliance with an international standard having a visible delineation without being continuous shall also be acceptable. The LLL shall be installed at least on one side of the corridor, either on the wall no more than 0,3 m from the floor, or on the floor no more than 0,15 m from the wall. In corridors more than two metres wide, LLL shall be installed on both sides.
3.2. In dead-end corridors, the LLL shall have arrows placed at intervals of no more than 1 m, or equivalent direction indicators, pointing in the direction of the escape route.
3.3. In all stairways, LLL shall be installed on at least one side at no more than 0,3 m above the steps, which will make the location of each step readily identifiable to any person standing above and below that step. Low-location lighting shall be installed on both sides if the width of the stairway is two metres or more. The top and bottom of each set of stairs shall be identified to show that there are no further steps. 4. Doors
4.1. Low-location lighting shall lead to the exit door handle. To prevent confusion, no other doors shall be similarly marked.
4.2. Where sliding doors are fitted in partitions in accordance with Article 15.11(2) and in bulkheads in accordance with Article 15.02(5), the direction of opening shall be indicated. 5. Signs and markings
5.1. All escape route signs shall be of photoluminescent material or marked by electric lighting. The dimensions of such signs and markings shall be commensurate with the rest of the LLL system.
5.2. Low-location lighting exit signs shall be provided at all exits. The signs shall be located within the prescribed area on the side of the exit doors where the handle is located.
5.3. All signs shall contrast in colour to the background (wall or floor) on which they are installed.
5.4. Standardised symbols (for example those described in IMO Decision A.760(18)) shall be used for the LLL. 6. Photoluminescent systems
6.1. PL strips shall be no less than 0,075 m wide. Narrower strips may however be used if their luminance is increased proportionally to compensate for their width.
6.2. Photoluminescent materials shall provide at least 15 mcd/m2 measured 10 minutes after the removal of all external illuminating sources. The system shall then continue to provide luminance values greater than 2 mcd/m2 for 20 minutes.
6.3. Any PL system materials shall be provided with not less than the minimum level of ambient light necessary to charge the PL material to meet the above luminance requirements. 7. Electrically powered systems
7.1. Electrically powered systems shall be connected to the emergency switchboard required by Article 15.10(4) so as to be powered by the main source of electrical power under normal circumstances and also by the emergency source of electrical power when the latter is in operation. For the purpose of dimensioning the capacity of the emergency source of electrical power the EP systems shall be included in the list of emergency consumers.
7.2. Electrically powered systems shall either switch on automatically or be capable of being activated by means of a single operation at the steering position.
7.3. Where electrically powered systems are installed, the following standards of luminance shall be applied: 1. the active parts of electrically powered systems shall have a minimum luminance of 10 cd/m2; 2. the point sources of miniature incandescent lamps shall provide not less than 150 mcd mean spherical intensity with a spacing of not more than 0,1 m between lamps; 3. the point sources of light-emitting-diode systems shall have a minimum peak intensity of 35 mcd. The angle of half-intensity cone shall be appropriate to the likely track directions of approach and viewing. Spacing between lamps shall be no more than 0,3 m; and 4. for electroluminescent systems, these shall function for 30 minutes from the instant when the main power supply to which it was required to be connected by Section 7.1 fails.
7.4. All EP systems shall be arranged so that the failure of any single light, lighting strip, or battery will not result in the marking being ineffective.
7.5. Electrically powered systems shall meet the requirements of Article 9.20 for vibration and heat testing. By way of derogation from Article 9.20(2)(c) the heat test may be conducted at a reference ambient temperature of 40 °C.
7.6. Electrically powered systems shall meet the electromagnetic compatibility requirements laid down in Article 9.21. 7.7. Electrically powered systems shall provide a type of minimum protection of IP 55 in accordance with IEC 60529:1992. 8. Tests
LLL systems shall have their luminance tested by an expert at least once every five years. A test certificate shall be signed by the expert, indicating the date of the test. If the luminance for a particular reading does not meet the requirements of this Administrative instruction, readings shall be taken in at least ten locations equally spaced apart. If more than 30 % of the readings do not meet the requirements of this Administrative instruction, the LLL shall be replaced. If between 20 % and 30 % of the readings do not meet the requirements of this Administrative instruction, the LLL shall be checked again within one year.
‘ADMINISTRATIVE INSTRUCTION No 22
Specific safety needs of persons with reduced mobility
(Article 1.01(104), Article 15.01(4), Article 15.06(3) to (5), (9), (10), (13) and (17), Article 15.08(3), Article 15.10(3), Article 15.13(1) to (4) of Annex II) 1. Introduction
Persons with reduced mobility have safety needs exceeding those of other passengers. These needs are taken into account in the requirements of Chapter 15, which are explained as follows.
These requirements are intended to ensure that persons with reduced mobility can stay and move safely on board vessels. In addition, in an emergency such persons should have the same level of safety as other passengers.
It is not necessary that all passenger areas fulfil the specific safety requirements of persons with reduced mobility. Therefore those requirements apply only to certain areas. However, the persons in question must be given the opportunity of being informed of the areas specially adapted for them in view of safety, so that they can organise their stay on board accordingly. It is the responsibility of the ship-owner to make the corresponding areas available, make them known and communicate them to persons with reduced mobility.
The provisions concerning persons with reduced mobility make reference to:
—
Directive 2003/24/EC of the European Parliament and of the Council of 14 April 2003 amending Council Directive 98/18/EC on safety rules and standards for passenger ships, and
—
the guide for the adaptation of inland waterway passenger vessels to people with disabilities in accordance with Resolution No 25 of the United Nations Economic Commission for Europe.
The definition of the term “persons with reduced mobility” used in Annex II is largely identical to that of the Directive and most of the technical requirements are based on the guide. In cases of doubt, therefore, both can be referred to when taking decisions. In general, the requirements of the Directive and guide go beyond those of Annex II.
The requirements of Annex II do not concern berths and similar installations. These are subject to national provisions. 2. Article 1.01(104) — Term “Persons with reduced mobility”
“Persons with reduced mobility” means anyone who, as a result of physical impairments, cannot move or distinguish their surroundings in the same way as other passengers. This definition includes persons with impaired eyesight or hearing or persons accompanying children in buggies or being carried. However, for the purposes of these provisions, persons with reduced mobility do not include anyone with psychic impairments. 3. Article 15.01(4) — General provisions: Areas provided for use by persons with reduced mobility
Areas provided for use by persons with reduced mobility range from, in the simplest case, the entrance area to the places from which an evacuation will take place in an emergency. They shall include:
—
a place where life-saving equipment is stowed or issued in an emergency,
—
seats,
—
a suitably-adapted toilet (No 10 of these guidelines), and
—
connecting corridors.
The number of seats corresponds at least approximately to the number of persons with reduced mobility that — over a lengthy period — are most frequently onboard simultaneously. The number should be determined by the ship-owner on the basis of experience, as this is beyond the knowledge of the competent authority.
On cabin vessels consideration shall also be given to connecting corridors to passenger cabins used by persons with reduced mobility. The number of such cabins is to be determined by the ship-owner in the same way as the number of seats. With the exception of the width of doors, no requirements are imposed for the special arrangement of cabins. It is the responsibility of the owner to make any further necessary arrangements.
Sentence 2 is identical to Article 24.04(4), taking into account the special safety requirements of persons with reduced mobility. It shall therefore be applied likewise. Should the recommendations require alternative measures, these may in particular be of organisational nature. 4. Article 15.06(3)(g) — Exits of rooms
With regard to the requirements concerning the width of connecting corridors, exits and openings in bulwarks or guard rails intended for use by persons with reduced mobility or usually used for the embarkation or disembarkation of persons with reduced mobility, consideration shall be given to buggies and the fact that people may be dependent on various types of walking aids or wheelchairs. In the case of exits or openings for embarkation or disembarkation account shall also be taken of the additional space needed for any assisting staff. 5. Article 15.06(4)(d) — Doors
The requirements regarding the arrangement of the area surrounding doors intended for use by persons with reduced mobility shall ensure that persons dependent for example on walking aids can open such doors safely. 6. Article 15.06(5)(c) — Connecting corridors
See point 4 of this Administrative instruction. 7. Article 15.06(9) — Stairways and elevators
The requirements for the arrangement of stairways shall, in addition to possible reduced mobility, also take into account eyesight impediments. 8. Article 15.06(10)(a) and (b) — Bulwarks and guard rails
The requirements for bulwarks and guard rails of decks intended for use by persons with reduced mobility shall provide for a greater height since such persons are more likely to lose their balance or be unable to hold on by themselves.
See also point 4 of this Administrative instruction. 9. Article 15.06(13) — Traffic areas
For various reasons, persons with reduced mobility need to support themselves or hold on more frequently, so walls in traffic areas intended for use by persons with reduced mobility shall be equipped with handrails at an appropriate height.
See also point 4 of this Administrative instruction 10. Article 15.06(17) — Toilets
Persons with reduced mobility shall also be able to stay and move safely in toilets, so at least one toilet shall be adapted accordingly. 11. Article 15.08(3)(a and b) — Alarm system
Persons with reduced mobility are more likely to encounter situations in which they are dependent on the help of others. In rooms in which, as a general rule, they cannot be seen by crew members, on-board personnel or passengers, the possibility of triggering an alarm should therefore be provided for. This applies to toilets intended for use by persons with reduced mobility.
Persons with reduced mobility include persons with impaired eyesight or hearing. Consequently, at least in areas intended for use by persons with reduced mobility, the passenger alarm system shall provide suitable visual and audible alarms. 12. Article 15.10(3)(d) — Sufficient lighting
Persons with reduced mobility also include persons with impaired eyesight. Sufficient lighting in areas intended for use by persons with reduced mobility is therefore essential and shall meet higher requirements than lighting for other passenger areas. 13. Article 15.13(1) — Safety rota
The special safety measures necessary for persons with reduced mobility to be taken into consideration in the safety rota shall take into account both the possibility of reduced mobility and impaired hearing and eyesight. For such persons measures for normal operation shall be taken into account in addition to measures in the event of emergencies. 14. Article 15.13(2) — Safety plan
The areas covered by point 3 of this Administrative instruction shall be designated. 15. Article 15.13(3)(b) — Displaying the safety rota and the safety plan
At least the copies of the safety rota and the safety plan displayed in the areas intended for use by persons with reduced mobility shall be such that they can, where possible, also be read by persons with impaired eyesight. This can be achieved for example by appropriate use of contrast and character size.
In addition, the plans shall be displayed at a height so that wheelchair users can read them as well. 16. Article 15.13(4) — Code of conduct for passengers
Point 15 of this Administrative instruction applies accordingly
‘ADMINISTRATIVE INSTRUCTION No 23
(Left void)
‘ADMINISTRATIVE INSTRUCTION No 24
Suitable gas warning equipment
(Article 15.15(9) of Annex II) 1. In accordance with Sections 24.02(2) and 24.06(5) (in each case transitional provision to Section 15.01(2)(e)) liquefied petroleum gas (LPG) systems for household purposes on board existing passenger vessels may only be operated until the first renewal of the Community Certificate after 1 January 2045, on condition that a gas warning equipment in accordance with Section 15.15(9) is available. In accordance with Section 15.15(9), LPG systems for household purposes may in the future also be installed on passenger vessels put into operation for the first time and of which the length does not exceed 45 m, if such warning equipment is installed at the same time. 2. In accordance with Sections 24.02(2) and 24.06(5) (in each case transitional provision to Section 15.15(9)) this gas warning equipment shall be installed on the first renewal of the certificate in accordance with Section 14.15. The gas warning equipment consists of sensors, equipment and pipes and shall be considered suitable if it at least meets the following prescribed requirements:
Requirements to be met by the system (sensors, equipment, pipes):
3.1.1. Gas warning shall be given at the latest when reaching or exceeding one of the following values:
(a) 10 % lower explosion limit (LEL) of a propane-air mixture; and
(b) 30 ppm CO (carbon monoxide).
3.1.2. The time until activation of the alarm for the whole system must not exceed 20 s.
3.1.3. The limit values mentioned in numbers 3.1.1 and 3.1.2 must not be adjustable.
3.1.4. The test gas production shall be so designed that any interruption or obstruction is detected. Any falsification due to air admission or loss of test gas as a consequence of leakage shall be avoided or detected and reported.
3.1.5. The equipment shall be designed for temperatures ranging from –10 to 40° C and an air humidity ranging from 20 to 100 %.
3.1.6. The gas warning equipment must be self-monitoring. It shall be impossible to switch off the equipment unauthorised.
3.1.7. Gas warning equipment supplied by the onboard power supply network shall be buffered against power failure. Battery-powered appliances shall be provided with a warning device indicating a reduction of the battery voltage.
Requirements to be met by the equipment:
3.2.1. The equipment shall consist of an evaluation and display unit.
3.2.2. The alarm indicating that the limit values in points 3.1.1(a) and (b) have been reached or exceeded shall be given optically and acoustically, both in the room monitored and in the wheelhouse or at any other permanently manned location. It shall be clearly visible and audible even in operating conditions with the highest noise level. It shall be clearly distinguishable from any other acoustic and optical signals in the room to be protected. The acoustic alarm shall also be clearly audible with closed connecting doors at the entrances and in neighbouring rooms. The acoustic alarm may be silenced after activation, the optical alarm may only be cancelled if the limit values fall below those given mentioned in point 3.1.1. 3.2.3. It shall be possible to separately detect and clearly assign the reports indicating that the limit values in points 3.1.1(a) and (b) have been reached or exceeded.
3.2.4. If the appliance has a special status (start-up, failure, calibration, parameterisation, maintenance etc.), this shall be indicated. The failure of the whole system or one of the components shall be indicated by an alarm in analogy to point 3.2.2. The acoustic alarm may be silenced after activation, the optical alarm may only be cancelled if the failure is removed.
3.2.5. If it is possible to issue different reports (limit values, special status) it shall also be possible to discern them separately and to assign them clearly. If necessary, a collective signal shall be displayed indicating that it is not possible to issue all reports. In this case, the reports shall be issued by order of priority, beginning with the report with the highest safety relevance. The display of the reports which cannot be issued shall be possible by pressing a button. The order of priority shall be evident from the documentation of the appliance.
3.2.6. The equipment shall be so designed that unauthorised interference is not possible.
3.2.7. In all cases where detection and alarm equipment are used, the control alarm unit and indicating device shall be operable from outside the spaces containing the gas storage and consuming appliances.
Requirements to be met by the sensors/sampling devices:
3.3.1. In every room with consuming appliances, sensors of the gas warning equipment shall be provided in the vicinity of these appliances. The sensors/sampling devices shall be installed in such a way that gas accumulation is detected before the limit values mentioned in point 3.1.1 are reached. Arrangement and installation of the sensors shall be documented. The selection of the locations shall be substantiated by the manufacturer or the specialised firm installing the equipment. The pipes of the sampling devices should be as short as possible.
3.3.2. The sensors shall be easily accessible in order to enable regular calibration, maintenance and safety checks.
Requirements to be met by the installation:
3.4.1. The whole gas warning equipment shall be installed by a specialised firm.
3.4.2. For the installation, the following aspects shall be taken into consideration:
(a) local ventilation systems;
(b) structural arrangements (design of walls, partitions etc.) facilitating or complicating the accumulation of gases; and
(c) prevention of adverse effects due to mechanical damage, water or heat damage.
3.4.3. All pipes of the sampling devices shall be arranged in such a way that condensate formation is not possible.
3.4.4. The installation shall be effected in such a way that any unauthorised tampering is not possible.
Calibration/inspection of the equipment
4.1. Before the starting-up of the gas warning equipment, it shall be calibrated in accordance with the manufacturer’s details.
4.2. The gas warning equipment shall be regularly calibrated and inspected by an approved expert or an expert in accordance with the manufacturer’s details. An inspection certificate shall be issued, signed by the approved expert or an expert in accordance with the manufacturer’s details and showing the date of the inspection.
4.3. Elements of the gas warning equipment with limited lifespan shall be replaced in due time before the expiry of the expected lifespan.
Marking
5.1. All appliances shall at least show the following information in a clearly legible and indelible form:
(a) name and address of the manufacturer;
(b) legal marking;
(c) designation of series and type;
(d) if possible, serial number;
(e) if required, any advice indispensable for safe use; and
(f) for each sensor the indication of the calibration gas.
5.2. Elements of the gas warning equipment with limited restricted lifespan shall be clearly marked as such. 6. Manufacturer’s details relating to the gas warning equipment:
(a) complete instructions, drawings and diagrams concerning the safe and proper operation as well as the installation, starting-up and maintenance of the gas warning equipment;
(b) operating instructions containing at least:
(aa)
measures to be taken in the case of an alarm or error indication;
(bb)
safety measures in the case of non-availability (e.g. calibration, inspection, interruption); and
(cc) persons responsible for installation and maintenance;
(c) instructions for calibration before the starting-up, and for routine calibration, including time intervals to be followed;
(d) supply voltage;
(e) type and meaning of the alarms and displays (e.g. special status);
(f) information concerning the detection of operating difficulties and the removal of faults;
(g) type and scope of the replacement of components with limited lifespan; and
(h) type, scope and time interval of the inspections.
‘ADMINISTRATIVE INSTRUCTION No 25
Electric cables
(Article 9.15 and 15.10(6) of Annex II)
General (all vessels) — Article 9.15 1. When applying Article 9.15, Section 5, reduced ventilation of shielded cables or cables in totally enclosed trunks has to be taken into account. 2. In Article 9.15, Section 9 the number of cable joints should be kept to a minimum. They may be used for repair or replacement purposes as well as, exceptionally, for the simplification of installation. Cable joints made in accordance with 3.28 and Annex D to IEC 60092-352:2005, or equivalent regulations recognised by one of the Member States, will be considered acceptable.
Passenger vessels — Article 15.10(6) 1. On passenger vessels, cables and cable routing are considered to be satisfactory if they meet the conditions in 2 and 3. 2. For cables providing power in an emergency to equipment listed in Article 15.10, Section 4, compliance with Article 15.10, Section 6 second paragraph will require that:
(a) the cables are run in such a manner as to avoid being rendered unserviceable by heating of the bulkheads and decks that may be caused by a fire in an adjacent space;
(b) where the cables supply equipment located within high fire risk areas, the cable runs within such areas must avoid routes which pass over or near the top of diesel engines and oil-fired equipment, or near to hot surfaces e.g. diesel engine exhaust systems. Where there is no alternative route, cables must be protected from heat and fire damage. Such fire protection could be in the form of a steel plate or trunk;
(c) the cables and associated equipment supplied from the emergency source of power should, as far as practicable, be kept within the safe area;
(d) cable systems are arranged so that fire in any area bounded by Type A partitions as shown in Article 15.11, Section 2 will not interfere with services essential for safety in any other such area. This requirement will be met if main and emergency cables do not pass through the same area. If they pass through the same area, the requirement will be met if:
(aa)
they are separated as wide as is practicable; or
(bb)
the emergency cable is of the fire resistant type. 3. Consideration should be given to the arrangements of bunched cable runs to ensure that the flame-retardant characteristics of the cables are not impaired. This requirement is met if the cables are in accordance with IEC 60332-3:2000. If compliance with IEC 60332-3:2000, or equivalent regulations recognised by one of the Member States, is not met, fire stops in long runs of bunched cables (over 6 m vertical and 14 m horizontal) should be considered, unless the cables are totally enclosed in cable trunks. The use of unsuitable paints, trunking and casings may significantly affect the fire propagation characteristics of cables and shall be avoided. The use of special types of cables such as radio frequency cables may be permitted without complying with the foregoing.

(*2) Delete as appropriate.”
(*1) In accordance with the decision of the nautical expert.
(*3) Delete as appropriate.
(*4)
Dwt = deadweight.
(*5)
Dwt = deadweight.
(*6) Delete as appropriate.
(*7) Delete as appropriate.

Pending: 32008L0114

January 16, 2026
23.12.2008 EN Official Journal of the European Union L 345/75
(1) In June 2004 the European Council asked for the preparation of an overall strategy to protect critical infrastructures. In response, on 20 October 2004, the Commission adopted a Communication on critical infrastructure protection in the fight against terrorism which put forward suggestions as to what would enhance European prevention of, preparedness for and response to terrorist attacks involving critical infrastructures.
(2) On 17 November 2005 the Commission adopted a Green Paper on a European programme for critical infrastructure protection which provided policy options on the establishment of the programme and the Critical Infrastructure Warning Information Network. The responses received to the Green Paper emphasised the added value of a Community framework concerning critical infrastructure protection. The need to increase the critical infrastructure protection capability in Europe and to help reduce vulnerabilities concerning critical infrastructures was acknowledged. The importance of the key principles of subsidiarity, proportionality and complementarity, as well as of stakeholder dialogue was emphasised.
(3) In December 2005 the Justice and Home Affairs Council called upon the Commission to make a proposal for a European programme for critical infrastructure protection (‘EPCIP’) and decided that it should be based on an all-hazards approach while countering threats from terrorism as a priority. Under this approach, man-made, technological threats and natural disasters should be taken into account in the critical infrastructure protection process, but the threat of terrorism should be given priority.
(4) In April 2007 the Council adopted conclusions on the EPCIP in which it reiterated that it was the ultimate responsibility of the Member States to manage arrangements for the protection of critical infrastructures within their national borders while welcoming the efforts of the Commission to develop a European procedure for the identification and designation of European critical infrastructures (‘ECIs’) and the assessment of the need to improve their protection.
(5) This Directive constitutes a first step in a step-by-step approach to identify and designate ECIs and assess the need to improve their protection. As such, this Directive concentrates on the energy and transport sectors and should be reviewed with a view to assessing its impact and the need to include other sectors within its scope,inter alia, the information and communication technology (‘ICT’) sector.
(6) The primary and ultimate responsibility for protecting ECIs falls on the Member States and the owners/operators of such infrastructures.
(7) There are a certain number of critical infrastructures in the Community, the disruption or destruction of which would have significant cross-border impacts. This may include transboundary cross-sector effects resulting from interdependencies between interconnected infrastructures. Such ECIs should be identified and designated by means of a common procedure. The evaluation of security requirements for such infrastructures should be done under a common minimum approach. Bilateral schemes for cooperation between Member States in the field of critical infrastructure protection constitute a well-established and efficient means of dealing with transboundary critical infrastructures. EPCIP should build on such cooperation. Information pertaining to the designation of a particular infrastructure as an ECI should be classified at an appropriate level in accordance with existing Community and Member State legislation.
(8) Since various sectors have particular experience, expertise and requirements concerning critical infrastructure protection, a Community approach to critical infrastructure protection should be developed and implemented taking into account sector specificities and existing sector based measures including those already existing at Community, national or regional level, and where relevant cross-border mutual aid agreements between owners/operators of critical infrastructures already in place. Given the very significant private sector involvement in overseeing and managing risks, business continuity planning and post-disaster recovery, a Community approach needs to encourage full private sector involvement.
(9) In terms of the energy sector and in particular the methods of electricity generation and transmission (in respect of supply of electricity), it is understood that where deemed appropriate, electricity generation may include electricity transmission parts of nuclear power plants, but exclude the specifically nuclear elements covered by relevant nuclear legislation including treaties and Community law.
(10) This Directive complements existing sectoral measures at Community level and in the Member States. Where Community mechanisms are already in place, they should continue to be used and will contribute to the overall implementation of this Directive. Duplication of, or contradiction between, different acts or provisions should be avoided.
(11) Operator security plans (‘OSPs’) or equivalent measures comprising an identification of important assets, a risk assessment and the identification, selection and prioritisation of counter measures and procedures should be in place in all designated ECIs. With a view to avoiding unnecessary work and duplication, each Member State should first assess whether the owners/operators of designated ECIs possess relevant OSPs or similar measures. Where such plans do not exist, each Member State should take the necessary steps to make sure that appropriate measures are put in place. It is up to each Member State to decide on the most appropriate form of action with regard to the establishment of OSPs.
(12) Measures, principles, guidelines, including Community measures as well as bilateral and/or multilateral cooperation schemes that provide for a plan similar or equivalent to an OSP or provide for a Security Liaison Officer or equivalent, should be deemed to satisfy the requirements of this Directive in relation to the OSP or the Security Liaison Officer respectively.
(13) Security Liaison Officers should be identified for all designated ECIs in order to facilitate cooperation and communication with relevant national critical infrastructure protection authorities. With a view to avoiding unnecessary work and duplication, each Member State should first assess whether the owners/operators of designated ECIs already possess a Security Liaison Officer or equivalent. Where such a Security Liaison Officer does not exist, each Member State should take the necessary steps to make sure that appropriate measures are put in place. It is up to each Member State to decide on the most appropriate form of action with regard to the designation of Security Liaison Officers.
(14) The efficient identification of risks, threats and vulnerabilities in the particular sectors requires communication both between owners/operators of ECIs and the Member States, and between the Member States and the Commission. Each Member State should collect information concerning ECIs located within its territory. The Commission should receive generic information from the Member States concerning risks, threats and vulnerabilities in sectors where ECIs were identified, including where relevant information on possible improvements in the ECIs and cross-sector dependencies, which could be the basis for the development of specific proposals by the Commission on improving the protection of ECIs, where necessary.
(15) In order to facilitate improvements in the protection of ECIs, common methodologies may be developed for the identification and classification of risks, threats and vulnerabilities to infrastructure assets.
(16) Owners/operators of ECIs should be given access primarily through relevant Member State authorities to best practices and methodologies concerning critical infrastructure protection.
(17) Effective protection of ECIs requires communication, coordination, and cooperation at national and Community level. This is best achieved through the nomination of European critical infrastructure protection contact points (‘ECIP contact points’) in each Member State, who should coordinate European critical infrastructure protection issues internally, as well as with other Member States and the Commission.
(18) In order to develop European critical infrastructure protection activities in areas which require a degree of confidentiality, it is appropriate to ensure a coherent and secure information exchange in the framework of this Directive. It is important that the rules of confidentiality according to applicable national law or Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(3)are observed with regard to specific facts about critical infrastructure assets, which could be used to plan and act with a view to causing unacceptable consequences for critical infrastructure installations. Classified information should be protected in accordance with relevant Community and Member State legislation. Each Member State and the Commission should respect the relevant security classification given by the originator of a document.
(19) Information sharing regarding ECIs should take place in an environment of trust and security. The sharing of information requires a relationship of trust such that companies and organisations know that their sensitive and confidential data will be sufficiently protected.
(20) Since the objectives of this Directive, namely the creation of a procedure for the identification and designation of ECIs, and a common approach to the assessment of the need to improve the protection of such infrastructures, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.
(21) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,
(a) ‘critical infrastructure’ means an asset, system or part thereof located in Member States which is essential for the maintenance of vital societal functions, health, safety, security, economic or social well-being of people, and the disruption or destruction of which would have a significant impact in a Member State as a result of the failure to maintain those functions;
(b) ‘European critical infrastructure’ or ‘ECI’ means critical infrastructure located in Member States the disruption or destruction of which would have a significant impact on at least two Member States. The significance of the impact shall be assessed in terms of cross-cutting criteria. This includes effects resulting from cross-sector dependencies on other types of infrastructure;
(c) ‘risk analysis’ means consideration of relevant threat scenarios, in order to assess the vulnerability and the potential impact of disruption or destruction of critical infrastructure;
(d) ‘sensitive critical infrastructure protection related information’ means facts about a critical infrastructure, which if disclosed could be used to plan and act with a view to causing disruption or destruction of critical infrastructure installations;
(e) ‘protection’ means all activities aimed at ensuring the functionality, continuity and integrity of critical infrastructures in order to deter, mitigate and neutralise a threat, risk or vulnerability;
(f) ‘owners/operators of ECIs’ means those entities responsible for investments in, and/or day-to-day operation of, a particular asset, system or part thereof designated as an ECI under this Directive.
(a) casualties criterion (assessed in terms of the potential number of fatalities or injuries);
(b) economic effects criterion (assessed in terms of the significance of economic loss and/or degradation of products or services; including potential environmental effects);
(c) public effects criterion (assessed in terms of the impact on public confidence, physical suffering and disruption of daily life; including the loss of essential services).
Sector Subsector
IEnergy I Energy 1.Electricity 1. Electricity Infrastructures and facilities for generation and transmission of electricity in respect of supply electricity
I Energy
1. Electricity
2.Oil 2. Oil Oil production, refining, treatment, storage and transmission by pipelines
2. Oil
3.Gas 3. Gas Gas production, refining, treatment, storage and transmission by pipelinesLNG terminals
3. Gas
IITransport II Transport 4.Road transport 4. Road transport
II Transport
4. Road transport
5.Rail transport 5. Rail transport
5. Rail transport
6.Air transport 6. Air transport
6. Air transport
7.Inland waterways transport 7. Inland waterways transport
7. Inland waterways transport
8.Ocean and short-sea shipping and ports 8. Ocean and short-sea shipping and ports
8. Ocean and short-sea shipping and ports
I Energy
1. Electricity
2. Oil
3. Gas
II Transport
4. Road transport
5. Rail transport
6. Air transport
7. Inland waterways transport
8. Ocean and short-sea shipping and ports
1. identification of important assets;
2. conducting a risk analysis based on major threat scenarios, vulnerability of each asset, and potential impact; and
3. identification, selection and prioritisation of counter-measures and procedures with a distinction between:—permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems,—graduated security measures, which can be activated according to varying risk and threat levels. — permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems, — graduated security measures, which can be activated according to varying risk and threat levels.
— permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems,
— graduated security measures, which can be activated according to varying risk and threat levels.
— permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems,
— graduated security measures, which can be activated according to varying risk and threat levels.
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 308 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament(1),
Having regard to the opinion of the European Central Bank(2),
(1) In June 2004 the European Council asked for the preparation of an overall strategy to protect critical infrastructures. In response, on 20 October 2004, the Commission adopted a Communication on critical infrastructure protection in the fight against terrorism which put forward suggestions as to what would enhance European prevention of, preparedness for and response to terrorist attacks involving critical infrastructures.
(2) On 17 November 2005 the Commission adopted a Green Paper on a European programme for critical infrastructure protection which provided policy options on the establishment of the programme and the Critical Infrastructure Warning Information Network. The responses received to the Green Paper emphasised the added value of a Community framework concerning critical infrastructure protection. The need to increase the critical infrastructure protection capability in Europe and to help reduce vulnerabilities concerning critical infrastructures was acknowledged. The importance of the key principles of subsidiarity, proportionality and complementarity, as well as of stakeholder dialogue was emphasised.
(3) In December 2005 the Justice and Home Affairs Council called upon the Commission to make a proposal for a European programme for critical infrastructure protection (‘EPCIP’) and decided that it should be based on an all-hazards approach while countering threats from terrorism as a priority. Under this approach, man-made, technological threats and natural disasters should be taken into account in the critical infrastructure protection process, but the threat of terrorism should be given priority.
(4) In April 2007 the Council adopted conclusions on the EPCIP in which it reiterated that it was the ultimate responsibility of the Member States to manage arrangements for the protection of critical infrastructures within their national borders while welcoming the efforts of the Commission to develop a European procedure for the identification and designation of European critical infrastructures (‘ECIs’) and the assessment of the need to improve their protection.
(5) This Directive constitutes a first step in a step-by-step approach to identify and designate ECIs and assess the need to improve their protection. As such, this Directive concentrates on the energy and transport sectors and should be reviewed with a view to assessing its impact and the need to include other sectors within its scope,inter alia, the information and communication technology (‘ICT’) sector.
(6) The primary and ultimate responsibility for protecting ECIs falls on the Member States and the owners/operators of such infrastructures.
(7) There are a certain number of critical infrastructures in the Community, the disruption or destruction of which would have significant cross-border impacts. This may include transboundary cross-sector effects resulting from interdependencies between interconnected infrastructures. Such ECIs should be identified and designated by means of a common procedure. The evaluation of security requirements for such infrastructures should be done under a common minimum approach. Bilateral schemes for cooperation between Member States in the field of critical infrastructure protection constitute a well-established and efficient means of dealing with transboundary critical infrastructures. EPCIP should build on such cooperation. Information pertaining to the designation of a particular infrastructure as an ECI should be classified at an appropriate level in accordance with existing Community and Member State legislation.
(8) Since various sectors have particular experience, expertise and requirements concerning critical infrastructure protection, a Community approach to critical infrastructure protection should be developed and implemented taking into account sector specificities and existing sector based measures including those already existing at Community, national or regional level, and where relevant cross-border mutual aid agreements between owners/operators of critical infrastructures already in place. Given the very significant private sector involvement in overseeing and managing risks, business continuity planning and post-disaster recovery, a Community approach needs to encourage full private sector involvement.
(9) In terms of the energy sector and in particular the methods of electricity generation and transmission (in respect of supply of electricity), it is understood that where deemed appropriate, electricity generation may include electricity transmission parts of nuclear power plants, but exclude the specifically nuclear elements covered by relevant nuclear legislation including treaties and Community law.
(10) This Directive complements existing sectoral measures at Community level and in the Member States. Where Community mechanisms are already in place, they should continue to be used and will contribute to the overall implementation of this Directive. Duplication of, or contradiction between, different acts or provisions should be avoided.
(11) Operator security plans (‘OSPs’) or equivalent measures comprising an identification of important assets, a risk assessment and the identification, selection and prioritisation of counter measures and procedures should be in place in all designated ECIs. With a view to avoiding unnecessary work and duplication, each Member State should first assess whether the owners/operators of designated ECIs possess relevant OSPs or similar measures. Where such plans do not exist, each Member State should take the necessary steps to make sure that appropriate measures are put in place. It is up to each Member State to decide on the most appropriate form of action with regard to the establishment of OSPs.
(12) Measures, principles, guidelines, including Community measures as well as bilateral and/or multilateral cooperation schemes that provide for a plan similar or equivalent to an OSP or provide for a Security Liaison Officer or equivalent, should be deemed to satisfy the requirements of this Directive in relation to the OSP or the Security Liaison Officer respectively.
(13) Security Liaison Officers should be identified for all designated ECIs in order to facilitate cooperation and communication with relevant national critical infrastructure protection authorities. With a view to avoiding unnecessary work and duplication, each Member State should first assess whether the owners/operators of designated ECIs already possess a Security Liaison Officer or equivalent. Where such a Security Liaison Officer does not exist, each Member State should take the necessary steps to make sure that appropriate measures are put in place. It is up to each Member State to decide on the most appropriate form of action with regard to the designation of Security Liaison Officers.
(14) The efficient identification of risks, threats and vulnerabilities in the particular sectors requires communication both between owners/operators of ECIs and the Member States, and between the Member States and the Commission. Each Member State should collect information concerning ECIs located within its territory. The Commission should receive generic information from the Member States concerning risks, threats and vulnerabilities in sectors where ECIs were identified, including where relevant information on possible improvements in the ECIs and cross-sector dependencies, which could be the basis for the development of specific proposals by the Commission on improving the protection of ECIs, where necessary.
(15) In order to facilitate improvements in the protection of ECIs, common methodologies may be developed for the identification and classification of risks, threats and vulnerabilities to infrastructure assets.
(16) Owners/operators of ECIs should be given access primarily through relevant Member State authorities to best practices and methodologies concerning critical infrastructure protection.
(17) Effective protection of ECIs requires communication, coordination, and cooperation at national and Community level. This is best achieved through the nomination of European critical infrastructure protection contact points (‘ECIP contact points’) in each Member State, who should coordinate European critical infrastructure protection issues internally, as well as with other Member States and the Commission.
(18) In order to develop European critical infrastructure protection activities in areas which require a degree of confidentiality, it is appropriate to ensure a coherent and secure information exchange in the framework of this Directive. It is important that the rules of confidentiality according to applicable national law or Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(3)are observed with regard to specific facts about critical infrastructure assets, which could be used to plan and act with a view to causing unacceptable consequences for critical infrastructure installations. Classified information should be protected in accordance with relevant Community and Member State legislation. Each Member State and the Commission should respect the relevant security classification given by the originator of a document.
(19) Information sharing regarding ECIs should take place in an environment of trust and security. The sharing of information requires a relationship of trust such that companies and organisations know that their sensitive and confidential data will be sufficiently protected.
(20) Since the objectives of this Directive, namely the creation of a procedure for the identification and designation of ECIs, and a common approach to the assessment of the need to improve the protection of such infrastructures, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.
(21) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,
HAS ADOPTED THIS DIRECTIVE:

Subject matter
Article 1
This Directive establishes a procedure for the identification and designation of European critical infrastructures (‘ECIs’), and a common approach to the assessment of the need to improve the protection of such infrastructures in order to contribute to the protection of people.

Definitions
Article 2
For the purpose of this Directive:
(a)
‘critical infrastructure’ means an asset, system or part thereof located in Member States which is essential for the maintenance of vital societal functions, health, safety, security, economic or social well-being of people, and the disruption or destruction of which would have a significant impact in a Member State as a result of the failure to maintain those functions;
(b)
‘European critical infrastructure’ or ‘ECI’ means critical infrastructure located in Member States the disruption or destruction of which would have a significant impact on at least two Member States. The significance of the impact shall be assessed in terms of cross-cutting criteria. This includes effects resulting from cross-sector dependencies on other types of infrastructure;
(c)
‘risk analysis’ means consideration of relevant threat scenarios, in order to assess the vulnerability and the potential impact of disruption or destruction of critical infrastructure;
(d)
‘sensitive critical infrastructure protection related information’ means facts about a critical infrastructure, which if disclosed could be used to plan and act with a view to causing disruption or destruction of critical infrastructure installations;
(e)
‘protection’ means all activities aimed at ensuring the functionality, continuity and integrity of critical infrastructures in order to deter, mitigate and neutralise a threat, risk or vulnerability;
(f)
‘owners/operators of ECIs’ means those entities responsible for investments in, and/or day-to-day operation of, a particular asset, system or part thereof designated as an ECI under this Directive.

Identification of ECIs
Article 3
1. Pursuant to the procedure provided in Annex III, each Member State shall identify potential ECIs which both satisfy the cross-cutting and sectoral criteria and meet the definitions set out in Article 2(a) and (b).
The Commission may assist Member States at their request to identify potential ECIs.
The Commission may draw the attention of the relevant Member States to the existence of potential critical infrastructures which may be deemed to satisfy the requirements for designation as an ECI.
Each Member State and the Commission shall continue on an ongoing basis the process of identifying potential ECIs.
2. The cross-cutting criteria referred to in paragraph 1 shall comprise the following:
(a)
casualties criterion (assessed in terms of the potential number of fatalities or injuries);
(b)
economic effects criterion (assessed in terms of the significance of economic loss and/or degradation of products or services; including potential environmental effects);
(c)
public effects criterion (assessed in terms of the impact on public confidence, physical suffering and disruption of daily life; including the loss of essential services).
The cross-cutting criteria thresholds shall be based on the severity of the impact of the disruption or destruction of a particular infrastructure. The precise thresholds applicable to the cross-cutting criteria shall be determined on a case-by-case basis by the Member States concerned by a particular critical infrastructure. Each Member State shall inform the Commission on an annual basis of the number of infrastructures per sector for which discussions were held concerning the cross-cutting criteria thresholds.
The sectoral criteria shall take into account the characteristics of individual ECI sectors.
The Commission together with the Member States shall develop guidelines for the application of the cross-cutting and sectoral criteria and approximate thresholds to be used to identify ECIs. The criteria shall be classified. The use of such guidelines shall be optional for the Member States.
3. The sectors to be used for the purposes of implementing this Directive shall be the energy and transport sectors. The subsectors are identified in Annex I.
If deemed appropriate and in conjunction with the review of this Directive as laid down in Article 11, subsequent sectors to be used for the purpose of implementing this Directive may be identified. Priority shall be given to the ICT sector.

Designation of ECIs
Article 4
1. Each Member State shall inform the other Member States which may be significantly affected by a potential ECI about its identity and the reasons for designating it as a potential ECI.
2. Each Member State on whose territory a potential ECI is located shall engage in bilateral and/or multilateral discussions with the other Member States which may be significantly affected by the potential ECI. The Commission may participate in these discussions but shall not have access to detailed information which would allow for the unequivocal identification of a particular infrastructure.
A Member State that has reason to believe that it may be significantly affected by the potential ECI, but has not been identified as such by the Member State on whose territory the potential ECI is located, may inform the Commission about its wish to be engaged in bilateral and/or multilateral discussions on this issue. The Commission shall without delay communicate this wish to the Member State on whose territory the potential ECI is located and endeavour to facilitate agreement between the parties.
3. The Member State on whose territory a potential ECI is located shall designate it as an ECI following an agreement between that Member State and those Member States that may be significantly affected.
The acceptance of the Member State on whose territory the infrastructure to be designated as an ECI is located, shall be required.
4. The Member State on whose territory a designated ECI is located shall inform the Commission on an annual basis of the number of designated ECIs per sector and of the number of Member States dependent on each designated ECI. Only those Member States that may be significantly affected by an ECI shall know its identity.
5. The Member States on whose territory an ECI is located shall inform the owner/operator of the infrastructure concerning its designation as an ECI. Information concerning the designation of an infrastructure as an ECI shall be classified at an appropriate level.
6. The process of identifying and designating ECIs pursuant to Article 3 and this Article shall be completed by 12 January 2011 and reviewed on a regular basis.

Operator security plans
Article 5
1. The operator security plan (‘OSP’) procedure shall identify the critical infrastructure assets of the ECI and which security solutions exist or are being implemented for their protection. The minimum content to be addressed by an ECI OSP procedure is set out in Annex II.
2. Each Member State shall assess whether each designated ECI located on its territory possesses an OSP or has in place equivalent measures addressing the issues identified in Annex II. If a Member State finds that such an OSP or equivalent exists and is updated regularly, no further implementation action shall be necessary.
3. If a Member State finds that such an OSP or equivalent has not been prepared, it shall ensure by any measures deemed appropriate, that the OSP or equivalent is prepared addressing the issues identified in Annex II.
Each Member State shall ensure that the OSP or equivalent is in place and is reviewed regularly within one year following designation of the critical infrastructure as an ECI. This period may be extended in exceptional circumstances, by agreement with the Member State authority and with a notification to the Commission.
4. In a case where supervisory or oversight arrangements already exist in relation to an ECI such arrangements are not affected by this Article and the relevant Member State authority referred to in this Article shall be the supervisor under those existing arrangements.
5. Compliance with measures including Community measures which in a particular sector require, or refer to a need to have, a plan similar or equivalent to an OSP and oversight by the relevant authority of such a plan, is deemed to satisfy all the requirements of Member States under, or adopted pursuant to, this Article. The guidelines for application referred to in Article 3(2) shall contain an indicative list of such measures.

Security Liaison Officers
Article 6
1. The Security Liaison Officer shall function as the point of contact for security related issues between the owner/operator of the ECI and the relevant Member State authority.
2. Each Member State shall assess whether each designated ECI located on its territory possesses a Security Liaison Officer or equivalent. If a Member State finds that such a Security Liaison Officer is in place or an equivalent exists, no further implementation action shall be necessary.
3. If a Member State finds that a Security Liaison Officer or equivalent does not exist in relation to a designated ECI, it shall ensure by any measures deemed appropriate, that such a Security Liaison Officer or equivalent is designated.
4. Each Member State shall implement an appropriate communication mechanism between the relevant Member State authority and the Security Liaison Officer or equivalent with the objective of exchanging relevant information concerning identified risks and threats in relation to the ECI concerned. This communication mechanism shall be without prejudice to national requirements concerning access to sensitive and classified information.
5. Compliance with measures including Community measures which in a particular sector require, or refer to a need to have, a Security Liaison Officer or equivalent, is deemed to satisfy all the requirements of Member States in, or adopted pursuant to, this Article. The guidelines for application referred to in Article 3(2) shall contain an indicative list of such measures.

Reporting
Article 7
1. Each Member State shall conduct a threat assessment in relation to ECI subsectors within one year following the designation of critical infrastructure on its territory as an ECI within those subsectors.
2. Each Member State shall report every two years to the Commission generic data on a summary basis on the types of risks, threats and vulnerabilities encountered per ECI sector in which an ECI has been designated pursuant to Article 4 and is located on its territory.
A common template for these reports may be developed by the Commission in cooperation with the Member States.
Each report shall be classified at an appropriate level as deemed necessary by the originating Member State.
3. Based on the reports referred to in paragraph 2, the Commission and the Member States shall assess on a sectoral basis whether further protection measures at Community level should be considered for ECIs. This process shall be undertaken in conjunction with the review of this Directive as laid down in Article 11.
4. Common methodological guidelines for carrying out risk analyses in respect of ECIs may be developed by the Commission in cooperation with the Member States. The use of such guidelines shall be optional for the Member States.

Commission support for ECIs
Article 8
The Commission shall support, through the relevant Member State authority, the owners/operators of designated ECIs by providing access to available best practices and methodologies as well as support training and the exchange of information on new technical developments related to critical infrastructure protection.

Sensitive European critical infrastructure protection-related information
Article 9
1. Any person handling classified information pursuant to this Directive on behalf of a Member State or the Commission shall have an appropriate level of security vetting.
Member States, the Commission and relevant supervisory bodies shall ensure that sensitive European critical infrastructure protection-related information submitted to the Member States or to the Commission is not used for any purpose other than the protection of critical infrastructures.
2. This Article shall also apply to non-written information exchanged during meetings at which sensitive subjects are discussed.

European critical infrastructure protection contact points
Article 10
1. Each Member State shall appoint a European critical infrastructure protection contact point (‘ECIP contact point’).
2. ECIP contact points shall coordinate European critical infrastructure protection issues within the Member State, with other Member States and with the Commission. The appointment of an ECIP contact point does not preclude other authorities in a Member State from being involved in European critical infrastructure protection issues.

Review
Article 11
A review of this Directive shall begin on 12 January 2012.

Implementation
Article 12
Member States shall take the necessary measures to comply with this Directive by 12 January 2011. They shall forthwith inform the Commission thereof and communicate the text of those measures and their correlation with this Directive.
When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Entry into force
Article 13
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Addressees
Article 14
This Directive is addressed to the Member States.

THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 308 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament(1),
Having regard to the opinion of the European Central Bank(2),
(1) In June 2004 the European Council asked for the preparation of an overall strategy to protect critical infrastructures. In response, on 20 October 2004, the Commission adopted a Communication on critical infrastructure protection in the fight against terrorism which put forward suggestions as to what would enhance European prevention of, preparedness for and response to terrorist attacks involving critical infrastructures.
(2) On 17 November 2005 the Commission adopted a Green Paper on a European programme for critical infrastructure protection which provided policy options on the establishment of the programme and the Critical Infrastructure Warning Information Network. The responses received to the Green Paper emphasised the added value of a Community framework concerning critical infrastructure protection. The need to increase the critical infrastructure protection capability in Europe and to help reduce vulnerabilities concerning critical infrastructures was acknowledged. The importance of the key principles of subsidiarity, proportionality and complementarity, as well as of stakeholder dialogue was emphasised.
(3) In December 2005 the Justice and Home Affairs Council called upon the Commission to make a proposal for a European programme for critical infrastructure protection (‘EPCIP’) and decided that it should be based on an all-hazards approach while countering threats from terrorism as a priority. Under this approach, man-made, technological threats and natural disasters should be taken into account in the critical infrastructure protection process, but the threat of terrorism should be given priority.
(4) In April 2007 the Council adopted conclusions on the EPCIP in which it reiterated that it was the ultimate responsibility of the Member States to manage arrangements for the protection of critical infrastructures within their national borders while welcoming the efforts of the Commission to develop a European procedure for the identification and designation of European critical infrastructures (‘ECIs’) and the assessment of the need to improve their protection.
(5) This Directive constitutes a first step in a step-by-step approach to identify and designate ECIs and assess the need to improve their protection. As such, this Directive concentrates on the energy and transport sectors and should be reviewed with a view to assessing its impact and the need to include other sectors within its scope,inter alia, the information and communication technology (‘ICT’) sector.
(6) The primary and ultimate responsibility for protecting ECIs falls on the Member States and the owners/operators of such infrastructures.
(7) There are a certain number of critical infrastructures in the Community, the disruption or destruction of which would have significant cross-border impacts. This may include transboundary cross-sector effects resulting from interdependencies between interconnected infrastructures. Such ECIs should be identified and designated by means of a common procedure. The evaluation of security requirements for such infrastructures should be done under a common minimum approach. Bilateral schemes for cooperation between Member States in the field of critical infrastructure protection constitute a well-established and efficient means of dealing with transboundary critical infrastructures. EPCIP should build on such cooperation. Information pertaining to the designation of a particular infrastructure as an ECI should be classified at an appropriate level in accordance with existing Community and Member State legislation.
(8) Since various sectors have particular experience, expertise and requirements concerning critical infrastructure protection, a Community approach to critical infrastructure protection should be developed and implemented taking into account sector specificities and existing sector based measures including those already existing at Community, national or regional level, and where relevant cross-border mutual aid agreements between owners/operators of critical infrastructures already in place. Given the very significant private sector involvement in overseeing and managing risks, business continuity planning and post-disaster recovery, a Community approach needs to encourage full private sector involvement.
(9) In terms of the energy sector and in particular the methods of electricity generation and transmission (in respect of supply of electricity), it is understood that where deemed appropriate, electricity generation may include electricity transmission parts of nuclear power plants, but exclude the specifically nuclear elements covered by relevant nuclear legislation including treaties and Community law.
(10) This Directive complements existing sectoral measures at Community level and in the Member States. Where Community mechanisms are already in place, they should continue to be used and will contribute to the overall implementation of this Directive. Duplication of, or contradiction between, different acts or provisions should be avoided.
(11) Operator security plans (‘OSPs’) or equivalent measures comprising an identification of important assets, a risk assessment and the identification, selection and prioritisation of counter measures and procedures should be in place in all designated ECIs. With a view to avoiding unnecessary work and duplication, each Member State should first assess whether the owners/operators of designated ECIs possess relevant OSPs or similar measures. Where such plans do not exist, each Member State should take the necessary steps to make sure that appropriate measures are put in place. It is up to each Member State to decide on the most appropriate form of action with regard to the establishment of OSPs.
(12) Measures, principles, guidelines, including Community measures as well as bilateral and/or multilateral cooperation schemes that provide for a plan similar or equivalent to an OSP or provide for a Security Liaison Officer or equivalent, should be deemed to satisfy the requirements of this Directive in relation to the OSP or the Security Liaison Officer respectively.
(13) Security Liaison Officers should be identified for all designated ECIs in order to facilitate cooperation and communication with relevant national critical infrastructure protection authorities. With a view to avoiding unnecessary work and duplication, each Member State should first assess whether the owners/operators of designated ECIs already possess a Security Liaison Officer or equivalent. Where such a Security Liaison Officer does not exist, each Member State should take the necessary steps to make sure that appropriate measures are put in place. It is up to each Member State to decide on the most appropriate form of action with regard to the designation of Security Liaison Officers.
(14) The efficient identification of risks, threats and vulnerabilities in the particular sectors requires communication both between owners/operators of ECIs and the Member States, and between the Member States and the Commission. Each Member State should collect information concerning ECIs located within its territory. The Commission should receive generic information from the Member States concerning risks, threats and vulnerabilities in sectors where ECIs were identified, including where relevant information on possible improvements in the ECIs and cross-sector dependencies, which could be the basis for the development of specific proposals by the Commission on improving the protection of ECIs, where necessary.
(15) In order to facilitate improvements in the protection of ECIs, common methodologies may be developed for the identification and classification of risks, threats and vulnerabilities to infrastructure assets.
(16) Owners/operators of ECIs should be given access primarily through relevant Member State authorities to best practices and methodologies concerning critical infrastructure protection.
(17) Effective protection of ECIs requires communication, coordination, and cooperation at national and Community level. This is best achieved through the nomination of European critical infrastructure protection contact points (‘ECIP contact points’) in each Member State, who should coordinate European critical infrastructure protection issues internally, as well as with other Member States and the Commission.
(18) In order to develop European critical infrastructure protection activities in areas which require a degree of confidentiality, it is appropriate to ensure a coherent and secure information exchange in the framework of this Directive. It is important that the rules of confidentiality according to applicable national law or Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(3)are observed with regard to specific facts about critical infrastructure assets, which could be used to plan and act with a view to causing unacceptable consequences for critical infrastructure installations. Classified information should be protected in accordance with relevant Community and Member State legislation. Each Member State and the Commission should respect the relevant security classification given by the originator of a document.
(19) Information sharing regarding ECIs should take place in an environment of trust and security. The sharing of information requires a relationship of trust such that companies and organisations know that their sensitive and confidential data will be sufficiently protected.
(20) Since the objectives of this Directive, namely the creation of a procedure for the identification and designation of ECIs, and a common approach to the assessment of the need to improve the protection of such infrastructures, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives.
(21) This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union,
HAS ADOPTED THIS DIRECTIVE:

Subject matter

This Directive establishes a procedure for the identification and designation of European critical infrastructures (‘ECIs’), and a common approach to the assessment of the need to improve the protection of such infrastructures in order to contribute to the protection of people.

Definitions

For the purpose of this Directive:
(a)
‘critical infrastructure’ means an asset, system or part thereof located in Member States which is essential for the maintenance of vital societal functions, health, safety, security, economic or social well-being of people, and the disruption or destruction of which would have a significant impact in a Member State as a result of the failure to maintain those functions;
(b)
‘European critical infrastructure’ or ‘ECI’ means critical infrastructure located in Member States the disruption or destruction of which would have a significant impact on at least two Member States. The significance of the impact shall be assessed in terms of cross-cutting criteria. This includes effects resulting from cross-sector dependencies on other types of infrastructure;
(c)
‘risk analysis’ means consideration of relevant threat scenarios, in order to assess the vulnerability and the potential impact of disruption or destruction of critical infrastructure;
(d)
‘sensitive critical infrastructure protection related information’ means facts about a critical infrastructure, which if disclosed could be used to plan and act with a view to causing disruption or destruction of critical infrastructure installations;
(e)
‘protection’ means all activities aimed at ensuring the functionality, continuity and integrity of critical infrastructures in order to deter, mitigate and neutralise a threat, risk or vulnerability;
(f)
‘owners/operators of ECIs’ means those entities responsible for investments in, and/or day-to-day operation of, a particular asset, system or part thereof designated as an ECI under this Directive.

Identification of ECIs

1. Pursuant to the procedure provided in Annex III, each Member State shall identify potential ECIs which both satisfy the cross-cutting and sectoral criteria and meet the definitions set out in Article 2(a) and (b).
The Commission may assist Member States at their request to identify potential ECIs.
The Commission may draw the attention of the relevant Member States to the existence of potential critical infrastructures which may be deemed to satisfy the requirements for designation as an ECI.
Each Member State and the Commission shall continue on an ongoing basis the process of identifying potential ECIs.
2. The cross-cutting criteria referred to in paragraph 1 shall comprise the following:
(a)
casualties criterion (assessed in terms of the potential number of fatalities or injuries);
(b)
economic effects criterion (assessed in terms of the significance of economic loss and/or degradation of products or services; including potential environmental effects);
(c)
public effects criterion (assessed in terms of the impact on public confidence, physical suffering and disruption of daily life; including the loss of essential services).
The cross-cutting criteria thresholds shall be based on the severity of the impact of the disruption or destruction of a particular infrastructure. The precise thresholds applicable to the cross-cutting criteria shall be determined on a case-by-case basis by the Member States concerned by a particular critical infrastructure. Each Member State shall inform the Commission on an annual basis of the number of infrastructures per sector for which discussions were held concerning the cross-cutting criteria thresholds.
The sectoral criteria shall take into account the characteristics of individual ECI sectors.
The Commission together with the Member States shall develop guidelines for the application of the cross-cutting and sectoral criteria and approximate thresholds to be used to identify ECIs. The criteria shall be classified. The use of such guidelines shall be optional for the Member States.
3. The sectors to be used for the purposes of implementing this Directive shall be the energy and transport sectors. The subsectors are identified in Annex I.
If deemed appropriate and in conjunction with the review of this Directive as laid down in Article 11, subsequent sectors to be used for the purpose of implementing this Directive may be identified. Priority shall be given to the ICT sector.

Designation of ECIs

1. Each Member State shall inform the other Member States which may be significantly affected by a potential ECI about its identity and the reasons for designating it as a potential ECI.
2. Each Member State on whose territory a potential ECI is located shall engage in bilateral and/or multilateral discussions with the other Member States which may be significantly affected by the potential ECI. The Commission may participate in these discussions but shall not have access to detailed information which would allow for the unequivocal identification of a particular infrastructure.
A Member State that has reason to believe that it may be significantly affected by the potential ECI, but has not been identified as such by the Member State on whose territory the potential ECI is located, may inform the Commission about its wish to be engaged in bilateral and/or multilateral discussions on this issue. The Commission shall without delay communicate this wish to the Member State on whose territory the potential ECI is located and endeavour to facilitate agreement between the parties.
3. The Member State on whose territory a potential ECI is located shall designate it as an ECI following an agreement between that Member State and those Member States that may be significantly affected.
The acceptance of the Member State on whose territory the infrastructure to be designated as an ECI is located, shall be required.
4. The Member State on whose territory a designated ECI is located shall inform the Commission on an annual basis of the number of designated ECIs per sector and of the number of Member States dependent on each designated ECI. Only those Member States that may be significantly affected by an ECI shall know its identity.
5. The Member States on whose territory an ECI is located shall inform the owner/operator of the infrastructure concerning its designation as an ECI. Information concerning the designation of an infrastructure as an ECI shall be classified at an appropriate level.
6. The process of identifying and designating ECIs pursuant to Article 3 and this Article shall be completed by 12 January 2011 and reviewed on a regular basis.

Operator security plans

1. The operator security plan (‘OSP’) procedure shall identify the critical infrastructure assets of the ECI and which security solutions exist or are being implemented for their protection. The minimum content to be addressed by an ECI OSP procedure is set out in Annex II.
2. Each Member State shall assess whether each designated ECI located on its territory possesses an OSP or has in place equivalent measures addressing the issues identified in Annex II. If a Member State finds that such an OSP or equivalent exists and is updated regularly, no further implementation action shall be necessary.
3. If a Member State finds that such an OSP or equivalent has not been prepared, it shall ensure by any measures deemed appropriate, that the OSP or equivalent is prepared addressing the issues identified in Annex II.
Each Member State shall ensure that the OSP or equivalent is in place and is reviewed regularly within one year following designation of the critical infrastructure as an ECI. This period may be extended in exceptional circumstances, by agreement with the Member State authority and with a notification to the Commission.
4. In a case where supervisory or oversight arrangements already exist in relation to an ECI such arrangements are not affected by this Article and the relevant Member State authority referred to in this Article shall be the supervisor under those existing arrangements.
5. Compliance with measures including Community measures which in a particular sector require, or refer to a need to have, a plan similar or equivalent to an OSP and oversight by the relevant authority of such a plan, is deemed to satisfy all the requirements of Member States under, or adopted pursuant to, this Article. The guidelines for application referred to in Article 3(2) shall contain an indicative list of such measures.

Security Liaison Officers

1. The Security Liaison Officer shall function as the point of contact for security related issues between the owner/operator of the ECI and the relevant Member State authority.
2. Each Member State shall assess whether each designated ECI located on its territory possesses a Security Liaison Officer or equivalent. If a Member State finds that such a Security Liaison Officer is in place or an equivalent exists, no further implementation action shall be necessary.
3. If a Member State finds that a Security Liaison Officer or equivalent does not exist in relation to a designated ECI, it shall ensure by any measures deemed appropriate, that such a Security Liaison Officer or equivalent is designated.
4. Each Member State shall implement an appropriate communication mechanism between the relevant Member State authority and the Security Liaison Officer or equivalent with the objective of exchanging relevant information concerning identified risks and threats in relation to the ECI concerned. This communication mechanism shall be without prejudice to national requirements concerning access to sensitive and classified information.
5. Compliance with measures including Community measures which in a particular sector require, or refer to a need to have, a Security Liaison Officer or equivalent, is deemed to satisfy all the requirements of Member States in, or adopted pursuant to, this Article. The guidelines for application referred to in Article 3(2) shall contain an indicative list of such measures.

Reporting

1. Each Member State shall conduct a threat assessment in relation to ECI subsectors within one year following the designation of critical infrastructure on its territory as an ECI within those subsectors.
2. Each Member State shall report every two years to the Commission generic data on a summary basis on the types of risks, threats and vulnerabilities encountered per ECI sector in which an ECI has been designated pursuant to Article 4 and is located on its territory.
A common template for these reports may be developed by the Commission in cooperation with the Member States.
Each report shall be classified at an appropriate level as deemed necessary by the originating Member State.
3. Based on the reports referred to in paragraph 2, the Commission and the Member States shall assess on a sectoral basis whether further protection measures at Community level should be considered for ECIs. This process shall be undertaken in conjunction with the review of this Directive as laid down in Article 11.
4. Common methodological guidelines for carrying out risk analyses in respect of ECIs may be developed by the Commission in cooperation with the Member States. The use of such guidelines shall be optional for the Member States.

Commission support for ECIs

The Commission shall support, through the relevant Member State authority, the owners/operators of designated ECIs by providing access to available best practices and methodologies as well as support training and the exchange of information on new technical developments related to critical infrastructure protection.

Sensitive European critical infrastructure protection-related information

1. Any person handling classified information pursuant to this Directive on behalf of a Member State or the Commission shall have an appropriate level of security vetting.
Member States, the Commission and relevant supervisory bodies shall ensure that sensitive European critical infrastructure protection-related information submitted to the Member States or to the Commission is not used for any purpose other than the protection of critical infrastructures.
2. This Article shall also apply to non-written information exchanged during meetings at which sensitive subjects are discussed.

European critical infrastructure protection contact points

1. Each Member State shall appoint a European critical infrastructure protection contact point (‘ECIP contact point’).
2. ECIP contact points shall coordinate European critical infrastructure protection issues within the Member State, with other Member States and with the Commission. The appointment of an ECIP contact point does not preclude other authorities in a Member State from being involved in European critical infrastructure protection issues.

Review

A review of this Directive shall begin on 12 January 2012.

Implementation

Member States shall take the necessary measures to comply with this Directive by 12 January 2011. They shall forthwith inform the Commission thereof and communicate the text of those measures and their correlation with this Directive.
When they are adopted by Member States, these measures shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Entry into force

This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Addressees

This Directive is addressed to the Member States.

List of ECI sectors

ANNEX I
Sector | Subsector
IEnergy | I | Energy | 1.Electricity | 1. | Electricity | Infrastructures and facilities for generation and transmission of electricity in respect of supply electricity
I | Energy
1. | Electricity
2.Oil | 2. | Oil | Oil production, refining, treatment, storage and transmission by pipelines
2. | Oil
3.Gas | 3. | Gas | Gas production, refining, treatment, storage and transmission by pipelinesLNG terminals
3. | Gas
IITransport | II | Transport | 4.Road transport | 4. | Road transport
II | Transport
4. | Road transport
5.Rail transport | 5. | Rail transport
5. | Rail transport
6.Air transport | 6. | Air transport
6. | Air transport
7.Inland waterways transport | 7. | Inland waterways transport
7. | Inland waterways transport
8.Ocean and short-sea shipping and ports | 8. | Ocean and short-sea shipping and ports
8. | Ocean and short-sea shipping and portsThe identification by the Member States of critical infrastructures which may be designated as ECIs is undertaken pursuant to Article 3. Therefore the list of ECI sectors in itself does not generate a generic obligation to designate an ECI in each sector.

ECI OSP PROCEDURE

ANNEX IIThe OSP will identify critical infrastructure assets and which security solutions exist or are being implemented for their protection. The ECI OSP procedure will cover at least:

1. | identification of important assets;
2. | conducting a risk analysis based on major threat scenarios, vulnerability of each asset, and potential impact; and
3. | identification, selection and prioritisation of counter-measures and procedures with a distinction between:—permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems,—graduated security measures, which can be activated according to varying risk and threat levels. | — | permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems, | — | graduated security measures, which can be activated according to varying risk and threat levels.
— | permanent security measures, which identify indispensable security investments and means which are relevant to be employed at all times. This heading will include information concerning general measures such as technical measures (including installation of detection, access control, protection and prevention means); organisational measures (including procedures for alerts and crisis management); control and verification measures; communication; awareness raising and training; and security of information systems,
— | graduated security measures, which can be activated according to varying risk and threat levels.

Procedure for the identification by the Member States of critical infrastructures which may be designated as an ECI pursuant to Article 3

ANNEX IIIArticle 3 requires each Member State to identify the critical infrastructures which may be designated as an ECI. This procedure shall be implemented by each Member State through the following series of consecutive steps.
A potential ECI which does not satisfy the requirements of one of the following sequential steps is considered to be ‘non-ECI’ and is excluded from the procedure. A potential ECI which does satisfy the requirements shall be subjected to the next steps of this procedure.
Step 1Each Member State shall apply the sectoral criteria in order to make a first selection of critical infrastructures within a sector.
Step 2Each Member State shall apply the definition of critical infrastructure pursuant to Article 2(a) to the potential ECI identified under step 1.
The significance of the impact will be determined either by using national methods for identifying critical infrastructures or with reference to the cross-cutting criteria, at an appropriate national level. For infrastructure providing an essential service, the availability of alternatives, and the duration of disruption/recovery will be taken into account.
Step 3Each Member State shall apply the transboundary element of the definition of ECI pursuant to Article 2(b) to the potential ECI that has passed the first two steps of this procedure. A potential ECI which does satisfy the definition will follow the next step of the procedure. For infrastructure providing an essential service, the availability of alternatives, and the duration of disruption/recovery will be taken into account.
Step 4Each Member State shall apply the cross-cutting criteria to the remaining potential ECIs. The cross-cutting criteria shall take into account: the severity of impact; and, for infrastructure providing an essential service, the availability of alternatives; and the duration of disruption/recovery. A potential ECI which does not satisfy the cross-cutting criteria will not be considered to be an ECI.
A potential ECI which has passed through this procedure shall only be communicated to the Member States which may be significantly affected by the potential ECI.

Pending: 32008L0106

January 16, 2026
3.12.2008 EN Official Journal of the European Union L 323/33
(1) Directive 2001/25/EC of the European Parliament and of the Council of 4 April 2001 on the minimum level of training of seafarers(3)has been significantly amended on several occasions(4). Now that new amendments are being made to that Directive, it is desirable, for reasons of clarity, that the provisions in question should be recast.
(2) Actions to be taken at Community level in the field of maritime safety and pollution prevention at sea should be in line with internationally agreed rules and standards.
(3) In order to maintain and develop the level of knowledge and skills in the maritime sector in the Community, it is important to pay appropriate attention to maritime training and the status of seafarers in the Community.
(4) A consistent level of training for the award of vocational competency certificates to seafarers should be ensured in the interests of maritime safety.
(5) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications(5)applies to maritime occupations covered by this Directive. It will help promote compliance with the obligations laid down in the Treaty abolishing obstacles to the free movement of persons and services between Member States.
(6) The mutual recognition of diplomas and certificates provided for under Directive 2005/36/EC does not always ensure a standardised level of training for all seafarers serving on board vessels flying the flag of a Member State. This is, however, vital from the viewpoint of maritime safety.
(7) It is therefore essential to define a minimum level of training for seafarers in the Community. That level should be based on the standards of training already agreed at international level, namely the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978 (STCW Convention), as revised in 1995. All Member States are Parties to that Convention.
(8) Member States may establish standards higher than the minimum standards laid down in the STCW Convention and this Directive.
(9) The Regulations of the STCW Convention annexed to this Directive should be supplemented by the mandatory provisions contained in Part A of the Seafarers’ Training, Certification and Watchkeeping Code (STCW Code). Part B of the STCW Code contains recommended guidance intended to assist Parties to the STCW Convention and those involved in implementing, applying or enforcing its measures to give the Convention full and complete effect in a uniform manner.
(10) For the enhancement of maritime safety and pollution prevention at sea, provisions on minimum rest periods for watchkeeping personnel should be established in this Directive in accordance with the STCW Convention. Those provisions should be applied without prejudice to the provisions of Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners’ Association (ECSA) and the Federation of Transport Workers’ Unions in the European Union (FST)(6).
(11) Member States should take and enforce specific measures to prevent and penalise fraudulent practices associated with certificates of competency as well as pursue their efforts within the IMO to achieve strict and enforceable agreements on the worldwide combating of such practices.
(12) In order to enhance maritime safety and prevent loss of human life and maritime pollution, communication among crew members on board ships sailing in Community waters should be improved.
(13) Personnel on board passenger ships nominated to assist passengers in emergency situations should be able to communicate with the passengers.
(14) Crews serving on board tankers carrying noxious or polluting cargo should be capable of coping effectively with accident prevention and emergency situations. It is paramount that a proper communication link between the master, officers and ratings is established, covering the requirements provided for in this Directive.
(15) It is essential to ensure that seafarers holding certificates issued by third countries and serving on board Community ships have a level of competence equivalent to that required by the STCW Convention. This Directive should lay down procedures and common criteria for the recognition by the Member States of certificates issued by third countries, based on the training and certification requirements as agreed in the framework of the STCW Convention.
(16) In the interests of safety at sea, Member States should recognise qualifications proving the required level of training only where these are issued by or on behalf of Parties to the STCW Convention which have been identified by the IMO Maritime Safety Committee (MSC) as having been shown to have given, and still to be giving, full effect to the standards set out in that Convention. To bridge the time gap until the MSC has been able to carry out such identification, a procedure for the preliminary recognition of certificates is needed.
(17) Where appropriate, maritime institutes, training programmes and courses should be inspected. Criteria for such inspection should therefore be established.
(18) The Commission should be assisted by a committee in carrying out the tasks related to the recognition of certificates issued by training institutes or administrations of third countries.
(19) The European Maritime Safety Agency established by Regulation (EC) No 1406/2002 of the European Parliament and of the Council(7)should assist the Commission in verifying that Member States comply with the requirements laid down in this Directive.
(20) Member States, as port authorities, are required to enhance safety and prevention of pollution in Community waters through priority inspection of vessels flying the flag of a third country which has not ratified the STCW Convention, thereby ensuring no more favourable treatment to vessels flying the flag of a third country.
(21) It is appropriate to include in this Directive provisions on port State control, pending the amendment of Council Directive 95/21/EC(8)on port State control of shipping in order to transfer to that Directive the provisions on port State control which are included in this Directive.
(22) It is necessary to provide for procedures for adapting this Directive to changes in international conventions and codes.
(23) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).
(24) In particular the Commission should be empowered to amend this Directive in order to apply, for the purposes of this Directive, subsequent amendments to certain international codes and any relevant amendment to Community legislation. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(25) The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.
(26) This Directive should be without prejudice to the obligations of the Members States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B,
1. ‘master’ means the person having command of a ship;
2. ‘officer’ means a member of the crew, other than the master, designated as such by national law or regulations or, in the absence of such designation, by collective agreement or custom;
3. ‘deck officer’ means an officer qualified in accordance with the provisions of Chapter II of Annex I;
4. ‘chief mate’ means the officer next in rank to the master upon whom the command of the ship will fall in the event of the incapacity of the master;
5. ‘engineer officer’ means an officer qualified in accordance with the provisions of Chapter III of Annex I;
6. ‘chief engineer officer’ means the senior engineer officer responsible for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship;
7. ‘second engineer officer’ means the engineer officer next in rank to the chief engineer officer upon whom the responsibility for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship will fall in the event of the incapacity of the chief engineer officer;
8. ‘assistant engineer officer’ means a person under training to become an engineer officer and designated as such by national law or regulations;
9. ‘radio operator’ means a person holding an appropriate certificate issued or recognised by the competent authorities under the provisions of the Radio Regulations;
10. ‘rating’ means a member of the ship’s crew other than the master or an officer;
11. ‘seagoing ship’ means a ship other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply;
12. ‘ship flying the flag of a Member State’ means a ship registered in and flying the flag of a Member State in accordance with its legislation; a ship not corresponding to this definition shall be regarded as a ship flying the flag of a third country;
13. ‘near-coastal voyages’ means voyages in the vicinity of a Member State as defined by that Member State;
14. ‘propulsion power’ means the total maximum continuous rated output power in kilowatts of all of a ship’s main propulsion machinery which appears on the ship’s certificate of registry or other official document;
15. ‘oil-tanker’ means a ship constructed and used for the carriage of petroleum and petroleum products in bulk;
16. ‘chemical tanker’ means a ship constructed or adapted and used for the carriage in bulk of any liquid product listed in Chapter 17 of the International Bulk Chemical Code, in its up-to-date version;
17. ‘liquefied-gas tanker’ means a ship constructed or adapted and used for the carriage in bulk of any liquefied gas or other product listed in Chapter 19 of the International Gas Carrier Code, in its up-to-date version;
18. ‘Radio Regulations’ means the revised radio regulations, adopted by the World Administrative Radio Conference for the Mobile Service in their up-to-date version;
19. ‘passenger ship’ means a seagoing ship which carries more than 12 passengers;
20. ‘fishing vessel’ shall mean a vessel used for catching fish or other living resources of the sea;
21. ‘STCW Convention’ means the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as it applies to the matters concerned taking into account the transitional provisions of Article VII and Regulation I/15 of the Convention and including, where appropriate, the applicable provisions of the STCW Code, all being applied in their up-to-date versions;
22. ‘radio duties’ includes, as appropriate, watchkeeping and technical maintenance and repairs conducted in accordance with the Radio Regulations, the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74) and, at the discretion of each Member State, the relevant recommendations of the IMO, in their up-to-date versions;
23. ‘ro-ro passenger ship’ means a passenger ship with ro-ro cargo spaces or special-category spaces as defined in the SOLAS 74, in its up-to-date version;
24. ‘STCW Code’ means the Seafarers’ Training, Certification and Watchkeeping (STCW) Code as adopted by Resolution 2 of the 1995 STCW Conference of Parties, in its up-to-date version;
25. ‘function’ means a group of tasks, duties and responsibilities, as specified in the STCW Code, necessary for ship operation, safety of life at sea or protection of the marine environment;
26. ‘company’ means the owner of the ship or any other organisation or person such as the manager or the bareboat charterer who has assumed the responsibility for operation of the ship from the shipowner and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed on the company by this Directive;
27. ‘appropriate certificate’ means a certificate issued and endorsed in accordance with this Directive and entitling the lawful holder thereof to serve in the capacity and perform the functions involved at the level of responsibility specified therein on a ship of the type, tonnage, power and means of propulsion concerned while engaged on the particular voyage concerned;
28. ‘seagoing service’ means service on board a ship relevant to the issue of a certificate or other qualification;
29. ‘approved’ means approved by a Member State in accordance with this Directive;
30. ‘third country’ means any country which is not a Member State;
31. ‘month’ means a calendar month or 30 days made up of periods of less than one month.
(a) warships, naval auxiliaries or other ships owned or operated by a Member State and engaged only on government non-commercial service;
(b) fishing vessels;
(c) pleasure yachts not engaged in trade;
(d) wooden ships of primitive build.
(a) include the additional knowledge required by the relevant regulations in the examination for the issue of a certificate complying with the Radio Regulations; or
(b) issue a separate certificate indicating that the holder has the additional knowledge required by the relevant regulations.
(a) may be issued as separate documents;
(b) shall each be assigned a unique number, other than endorsements attesting the issue of a certificate which may be assigned the same number as the certificate concerned, provided that that number is unique; and
(c) shall each expire as soon as the certificate endorsed expires or is withdrawn, suspended or cancelled by the Member State or third country which issued them and, in any case, within five years of their date of issue.
(a) a company or a master has engaged a person not holding a certificate as required by this Directive;
(b) a master has allowed any function or service in any capacity which under this Directive must be performed by a person holding an appropriate certificate to be performed by a person not holding the required certificate, a valid dispensation or having the documentary proof required by Article 19(7); or
(c) a person has obtained by fraud or forged documents an engagement to perform any function or serve in any capacity which under this Directive must be performed or fulfilled by a person holding a certificate or dispensation.
(a) all training, assessment of competence, certification, endorsement and revalidation activities carried out by non-governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives, including those concerning the qualifications and experience of instructors and assessors;
(b) where governmental agencies or entities perform such activities, there is a quality-standards system;
(c) the education and training objectives and related quality standards of competence to be achieved are clearly defined and identify the levels of knowledge, understanding and skills appropriate to the examinations and assessments required under the STCW Convention;
(d) the fields of application of the quality standards cover the administration of the certification systems, all training courses and programmes, examinations and assessments carried out by or under the authority of each Member State and the qualifications and experience required of instructors and assessors, having regard to the policies, systems, controls and internal quality-assurance reviews established to ensure achievement of the defined objectives.
(a) all internal management control and monitoring measures and follow-up actions comply with planned arrangements and documental procedures and are effective in ensuring that the defined objectives are achieved;
(b) the results of each independent evaluation are documented and brought to the attention of those responsible for the area evaluated;
(c) timely action is taken to correct deficiencies.
(a) of his or her identity;
(b) that his or her age is not less than that prescribed in the Regulations in Annex I relevant to the certificate applied for;
(c) that he or she meets the standards of medical fitness, particularly regarding eyesight and hearing, established by the Member State and holds a valid document attesting to his or her medical fitness, issued by a duly qualified medical practitioner recognised by the competent authority of the Member State;
(d) of having completed the seagoing service and any related compulsory training prescribed in the Regulations in Annex I for the certificate applied for;
(e) that he or she meets the standards of competence prescribed in the Regulations in Annex I for the capacities, functions and levels that are to be identified in the endorsement to the certificate.
(a) to maintain a register or registers of all certificates and endorsements for masters and officers and, as appropriate, ratings, which are issued, have expired or have been revalidated, suspended, cancelled or reported lost or destroyed and of dispensations issued;
(b) to make available information on the status of such certificates, endorsements and dispensations to other Member States or other Parties to the STCW Convention and companies which request verification of the authenticity and validity of certificates produced to them by seafarers seeking recognition of their certificates or employment on board ship.
(a) to meet the standards of medical fitness prescribed by Article 11; and
(b) to establish continued professional competence in accordance with section A-I/11 of the STCW Code.
(a) all mandatory simulator-based training;
(b) any assessment of competence required by Part A of the STCW Code which is carried out by means of a simulator;
(c) any demonstration, by means of a simulator, of continued proficiency required by Part A of the STCW Code.
(a) each seafarer assigned to any of its ships holds an appropriate certificate in accordance with the provisions of this Directive and as established by the Member State;
(b) its ships are manned in accordance with the applicable safe-manning requirements of the Member State;
(c) documentation and data relevant to all seafarers employed on its ships are maintained and readily accessible, and include, without being limited to, documentation and data on their experience, training, medical fitness and competence in assigned duties;
(d) on being assigned to any of its ships seafarers are familiarised with their specific duties and with all ship arrangements, installations, equipment, procedures, and ship characteristics that are relevant to their routine or emergency duties;
(e) the ship’s complement can effectively coordinate their activities in an emergency situation and in performing functions vital to safety or to the prevention or mitigation of pollution.
(a) the allocation of a reasonable period of time during which each newly employed seafarer will have an opportunity to become acquainted with:(i)the specific equipment the seafarer will be using or operating; and(ii)ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly; (i) the specific equipment the seafarer will be using or operating; and (ii) ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly;
(i) the specific equipment the seafarer will be using or operating; and
(ii) ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly;
(i) the specific equipment the seafarer will be using or operating; and
(ii) ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly;
(b) the designation of a knowledgeable crew member who will be responsible for ensuring that each newly employed seafarer is given an opportunity to receive essential information in a language the seafarer understands.
(a) give the training referred to in Article 3;
(b) organise and/or supervise the examinations where required;
(c) issue the certificates of competence referred to in Article 11;
(d) grant the dispensations provided for in Article 16.
(a) all training and assessment of seafarers is:(i)structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and(ii)conducted, monitored, evaluated and supported by persons qualified in accordance with points (d), (e) and (f); (i) structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and (ii) conducted, monitored, evaluated and supported by persons qualified in accordance with points (d), (e) and (f);
(i) structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and
(ii) conducted, monitored, evaluated and supported by persons qualified in accordance with points (d), (e) and (f);
(i) structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and
(ii) conducted, monitored, evaluated and supported by persons qualified in accordance with points (d), (e) and (f);
(b) persons conducting in-service training or assessment on board ship do so only when such training or assessment will not adversely affect the normal operation of the ship and they can dedicate their time and attention to training or assessment;
(c) instructors, supervisors and assessors are appropriately qualified for the particular types and levels of training or assessment of competence of seafarers either on board or ashore;
(d) any person conducting in-service training of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under this Directive:(i)has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted;(ii)is qualified in the task for which training is being conducted; and(iii)if conducting training using a simulator:—has received appropriate guidance in instructional techniques involving the use of simulators, and—has gained practical operational experience on the particular type of simulator being used; (i) has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted; (ii) is qualified in the task for which training is being conducted; and (iii) if conducting training using a simulator:—has received appropriate guidance in instructional techniques involving the use of simulators, and—has gained practical operational experience on the particular type of simulator being used; — has received appropriate guidance in instructional techniques involving the use of simulators, and — has gained practical operational experience on the particular type of simulator being used;
(i) has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted;
(ii) is qualified in the task for which training is being conducted; and
(iii) if conducting training using a simulator:—has received appropriate guidance in instructional techniques involving the use of simulators, and—has gained practical operational experience on the particular type of simulator being used; — has received appropriate guidance in instructional techniques involving the use of simulators, and — has gained practical operational experience on the particular type of simulator being used;
— has received appropriate guidance in instructional techniques involving the use of simulators, and
— has gained practical operational experience on the particular type of simulator being used;
(i) has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted;
(ii) is qualified in the task for which training is being conducted; and
(iii) if conducting training using a simulator:—has received appropriate guidance in instructional techniques involving the use of simulators, and—has gained practical operational experience on the particular type of simulator being used; — has received appropriate guidance in instructional techniques involving the use of simulators, and — has gained practical operational experience on the particular type of simulator being used;
— has received appropriate guidance in instructional techniques involving the use of simulators, and
— has gained practical operational experience on the particular type of simulator being used;
— has received appropriate guidance in instructional techniques involving the use of simulators, and
— has gained practical operational experience on the particular type of simulator being used;
(e) any person responsible for the supervision of the in-service training of a seafarer intended to be used in qualifying for certification has a full understanding of the training programme and the specific objectives for each type of training being conducted;
(f) any person conducting in-service assessment of the competence of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under this Directive:(i)has an appropriate level of knowledge and understanding of the competence to be assessed;(ii)is qualified in the task for which the assessment is being made;(iii)has received appropriate guidance in assessment methods and practice;(iv)has gained practical assessment experience; and(v)if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor; (i) has an appropriate level of knowledge and understanding of the competence to be assessed; (ii) is qualified in the task for which the assessment is being made; (iii) has received appropriate guidance in assessment methods and practice; (iv) has gained practical assessment experience; and (v) if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor;
(i) has an appropriate level of knowledge and understanding of the competence to be assessed;
(ii) is qualified in the task for which the assessment is being made;
(iii) has received appropriate guidance in assessment methods and practice;
(iv) has gained practical assessment experience; and
(v) if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor;
(i) has an appropriate level of knowledge and understanding of the competence to be assessed;
(ii) is qualified in the task for which the assessment is being made;
(iii) has received appropriate guidance in assessment methods and practice;
(iv) has gained practical assessment experience; and
(v) if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor;
(g) when a Member State recognises a course of training, a training institution, or a qualification granted by a training institution, as part of its requirements for the issue of a certificate, the qualifications and experience of instructors and assessors are covered in the application of the quality standard provisions of Article 10; such qualification, experience and application of quality standards shall incorporate appropriate training in instructional techniques and training and assessment methods and practice and comply with all applicable requirements of points (d), (e) and (f).
(a) without prejudice to points (b) and (d), there are at all times, on board all ships flying the flag of a Member State, means in place for effective oral communication relating to safety between all members of the ship’s crew, particularly with regard to the correct and timely reception and understanding of messages and instructions;
(b) on board all passenger ships flying the flag of a Member State and on board all passenger ships starting and/or finishing a voyage in a Member State port, in order to ensure effective crew performance in safety matters, a working language is established and recorded in the ship’s log-book;the company or the master, as appropriate, shall determine the appropriate working language; each seafarer shall be required to understand and, where appropriate, give orders and instructions and report back in that language;if the working language is not an official language of the Member State, all plans and lists that must be posted shall include translations into the working language;
(c) on board passenger ships, personnel nominated on muster lists to assist passengers in emergency situations are readily identifiable and have communication skills that are sufficient for that purpose, taking into account an appropriate and adequate combination of any of the following factors:(i)the language or languages appropriate to the principal nationalities of passengers carried on a particular route;(ii)the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language;(iii)the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes) when verbal communication is impractical;(iv)the extent to which complete safety instructions have been provided to passengers in their native language or languages;(v)the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers; (i) the language or languages appropriate to the principal nationalities of passengers carried on a particular route; (ii) the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language; (iii) the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes) when verbal communication is impractical; (iv) the extent to which complete safety instructions have been provided to passengers in their native language or languages; (v) the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers;
(i) the language or languages appropriate to the principal nationalities of passengers carried on a particular route;
(ii) the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language;
(iii) the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes) when verbal communication is impractical;
(iv) the extent to which complete safety instructions have been provided to passengers in their native language or languages;
(v) the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers;
(i) the language or languages appropriate to the principal nationalities of passengers carried on a particular route;
(ii) the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language;
(iii) the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes) when verbal communication is impractical;
(iv) the extent to which complete safety instructions have been provided to passengers in their native language or languages;
(v) the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers;
(d) on board oil tankers, chemical tankers and liquefied gas tankers flying the flag of a Member State, the master, officers and rating are able to communicate with each other in (a) common working language(s);
(e) there are adequate means for communication between the ship and the shore-based authorities; these communications shall be conducted in accordance with Chapter V, Regulation 14, paragraph 4, of the SOLAS 74;
(f) when carrying out port State control under Directive 95/21/EC, Member States also check that ships flying the flag of a State other than a Member State comply with this Article.
(a) verification that every seafarer serving on board who must be certificated in accordance with the STCW Convention holds an appropriate certificate or a valid dispensation or provides documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the flag State;
(b) verification that the numbers and certificates of the seafarers serving on board are in accordance with the safe-manning requirements of the authorities of the flag State.
(a) the ship has been involved in a collision, grounding or stranding;
(b) there has been a discharge of substances from the ship when under way, at anchor or at berth which is illegal under an international convention;
(c) the ship has been manoeuvred in an erratic or unsafe manner whereby routing measures adopted by the IMO, or safe navigation practices and procedures have not been followed;
(d) the ship is otherwise being operated in such a manner as to pose a danger to persons, property or the environment;
(e) a certificate has been fraudulently obtained or the holder of a certificate is not the person to whom that certificate was originally issued;
(f) the ship is flying the flag of a country which has not ratified the STCW Convention, or has a master, officer or rating holding a certificate issued by a third country which has not ratified the STCW Convention.
(a) failure of seafarers to hold certificates, to have appropriate certificates, to have valid dispensations or provide documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the flag State;
(b) failure to comply with the applicable safe-manning requirements of the flag State;
(c) failure of navigational or engineering-watch arrangements to conform to the requirements specified for the ship by the flag State;
(d) absence in a watch of a person qualified to operate equipment essential to safe navigation, safety radio communications or the prevention of marine pollution;
(e) failure to provide proof of professional proficiency for the duties assigned to seafarers for the safety of the ship and the prevention of pollution;
(f) inability to provide for the first watch at the commencement of a voyage and for subsequent relieving watches persons who are sufficiently rested and otherwise fit for duty.
(a) ‘200 gross registered tonnes’ may be replaced by ‘500 gross tonnage’;
(b) ‘1 600 gross registered tonnes’ may be replaced by ‘3 000 gross tonnage’.
1. The Regulations referred to in this Annex are supplemented by the mandatory provisions contained in Part A of the STCW Code with the exception of Chapter VIII, Regulation VIII/2.Any reference to a requirement in a Regulation also constitutes a reference to the corresponding section of Part A of the STCW Code.
2. Member States shall ensure that seafarers possess adequate language proficiency, as defined in Sections A-II/1, A-III/1, A-IV/2 and A-II/4 of the STCW Code so as to enable them to perform their specific duties on a vessel flying the flag of a host Member State.
3. Part A of the STCW Code contains standards of competence required to be demonstrated by candidates for the issue, and revalidation of certificates of competency under the provisions of the STCW Convention. To clarify the linkage between the alternative certification provisions of Chapter VII and the certification provisions of Chapters II, III and IV, the abilities specified in the standards of competence are grouped as appropriate under the following seven functions:1.Navigation;2.Cargo handling and stowage;3.Controlling the operation of the ship and care for persons on board;4.Marine engineering;5.Electrical, electronic and control engineering;6.Maintenance and repair;7.Radio communications,at the following levels of responsibility:1.Management level;2.Operational level;3.Support level.Functions and levels of responsibility are identified by subtitle in the tables of standards of competence given specified in Chapters II, III and IV of the Part A of the STCW Code. 1. Navigation; 2. Cargo handling and stowage; 3. Controlling the operation of the ship and care for persons on board; 4. Marine engineering; 5. Electrical, electronic and control engineering; 6. Maintenance and repair; 7. Radio communications, 1. Management level; 2. Operational level; 3. Support level.
1. Navigation;
2. Cargo handling and stowage;
3. Controlling the operation of the ship and care for persons on board;
4. Marine engineering;
5. Electrical, electronic and control engineering;
6. Maintenance and repair;
7. Radio communications,
1. Management level;
2. Operational level;
3. Support level.
1. Navigation;
2. Cargo handling and stowage;
3. Controlling the operation of the ship and care for persons on board;
4. Marine engineering;
5. Electrical, electronic and control engineering;
6. Maintenance and repair;
7. Radio communications,
1. Management level;
2. Operational level;
3. Support level.
1. Every officer in charge of a navigational watch serving on a seagoing ship of 500 gross tonnage or more shall hold an appropriate certificate.
2. Every candidate for certification shall:2.1.be not less than 18 years of age;2.2.have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years;2.3.have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months;2.4.meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations;2.5.have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code. 2.1. be not less than 18 years of age; 2.2. have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years; 2.3. have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months; 2.4. meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations; 2.5. have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code.
2.1. be not less than 18 years of age;
2.2. have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years;
2.3. have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months;
2.4. meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations;
2.5. have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code.
2.1. be not less than 18 years of age;
2.2. have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years;
2.3. have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months;
2.4. meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations;
2.5. have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code.
1. Every master and chief mate on a seagoing ship of 3 000 gross tonnage or more shall hold an appropriate certificate.
2. Every candidate for certification shall:2.1.meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;2.2.have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more. 2.1. meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; 2.1.1. for certification as chief mate, not less than 12 months; and 2.1.2. for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; 2.2. have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more.
2.1. meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; 2.1.1. for certification as chief mate, not less than 12 months; and 2.1.2. for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.1.1. for certification as chief mate, not less than 12 months; and
2.1.2. for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.2. have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more.
2.1. meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; 2.1.1. for certification as chief mate, not less than 12 months; and 2.1.2. for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.1.1. for certification as chief mate, not less than 12 months; and
2.1.2. for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.1.1. for certification as chief mate, not less than 12 months; and
2.1.2. for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.2. have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more.
3. Every master and chief mate on a seagoing ship of between 500 and 3 000 gross tonnage shall hold an appropriate certificate.
4. Every candidate for certification shall:4.1.for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more;4.2.for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;4.3.have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage. 4.1. for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more; 4.2. for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; 4.3. have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage.
4.1. for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more;
4.2. for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
4.3. have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage.
4.1. for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more;
4.2. for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
4.3. have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage.
1. Every officer in charge of a navigational watch serving on a seagoing ship of less than 500 gross tonnage not engaged on near-coastal voyages shall hold an appropriate certificate for ships of 500 gross tonnage or more.
2. Every master serving on a seagoing ship of less than 500 gross tonnage not engaged on near-coastal voyages shall hold an appropriate certificate for service as master on ships of between 500 and 3 000 gross tonnage.
3. Every officer in charge of a navigational watch on a seagoing ship of less than 500 gross tonnage engaged on near-coastal voyages shall hold an appropriate certificate.
4. Every candidate for certification as officer in charge of a navigational watch on a seagoing ship of less than 500 gross tonnage engaged on near-coastal voyages shall:4.1.be not less than 18 years of age;4.2.have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years;4.3.meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;4.4.have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages. 4.1. be not less than 18 years of age; 4.2. have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years; 4.2.1. special training, including an adequate period of appropriate seagoing service as required by the Administration; or 4.2.2. approved seagoing service in the deck department of not less than three years; 4.3. meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations; 4.4. have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages.
4.1. be not less than 18 years of age;
4.2. have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years; 4.2.1. special training, including an adequate period of appropriate seagoing service as required by the Administration; or 4.2.2. approved seagoing service in the deck department of not less than three years;
4.2.1. special training, including an adequate period of appropriate seagoing service as required by the Administration; or
4.2.2. approved seagoing service in the deck department of not less than three years;
4.3. meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;
4.4. have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages.
4.1. be not less than 18 years of age;
4.2. have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years; 4.2.1. special training, including an adequate period of appropriate seagoing service as required by the Administration; or 4.2.2. approved seagoing service in the deck department of not less than three years;
4.2.1. special training, including an adequate period of appropriate seagoing service as required by the Administration; or
4.2.2. approved seagoing service in the deck department of not less than three years;
4.2.1. special training, including an adequate period of appropriate seagoing service as required by the Administration; or
4.2.2. approved seagoing service in the deck department of not less than three years;
4.3. meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;
4.4. have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages.
5. Every master serving on a seagoing ship of less than 500 gross tonnage engaged on near-coastal voyages shall hold an appropriate certificate.
6. Every candidate for certification as master on a seagoing ship of less than 500 gross tonnage engaged on a near-coastal voyages shall:6.1.be not less than 20 years of age;6.2.have approved seagoing service of not less than 12 months as officer in charge of a navigational watch;6.3.have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages. 6.1. be not less than 20 years of age; 6.2. have approved seagoing service of not less than 12 months as officer in charge of a navigational watch; 6.3. have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages.
6.1. be not less than 20 years of age;
6.2. have approved seagoing service of not less than 12 months as officer in charge of a navigational watch;
6.3. have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages.
6.1. be not less than 20 years of age;
6.2. have approved seagoing service of not less than 12 months as officer in charge of a navigational watch;
6.3. have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages.
7. ExemptionsThe Administration, if it considers that a ship’s size and the conditions of its voyage are such as to render the application of the full requirements of this regulation and Section A-II/3 of the STCW Code unreasonable or impracticable, may to that extent exempt the master and the officer in charge of a navigational watch on such a ship or class of ships from some of the requirements, bearing in mind the safety of all ships which may be operating in the same waters.
1. Every rating forming part of a navigational watch on a seagoing ship of 500 gross tonnage or more, other than ratings under training and ratings whose duties while on watch are of an unskilled nature, shall be duly certificated to perform such duties.
2. Every candidate for certification shall:2.1.be not less than 16 years of age;2.2.have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;2.3.meet the standard of competence specified in Section A-II/4 of the STCW Code. 2.1. be not less than 16 years of age; 2.2. have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.2.1. approved seagoing service including not less than six months training and experience; or 2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.3. meet the standard of competence specified in Section A-II/4 of the STCW Code.
2.1. be not less than 16 years of age;
2.2. have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.2.1. approved seagoing service including not less than six months training and experience; or 2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. approved seagoing service including not less than six months training and experience; or
2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.3. meet the standard of competence specified in Section A-II/4 of the STCW Code.
2.1. be not less than 16 years of age;
2.2. have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.2.1. approved seagoing service including not less than six months training and experience; or 2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. approved seagoing service including not less than six months training and experience; or
2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. approved seagoing service including not less than six months training and experience; or
2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.3. meet the standard of competence specified in Section A-II/4 of the STCW Code.
3. The seagoing service, training and experience required by points 2.2.1 and 2.2.2 shall be associated with navigational watchkeeping functions and involve the performance of duties carried out under the direct supervision of the master, the officer in charge of the navigational watch or a qualified rating.
4. Seafarers may be considered by a Member State to have met the requirements of this regulation if they have served in a relevant capacity in the deck department for a period of not less than one year within the last five preceding the entry into force of the STCW Convention for that Member State.
1. Every officer in charge of an engineering watch in a manned engine-room or designated duty engineer officer in a periodically unmanned engine-room on a seagoing ship powered by main propulsion machinery of 750 kW propulsion power or more shall hold an appropriate certificate.
2. Every candidate for certification shall:2.1.be not less than 18 years of age;2.2.have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code;2.3.have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code. 2.1. be not less than 18 years of age; 2.2. have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code; 2.3. have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code.
2.1. be not less than 18 years of age;
2.2. have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code;
2.3. have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code.
2.1. be not less than 18 years of age;
2.2. have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code;
2.3. have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code.
1. Every chief engineer officer and second engineer officer on a seagoing ship powered by main propulsion machinery of 3 000 kW propulsion power or more shall hold an appropriate certificate.
2. Every candidate for certification shall:2.1.meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;2.2.have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code. 2.1. meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; 2.1.1. for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and 2.1.2. for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; 2.2. have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code.
2.1. meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; 2.1.1. for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and 2.1.2. for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.1.1. for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.2. have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code.
2.1. meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; 2.1.1. for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and 2.1.2. for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.1.1. for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.1.1. for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.2. have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code.
1. Every chief engineer officer and second engineer officer on a seagoing ship powered by main propulsion machinery of between 750 and 3 000 kW propulsion power shall hold an appropriate certificate.
2. Every candidate for certification shall:2.1.meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;2.2.have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code. 2.1. meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; 2.1.1. for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and 2.1.2. for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; 2.2. have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code.
2.1. meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; 2.1.1. for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and 2.1.2. for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.1.1. for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.2. have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code.
2.1. meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; 2.1.1. for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and 2.1.2. for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.1.1. for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.1.1. for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.2. have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code.
3. Every engineer officer who is qualified to serve as second engineer officer on ships powered by main propulsion machinery of 3 000 kW propulsion power or more, may serve as chief engineer officer on ships powered by main propulsion machinery of less than 3 000 kW propulsion power, provided that not less than 12 months approved seagoing service shall have been served as an engineer officer in a position of responsibility and the certificate is so endorsed.
1. Every rating forming part of an engine-room watch or designated to perform duties in a periodically unmanned engine-room on a seagoing ship powered by main propulsion machinery of 750 kW propulsion power or more, other than ratings under training and ratings whose duties are of an unskilled nature, shall be duly certificated to perform such duties.
2. Every candidate for certification shall:2.1.be not less than 16 years of age;2.2.have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;2.3.meet the standard of competence specified in Section A-III/4 of the STCW Code. 2.1. be not less than 16 years of age; 2.2. have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.2.1. approved seagoing service including not less than six months training and experience; or 2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.3. meet the standard of competence specified in Section A-III/4 of the STCW Code.
2.1. be not less than 16 years of age;
2.2. have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.2.1. approved seagoing service including not less than six months training and experience; or 2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. approved seagoing service including not less than six months training and experience; or
2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.3. meet the standard of competence specified in Section A-III/4 of the STCW Code.
2.1. be not less than 16 years of age;
2.2. have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; 2.2.1. approved seagoing service including not less than six months training and experience; or 2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. approved seagoing service including not less than six months training and experience; or
2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. approved seagoing service including not less than six months training and experience; or
2.2.2. special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.3. meet the standard of competence specified in Section A-III/4 of the STCW Code.
3. The seagoing service, training and experience required by points 2.2.1 and 2.2.2 shall be associated with engine-room watchkeeping functions and involve the performance of duties carried out under the direct supervision of a qualified engineer officer or a qualified rating.
4. Seafarers may be considered by a Member State to have met the requirements of this regulation if they have served in a relevant capacity in the engine department for a period of not less than one year within the last five years preceding the entry into force of the STCW Convention for that Member State.
1. Except as provided in point 2, the provisions of this chapter apply to radio personnel on ships operating in the global maritime distress and safety system (GMDSS) as prescribed by the SOLAS 74, as amended.
2. Radio personnel on ships not required to comply with the provisions of the GMDSS in Chapter IV of the SOLAS 74 are not required to meet the provisions of this chapter. Radio personnel on these ships are, nevertheless, required to comply with the Radio Regulations. The Administration shall ensure that the appropriate certificates as prescribed by the Radio Regulations are issued to or recognised in respect of such radio personnel.
1. Every person in charge of or performing radio duties on a ship required to participate in the GMDSS shall hold an appropriate certificate related to the GMDSS, issued or recognised by the Administration under the provisions of the Radio Regulations.
2. In addition, every candidate for certification under this regulation for service on a ship which is required by the SOLAS 74, as amended, to have a radio installation shall:2.1.be not less than 18 years of age; and2.2.have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code. 2.1. be not less than 18 years of age; and 2.2. have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code.
2.1. be not less than 18 years of age; and
2.2. have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code.
2.1. be not less than 18 years of age; and
2.2. have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code.
1. Officers and ratings assigned specific duties and responsibilities relating to cargo or cargo equipment on tankers shall have completed an approved shore-based firefighting course in addition to the training required by Regulation VI/1 and shall have completed:1.1.at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or1.2.an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided:1.3.the period so accepted is not less than one month;1.4.the tanker is of less than 3 000 gross tonnage;1.5.the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours;1.6.the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired. 1.1. at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or 1.2. an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided: 1.3. the period so accepted is not less than one month; 1.4. the tanker is of less than 3 000 gross tonnage; 1.5. the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours; 1.6. the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired.
1.1. at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or
1.2. an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided:
1.3. the period so accepted is not less than one month;
1.4. the tanker is of less than 3 000 gross tonnage;
1.5. the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours;
1.6. the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired.
1.1. at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or
1.2. an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided:
1.3. the period so accepted is not less than one month;
1.4. the tanker is of less than 3 000 gross tonnage;
1.5. the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours;
1.6. the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired.
2. Masters, chief engineer officers, chief mates, second engineer officers and any person with immediate responsibility for loading, discharging and care in transit or handling of cargo shall, in addition to meeting the requirements of point 1.1 or 1.2, have:2.1.experience appropriate to their duties on the type of tanker on which they serve; and2.2.completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve. 2.1. experience appropriate to their duties on the type of tanker on which they serve; and 2.2. completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve.
2.1. experience appropriate to their duties on the type of tanker on which they serve; and
2.2. completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve.
2.1. experience appropriate to their duties on the type of tanker on which they serve; and
2.2. completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve.
3. Within two years after the entry into force of the STCW Convention for a Member State, seafarers may be considered to have met the requirements of point 2.2 if they have served in a relevant capacity on board the type of tanker concerned for a period of not less than one year within the preceding five years.
4. Administrations shall ensure that an appropriate certificate is issued to masters and officers, who are qualified in accordance with points 1 or 2 as appropriate, or that an existing certificate is duly endorsed. Every rating who is so qualified shall be duly certificated.
1. This Regulation applies to masters, officers, ratings and other personnel serving on board ro-ro passenger ships engaged on international voyages. Administrations shall determine the applicability of these requirements to personnel serving on ro-ro passenger ships engaged on domestic voyages.
2. Prior to being assigned shipboard duties on board ro-ro passenger ships, seafarers shall have completed the training required by points 4 to 8 in accordance with their capacities, duties and responsibilities.
3. Seafarers who are required to be trained in accordance with points 4, 7 and 8 shall at intervals not exceeding five years undertake appropriate refresher training or be required to provide evidence of having achieved the required standard of competence within the previous five years.
4. Masters, officers and other personnel designated on muster lists to assist passengers in emergency situations on board ro-ro passenger ships shall have completed training in crowd management as specified in Section A-V/2, paragraph 1, of the STCW Code.
5. Masters, officers and other personnel assigned specific duties and responsibilities on board ro-ro passenger ships shall have completed the familiarisation training specified in Section A-V/2, paragraph 2, of the STCW Code.
6. Personnel providing direct service to passengers in passenger spaces on board ro-ro passenger ships shall have completed the safety training specified in Section A-V/2, paragraph 3, of the STCW Code.
7. Masters, chief mates, chief engineer officers, second engineer officers and every person assigned immediate responsibility for embarking and disembarking passengers, loading, discharging or securing cargo, or closing hull openings on board ro-ro passenger ships shall have completed approved training in passenger safety, cargo safety and hull integrity as specified in Section A-V/2, paragraph 4, of the STCW Code.
8. Masters, chief mates, chief engineer officers, second engineer officers and any person having responsibility for the safety of passengers in emergency situations on board ro-ro passenger ships shall have completed approved training in crisis management and human behaviour as specified in Section A-V/2, paragraph 5, of the STCW Code.
9. Administrations shall ensure that documentary evidence of the training which has been completed is issued to every person found qualified under the provisions of this Regulation.
1. This Regulation applies to masters, officers, ratings and other personnel serving on board passenger ships, other than ro-ro passenger ships, engaged on international voyages. Administrations shall determine the applicability of these requirements to personnel serving on passenger ships engaged on domestic voyages.
2. Prior to being assigned shipboard duties on board passenger ships, seafarers shall have completed the training required by points 4 to 8 in accordance with their capacity, duties and responsibilities.
3. Seafarers who are required to be trained in accordance with points 4, 7 and 8 shall, at intervals not exceeding five years, undertake appropriate refresher training or be required to provide evidence of having achieved the required standard of competence within the previous five years.
4. Personnel designated on muster lists to assist passengers in emergency situations on board passenger ships shall have completed training in crowd management as specified in Section A-V/3, paragraph 1, of the STCW Code.
5. Masters, officers and other personnel assigned specific duties and responsibilities on board passenger ships shall have completed the familiarisation training specified in Section A-V/3, paragraph 2, of the STCW Code.
6. Personnel providing direct service to passengers on board passenger ships in passenger spaces shall have completed the safety training specified in Section A-V/3, paragraph 3, of the STCW Code.
7. Masters, chief mates and every person assigned immediate responsibility for embarking and disembarking passengers shall have completed approved training in passenger safety as specified in Section A-V/3, paragraph 4, of the STCW Code.
8. Masters, chief mates, chief engineer officers, second engineer officers and any person having responsibility for the safety of passengers in emergency situations on board passenger ships shall have completed approved training in crisis management and human behaviour as specified in Section A-V/3, paragraph 5, of the STCW Code.
9. Administrations shall ensure that documentary evidence of the training which has been completed is issued for every person found qualified under the provisions of this Regulation.
1. Every candidate for a certificate of proficiency in survival craft and rescue boats other than fast rescue boats shall:1.1.be not less than 18 years of age;1.2.have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months;1.3.meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code. 1.1. be not less than 18 years of age; 1.2. have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months; 1.3. meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code.
1.1. be not less than 18 years of age;
1.2. have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months;
1.3. meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code.
1.1. be not less than 18 years of age;
1.2. have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months;
1.3. meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code.
2. Every candidate for a certificate of proficiency in fast rescue boats shall:2.1.be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats;2.2.have attended an approved training course;2.3.meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code. 2.1. be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats; 2.2. have attended an approved training course; 2.3. meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code.
2.1. be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats;
2.2. have attended an approved training course;
2.3. meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code.
2.1. be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats;
2.2. have attended an approved training course;
2.3. meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code.
1. Seafarers designated to control firefighting operations shall have successfully completed advanced training in techniques for fighting fire with particular emphasis on organisation, tactics and command in accordance with the provisions of Section A-VI/3 of the STCW Code and shall meet the standard of competence specified therein.
2. Where training in advanced firefighting is not included in the qualifications for the certificate to be issued, a special certificate or documentary evidence, as appropriate, shall be issued indicating that the holder has attended a course of training in advanced firefighting.
1. Seafarers designated to provide medical first aid on board ship shall meet the standard of competence in medical first aid specified in Section A-VI/4, paragraphs 1, 2 and 3, of the STCW Code.
2. Seafarers designated to take charge of medical care on board ship shall meet the standard of competence in medical care on board ships specified in Section A-VI/4, paragraphs 4, 5 and 6, of the STCW Code.
3. Where training in medical first aid or medical care is not included in the qualifications for the certificate to be issued, a special certificate or documentary evidence, as appropriate, shall be issued indicating that the holder has attended a course of training in medical first aid or in medical care.
1. Notwithstanding the requirements for certification laid down in Chapters II and III of this Annex, Member States may elect to issue or authorise the issue of certificates other than those mentioned in the regulations of those chapters, provided that:1.1.the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code;1.2.the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements;1.3.the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code;1.4.the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;1.5.the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code. 1.1. the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code; 1.2. the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements; 1.3. the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code; 1.4. the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations; 1.5. the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code.
1.1. the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code;
1.2. the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements;
1.3. the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code;
1.4. the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;
1.5. the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code.
1.1. the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code;
1.2. the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements;
1.3. the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code;
1.4. the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;
1.5. the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code.
2. No certificate shall be issued under this chapter unless the Member State has communicated the information required by the STCW Convention to the Commission.
1. A Member State which elects to issue or authorise the issue of alternative certificates shall ensure that the following principles are observed:1.1.no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters;1.2.any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters. 1.1. no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters; 1.2. any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters.
1.1. no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters;
1.2. any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters.
1.1. no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters;
1.2. any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters.
2. The principle of interchangeability in point 1 shall ensure that:2.1.seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation;2.2.seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere. 2.1. seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation; 2.2. seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere.
2.1. seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation;
2.2. seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere.
2.1. seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation;
2.2. seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere.
3. In issuing any certificate under the provisions of this chapter the following principles shall be taken into account:3.1.the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;3.2.the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification. 3.1. the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; 3.1.1. to reduce the number of crew on board; 3.1.2. to lower the integrity of the profession or ‘deskill’ seafarers; or 3.1.3. to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; 3.2. the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification.
3.1. the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; 3.1.1. to reduce the number of crew on board; 3.1.2. to lower the integrity of the profession or ‘deskill’ seafarers; or 3.1.3. to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.1.1. to reduce the number of crew on board;
3.1.2. to lower the integrity of the profession or ‘deskill’ seafarers; or
3.1.3. to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.2. the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification.
3.1. the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; 3.1.1. to reduce the number of crew on board; 3.1.2. to lower the integrity of the profession or ‘deskill’ seafarers; or 3.1.3. to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.1.1. to reduce the number of crew on board;
3.1.2. to lower the integrity of the profession or ‘deskill’ seafarers; or
3.1.3. to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.1.1. to reduce the number of crew on board;
3.1.2. to lower the integrity of the profession or ‘deskill’ seafarers; or
3.1.3. to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.2. the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification.
4. The principles contained in points 1 and 2 shall ensure that the competency of both deck and engineer officers is maintained.
1. The third country must be a Party to the STCW Convention.
2. The third country must have been identified by the Maritime Safety Committee as having demonstrated that full and complete effect is given to the provisions of the STCW Convention.
3. The Commission, assisted by the European Maritime Safety Agency and with the possible involvement of any Member State concerned, must have confirmed, through all necessary measures, which may include the inspection of facilities and procedures, that the requirements concerning the standard of competence, the issue and endorsement of certificates and record keeping are fully complied with, and that a quality standards system has been established pursuant to Regulation I/8 of the STCW Convention.
4. The Member State is in the process of agreeing an undertaking with the third country concerned that prompt notification will be given of any significant change in the arrangements for training and certification provided in accordance with the STCW Convention.
5. The Member State has introduced measures to ensure that seafarers who present for recognition certificates for functions at management level have an appropriate knowledge of the maritime legislation of the Member State relevant to the functions they are permitted to perform.
6. If a Member State wishes to supplement assessment of compliance of a third country by evaluating certain maritime training institutes, it shall proceed according to the provisions of section A-I/6 of the STCW Code.
Directive 2001/25/EC of the European Parliament and of the Council(OJ L 136, 18.5.2001, p. 17).
Directive 2002/84/EC of the European Parliament and of the Council(OJ L 324, 29.11.2002, p. 53). only Article 11
Directive 2003/103/EC of the European Parliament and of the Council(OJ L 326, 13.12.2003, p. 28).
Commission Directive 2005/23/EC(OJ L 62, 9.3.2005, p. 14).
Directive 2005/45/EC of the European Parliament and of the Council(OJ L 255, 30.9.2005, p. 160). only Article 4
Directive Deadline for transposition
2002/84/EC 23 November 2003
2003/103/EC 14 May 2005
2005/23/EC 29 September 2005
2005/45/EC 20 October 2007
Directive 2001/25/EC This Directive
Article 1 Article 1
Article 2, introductory words Article 2, introductory words
Article 2, first to fourth indent Article 2(a) to (d)
Articles 3 to 7 Articles 3 to 7
Article 7a Article 8
Article 8 Article 9
Article 9(1) introductory wording Article 10(1) first subparagraph introductory wording
Article 9(1)(a) and (b) Article 10(1) first subparagraph (a) and (b)
Article 9(1)(c) first sentence Article 10(1) first subparagraph (c)
Article 9(1)(c) second sentence Article 10(1) second subparagraph
Article 9(1)(d) Article 10(1) first subparagraph (d)
Article 9(2) and (3) Article 10(2) and (3)
Article 10 Article 11
Article 11 Article 12
Article 12 Article 13
Article 13 Article 14
Article 14 Article 15
Article 15 Article 16
Article 16(1), introductory phrase Article 17(1), introductory phrase
Article 16(1), first indent to fourth indent Article 17(1)(a) to (d)
Article 16(2), introductory wording Article 17(2), introductory wording
Article 16(2)(a)(1) and (2) Article 17(2)(a)(i) and (ii)
Article 16(2)(b) and (c) Article 17(2)(b) and (c)
Article 16(2)(d)(1) and (2) Article 17(2)(d)(i) and (ii)
Article 16(2)(d)(3)(i) and (ii) Article 17(2)(d)(iii), first and second indent
Article 16(2)(e) Article 17(2)(e)
Article 16(2)(f)(1) to (5) Article 17(2)(f)(i) to (v)
Article 16(2)(g) Article 17(2)(g)
Article 17 Article 18
Article 18(1) and (2) –
Article 18(3), introductory phrase Article 19(1)
Article 18(3)(a) Article 19(2)
Article 18(3)(b) Article 19(3), first subparagraph
Article 18(3)(c) Article 19(3), second subparagraph
Article 18(3)(d) Article 19(4)
Article 18(3)(e) Article 19(5)
Article 18(3)(f) Article 19(6)
Article 18(4) Article 19(7)
Article 18a(1), first and second sentence Article 20(1), first and second subparagraph
Article 18a(2), first and second sentence Article 20(2), first and second subparagraph
Article 18a(3) to (5) Article 20(3) to (5)
Article 18a(6), first and second sentence Article 20(6), first and second subparagraph
Article 18a(7) Article 20(7)
Article 18b Article 21
Article 19 Article 22
Article 20(1), introductory words Article 23(1), introductory words
Article 20(1), first and second indent Article 23(1)(a) and (b)
Article 20(2), introductory words Article 23(2), introductory words
Article 20(2), first to sixth indent Article 23(2)(a) to (f)
Article 20(3) Article 23(3)
Article 21 Article 24
Article 21a Article 25
– Article 26(1)
Article 21b, first sentence Article 26(2), first subparagraph
Article 21b, second sentence Article 26(2), second subparagraph
Article 22(1), first sentence Article 27(1), first subparagraph
Article 22(1) second sentence Article 27(1), second subparagraph
– Article 27(1), third subparagraph
Article 22(3) and (4) Article 27(2) and (3)
Article 23(1) and (2) Article 28(1) and (2)
– Article 28(3)
Article 23(3) –
Article 24(1) and (2) –
Article 24(3)(1) and (2) Article 29(a) and (b)
Article 25 Article 30
Article 26, first sentence Article 31, first paragraph
Article 26, second sentence Article 31, second paragraph
Article 27 Article 32
Article 28 Article 33
Article 29 Article 34
Annexes I and II Annexes I and II
Annex III –
Annex IV –
– Annex III
– Annex IV
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
(1) Directive 2001/25/EC of the European Parliament and of the Council of 4 April 2001 on the minimum level of training of seafarers(3)has been significantly amended on several occasions(4). Now that new amendments are being made to that Directive, it is desirable, for reasons of clarity, that the provisions in question should be recast.
(2) Actions to be taken at Community level in the field of maritime safety and pollution prevention at sea should be in line with internationally agreed rules and standards.
(3) In order to maintain and develop the level of knowledge and skills in the maritime sector in the Community, it is important to pay appropriate attention to maritime training and the status of seafarers in the Community.
(4) A consistent level of training for the award of vocational competency certificates to seafarers should be ensured in the interests of maritime safety.
(5) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications(5)applies to maritime occupations covered by this Directive. It will help promote compliance with the obligations laid down in the Treaty abolishing obstacles to the free movement of persons and services between Member States.
(6) The mutual recognition of diplomas and certificates provided for under Directive 2005/36/EC does not always ensure a standardised level of training for all seafarers serving on board vessels flying the flag of a Member State. This is, however, vital from the viewpoint of maritime safety.
(7) It is therefore essential to define a minimum level of training for seafarers in the Community. That level should be based on the standards of training already agreed at international level, namely the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978 (STCW Convention), as revised in 1995. All Member States are Parties to that Convention.
(8) Member States may establish standards higher than the minimum standards laid down in the STCW Convention and this Directive.
(9) The Regulations of the STCW Convention annexed to this Directive should be supplemented by the mandatory provisions contained in Part A of the Seafarers’ Training, Certification and Watchkeeping Code (STCW Code). Part B of the STCW Code contains recommended guidance intended to assist Parties to the STCW Convention and those involved in implementing, applying or enforcing its measures to give the Convention full and complete effect in a uniform manner.
(10) For the enhancement of maritime safety and pollution prevention at sea, provisions on minimum rest periods for watchkeeping personnel should be established in this Directive in accordance with the STCW Convention. Those provisions should be applied without prejudice to the provisions of Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners’ Association (ECSA) and the Federation of Transport Workers’ Unions in the European Union (FST)(6).
(11) Member States should take and enforce specific measures to prevent and penalise fraudulent practices associated with certificates of competency as well as pursue their efforts within the IMO to achieve strict and enforceable agreements on the worldwide combating of such practices.
(12) In order to enhance maritime safety and prevent loss of human life and maritime pollution, communication among crew members on board ships sailing in Community waters should be improved.
(13) Personnel on board passenger ships nominated to assist passengers in emergency situations should be able to communicate with the passengers.
(14) Crews serving on board tankers carrying noxious or polluting cargo should be capable of coping effectively with accident prevention and emergency situations. It is paramount that a proper communication link between the master, officers and ratings is established, covering the requirements provided for in this Directive.
(15) It is essential to ensure that seafarers holding certificates issued by third countries and serving on board Community ships have a level of competence equivalent to that required by the STCW Convention. This Directive should lay down procedures and common criteria for the recognition by the Member States of certificates issued by third countries, based on the training and certification requirements as agreed in the framework of the STCW Convention.
(16) In the interests of safety at sea, Member States should recognise qualifications proving the required level of training only where these are issued by or on behalf of Parties to the STCW Convention which have been identified by the IMO Maritime Safety Committee (MSC) as having been shown to have given, and still to be giving, full effect to the standards set out in that Convention. To bridge the time gap until the MSC has been able to carry out such identification, a procedure for the preliminary recognition of certificates is needed.
(17) Where appropriate, maritime institutes, training programmes and courses should be inspected. Criteria for such inspection should therefore be established.
(18) The Commission should be assisted by a committee in carrying out the tasks related to the recognition of certificates issued by training institutes or administrations of third countries.
(19) The European Maritime Safety Agency established by Regulation (EC) No 1406/2002 of the European Parliament and of the Council(7)should assist the Commission in verifying that Member States comply with the requirements laid down in this Directive.
(20) Member States, as port authorities, are required to enhance safety and prevention of pollution in Community waters through priority inspection of vessels flying the flag of a third country which has not ratified the STCW Convention, thereby ensuring no more favourable treatment to vessels flying the flag of a third country.
(21) It is appropriate to include in this Directive provisions on port State control, pending the amendment of Council Directive 95/21/EC(8)on port State control of shipping in order to transfer to that Directive the provisions on port State control which are included in this Directive.
(22) It is necessary to provide for procedures for adapting this Directive to changes in international conventions and codes.
(23) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).
(24) In particular the Commission should be empowered to amend this Directive in order to apply, for the purposes of this Directive, subsequent amendments to certain international codes and any relevant amendment to Community legislation. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(25) The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.
(26) This Directive should be without prejudice to the obligations of the Members States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Definitions
Article 1
For the purposes of this Directive:
1.
‘master’ means the person having command of a ship;
2.
‘officer’ means a member of the crew, other than the master, designated as such by national law or regulations or, in the absence of such designation, by collective agreement or custom;
3.
‘deck officer’ means an officer qualified in accordance with the provisions of Chapter II of Annex I;
4.
‘chief mate’ means the officer next in rank to the master upon whom the command of the ship will fall in the event of the incapacity of the master;
5.
‘engineer officer’ means an officer qualified in accordance with the provisions of Chapter III of Annex I;
6.
‘chief engineer officer’ means the senior engineer officer responsible for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship;
7.
‘second engineer officer’ means the engineer officer next in rank to the chief engineer officer upon whom the responsibility for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship will fall in the event of the incapacity of the chief engineer officer;
8.
‘assistant engineer officer’ means a person under training to become an engineer officer and designated as such by national law or regulations;
9.
‘radio operator’ means a person holding an appropriate certificate issued or recognised by the competent authorities under the provisions of the Radio Regulations;
10.
‘rating’ means a member of the ship’s crew other than the master or an officer;
11.
‘seagoing ship’ means a ship other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply;
12.
‘ship flying the flag of a Member State’ means a ship registered in and flying the flag of a Member State in accordance with its legislation; a ship not corresponding to this definition shall be regarded as a ship flying the flag of a third country;
13.
‘near-coastal voyages’ means voyages in the vicinity of a Member State as defined by that Member State;
14.
‘propulsion power’ means the total maximum continuous rated output power in kilowatts of all of a ship’s main propulsion machinery which appears on the ship’s certificate of registry or other official document;
15.
‘oil-tanker’ means a ship constructed and used for the carriage of petroleum and petroleum products in bulk;
16.
‘chemical tanker’ means a ship constructed or adapted and used for the carriage in bulk of any liquid product listed in Chapter 17 of the International Bulk Chemical Code, in its up-to-date version;
17.
‘liquefied-gas tanker’ means a ship constructed or adapted and used for the carriage in bulk of any liquefied gas or other product listed in Chapter 19 of the International Gas Carrier Code, in its up-to-date version;
18.
‘Radio Regulations’ means the revised radio regulations, adopted by the World Administrative Radio Conference for the Mobile Service in their up-to-date version;
19.
‘passenger ship’ means a seagoing ship which carries more than 12 passengers;
20.
‘fishing vessel’ shall mean a vessel used for catching fish or other living resources of the sea;
21.
‘STCW Convention’ means the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as it applies to the matters concerned taking into account the transitional provisions of Article VII and Regulation I/15 of the Convention and including, where appropriate, the applicable provisions of the STCW Code, all being applied in their up-to-date versions;
22.
‘radio duties’ includes, as appropriate, watchkeeping and technical maintenance and repairs conducted in accordance with the Radio Regulations, the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74) and, at the discretion of each Member State, the relevant recommendations of the IMO, in their up-to-date versions;
23.
‘ro-ro passenger ship’ means a passenger ship with ro-ro cargo spaces or special-category spaces as defined in the SOLAS 74, in its up-to-date version;
24.
‘STCW Code’ means the Seafarers’ Training, Certification and Watchkeeping (STCW) Code as adopted by Resolution 2 of the 1995 STCW Conference of Parties, in its up-to-date version;
25.
‘function’ means a group of tasks, duties and responsibilities, as specified in the STCW Code, necessary for ship operation, safety of life at sea or protection of the marine environment;
26.
‘company’ means the owner of the ship or any other organisation or person such as the manager or the bareboat charterer who has assumed the responsibility for operation of the ship from the shipowner and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed on the company by this Directive;
27.
‘appropriate certificate’ means a certificate issued and endorsed in accordance with this Directive and entitling the lawful holder thereof to serve in the capacity and perform the functions involved at the level of responsibility specified therein on a ship of the type, tonnage, power and means of propulsion concerned while engaged on the particular voyage concerned;
28.
‘seagoing service’ means service on board a ship relevant to the issue of a certificate or other qualification;
29.
‘approved’ means approved by a Member State in accordance with this Directive;
30.
‘third country’ means any country which is not a Member State;
31.
‘month’ means a calendar month or 30 days made up of periods of less than one month.

Scope
Article 2
This Directive shall apply to the seafarers mentioned in this Directive serving on board seagoing ships flying the flag of a Member State with the exception of:
(a)
warships, naval auxiliaries or other ships owned or operated by a Member State and engaged only on government non-commercial service;
(b)
fishing vessels;
(c)
pleasure yachts not engaged in trade;
(d)
wooden ships of primitive build.

Training and certification
Article 3
1. Member States shall take the measures necessary to ensure that seafarers serving on ships as referred to in Article 2 are trained as a minimum in accordance with the requirements of the STCW Convention, as laid down in Annex I to this Directive, and hold certificates as defined in Article 4 or appropriate certificates as defined in Article 1(27).
2. Member States shall take the measures necessary to ensure that those crew members that must be certified in accordance with Regulation III/10.4 of the SOLAS 74 are trained and certificated in accordance with this Directive.

Certificate
Article 4
A certificate shall be any valid document, by whatever name it may be known, issued by or under the authority of the competent authority of a Member State in accordance with Article 5 and with the requirements laid down in Annex I.

Certificates and endorsements
Article 5
1. Certificates shall be issued in accordance with Article 11.
2. Certificates for masters, officers and radio operators shall be endorsed by the Member State as prescribed in this Article.
3. Certificates shall be issued in accordance with Regulation I/2, paragraph 1, of the STCW Convention.
4. In respect of radio operators, Member States may:
(a)
include the additional knowledge required by the relevant regulations in the examination for the issue of a certificate complying with the Radio Regulations; or
(b)
issue a separate certificate indicating that the holder has the additional knowledge required by the relevant regulations.
5. At the discretion of a Member State endorsements may be incorporated in the format of the certificates being issued as provided for in section A-I/2 of the STCW Code. If so incorporated the form used shall be that set out in section A-I/2, paragraph 1. If issued otherwise, the form of endorsements used shall be that set out in paragraph 2 of that section. Endorsements shall be issued in accordance with Article VI, paragraph 2, of the STCW Convention.
6. A Member State which recognises a certificate under the procedure laid down in Article 19(2) shall endorse that certificate to attest its recognition. The form of the endorsement used shall be that set out in paragraph 3 of section A-I/2 of the STCW Code.
7. The endorsements referred to in paragraphs 5 and 6:
(a)
may be issued as separate documents;
(b)
shall each be assigned a unique number, other than endorsements attesting the issue of a certificate which may be assigned the same number as the certificate concerned, provided that that number is unique; and
(c)
shall each expire as soon as the certificate endorsed expires or is withdrawn, suspended or cancelled by the Member State or third country which issued them and, in any case, within five years of their date of issue.
8. The capacity in which the holder of a certificate is authorised to serve shall be identified in the form of endorsement in terms identical to those used in the applicable safe-manning requirements of the Member State concerned.
9. A Member State may use a format different from the format laid down in section A-I/2 of the STCW Code, provided that, as a minimum, the required information is provided in Roman characters and Arabic figures, taking account of the variations permitted under section A-I/2.
10. Subject to Article 19(7) any certificate required by this Directive shall be kept available in its original form on board the ship on which the holder is serving.

Training requirements
Article 6
The training required pursuant to Article 3 shall be in a form appropriate to the theoretical knowledge and practical skills required by Annex I, in particular the use of life saving and fire-fighting equipment, and approved by the competent authority or body designated by each Member State.

Principles governing near-coastal voyages
Article 7
1. When defining near-coastal voyages Member States shall not impose training, experience or certification requirements on seafarers serving on board ships entitled to fly the flag of another Member State or another Party to the STCW Convention and engaged in such voyages in a manner resulting in more stringent requirements for such seafarers than for seafarers serving on board ships entitled to fly their own flag. In no case shall a Member State impose requirements in respect of seafarers serving on board ships flying the flag of another Member State or of another Party to the STCW Convention in excess of those of this Directive in respect of ships not engaged in near-coastal voyages.
2. With respect to ships entitled to fly the flag of a Member State regularly engaged in near-coastal voyages off the coast of another Member State or of another Party to the STCW Convention, the Member State the flag of which a ship is entitled to fly shall prescribe training, experience and certification requirements for seafarers serving on such ships at least equal to those of the Member State or the Party to the STCW Convention off the coast of which the ship is engaged, provided that they do not exceed the requirements of this Directive in respect of ships not engaged in near-coastal voyages. Seafarers serving on a ship which extends its voyage beyond what is defined as a near-coastal voyage by a Member State and enters waters not covered by that definition shall fulfil the appropriate requirements of this Directive.
3. A Member State may afford a ship which is entitled to fly its flag the benefits of the near-coastal voyage provisions of this Directive when it is regularly engaged off the coast of a non-Party to the STCW Convention on near-coastal voyages as defined by that Member State.
4. Upon deciding on the definition of near-coastal voyages and the conditions of education and training required thereof in accordance with the requirements of paragraphs 1, 2 and 3, Member States shall communicate to the Commission the details of the provisions they have adopted.

Prevention of fraud and other unlawful practices
Article 8
1. Member States shall take and enforce the appropriate measures to prevent fraud and other unlawful practices involving the certification process or certificates issued and endorsed by their competent authorities, and shall provide for penalties that are effective, proportionate and dissuasive.
2. Member States shall designate the national authorities competent to detect and combat fraud and other unlawful practices and exchange information with the competent authorities of other Member States and of third countries concerning the certification of seafarers.
Member States shall forthwith inform the other Member States and the Commission of the details of such competent national authorities.
Member States shall also forthwith inform any third countries with which they have entered into an undertaking in accordance with Regulation I/10, paragraph 1.2 of the STCW Convention of the details of such competent national authorities.
3. At the request of a host Member State, the competent authorities of another Member State shall provide written confirmation or denial of the authenticity of seafarers’ certificates, corresponding endorsements or any other documentary evidence of training issued in that other Member State.

Penalties or disciplinary measures
Article 9
1. Member States shall establish processes and procedures for the impartial investigation of any reported incompetence, act or omission, that may pose a direct threat to safety of life or property at sea or to the marine environment, on the part of the holders of certificates or endorsements issued by that Member State in connection with their performance of duties relating to their certificates and for the withdrawal, suspension and cancellation of such certificates for such cause and for the prevention of fraud.
2. Each Member State shall prescribe penalties or disciplinary measures for cases in which the provisions of this national legislation giving effect to this Directive are not complied with in respect of ships entitled to fly its flag or of seafarers duly certificated by it.
3. In particular, such penalties or disciplinary measures shall be prescribed and enforced in cases in which:
(a)
a company or a master has engaged a person not holding a certificate as required by this Directive;
(b)
a master has allowed any function or service in any capacity which under this Directive must be performed by a person holding an appropriate certificate to be performed by a person not holding the required certificate, a valid dispensation or having the documentary proof required by Article 19(7); or
(c)
a person has obtained by fraud or forged documents an engagement to perform any function or serve in any capacity which under this Directive must be performed or fulfilled by a person holding a certificate or dispensation.
4. Member States within the jurisdiction of which any company which or any person who is believed on clear grounds to have been responsible for or to have knowledge of any apparent non-compliance with this Directive specified in paragraph 3, is located shall extend cooperation to any Member State or other Party to the STCW Convention which advises them of its intention to initiate proceedings under its jurisdiction.

Quality standards
Article 10
1. Each Member State shall ensure that:
(a)
all training, assessment of competence, certification, endorsement and revalidation activities carried out by non-governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives, including those concerning the qualifications and experience of instructors and assessors;
(b)
where governmental agencies or entities perform such activities, there is a quality-standards system;
(c)
the education and training objectives and related quality standards of competence to be achieved are clearly defined and identify the levels of knowledge, understanding and skills appropriate to the examinations and assessments required under the STCW Convention;
(d)
the fields of application of the quality standards cover the administration of the certification systems, all training courses and programmes, examinations and assessments carried out by or under the authority of each Member State and the qualifications and experience required of instructors and assessors, having regard to the policies, systems, controls and internal quality-assurance reviews established to ensure achievement of the defined objectives.
The objectives and related quality standards referred to in point (c) of the first subparagraph may be specified separately for different courses and training programmes and shall cover the administration of the certification system.
2. Member States shall also ensure that independent evaluations of the knowledge, understanding, skills and competence acquisition and assessment activities, and of the administration of the certification system, are conducted at intervals of not more than five years by qualified persons who are not themselves involved in the activities concerned in order to verify that:
(a)
all internal management control and monitoring measures and follow-up actions comply with planned arrangements and documental procedures and are effective in ensuring that the defined objectives are achieved;
(b)
the results of each independent evaluation are documented and brought to the attention of those responsible for the area evaluated;
(c)
timely action is taken to correct deficiencies.
3. A report relating to each evaluation carried out pursuant to paragraph 2 shall be communicated by the Member State concerned to the Commission within six months of the date of the evaluation.

Medical standards — issue and registration of certificates
Article 11
1. Member States shall establish standards of medical fitness for seafarers, particularly regarding eyesight and hearing.
2. Member States shall ensure that certificates are issued only to candidates who comply with the requirements of this Article.
3. Each candidate for certification shall provide satisfactory proof:
(a)
of his or her identity;
(b)
that his or her age is not less than that prescribed in the Regulations in Annex I relevant to the certificate applied for;
(c)
that he or she meets the standards of medical fitness, particularly regarding eyesight and hearing, established by the Member State and holds a valid document attesting to his or her medical fitness, issued by a duly qualified medical practitioner recognised by the competent authority of the Member State;
(d)
of having completed the seagoing service and any related compulsory training prescribed in the Regulations in Annex I for the certificate applied for;
(e)
that he or she meets the standards of competence prescribed in the Regulations in Annex I for the capacities, functions and levels that are to be identified in the endorsement to the certificate.
4. Each Member State shall undertake:
(a)
to maintain a register or registers of all certificates and endorsements for masters and officers and, as appropriate, ratings, which are issued, have expired or have been revalidated, suspended, cancelled or reported lost or destroyed and of dispensations issued;
(b)
to make available information on the status of such certificates, endorsements and dispensations to other Member States or other Parties to the STCW Convention and companies which request verification of the authenticity and validity of certificates produced to them by seafarers seeking recognition of their certificates or employment on board ship.

Revalidation of certificates
Article 12
1. Every master, officer and radio operator holding a certificate issued or recognised under any chapter of Annex I other than Chapter VI who is serving at sea or intends to return to sea after a period ashore shall, in order to continue to qualify for seagoing service, be required at intervals not exceeding five years:
(a)
to meet the standards of medical fitness prescribed by Article 11; and
(b)
to establish continued professional competence in accordance with section A-I/11 of the STCW Code.
2. Every master, officer and radio operator shall, for continuing seagoing service on board ships for which special training requirements have been internationally agreed upon, successfully complete approved relevant training.
3. Each Member State shall compare the standards of competence which are required of candidates for certificates issued before 1 February 2002 with those specified for the appropriate certificate in Part A of the STCW Code, and shall determine the need to require the holders of such certificates to undergo appropriate refresher and updating training or assessment.
Refresher and updating courses shall be approved and include changes in relevant national and international regulations concerning the safety of life at sea and the protection of the marine environment and take account of any updating of the standard of competency concerned.
4. Each Member State shall, in consultation with those concerned, formulate or promote the formulation of a structure of refresher and updating courses as provided for in section A-I/11 of the STCW Code.
5. For the purpose of updating the knowledge of masters, officers and radio operators, each Member State shall ensure that the texts of recent changes in national and international regulations concerning the safety of life at sea and the protection of the marine environment are made available to ships entitled to fly its flag.

Use of simulators
Article 13
1. The performance standards and other provisions set out in section A-I/12 of the STCW Code and such other requirements as are prescribed in Part A of the STCW Code for any certificate concerned shall be complied with in respect of:
(a)
all mandatory simulator-based training;
(b)
any assessment of competence required by Part A of the STCW Code which is carried out by means of a simulator;
(c)
any demonstration, by means of a simulator, of continued proficiency required by Part A of the STCW Code.
2. Simulators installed or brought into use before 1 February 2002 may be exempted from full compliance with the performance standards referred to in paragraph 1 at the discretion of each Member State.

Responsibilities of companies
Article 14
1. In accordance with paragraphs 2 and 3 Member States shall hold companies responsible for the assignment of seafarers for service in their ships in accordance with this Directive, and shall require every company to ensure that:
(a)
each seafarer assigned to any of its ships holds an appropriate certificate in accordance with the provisions of this Directive and as established by the Member State;
(b)
its ships are manned in accordance with the applicable safe-manning requirements of the Member State;
(c)
documentation and data relevant to all seafarers employed on its ships are maintained and readily accessible, and include, without being limited to, documentation and data on their experience, training, medical fitness and competence in assigned duties;
(d)
on being assigned to any of its ships seafarers are familiarised with their specific duties and with all ship arrangements, installations, equipment, procedures, and ship characteristics that are relevant to their routine or emergency duties;
(e)
the ship’s complement can effectively coordinate their activities in an emergency situation and in performing functions vital to safety or to the prevention or mitigation of pollution.
2. Companies, masters and crew members shall each have responsibility for ensuring that the obligations set out in this Article are given full and complete effect and that such other measures as may be necessary are taken to ensure that each crew member can make a knowledgeable and informed contribution to the safe operation of the ship.
3. The company shall provide written instructions to the master of each ship to which this Directive applies, setting out the policies and the procedures to be followed to ensure that all seafarers who are newly employed on board the ship are given a reasonable opportunity to become familiar with the shipboard equipment, operating procedures and other arrangements needed for the proper performance of their duties, before being assigned to those duties. Such policies and procedures shall include:
(a)
the allocation of a reasonable period of time during which each newly employed seafarer will have an opportunity to become acquainted with:
(i)
the specific equipment the seafarer will be using or operating; and
(ii)
ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly;
(b)
the designation of a knowledgeable crew member who will be responsible for ensuring that each newly employed seafarer is given an opportunity to receive essential information in a language the seafarer understands.

Fitness for duty
Article 15
1. For the purpose of preventing fatigue, Member States shall establish and enforce rest periods for watchkeeping personnel and require that watch systems are arranged in such a way that the efficiency of watchkeeping personnel is not impaired by fatigue and that duties are organised in such a way that the first watch at the start of a voyage and subsequent relieving watches are sufficiently rested and otherwise fit for duty.
2. All persons who are assigned duty as officer in charge of a watch or as a rating forming part of a watch shall be allowed at least 10 hours of rest in any 24-hour period.
3. The hours of rest may be divided into no more than two periods, one of which shall be at least six hours long.
4. The requirements for rest periods laid down in paragraphs 1 and 2 need not be maintained in the event of an emergency or drill or in other overriding operational conditions.
5. Notwithstanding paragraphs 2 and 3, the minimum period of 10 hours may be reduced to not less than 6 consecutive hours provided that no such reduction shall extend beyond 2 days and at least 70 hours of rest are provided each 7-day period.
6. Member States shall require that watch schedules be posted where they are easily accessible.

Dispensation
Article 16
1. In circumstances of exceptional necessity, competent authorities may, if in their opinion this does not cause danger to persons, property or the environment, issue a dispensation permitting a specified seafarer to serve in a specified ship for a specified period not exceeding six months in a capacity, other than that of the radio operator, except as provided by the relevant Radio Regulations, for which he or she does not hold the appropriate certificate, provided that the person to whom the dispensation is issued shall be adequately qualified to fill the vacant post in a safe manner to the satisfaction of the competent authorities. However, dispensations shall not be granted to a master or chief engineer officer, except in circumstances of force majeure and then only for the shortest possible period.
2. Any dispensation granted for a post shall be granted only to a person properly certificated to fill the post immediately below. Where certification of the post below is not required, a dispensation may be issued to a person whose qualification and experience are, in the opinion of the competent authorities, of a clear equivalence to the requirements for the post to be filled, provided that, if such a person holds no appropriate certificate, he or she shall be required to pass a test accepted by the competent authorities as demonstrating that such a dispensation may safely be issued. In addition, the competent authorities shall ensure that the post in question is filled by the holder of an appropriate certificate as soon as possible.

Responsibilities of Member States with regard to training and assessment
Article 17
1. Member States shall designate the authorities or bodies which shall:
(a)
give the training referred to in Article 3;
(b)
organise and/or supervise the examinations where required;
(c)
issue the certificates of competence referred to in Article 11;
(d)
grant the dispensations provided for in Article 16.
2. Member States shall ensure that:
(a)
all training and assessment of seafarers is:
(i)
structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and
(ii)
conducted, monitored, evaluated and supported by persons qualified in accordance with points (d), (e) and (f);
(b)
persons conducting in-service training or assessment on board ship do so only when such training or assessment will not adversely affect the normal operation of the ship and they can dedicate their time and attention to training or assessment;
(c)
instructors, supervisors and assessors are appropriately qualified for the particular types and levels of training or assessment of competence of seafarers either on board or ashore;
(d)
any person conducting in-service training of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under this Directive:
(i)
has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted;
(ii)
is qualified in the task for which training is being conducted; and
(iii)
if conducting training using a simulator:
—
has received appropriate guidance in instructional techniques involving the use of simulators, and
—
has gained practical operational experience on the particular type of simulator being used;
(e)
any person responsible for the supervision of the in-service training of a seafarer intended to be used in qualifying for certification has a full understanding of the training programme and the specific objectives for each type of training being conducted;
(f)
any person conducting in-service assessment of the competence of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under this Directive:
(i)
has an appropriate level of knowledge and understanding of the competence to be assessed;
(ii)
is qualified in the task for which the assessment is being made;
(iii)
has received appropriate guidance in assessment methods and practice;
(iv)
has gained practical assessment experience; and
(v)
if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor;
(g)
when a Member State recognises a course of training, a training institution, or a qualification granted by a training institution, as part of its requirements for the issue of a certificate, the qualifications and experience of instructors and assessors are covered in the application of the quality standard provisions of Article 10; such qualification, experience and application of quality standards shall incorporate appropriate training in instructional techniques and training and assessment methods and practice and comply with all applicable requirements of points (d), (e) and (f).

On-board communication
Article 18
Member States shall ensure that:
(a)
without prejudice to points (b) and (d), there are at all times, on board all ships flying the flag of a Member State, means in place for effective oral communication relating to safety between all members of the ship’s crew, particularly with regard to the correct and timely reception and understanding of messages and instructions;
(b)
on board all passenger ships flying the flag of a Member State and on board all passenger ships starting and/or finishing a voyage in a Member State port, in order to ensure effective crew performance in safety matters, a working language is established and recorded in the ship’s log-book;
the company or the master, as appropriate, shall determine the appropriate working language; each seafarer shall be required to understand and, where appropriate, give orders and instructions and report back in that language;
if the working language is not an official language of the Member State, all plans and lists that must be posted shall include translations into the working language;
(c)
on board passenger ships, personnel nominated on muster lists to assist passengers in emergency situations are readily identifiable and have communication skills that are sufficient for that purpose, taking into account an appropriate and adequate combination of any of the following factors:
(i)
the language or languages appropriate to the principal nationalities of passengers carried on a particular route;
(ii)
the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language;
(iii)
the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes) when verbal communication is impractical;
(iv)
the extent to which complete safety instructions have been provided to passengers in their native language or languages;
(v)
the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers;
(d)
on board oil tankers, chemical tankers and liquefied gas tankers flying the flag of a Member State, the master, officers and rating are able to communicate with each other in (a) common working language(s);
(e)
there are adequate means for communication between the ship and the shore-based authorities; these communications shall be conducted in accordance with Chapter V, Regulation 14, paragraph 4, of the SOLAS 74;
(f)
when carrying out port State control under Directive 95/21/EC, Member States also check that ships flying the flag of a State other than a Member State comply with this Article.

Recognition of certificates
Article 19
1. Seafarers who do not possess the certificates referred to in Article 4 may be allowed to serve on ships flying the flag of a Member State, provided that a decision on the recognition of their appropriate certificates has been adopted through the procedure set out in paragraphs 2 to 6 of this Article.
2. A Member State which intends to recognise, by endorsement, appropriate certificates issued by a third country to a master, officer or radio operator, for service on ships flying its flag, shall submit a request for recognition of that third country to the Commission, stating its reasons.
The Commission, assisted by the European Maritime Safety Agency and with the possible involvement of any Member State concerned, shall collect the information referred to in Annex II and shall carry out an assessment of the training and certification systems in the third country for which the request for recognition was submitted, in order to verify whether the country concerned meets all the requirements of the STCW Convention and whether the appropriate measures have been taken to prevent fraud involving certificates.
3. The decision on the recognition of a third country shall be taken by the Commission in accordance with the regulatory procedure referred to in Article 28(2), within three months from the date of the request for recognition.
If granted, the recognition shall be valid subject to the provisions of Article 20.
If no decision is taken on recognition of the third country concerned within the period laid down in the first subparagraph, the Member State submitting the request may decide to recognise the third country unilaterally until a decision is taken in accordance with the regulatory procedure referred to in Article 28(2).
4. A Member State may decide, with respect to ships flying its flag, to endorse certificates issued by the third countries recognised by the Commission, account being taken of the provisions contained in Annex II, points (4) and (5).
5. Recognitions of certificates issued by recognised third countries and published in theOfficial Journal of the European Union, C series, before 14 June 2005 shall remain valid.
These recognitions may be used by all Member States unless the Commission has subsequently withdrawn them pursuant to Article 20.
6. The Commission shall draw up and update a list of the third countries that have been recognised. The list shall be published in theOfficial Journal of the European Union, C series.
7. Notwithstanding Article 5(6), a Member State may, if circumstances require, allow a seafarer to serve in a capacity other than radio officer or radio operator, except as provided by the Radio Regulations, for a period not exceeding three months on board a ship flying its flag, while holding an appropriate and valid certificate issued and endorsed as required by a third country, but not yet endorsed for recognition by the Member State concerned so as to render it appropriate for service on board a ship flying its flag.
Documentary proof shall be kept readily available that application for an endorsement has been submitted to the competent authorities.

Non-compliance with the requirements of the STCW Convention
Article 20
1. Notwithstanding the criteria specified in Annex II, when a Member State considers that a recognised third country no longer complies with the requirements of the STCW Convention, it shall notify the Commission immediately, giving substantiated reasons therefor.
The Commission shall without delay refer the matter to the Committee referred to in Article 28(1).
2. Notwithstanding the criteria set out in Annex II, when the Commission considers that a recognised third country no longer complies with the requirements of the STCW Convention, it shall notify the Member States immediately, giving substantiated reasons therefor.
The Commission shall without delay refer the matter to the Committee referred to in Article 28(1).
3. When a Member State intends to withdraw the endorsements of all certificates issued by a third country it shall without delay inform the Commission and the other Member States of its intention, giving substantiated reasons therefor.
4. The Commission, assisted by the European Maritime Safety Agency, shall reassess the recognition of the third country concerned in order to verify whether that country failed to comply with the requirements of the STCW Convention.
5. Where there are indications that a particular maritime training establishment no longer complies with the requirements of the STCW Convention, the Commission shall notify the country concerned that recognition of that country’s certificates will be withdrawn in two months’ time unless measures are taken to ensure compliance with all the requirements of the STCW Convention.
6. The decision on the withdrawal of the recognition shall be taken in accordance with the regulatory procedure referred to in Article 28(2), within two months from the date of the communication made by the Member State.
The Member States concerned shall take appropriate measures to implement the decision.
7. Endorsements attesting recognition of certificates, issued in accordance with Article 5(6) before the date on which the decision to withdraw recognition of the third country is taken, shall remain valid. Seafarers holding such endorsements may not claim an endorsement recognising a higher qualification, however, unless that upgrading is based solely on additional seagoing service experience.

Reassessment
Article 21
1. The third countries that have been recognised under the procedure referred to in the first subparagraph of Article 19(3), including those referred to in Article 19(6), shall be reassessed by the Commission, with the assistance of the European Maritime Safety Agency, on a regular basis and at least every five years to verify that they fulfil the relevant criteria set out in Annex II and whether the appropriate measures have been taken to prevent fraud involving certificates.
2. The Commission shall define the priority criteria for assessment of third countries on the basis of performance data provided by the port State control pursuant to Article 23, as well as the information relating to the reports of the independent evaluations communicated by third countries pursuant to section A-I/7 of the STCW Code.
3. The Commission shall provide the Member States with a report on the results of the assessment.

Port State control
Article 22
1. Irrespective of the flag it flies each ship, with the exception of those types of ships excluded by Article 2, shall, while in the ports of a Member State, be subject to port State control by officers duly authorised by that Member State to verify that all seafarers serving on board who are required to be certificated by the STCW Convention are so certificated or hold appropriate dispensations.
2. When exercising port State control under this Directive, Member States shall ensure that all relevant provisions and procedures laid down in Directive 95/21/EC are applied.

Port State control procedures
Article 23
1. Without prejudice to Directive 95/21/EC, port State control pursuant to Article 22 shall be limited to the following:
(a)
verification that every seafarer serving on board who must be certificated in accordance with the STCW Convention holds an appropriate certificate or a valid dispensation or provides documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the flag State;
(b)
verification that the numbers and certificates of the seafarers serving on board are in accordance with the safe-manning requirements of the authorities of the flag State.
2. The ability of the ship’s seafarers to maintain watchkeeping standards as required by the STCW Convention shall be assessed in accordance with Part A of the STCW Code if there are clear grounds for believing that such standards are not being maintained because any of the following has occurred:
(a)
the ship has been involved in a collision, grounding or stranding;
(b)
there has been a discharge of substances from the ship when under way, at anchor or at berth which is illegal under an international convention;
(c)
the ship has been manoeuvred in an erratic or unsafe manner whereby routing measures adopted by the IMO, or safe navigation practices and procedures have not been followed;
(d)
the ship is otherwise being operated in such a manner as to pose a danger to persons, property or the environment;
(e)
a certificate has been fraudulently obtained or the holder of a certificate is not the person to whom that certificate was originally issued;
(f)
the ship is flying the flag of a country which has not ratified the STCW Convention, or has a master, officer or rating holding a certificate issued by a third country which has not ratified the STCW Convention.
3. Notwithstanding verification of the certificate, assessment under paragraph 2 may require the seafarer to demonstrate the relevant competence at the place of duty. Such a demonstration may include verification that operational requirements in respect of watchkeeping standards have been met and that there is a proper response to emergency situations within the seafarer’s level of competence.

Detention
Article 24
Without prejudice to Directive 95/21/EC, the following deficiencies, in so far as they have been determined by the officer carrying out the port State control that they pose a danger to persons, property or the environment, shall be the only grounds under this Directive on which a Member State may detain a ship:
(a)
failure of seafarers to hold certificates, to have appropriate certificates, to have valid dispensations or provide documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the flag State;
(b)
failure to comply with the applicable safe-manning requirements of the flag State;
(c)
failure of navigational or engineering-watch arrangements to conform to the requirements specified for the ship by the flag State;
(d)
absence in a watch of a person qualified to operate equipment essential to safe navigation, safety radio communications or the prevention of marine pollution;
(e)
failure to provide proof of professional proficiency for the duties assigned to seafarers for the safety of the ship and the prevention of pollution;
(f)
inability to provide for the first watch at the commencement of a voyage and for subsequent relieving watches persons who are sufficiently rested and otherwise fit for duty.

Regular monitoring of compliance
Article 25
Without prejudice to the powers of the Commission under Article 226 of the Treaty, the Commission, assisted by the European Maritime Safety Agency, shall verify on a regular basis and at least every five years that Member States comply with the minimum requirements laid down by this Directive.

Reports
Article 26
1. Not later than 14 December 2008 the Commission shall submit an evaluation report to the European Parliament and the Council, based on a detailed analysis and evaluation of the provisions of the STCW Convention, the implementation thereof and new insights gained with regard to the correlation between safety and the level of training of ships’ crews.
2. Not later than 20 October 2010 the Commission shall submit to the European Parliament and the Council an evaluation report drawn up on the basis of the information obtained pursuant to Article 25.
In the report the Commission shall analyse the Member States’ compliance with this Directive and, where necessary, make proposals for additional measures.

Amendment
Article 27
1. This Directive may be amended by the Commission in order to apply, for the purposes of this Directive, subsequent amendments to the international codes referred to in points (16), (17), (18), (23) and (24) of Article 1 which have entered into force.
This Directive may also be amended by the Commission in order to apply, for the purposes of this Directive, any relevant amendments to Community legislation.
Those measures designed to amend non-essential elements of this Directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3).
2. Following the adoption of new instruments or protocols to the STCW Convention, the Council, acting on a proposal from the Commission, shall decide, taking into account the Member States’ parliamentary procedures, as well as the relevant procedures within the IMO on the detailed arrangements for ratifying those new instruments or protocols, while ensuring that they are applied uniformly and simultaneously in the Member States.
3. The amendments to the international instruments referred to in Article 1(16), (17), (18), (21), (22) and (24) may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(10).

Committee procedure
Article 28
1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS), established by Regulation (EC) No 2099/2002.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at eight weeks.
3. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Transitional provisions
Article 29
Where pursuant to Article 12 a Member State reissues or extends the validity of certificates which it originally issued under the provisions which applied before 1 February 1997, the Member State may, at its discretion, replace tonnage limitations appearing on the original certificates as follows:
(a)
‘200 gross registered tonnes’ may be replaced by ‘500 gross tonnage’;
(b)
‘1 600 gross registered tonnes’ may be replaced by ‘3 000 gross tonnage’.

Penalties
Article 30
Member States shall lay down systems of penalties for breaching the national provisions adopted pursuant to Articles 1, 3, 5, 7, 9 to 15, 17, 18, 19, 22, 23, 24 and 29, and Annexes I and II, and shall take all the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

Communication
Article 31
Member States shall immediately communicate to the Commission the texts of all the provisions which they adopt in the field governed by this Directive.
The Commission shall inform the other Member States thereof.

Repeal
Article 32
Directive 2001/25/EC, as amended by the Directives listed in Annex III, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.

Entry into force
Article 33
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Addressees
Article 34
This Directive is addressed to the Member States.

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),
(1) Directive 2001/25/EC of the European Parliament and of the Council of 4 April 2001 on the minimum level of training of seafarers(3)has been significantly amended on several occasions(4). Now that new amendments are being made to that Directive, it is desirable, for reasons of clarity, that the provisions in question should be recast.
(2) Actions to be taken at Community level in the field of maritime safety and pollution prevention at sea should be in line with internationally agreed rules and standards.
(3) In order to maintain and develop the level of knowledge and skills in the maritime sector in the Community, it is important to pay appropriate attention to maritime training and the status of seafarers in the Community.
(4) A consistent level of training for the award of vocational competency certificates to seafarers should be ensured in the interests of maritime safety.
(5) Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications(5)applies to maritime occupations covered by this Directive. It will help promote compliance with the obligations laid down in the Treaty abolishing obstacles to the free movement of persons and services between Member States.
(6) The mutual recognition of diplomas and certificates provided for under Directive 2005/36/EC does not always ensure a standardised level of training for all seafarers serving on board vessels flying the flag of a Member State. This is, however, vital from the viewpoint of maritime safety.
(7) It is therefore essential to define a minimum level of training for seafarers in the Community. That level should be based on the standards of training already agreed at international level, namely the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978 (STCW Convention), as revised in 1995. All Member States are Parties to that Convention.
(8) Member States may establish standards higher than the minimum standards laid down in the STCW Convention and this Directive.
(9) The Regulations of the STCW Convention annexed to this Directive should be supplemented by the mandatory provisions contained in Part A of the Seafarers’ Training, Certification and Watchkeeping Code (STCW Code). Part B of the STCW Code contains recommended guidance intended to assist Parties to the STCW Convention and those involved in implementing, applying or enforcing its measures to give the Convention full and complete effect in a uniform manner.
(10) For the enhancement of maritime safety and pollution prevention at sea, provisions on minimum rest periods for watchkeeping personnel should be established in this Directive in accordance with the STCW Convention. Those provisions should be applied without prejudice to the provisions of Council Directive 1999/63/EC of 21 June 1999 concerning the Agreement on the organisation of working time of seafarers concluded by the European Community Shipowners’ Association (ECSA) and the Federation of Transport Workers’ Unions in the European Union (FST)(6).
(11) Member States should take and enforce specific measures to prevent and penalise fraudulent practices associated with certificates of competency as well as pursue their efforts within the IMO to achieve strict and enforceable agreements on the worldwide combating of such practices.
(12) In order to enhance maritime safety and prevent loss of human life and maritime pollution, communication among crew members on board ships sailing in Community waters should be improved.
(13) Personnel on board passenger ships nominated to assist passengers in emergency situations should be able to communicate with the passengers.
(14) Crews serving on board tankers carrying noxious or polluting cargo should be capable of coping effectively with accident prevention and emergency situations. It is paramount that a proper communication link between the master, officers and ratings is established, covering the requirements provided for in this Directive.
(15) It is essential to ensure that seafarers holding certificates issued by third countries and serving on board Community ships have a level of competence equivalent to that required by the STCW Convention. This Directive should lay down procedures and common criteria for the recognition by the Member States of certificates issued by third countries, based on the training and certification requirements as agreed in the framework of the STCW Convention.
(16) In the interests of safety at sea, Member States should recognise qualifications proving the required level of training only where these are issued by or on behalf of Parties to the STCW Convention which have been identified by the IMO Maritime Safety Committee (MSC) as having been shown to have given, and still to be giving, full effect to the standards set out in that Convention. To bridge the time gap until the MSC has been able to carry out such identification, a procedure for the preliminary recognition of certificates is needed.
(17) Where appropriate, maritime institutes, training programmes and courses should be inspected. Criteria for such inspection should therefore be established.
(18) The Commission should be assisted by a committee in carrying out the tasks related to the recognition of certificates issued by training institutes or administrations of third countries.
(19) The European Maritime Safety Agency established by Regulation (EC) No 1406/2002 of the European Parliament and of the Council(7)should assist the Commission in verifying that Member States comply with the requirements laid down in this Directive.
(20) Member States, as port authorities, are required to enhance safety and prevention of pollution in Community waters through priority inspection of vessels flying the flag of a third country which has not ratified the STCW Convention, thereby ensuring no more favourable treatment to vessels flying the flag of a third country.
(21) It is appropriate to include in this Directive provisions on port State control, pending the amendment of Council Directive 95/21/EC(8)on port State control of shipping in order to transfer to that Directive the provisions on port State control which are included in this Directive.
(22) It is necessary to provide for procedures for adapting this Directive to changes in international conventions and codes.
(23) The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9).
(24) In particular the Commission should be empowered to amend this Directive in order to apply, for the purposes of this Directive, subsequent amendments to certain international codes and any relevant amendment to Community legislation. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(25) The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.
(26) This Directive should be without prejudice to the obligations of the Members States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Definitions

For the purposes of this Directive:
1.
‘master’ means the person having command of a ship;
2.
‘officer’ means a member of the crew, other than the master, designated as such by national law or regulations or, in the absence of such designation, by collective agreement or custom;
3.
‘deck officer’ means an officer qualified in accordance with the provisions of Chapter II of Annex I;
4.
‘chief mate’ means the officer next in rank to the master upon whom the command of the ship will fall in the event of the incapacity of the master;
5.
‘engineer officer’ means an officer qualified in accordance with the provisions of Chapter III of Annex I;
6.
‘chief engineer officer’ means the senior engineer officer responsible for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship;
7.
‘second engineer officer’ means the engineer officer next in rank to the chief engineer officer upon whom the responsibility for the mechanical propulsion and the operation and maintenance of the mechanical and electrical installations of the ship will fall in the event of the incapacity of the chief engineer officer;
8.
‘assistant engineer officer’ means a person under training to become an engineer officer and designated as such by national law or regulations;
9.
‘radio operator’ means a person holding an appropriate certificate issued or recognised by the competent authorities under the provisions of the Radio Regulations;
10.
‘rating’ means a member of the ship’s crew other than the master or an officer;
11.
‘seagoing ship’ means a ship other than those which navigate exclusively in inland waters or in waters within, or closely adjacent to, sheltered waters or areas where port regulations apply;
12.
‘ship flying the flag of a Member State’ means a ship registered in and flying the flag of a Member State in accordance with its legislation; a ship not corresponding to this definition shall be regarded as a ship flying the flag of a third country;
13.
‘near-coastal voyages’ means voyages in the vicinity of a Member State as defined by that Member State;
14.
‘propulsion power’ means the total maximum continuous rated output power in kilowatts of all of a ship’s main propulsion machinery which appears on the ship’s certificate of registry or other official document;
15.
‘oil-tanker’ means a ship constructed and used for the carriage of petroleum and petroleum products in bulk;
16.
‘chemical tanker’ means a ship constructed or adapted and used for the carriage in bulk of any liquid product listed in Chapter 17 of the International Bulk Chemical Code, in its up-to-date version;
17.
‘liquefied-gas tanker’ means a ship constructed or adapted and used for the carriage in bulk of any liquefied gas or other product listed in Chapter 19 of the International Gas Carrier Code, in its up-to-date version;
18.
‘Radio Regulations’ means the revised radio regulations, adopted by the World Administrative Radio Conference for the Mobile Service in their up-to-date version;
19.
‘passenger ship’ means a seagoing ship which carries more than 12 passengers;
20.
‘fishing vessel’ shall mean a vessel used for catching fish or other living resources of the sea;
21.
‘STCW Convention’ means the International Maritime Organisation (IMO) Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as it applies to the matters concerned taking into account the transitional provisions of Article VII and Regulation I/15 of the Convention and including, where appropriate, the applicable provisions of the STCW Code, all being applied in their up-to-date versions;
22.
‘radio duties’ includes, as appropriate, watchkeeping and technical maintenance and repairs conducted in accordance with the Radio Regulations, the International Convention for the Safety of Life at Sea, 1974 (SOLAS 74) and, at the discretion of each Member State, the relevant recommendations of the IMO, in their up-to-date versions;
23.
‘ro-ro passenger ship’ means a passenger ship with ro-ro cargo spaces or special-category spaces as defined in the SOLAS 74, in its up-to-date version;
24.
‘STCW Code’ means the Seafarers’ Training, Certification and Watchkeeping (STCW) Code as adopted by Resolution 2 of the 1995 STCW Conference of Parties, in its up-to-date version;
25.
‘function’ means a group of tasks, duties and responsibilities, as specified in the STCW Code, necessary for ship operation, safety of life at sea or protection of the marine environment;
26.
‘company’ means the owner of the ship or any other organisation or person such as the manager or the bareboat charterer who has assumed the responsibility for operation of the ship from the shipowner and who, on assuming such responsibility, has agreed to take over all the duties and responsibilities imposed on the company by this Directive;
27.
‘appropriate certificate’ means a certificate issued and endorsed in accordance with this Directive and entitling the lawful holder thereof to serve in the capacity and perform the functions involved at the level of responsibility specified therein on a ship of the type, tonnage, power and means of propulsion concerned while engaged on the particular voyage concerned;
28.
‘seagoing service’ means service on board a ship relevant to the issue of a certificate or other qualification;
29.
‘approved’ means approved by a Member State in accordance with this Directive;
30.
‘third country’ means any country which is not a Member State;
31.
‘month’ means a calendar month or 30 days made up of periods of less than one month.

Scope

This Directive shall apply to the seafarers mentioned in this Directive serving on board seagoing ships flying the flag of a Member State with the exception of:
(a)
warships, naval auxiliaries or other ships owned or operated by a Member State and engaged only on government non-commercial service;
(b)
fishing vessels;
(c)
pleasure yachts not engaged in trade;
(d)
wooden ships of primitive build.

Training and certification

1. Member States shall take the measures necessary to ensure that seafarers serving on ships as referred to in Article 2 are trained as a minimum in accordance with the requirements of the STCW Convention, as laid down in Annex I to this Directive, and hold certificates as defined in Article 4 or appropriate certificates as defined in Article 1(27).
2. Member States shall take the measures necessary to ensure that those crew members that must be certified in accordance with Regulation III/10.4 of the SOLAS 74 are trained and certificated in accordance with this Directive.

Certificate

A certificate shall be any valid document, by whatever name it may be known, issued by or under the authority of the competent authority of a Member State in accordance with Article 5 and with the requirements laid down in Annex I.

Certificates and endorsements

1. Certificates shall be issued in accordance with Article 11.
2. Certificates for masters, officers and radio operators shall be endorsed by the Member State as prescribed in this Article.
3. Certificates shall be issued in accordance with Regulation I/2, paragraph 1, of the STCW Convention.
4. In respect of radio operators, Member States may:
(a)
include the additional knowledge required by the relevant regulations in the examination for the issue of a certificate complying with the Radio Regulations; or
(b)
issue a separate certificate indicating that the holder has the additional knowledge required by the relevant regulations.
5. At the discretion of a Member State endorsements may be incorporated in the format of the certificates being issued as provided for in section A-I/2 of the STCW Code. If so incorporated the form used shall be that set out in section A-I/2, paragraph 1. If issued otherwise, the form of endorsements used shall be that set out in paragraph 2 of that section. Endorsements shall be issued in accordance with Article VI, paragraph 2, of the STCW Convention.
6. A Member State which recognises a certificate under the procedure laid down in Article 19(2) shall endorse that certificate to attest its recognition. The form of the endorsement used shall be that set out in paragraph 3 of section A-I/2 of the STCW Code.
7. The endorsements referred to in paragraphs 5 and 6:
(a)
may be issued as separate documents;
(b)
shall each be assigned a unique number, other than endorsements attesting the issue of a certificate which may be assigned the same number as the certificate concerned, provided that that number is unique; and
(c)
shall each expire as soon as the certificate endorsed expires or is withdrawn, suspended or cancelled by the Member State or third country which issued them and, in any case, within five years of their date of issue.
8. The capacity in which the holder of a certificate is authorised to serve shall be identified in the form of endorsement in terms identical to those used in the applicable safe-manning requirements of the Member State concerned.
9. A Member State may use a format different from the format laid down in section A-I/2 of the STCW Code, provided that, as a minimum, the required information is provided in Roman characters and Arabic figures, taking account of the variations permitted under section A-I/2.
10. Subject to Article 19(7) any certificate required by this Directive shall be kept available in its original form on board the ship on which the holder is serving.

Training requirements

The training required pursuant to Article 3 shall be in a form appropriate to the theoretical knowledge and practical skills required by Annex I, in particular the use of life saving and fire-fighting equipment, and approved by the competent authority or body designated by each Member State.

Principles governing near-coastal voyages

1. When defining near-coastal voyages Member States shall not impose training, experience or certification requirements on seafarers serving on board ships entitled to fly the flag of another Member State or another Party to the STCW Convention and engaged in such voyages in a manner resulting in more stringent requirements for such seafarers than for seafarers serving on board ships entitled to fly their own flag. In no case shall a Member State impose requirements in respect of seafarers serving on board ships flying the flag of another Member State or of another Party to the STCW Convention in excess of those of this Directive in respect of ships not engaged in near-coastal voyages.
2. With respect to ships entitled to fly the flag of a Member State regularly engaged in near-coastal voyages off the coast of another Member State or of another Party to the STCW Convention, the Member State the flag of which a ship is entitled to fly shall prescribe training, experience and certification requirements for seafarers serving on such ships at least equal to those of the Member State or the Party to the STCW Convention off the coast of which the ship is engaged, provided that they do not exceed the requirements of this Directive in respect of ships not engaged in near-coastal voyages. Seafarers serving on a ship which extends its voyage beyond what is defined as a near-coastal voyage by a Member State and enters waters not covered by that definition shall fulfil the appropriate requirements of this Directive.
3. A Member State may afford a ship which is entitled to fly its flag the benefits of the near-coastal voyage provisions of this Directive when it is regularly engaged off the coast of a non-Party to the STCW Convention on near-coastal voyages as defined by that Member State.
4. Upon deciding on the definition of near-coastal voyages and the conditions of education and training required thereof in accordance with the requirements of paragraphs 1, 2 and 3, Member States shall communicate to the Commission the details of the provisions they have adopted.

Prevention of fraud and other unlawful practices

1. Member States shall take and enforce the appropriate measures to prevent fraud and other unlawful practices involving the certification process or certificates issued and endorsed by their competent authorities, and shall provide for penalties that are effective, proportionate and dissuasive.
2. Member States shall designate the national authorities competent to detect and combat fraud and other unlawful practices and exchange information with the competent authorities of other Member States and of third countries concerning the certification of seafarers.
Member States shall forthwith inform the other Member States and the Commission of the details of such competent national authorities.
Member States shall also forthwith inform any third countries with which they have entered into an undertaking in accordance with Regulation I/10, paragraph 1.2 of the STCW Convention of the details of such competent national authorities.
3. At the request of a host Member State, the competent authorities of another Member State shall provide written confirmation or denial of the authenticity of seafarers’ certificates, corresponding endorsements or any other documentary evidence of training issued in that other Member State.

Penalties or disciplinary measures

1. Member States shall establish processes and procedures for the impartial investigation of any reported incompetence, act or omission, that may pose a direct threat to safety of life or property at sea or to the marine environment, on the part of the holders of certificates or endorsements issued by that Member State in connection with their performance of duties relating to their certificates and for the withdrawal, suspension and cancellation of such certificates for such cause and for the prevention of fraud.
2. Each Member State shall prescribe penalties or disciplinary measures for cases in which the provisions of this national legislation giving effect to this Directive are not complied with in respect of ships entitled to fly its flag or of seafarers duly certificated by it.
3. In particular, such penalties or disciplinary measures shall be prescribed and enforced in cases in which:
(a)
a company or a master has engaged a person not holding a certificate as required by this Directive;
(b)
a master has allowed any function or service in any capacity which under this Directive must be performed by a person holding an appropriate certificate to be performed by a person not holding the required certificate, a valid dispensation or having the documentary proof required by Article 19(7); or
(c)
a person has obtained by fraud or forged documents an engagement to perform any function or serve in any capacity which under this Directive must be performed or fulfilled by a person holding a certificate or dispensation.
4. Member States within the jurisdiction of which any company which or any person who is believed on clear grounds to have been responsible for or to have knowledge of any apparent non-compliance with this Directive specified in paragraph 3, is located shall extend cooperation to any Member State or other Party to the STCW Convention which advises them of its intention to initiate proceedings under its jurisdiction.

Quality standards

1. Each Member State shall ensure that:
(a)
all training, assessment of competence, certification, endorsement and revalidation activities carried out by non-governmental agencies or entities under its authority are continuously monitored through a quality standards system to ensure the achievement of defined objectives, including those concerning the qualifications and experience of instructors and assessors;
(b)
where governmental agencies or entities perform such activities, there is a quality-standards system;
(c)
the education and training objectives and related quality standards of competence to be achieved are clearly defined and identify the levels of knowledge, understanding and skills appropriate to the examinations and assessments required under the STCW Convention;
(d)
the fields of application of the quality standards cover the administration of the certification systems, all training courses and programmes, examinations and assessments carried out by or under the authority of each Member State and the qualifications and experience required of instructors and assessors, having regard to the policies, systems, controls and internal quality-assurance reviews established to ensure achievement of the defined objectives.
The objectives and related quality standards referred to in point (c) of the first subparagraph may be specified separately for different courses and training programmes and shall cover the administration of the certification system.
2. Member States shall also ensure that independent evaluations of the knowledge, understanding, skills and competence acquisition and assessment activities, and of the administration of the certification system, are conducted at intervals of not more than five years by qualified persons who are not themselves involved in the activities concerned in order to verify that:
(a)
all internal management control and monitoring measures and follow-up actions comply with planned arrangements and documental procedures and are effective in ensuring that the defined objectives are achieved;
(b)
the results of each independent evaluation are documented and brought to the attention of those responsible for the area evaluated;
(c)
timely action is taken to correct deficiencies.
3. A report relating to each evaluation carried out pursuant to paragraph 2 shall be communicated by the Member State concerned to the Commission within six months of the date of the evaluation.

Medical standards — issue and registration of certificates

1. Member States shall establish standards of medical fitness for seafarers, particularly regarding eyesight and hearing.
2. Member States shall ensure that certificates are issued only to candidates who comply with the requirements of this Article.
3. Each candidate for certification shall provide satisfactory proof:
(a)
of his or her identity;
(b)
that his or her age is not less than that prescribed in the Regulations in Annex I relevant to the certificate applied for;
(c)
that he or she meets the standards of medical fitness, particularly regarding eyesight and hearing, established by the Member State and holds a valid document attesting to his or her medical fitness, issued by a duly qualified medical practitioner recognised by the competent authority of the Member State;
(d)
of having completed the seagoing service and any related compulsory training prescribed in the Regulations in Annex I for the certificate applied for;
(e)
that he or she meets the standards of competence prescribed in the Regulations in Annex I for the capacities, functions and levels that are to be identified in the endorsement to the certificate.
4. Each Member State shall undertake:
(a)
to maintain a register or registers of all certificates and endorsements for masters and officers and, as appropriate, ratings, which are issued, have expired or have been revalidated, suspended, cancelled or reported lost or destroyed and of dispensations issued;
(b)
to make available information on the status of such certificates, endorsements and dispensations to other Member States or other Parties to the STCW Convention and companies which request verification of the authenticity and validity of certificates produced to them by seafarers seeking recognition of their certificates or employment on board ship.

Revalidation of certificates

1. Every master, officer and radio operator holding a certificate issued or recognised under any chapter of Annex I other than Chapter VI who is serving at sea or intends to return to sea after a period ashore shall, in order to continue to qualify for seagoing service, be required at intervals not exceeding five years:
(a)
to meet the standards of medical fitness prescribed by Article 11; and
(b)
to establish continued professional competence in accordance with section A-I/11 of the STCW Code.
2. Every master, officer and radio operator shall, for continuing seagoing service on board ships for which special training requirements have been internationally agreed upon, successfully complete approved relevant training.
3. Each Member State shall compare the standards of competence which are required of candidates for certificates issued before 1 February 2002 with those specified for the appropriate certificate in Part A of the STCW Code, and shall determine the need to require the holders of such certificates to undergo appropriate refresher and updating training or assessment.
Refresher and updating courses shall be approved and include changes in relevant national and international regulations concerning the safety of life at sea and the protection of the marine environment and take account of any updating of the standard of competency concerned.
4. Each Member State shall, in consultation with those concerned, formulate or promote the formulation of a structure of refresher and updating courses as provided for in section A-I/11 of the STCW Code.
5. For the purpose of updating the knowledge of masters, officers and radio operators, each Member State shall ensure that the texts of recent changes in national and international regulations concerning the safety of life at sea and the protection of the marine environment are made available to ships entitled to fly its flag.

Use of simulators

1. The performance standards and other provisions set out in section A-I/12 of the STCW Code and such other requirements as are prescribed in Part A of the STCW Code for any certificate concerned shall be complied with in respect of:
(a)
all mandatory simulator-based training;
(b)
any assessment of competence required by Part A of the STCW Code which is carried out by means of a simulator;
(c)
any demonstration, by means of a simulator, of continued proficiency required by Part A of the STCW Code.
2. Simulators installed or brought into use before 1 February 2002 may be exempted from full compliance with the performance standards referred to in paragraph 1 at the discretion of each Member State.

Responsibilities of companies

1. In accordance with paragraphs 2 and 3 Member States shall hold companies responsible for the assignment of seafarers for service in their ships in accordance with this Directive, and shall require every company to ensure that:
(a)
each seafarer assigned to any of its ships holds an appropriate certificate in accordance with the provisions of this Directive and as established by the Member State;
(b)
its ships are manned in accordance with the applicable safe-manning requirements of the Member State;
(c)
documentation and data relevant to all seafarers employed on its ships are maintained and readily accessible, and include, without being limited to, documentation and data on their experience, training, medical fitness and competence in assigned duties;
(d)
on being assigned to any of its ships seafarers are familiarised with their specific duties and with all ship arrangements, installations, equipment, procedures, and ship characteristics that are relevant to their routine or emergency duties;
(e)
the ship’s complement can effectively coordinate their activities in an emergency situation and in performing functions vital to safety or to the prevention or mitigation of pollution.
2. Companies, masters and crew members shall each have responsibility for ensuring that the obligations set out in this Article are given full and complete effect and that such other measures as may be necessary are taken to ensure that each crew member can make a knowledgeable and informed contribution to the safe operation of the ship.
3. The company shall provide written instructions to the master of each ship to which this Directive applies, setting out the policies and the procedures to be followed to ensure that all seafarers who are newly employed on board the ship are given a reasonable opportunity to become familiar with the shipboard equipment, operating procedures and other arrangements needed for the proper performance of their duties, before being assigned to those duties. Such policies and procedures shall include:
(a)
the allocation of a reasonable period of time during which each newly employed seafarer will have an opportunity to become acquainted with:
(i)
the specific equipment the seafarer will be using or operating; and
(ii)
ship-specific watchkeeping, safety, environmental protection and emergency procedures and arrangements the seafarer needs to know to perform the assigned duties properly;
(b)
the designation of a knowledgeable crew member who will be responsible for ensuring that each newly employed seafarer is given an opportunity to receive essential information in a language the seafarer understands.

Fitness for duty

1. For the purpose of preventing fatigue, Member States shall establish and enforce rest periods for watchkeeping personnel and require that watch systems are arranged in such a way that the efficiency of watchkeeping personnel is not impaired by fatigue and that duties are organised in such a way that the first watch at the start of a voyage and subsequent relieving watches are sufficiently rested and otherwise fit for duty.
2. All persons who are assigned duty as officer in charge of a watch or as a rating forming part of a watch shall be allowed at least 10 hours of rest in any 24-hour period.
3. The hours of rest may be divided into no more than two periods, one of which shall be at least six hours long.
4. The requirements for rest periods laid down in paragraphs 1 and 2 need not be maintained in the event of an emergency or drill or in other overriding operational conditions.
5. Notwithstanding paragraphs 2 and 3, the minimum period of 10 hours may be reduced to not less than 6 consecutive hours provided that no such reduction shall extend beyond 2 days and at least 70 hours of rest are provided each 7-day period.
6. Member States shall require that watch schedules be posted where they are easily accessible.

Dispensation

1. In circumstances of exceptional necessity, competent authorities may, if in their opinion this does not cause danger to persons, property or the environment, issue a dispensation permitting a specified seafarer to serve in a specified ship for a specified period not exceeding six months in a capacity, other than that of the radio operator, except as provided by the relevant Radio Regulations, for which he or she does not hold the appropriate certificate, provided that the person to whom the dispensation is issued shall be adequately qualified to fill the vacant post in a safe manner to the satisfaction of the competent authorities. However, dispensations shall not be granted to a master or chief engineer officer, except in circumstances of force majeure and then only for the shortest possible period.
2. Any dispensation granted for a post shall be granted only to a person properly certificated to fill the post immediately below. Where certification of the post below is not required, a dispensation may be issued to a person whose qualification and experience are, in the opinion of the competent authorities, of a clear equivalence to the requirements for the post to be filled, provided that, if such a person holds no appropriate certificate, he or she shall be required to pass a test accepted by the competent authorities as demonstrating that such a dispensation may safely be issued. In addition, the competent authorities shall ensure that the post in question is filled by the holder of an appropriate certificate as soon as possible.

Responsibilities of Member States with regard to training and assessment

1. Member States shall designate the authorities or bodies which shall:
(a)
give the training referred to in Article 3;
(b)
organise and/or supervise the examinations where required;
(c)
issue the certificates of competence referred to in Article 11;
(d)
grant the dispensations provided for in Article 16.
2. Member States shall ensure that:
(a)
all training and assessment of seafarers is:
(i)
structured in accordance with the written programmes, including such methods and media of delivery, procedures and course material as are necessary to achieve the prescribed standard of competence; and
(ii)
conducted, monitored, evaluated and supported by persons qualified in accordance with points (d), (e) and (f);
(b)
persons conducting in-service training or assessment on board ship do so only when such training or assessment will not adversely affect the normal operation of the ship and they can dedicate their time and attention to training or assessment;
(c)
instructors, supervisors and assessors are appropriately qualified for the particular types and levels of training or assessment of competence of seafarers either on board or ashore;
(d)
any person conducting in-service training of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under this Directive:
(i)
has an appreciation of the training programme and an understanding of the specific training objectives for the particular type of training being conducted;
(ii)
is qualified in the task for which training is being conducted; and
(iii)
if conducting training using a simulator:
—
has received appropriate guidance in instructional techniques involving the use of simulators, and
—
has gained practical operational experience on the particular type of simulator being used;
(e)
any person responsible for the supervision of the in-service training of a seafarer intended to be used in qualifying for certification has a full understanding of the training programme and the specific objectives for each type of training being conducted;
(f)
any person conducting in-service assessment of the competence of a seafarer, either on board or ashore, which is intended to be used in qualifying for certification under this Directive:
(i)
has an appropriate level of knowledge and understanding of the competence to be assessed;
(ii)
is qualified in the task for which the assessment is being made;
(iii)
has received appropriate guidance in assessment methods and practice;
(iv)
has gained practical assessment experience; and
(v)
if conducting assessment involving the use of simulators, has gained practical assessment experience on the particular type of simulator under the supervision and to the satisfaction of an experienced assessor;
(g)
when a Member State recognises a course of training, a training institution, or a qualification granted by a training institution, as part of its requirements for the issue of a certificate, the qualifications and experience of instructors and assessors are covered in the application of the quality standard provisions of Article 10; such qualification, experience and application of quality standards shall incorporate appropriate training in instructional techniques and training and assessment methods and practice and comply with all applicable requirements of points (d), (e) and (f).

On-board communication

Member States shall ensure that:
(a)
without prejudice to points (b) and (d), there are at all times, on board all ships flying the flag of a Member State, means in place for effective oral communication relating to safety between all members of the ship’s crew, particularly with regard to the correct and timely reception and understanding of messages and instructions;
(b)
on board all passenger ships flying the flag of a Member State and on board all passenger ships starting and/or finishing a voyage in a Member State port, in order to ensure effective crew performance in safety matters, a working language is established and recorded in the ship’s log-book;
the company or the master, as appropriate, shall determine the appropriate working language; each seafarer shall be required to understand and, where appropriate, give orders and instructions and report back in that language;
if the working language is not an official language of the Member State, all plans and lists that must be posted shall include translations into the working language;
(c)
on board passenger ships, personnel nominated on muster lists to assist passengers in emergency situations are readily identifiable and have communication skills that are sufficient for that purpose, taking into account an appropriate and adequate combination of any of the following factors:
(i)
the language or languages appropriate to the principal nationalities of passengers carried on a particular route;
(ii)
the likelihood that an ability to use elementary English vocabulary for basic instructions can provide a means of communicating with a passenger in need of assistance whether or not the passenger and crew member share a common language;
(iii)
the possible need to communicate during an emergency by some other means (e.g. by demonstration, hand signals, or calling attention to the location of instructions, muster stations, life-saving devices or evacuation routes) when verbal communication is impractical;
(iv)
the extent to which complete safety instructions have been provided to passengers in their native language or languages;
(v)
the languages in which emergency announcements may be broadcast during an emergency or drill to convey critical guidance to passengers and to facilitate crew members in assisting passengers;
(d)
on board oil tankers, chemical tankers and liquefied gas tankers flying the flag of a Member State, the master, officers and rating are able to communicate with each other in (a) common working language(s);
(e)
there are adequate means for communication between the ship and the shore-based authorities; these communications shall be conducted in accordance with Chapter V, Regulation 14, paragraph 4, of the SOLAS 74;
(f)
when carrying out port State control under Directive 95/21/EC, Member States also check that ships flying the flag of a State other than a Member State comply with this Article.

Recognition of certificates

1. Seafarers who do not possess the certificates referred to in Article 4 may be allowed to serve on ships flying the flag of a Member State, provided that a decision on the recognition of their appropriate certificates has been adopted through the procedure set out in paragraphs 2 to 6 of this Article.
2. A Member State which intends to recognise, by endorsement, appropriate certificates issued by a third country to a master, officer or radio operator, for service on ships flying its flag, shall submit a request for recognition of that third country to the Commission, stating its reasons.
The Commission, assisted by the European Maritime Safety Agency and with the possible involvement of any Member State concerned, shall collect the information referred to in Annex II and shall carry out an assessment of the training and certification systems in the third country for which the request for recognition was submitted, in order to verify whether the country concerned meets all the requirements of the STCW Convention and whether the appropriate measures have been taken to prevent fraud involving certificates.
3. The decision on the recognition of a third country shall be taken by the Commission in accordance with the regulatory procedure referred to in Article 28(2), within three months from the date of the request for recognition.
If granted, the recognition shall be valid subject to the provisions of Article 20.
If no decision is taken on recognition of the third country concerned within the period laid down in the first subparagraph, the Member State submitting the request may decide to recognise the third country unilaterally until a decision is taken in accordance with the regulatory procedure referred to in Article 28(2).
4. A Member State may decide, with respect to ships flying its flag, to endorse certificates issued by the third countries recognised by the Commission, account being taken of the provisions contained in Annex II, points (4) and (5).
5. Recognitions of certificates issued by recognised third countries and published in theOfficial Journal of the European Union, C series, before 14 June 2005 shall remain valid.
These recognitions may be used by all Member States unless the Commission has subsequently withdrawn them pursuant to Article 20.
6. The Commission shall draw up and update a list of the third countries that have been recognised. The list shall be published in theOfficial Journal of the European Union, C series.
7. Notwithstanding Article 5(6), a Member State may, if circumstances require, allow a seafarer to serve in a capacity other than radio officer or radio operator, except as provided by the Radio Regulations, for a period not exceeding three months on board a ship flying its flag, while holding an appropriate and valid certificate issued and endorsed as required by a third country, but not yet endorsed for recognition by the Member State concerned so as to render it appropriate for service on board a ship flying its flag.
Documentary proof shall be kept readily available that application for an endorsement has been submitted to the competent authorities.

Non-compliance with the requirements of the STCW Convention

1. Notwithstanding the criteria specified in Annex II, when a Member State considers that a recognised third country no longer complies with the requirements of the STCW Convention, it shall notify the Commission immediately, giving substantiated reasons therefor.
The Commission shall without delay refer the matter to the Committee referred to in Article 28(1).
2. Notwithstanding the criteria set out in Annex II, when the Commission considers that a recognised third country no longer complies with the requirements of the STCW Convention, it shall notify the Member States immediately, giving substantiated reasons therefor.
The Commission shall without delay refer the matter to the Committee referred to in Article 28(1).
3. When a Member State intends to withdraw the endorsements of all certificates issued by a third country it shall without delay inform the Commission and the other Member States of its intention, giving substantiated reasons therefor.
4. The Commission, assisted by the European Maritime Safety Agency, shall reassess the recognition of the third country concerned in order to verify whether that country failed to comply with the requirements of the STCW Convention.
5. Where there are indications that a particular maritime training establishment no longer complies with the requirements of the STCW Convention, the Commission shall notify the country concerned that recognition of that country’s certificates will be withdrawn in two months’ time unless measures are taken to ensure compliance with all the requirements of the STCW Convention.
6. The decision on the withdrawal of the recognition shall be taken in accordance with the regulatory procedure referred to in Article 28(2), within two months from the date of the communication made by the Member State.
The Member States concerned shall take appropriate measures to implement the decision.
7. Endorsements attesting recognition of certificates, issued in accordance with Article 5(6) before the date on which the decision to withdraw recognition of the third country is taken, shall remain valid. Seafarers holding such endorsements may not claim an endorsement recognising a higher qualification, however, unless that upgrading is based solely on additional seagoing service experience.

Reassessment

1. The third countries that have been recognised under the procedure referred to in the first subparagraph of Article 19(3), including those referred to in Article 19(6), shall be reassessed by the Commission, with the assistance of the European Maritime Safety Agency, on a regular basis and at least every five years to verify that they fulfil the relevant criteria set out in Annex II and whether the appropriate measures have been taken to prevent fraud involving certificates.
2. The Commission shall define the priority criteria for assessment of third countries on the basis of performance data provided by the port State control pursuant to Article 23, as well as the information relating to the reports of the independent evaluations communicated by third countries pursuant to section A-I/7 of the STCW Code.
3. The Commission shall provide the Member States with a report on the results of the assessment.

Port State control

1. Irrespective of the flag it flies each ship, with the exception of those types of ships excluded by Article 2, shall, while in the ports of a Member State, be subject to port State control by officers duly authorised by that Member State to verify that all seafarers serving on board who are required to be certificated by the STCW Convention are so certificated or hold appropriate dispensations.
2. When exercising port State control under this Directive, Member States shall ensure that all relevant provisions and procedures laid down in Directive 95/21/EC are applied.

Port State control procedures

1. Without prejudice to Directive 95/21/EC, port State control pursuant to Article 22 shall be limited to the following:
(a)
verification that every seafarer serving on board who must be certificated in accordance with the STCW Convention holds an appropriate certificate or a valid dispensation or provides documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the flag State;
(b)
verification that the numbers and certificates of the seafarers serving on board are in accordance with the safe-manning requirements of the authorities of the flag State.
2. The ability of the ship’s seafarers to maintain watchkeeping standards as required by the STCW Convention shall be assessed in accordance with Part A of the STCW Code if there are clear grounds for believing that such standards are not being maintained because any of the following has occurred:
(a)
the ship has been involved in a collision, grounding or stranding;
(b)
there has been a discharge of substances from the ship when under way, at anchor or at berth which is illegal under an international convention;
(c)
the ship has been manoeuvred in an erratic or unsafe manner whereby routing measures adopted by the IMO, or safe navigation practices and procedures have not been followed;
(d)
the ship is otherwise being operated in such a manner as to pose a danger to persons, property or the environment;
(e)
a certificate has been fraudulently obtained or the holder of a certificate is not the person to whom that certificate was originally issued;
(f)
the ship is flying the flag of a country which has not ratified the STCW Convention, or has a master, officer or rating holding a certificate issued by a third country which has not ratified the STCW Convention.
3. Notwithstanding verification of the certificate, assessment under paragraph 2 may require the seafarer to demonstrate the relevant competence at the place of duty. Such a demonstration may include verification that operational requirements in respect of watchkeeping standards have been met and that there is a proper response to emergency situations within the seafarer’s level of competence.

Detention

Without prejudice to Directive 95/21/EC, the following deficiencies, in so far as they have been determined by the officer carrying out the port State control that they pose a danger to persons, property or the environment, shall be the only grounds under this Directive on which a Member State may detain a ship:
(a)
failure of seafarers to hold certificates, to have appropriate certificates, to have valid dispensations or provide documentary proof that an application for an endorsement attesting recognition has been submitted to the authorities of the flag State;
(b)
failure to comply with the applicable safe-manning requirements of the flag State;
(c)
failure of navigational or engineering-watch arrangements to conform to the requirements specified for the ship by the flag State;
(d)
absence in a watch of a person qualified to operate equipment essential to safe navigation, safety radio communications or the prevention of marine pollution;
(e)
failure to provide proof of professional proficiency for the duties assigned to seafarers for the safety of the ship and the prevention of pollution;
(f)
inability to provide for the first watch at the commencement of a voyage and for subsequent relieving watches persons who are sufficiently rested and otherwise fit for duty.

Regular monitoring of compliance

Without prejudice to the powers of the Commission under Article 226 of the Treaty, the Commission, assisted by the European Maritime Safety Agency, shall verify on a regular basis and at least every five years that Member States comply with the minimum requirements laid down by this Directive.

Reports

1. Not later than 14 December 2008 the Commission shall submit an evaluation report to the European Parliament and the Council, based on a detailed analysis and evaluation of the provisions of the STCW Convention, the implementation thereof and new insights gained with regard to the correlation between safety and the level of training of ships’ crews.
2. Not later than 20 October 2010 the Commission shall submit to the European Parliament and the Council an evaluation report drawn up on the basis of the information obtained pursuant to Article 25.
In the report the Commission shall analyse the Member States’ compliance with this Directive and, where necessary, make proposals for additional measures.

Amendment

1. This Directive may be amended by the Commission in order to apply, for the purposes of this Directive, subsequent amendments to the international codes referred to in points (16), (17), (18), (23) and (24) of Article 1 which have entered into force.
This Directive may also be amended by the Commission in order to apply, for the purposes of this Directive, any relevant amendments to Community legislation.
Those measures designed to amend non-essential elements of this Directive shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3).
2. Following the adoption of new instruments or protocols to the STCW Convention, the Council, acting on a proposal from the Commission, shall decide, taking into account the Member States’ parliamentary procedures, as well as the relevant procedures within the IMO on the detailed arrangements for ratifying those new instruments or protocols, while ensuring that they are applied uniformly and simultaneously in the Member States.
3. The amendments to the international instruments referred to in Article 1(16), (17), (18), (21), (22) and (24) may be excluded from the scope of this Directive, pursuant to Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council of 5 November 2002 establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS)(10).

Committee procedure

1. The Commission shall be assisted by the Committee on Safe Seas and the Prevention of Pollution from Ships (COSS), established by Regulation (EC) No 2099/2002.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at eight weeks.
3. Where reference is made to this paragraph, Article 5a(1) to (4), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

Transitional provisions

Where pursuant to Article 12 a Member State reissues or extends the validity of certificates which it originally issued under the provisions which applied before 1 February 1997, the Member State may, at its discretion, replace tonnage limitations appearing on the original certificates as follows:
(a)
‘200 gross registered tonnes’ may be replaced by ‘500 gross tonnage’;
(b)
‘1 600 gross registered tonnes’ may be replaced by ‘3 000 gross tonnage’.

Penalties

Member States shall lay down systems of penalties for breaching the national provisions adopted pursuant to Articles 1, 3, 5, 7, 9 to 15, 17, 18, 19, 22, 23, 24 and 29, and Annexes I and II, and shall take all the measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.

Communication

Member States shall immediately communicate to the Commission the texts of all the provisions which they adopt in the field governed by this Directive.
The Commission shall inform the other Member States thereof.

Repeal

Directive 2001/25/EC, as amended by the Directives listed in Annex III, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex III, Part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.

Entry into force

This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Addressees

This Directive is addressed to the Member States.

TRAINING REQUIREMENTS OF THE STCW CONVENTION, REFERRED TO IN ARTICLE 3

ANNEX ICHAPTER IGENERAL PROVISIONS
| 1. | The Regulations referred to in this Annex are supplemented by the mandatory provisions contained in Part A of the STCW Code with the exception of Chapter VIII, Regulation VIII/2.Any reference to a requirement in a Regulation also constitutes a reference to the corresponding section of Part A of the STCW Code.
| 2. | Member States shall ensure that seafarers possess adequate language proficiency, as defined in Sections A-II/1, A-III/1, A-IV/2 and A-II/4 of the STCW Code so as to enable them to perform their specific duties on a vessel flying the flag of a host Member State.
| 3. | Part A of the STCW Code contains standards of competence required to be demonstrated by candidates for the issue, and revalidation of certificates of competency under the provisions of the STCW Convention. To clarify the linkage between the alternative certification provisions of Chapter VII and the certification provisions of Chapters II, III and IV, the abilities specified in the standards of competence are grouped as appropriate under the following seven functions:1.Navigation;2.Cargo handling and stowage;3.Controlling the operation of the ship and care for persons on board;4.Marine engineering;5.Electrical, electronic and control engineering;6.Maintenance and repair;7.Radio communications,at the following levels of responsibility:1.Management level;2.Operational level;3.Support level.Functions and levels of responsibility are identified by subtitle in the tables of standards of competence given specified in Chapters II, III and IV of the Part A of the STCW Code. | 1. | Navigation; | 2. | Cargo handling and stowage; | 3. | Controlling the operation of the ship and care for persons on board; | 4. | Marine engineering; | 5. | Electrical, electronic and control engineering; | 6. | Maintenance and repair; | 7. | Radio communications, | 1. | Management level; | 2. | Operational level; | 3. | Support level.
1. | Navigation;
2. | Cargo handling and stowage;
3. | Controlling the operation of the ship and care for persons on board;
4. | Marine engineering;
5. | Electrical, electronic and control engineering;
6. | Maintenance and repair;
7. | Radio communications,
1. | Management level;
2. | Operational level;
3. | Support level.CHAPTER IIMASTER AND DECK DEPARTMENTRegulation II/1Mandatory minimum requirements for certification of officers in charge of a navigational watch on ships of 500 gross tonnage or more
| 1. | Every officer in charge of a navigational watch serving on a seagoing ship of 500 gross tonnage or more shall hold an appropriate certificate.
| 2. | Every candidate for certification shall:2.1.be not less than 18 years of age;2.2.have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years;2.3.have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months;2.4.meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations;2.5.have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code. | 2.1. | be not less than 18 years of age; | 2.2. | have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years; | 2.3. | have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months; | 2.4. | meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations; | 2.5. | have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code.
2.1. | be not less than 18 years of age;
2.2. | have approved seagoing service of not less than one year as part of an approved training programme which includes on-board training which meets the requirements of Section A-II/1 of the STCW Code and is documented in an approved training record book, or otherwise have approved seagoing service of not less than three years;
2.3. | have performed, during the required seagoing service, bridge watchkeeping duties under the supervision of the master or a qualified officer for a period of not less than six months;
2.4. | meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designed radio duties in accordance with the Radio Regulations;
2.5. | have completed approved education and training and meet the standard of competence specified in Section A-II/1 of the STCW Code.Regulation II/2Mandatory minimum requirements for certification of masters and chief mates on ships of 500 gross tonnage or moreMaster and chief mate on ships of 3 000 gross tonnage or more
| 1. | Every master and chief mate on a seagoing ship of 3 000 gross tonnage or more shall hold an appropriate certificate.
| 2. | Every candidate for certification shall:2.1.meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;2.2.have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more. | 2.1. | meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; | 2.1.1. | for certification as chief mate, not less than 12 months; and | 2.1.2. | for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; | 2.2. | have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more.
2.1. | meet the requirements for certification as an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service in that capacity:2.1.1.for certification as chief mate, not less than 12 months; and2.1.2.for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; | 2.1.1. | for certification as chief mate, not less than 12 months; and | 2.1.2. | for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.1.1. | for certification as chief mate, not less than 12 months; and
2.1.2. | for certification as master, not less than 36 months; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
2.2. | have completed approved education and training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of 3 000 gross tonnage or more.Master and chief mate on ships of between 500 and 3 000 gross tonnage
| 3. | Every master and chief mate on a seagoing ship of between 500 and 3 000 gross tonnage shall hold an appropriate certificate.
| 4. | Every candidate for certification shall:4.1.for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more;4.2.for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;4.3.have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage. | 4.1. | for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more; | 4.2. | for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate; | 4.3. | have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage.
4.1. | for certification as chief mate, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more;
4.2. | for certification as master, meet the requirements of an officer in charge of a navigational watch on ships of 500 gross tonnage or more and have approved seagoing service of not less than 36 months in that capacity; however, this period may be reduced to not less than 24 months if not less than 12 months of such seagoing service has been served as chief mate;
4.3. | have completed approved training and meet the standard of competence specified in Section A-II/2 of the STCW Code for masters and chief mates on ships of between 500 and 3 000 gross tonnage.Regulation II/3Mandatory minimum requirements for certification of officers in charge of a navigational watch and of masters on ships of less than 500 gross tonnageShips not engaged on near-coastal voyages
| 1. | Every officer in charge of a navigational watch serving on a seagoing ship of less than 500 gross tonnage not engaged on near-coastal voyages shall hold an appropriate certificate for ships of 500 gross tonnage or more.
| 2. | Every master serving on a seagoing ship of less than 500 gross tonnage not engaged on near-coastal voyages shall hold an appropriate certificate for service as master on ships of between 500 and 3 000 gross tonnage.Ships engaged on near-coastal voyagesOfficer in charge of a navigational watch
| 3. | Every officer in charge of a navigational watch on a seagoing ship of less than 500 gross tonnage engaged on near-coastal voyages shall hold an appropriate certificate.
| 4. | Every candidate for certification as officer in charge of a navigational watch on a seagoing ship of less than 500 gross tonnage engaged on near-coastal voyages shall:4.1.be not less than 18 years of age;4.2.have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years;4.3.meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;4.4.have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages. | 4.1. | be not less than 18 years of age; | 4.2. | have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years; | 4.2.1. | special training, including an adequate period of appropriate seagoing service as required by the Administration; or | 4.2.2. | approved seagoing service in the deck department of not less than three years; | 4.3. | meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations; | 4.4. | have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages.
4.1. | be not less than 18 years of age;
4.2. | have completed:4.2.1.special training, including an adequate period of appropriate seagoing service as required by the Administration; or4.2.2.approved seagoing service in the deck department of not less than three years; | 4.2.1. | special training, including an adequate period of appropriate seagoing service as required by the Administration; or | 4.2.2. | approved seagoing service in the deck department of not less than three years;
4.2.1. | special training, including an adequate period of appropriate seagoing service as required by the Administration; or
4.2.2. | approved seagoing service in the deck department of not less than three years;
4.3. | meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;
4.4. | have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for officers in charge of a navigational watch on ships of less than 500 gross tonnage engaged on near-coastal voyages.Master
| 5. | Every master serving on a seagoing ship of less than 500 gross tonnage engaged on near-coastal voyages shall hold an appropriate certificate.
| 6. | Every candidate for certification as master on a seagoing ship of less than 500 gross tonnage engaged on a near-coastal voyages shall:6.1.be not less than 20 years of age;6.2.have approved seagoing service of not less than 12 months as officer in charge of a navigational watch;6.3.have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages. | 6.1. | be not less than 20 years of age; | 6.2. | have approved seagoing service of not less than 12 months as officer in charge of a navigational watch; | 6.3. | have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages.
6.1. | be not less than 20 years of age;
6.2. | have approved seagoing service of not less than 12 months as officer in charge of a navigational watch;
6.3. | have completed approved education and training and meet the standard of competence specified in Section A-II/3 of the STCW Code for masters on ships of less than 500 gross tonnage engaged on near-coastal voyages.
| 7. | ExemptionsThe Administration, if it considers that a ship’s size and the conditions of its voyage are such as to render the application of the full requirements of this regulation and Section A-II/3 of the STCW Code unreasonable or impracticable, may to that extent exempt the master and the officer in charge of a navigational watch on such a ship or class of ships from some of the requirements, bearing in mind the safety of all ships which may be operating in the same waters.Regulation II/4Mandatory minimum requirements for certification of ratings forming part of a navigational watch
| 1. | Every rating forming part of a navigational watch on a seagoing ship of 500 gross tonnage or more, other than ratings under training and ratings whose duties while on watch are of an unskilled nature, shall be duly certificated to perform such duties.
| 2. | Every candidate for certification shall:2.1.be not less than 16 years of age;2.2.have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;2.3.meet the standard of competence specified in Section A-II/4 of the STCW Code. | 2.1. | be not less than 16 years of age; | 2.2. | have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; | 2.2.1. | approved seagoing service including not less than six months training and experience; or | 2.2.2. | special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; | 2.3. | meet the standard of competence specified in Section A-II/4 of the STCW Code.
2.1. | be not less than 16 years of age;
2.2. | have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; | 2.2.1. | approved seagoing service including not less than six months training and experience; or | 2.2.2. | special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. | approved seagoing service including not less than six months training and experience; or
2.2.2. | special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.3. | meet the standard of competence specified in Section A-II/4 of the STCW Code.
| 3. | The seagoing service, training and experience required by points 2.2.1 and 2.2.2 shall be associated with navigational watchkeeping functions and involve the performance of duties carried out under the direct supervision of the master, the officer in charge of the navigational watch or a qualified rating.
| 4. | Seafarers may be considered by a Member State to have met the requirements of this regulation if they have served in a relevant capacity in the deck department for a period of not less than one year within the last five preceding the entry into force of the STCW Convention for that Member State.CHAPTER IIIENGINE DEPARTMENTRegulation III/1Mandatory minimum requirements for certification of officers in charge of an engineering watch in a manned engine-room or designated duty engineers in a periodically unmanned engine-room
| 1. | Every officer in charge of an engineering watch in a manned engine-room or designated duty engineer officer in a periodically unmanned engine-room on a seagoing ship powered by main propulsion machinery of 750 kW propulsion power or more shall hold an appropriate certificate.
| 2. | Every candidate for certification shall:2.1.be not less than 18 years of age;2.2.have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code;2.3.have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code. | 2.1. | be not less than 18 years of age; | 2.2. | have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code; | 2.3. | have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code.
2.1. | be not less than 18 years of age;
2.2. | have completed not less than six months seagoing service in the engine department in accordance with Section A-III/1 of the STCW Code;
2.3. | have completed approved education and training of at least 30 months which includes on-board training documented in an approved training record book and meet the standards of competence specified in Section A-III/1 of the STCW Code.Regulation III/2Mandatory minimum requirements for certification of chief engineer officers and second engineer officers on ships powered by main propulsion machinery of 3 000 kW propulsion power or more
| 1. | Every chief engineer officer and second engineer officer on a seagoing ship powered by main propulsion machinery of 3 000 kW propulsion power or more shall hold an appropriate certificate.
| 2. | Every candidate for certification shall:2.1.meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;2.2.have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code. | 2.1. | meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; | 2.1.1. | for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and | 2.1.2. | for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; | 2.2. | have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code.
2.1. | meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer; | 2.1.1. | for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and | 2.1.2. | for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.1.1. | for certification as a second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. | for certification as chief engineer officer, shall have not less than 36 months approved seagoing service of which not less than 12 months shall have been served as an engineer officer in a position of responsibility while qualified to serve as second engineer officer;
2.2. | have completed approved education and training and meet the standard of competence specified in Section A-III/2 of the STCW Code.Regulation III/3Mandatory minimum requirements for certification of chief engineer officers and second engineer officers on ships powered by main propulsion machinery of between 750 kW and 3 000 kW propulsion power
| 1. | Every chief engineer officer and second engineer officer on a seagoing ship powered by main propulsion machinery of between 750 and 3 000 kW propulsion power shall hold an appropriate certificate.
| 2. | Every candidate for certification shall:2.1.meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;2.2.have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code. | 2.1. | meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; | 2.1.1. | for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and | 2.1.2. | for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; | 2.2. | have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code.
2.1. | meet the requirements for certification as an officer in charge of an engineering watch and:2.1.1.for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and2.1.2.for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer; | 2.1.1. | for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and | 2.1.2. | for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.1.1. | for certification as second engineer officer, shall have not less than 12 months approved seagoing service as assistant engineer officer or engineer officer; and
2.1.2. | for certification as chief engineer officer, shall have not less than 24 months approved seagoing service of which not less than 12 months shall be served while qualified to serve as second engineer officer;
2.2. | have completed approved education and training and meet the standard of competence specified in Section A-III/3 of the STCW Code.
| 3. | Every engineer officer who is qualified to serve as second engineer officer on ships powered by main propulsion machinery of 3 000 kW propulsion power or more, may serve as chief engineer officer on ships powered by main propulsion machinery of less than 3 000 kW propulsion power, provided that not less than 12 months approved seagoing service shall have been served as an engineer officer in a position of responsibility and the certificate is so endorsed.Regulation III/4Mandatory minimum requirements for certification of ratings forming part of a watch in a manned engine-room or designated to perform duties in a periodically unmanned engine-room
| 1. | Every rating forming part of an engine-room watch or designated to perform duties in a periodically unmanned engine-room on a seagoing ship powered by main propulsion machinery of 750 kW propulsion power or more, other than ratings under training and ratings whose duties are of an unskilled nature, shall be duly certificated to perform such duties.
| 2. | Every candidate for certification shall:2.1.be not less than 16 years of age;2.2.have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;2.3.meet the standard of competence specified in Section A-III/4 of the STCW Code. | 2.1. | be not less than 16 years of age; | 2.2. | have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; | 2.2.1. | approved seagoing service including not less than six months training and experience; or | 2.2.2. | special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; | 2.3. | meet the standard of competence specified in Section A-III/4 of the STCW Code.
2.1. | be not less than 16 years of age;
2.2. | have completed:2.2.1.approved seagoing service including not less than six months training and experience; or2.2.2.special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months; | 2.2.1. | approved seagoing service including not less than six months training and experience; or | 2.2.2. | special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.2.1. | approved seagoing service including not less than six months training and experience; or
2.2.2. | special training, either pre-sea or on board ship, including an approved period of seagoing service which shall not be less than two months;
2.3. | meet the standard of competence specified in Section A-III/4 of the STCW Code.
| 3. | The seagoing service, training and experience required by points 2.2.1 and 2.2.2 shall be associated with engine-room watchkeeping functions and involve the performance of duties carried out under the direct supervision of a qualified engineer officer or a qualified rating.
| 4. | Seafarers may be considered by a Member State to have met the requirements of this regulation if they have served in a relevant capacity in the engine department for a period of not less than one year within the last five years preceding the entry into force of the STCW Convention for that Member State.CHAPTER IVRADIO COMMUNICATION AND RADIO PERSONNELExplanatory noteMandatory provisions relating to radio watchkeeping are set forth in the Radio Regulations and in the SOLAS 74, as amended. Provisions for radio maintenance are set forth in the SOLAS 74, as amended, and the guidelines adopted by the International Maritime Organisation.
Regulation IV/1Application
| 1. | Except as provided in point 2, the provisions of this chapter apply to radio personnel on ships operating in the global maritime distress and safety system (GMDSS) as prescribed by the SOLAS 74, as amended.
| 2. | Radio personnel on ships not required to comply with the provisions of the GMDSS in Chapter IV of the SOLAS 74 are not required to meet the provisions of this chapter. Radio personnel on these ships are, nevertheless, required to comply with the Radio Regulations. The Administration shall ensure that the appropriate certificates as prescribed by the Radio Regulations are issued to or recognised in respect of such radio personnel.Regulation IV/2Mandatory minimum requirements for certification of GMDSS radio personnel
| 1. | Every person in charge of or performing radio duties on a ship required to participate in the GMDSS shall hold an appropriate certificate related to the GMDSS, issued or recognised by the Administration under the provisions of the Radio Regulations.
| 2. | In addition, every candidate for certification under this regulation for service on a ship which is required by the SOLAS 74, as amended, to have a radio installation shall:2.1.be not less than 18 years of age; and2.2.have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code. | 2.1. | be not less than 18 years of age; and | 2.2. | have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code.
2.1. | be not less than 18 years of age; and
2.2. | have completed approved education and training and meet the standard of competence specified in Section A-IV/2 of the STCW Code.CHAPTER VSPECIAL TRAINING REQUIREMENTS FOR PERSONNEL ON CERTAIN TYPES OF SHIPSRegulation V/1Mandatory minimum requirements for the training and qualification of masters, officers and ratings on tankers
| 1. | Officers and ratings assigned specific duties and responsibilities relating to cargo or cargo equipment on tankers shall have completed an approved shore-based firefighting course in addition to the training required by Regulation VI/1 and shall have completed:1.1.at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or1.2.an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided:1.3.the period so accepted is not less than one month;1.4.the tanker is of less than 3 000 gross tonnage;1.5.the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours;1.6.the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired. | 1.1. | at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or | 1.2. | an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided: | 1.3. | the period so accepted is not less than one month; | 1.4. | the tanker is of less than 3 000 gross tonnage; | 1.5. | the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours; | 1.6. | the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired.
1.1. | at least three months of approved seagoing service on tankers in order to acquire adequate knowledge of safe operational practices; or
1.2. | an approved tanker-familiarisation course covering at least the syllabus given for that course in Section A-V/1 of the STCW Code.However the Administration may accept a period of supervised seagoing service shorter than that prescribed by point 1.1, provided:
1.3. | the period so accepted is not less than one month;
1.4. | the tanker is of less than 3 000 gross tonnage;
1.5. | the duration of each voyage on which the tanker is engaged during the period does not exceed 72 hours;
1.6. | the operational characteristics of the tanker and the number of voyages and loading and discharging operations completed during the period allow the same level of knowledge and experience to be acquired.
| 2. | Masters, chief engineer officers, chief mates, second engineer officers and any person with immediate responsibility for loading, discharging and care in transit or handling of cargo shall, in addition to meeting the requirements of point 1.1 or 1.2, have:2.1.experience appropriate to their duties on the type of tanker on which they serve; and2.2.completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve. | 2.1. | experience appropriate to their duties on the type of tanker on which they serve; and | 2.2. | completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve.
2.1. | experience appropriate to their duties on the type of tanker on which they serve; and
2.2. | completed an approved specialised training programme which at least covers the subjects set out in Section A-V/1 of the STCW Code that are appropriate to their duties on the oil tanker, chemical tanker or liquefied gas tanker on which they serve.
| 3. | Within two years after the entry into force of the STCW Convention for a Member State, seafarers may be considered to have met the requirements of point 2.2 if they have served in a relevant capacity on board the type of tanker concerned for a period of not less than one year within the preceding five years.
| 4. | Administrations shall ensure that an appropriate certificate is issued to masters and officers, who are qualified in accordance with points 1 or 2 as appropriate, or that an existing certificate is duly endorsed. Every rating who is so qualified shall be duly certificated.Regulation V/2Mandatory minimum requirements for the training and qualifications of masters, officers, ratings and other personnel on ro-ro passenger ships
| 1. | This Regulation applies to masters, officers, ratings and other personnel serving on board ro-ro passenger ships engaged on international voyages. Administrations shall determine the applicability of these requirements to personnel serving on ro-ro passenger ships engaged on domestic voyages.
| 2. | Prior to being assigned shipboard duties on board ro-ro passenger ships, seafarers shall have completed the training required by points 4 to 8 in accordance with their capacities, duties and responsibilities.
| 3. | Seafarers who are required to be trained in accordance with points 4, 7 and 8 shall at intervals not exceeding five years undertake appropriate refresher training or be required to provide evidence of having achieved the required standard of competence within the previous five years.
| 4. | Masters, officers and other personnel designated on muster lists to assist passengers in emergency situations on board ro-ro passenger ships shall have completed training in crowd management as specified in Section A-V/2, paragraph 1, of the STCW Code.
| 5. | Masters, officers and other personnel assigned specific duties and responsibilities on board ro-ro passenger ships shall have completed the familiarisation training specified in Section A-V/2, paragraph 2, of the STCW Code.
| 6. | Personnel providing direct service to passengers in passenger spaces on board ro-ro passenger ships shall have completed the safety training specified in Section A-V/2, paragraph 3, of the STCW Code.
| 7. | Masters, chief mates, chief engineer officers, second engineer officers and every person assigned immediate responsibility for embarking and disembarking passengers, loading, discharging or securing cargo, or closing hull openings on board ro-ro passenger ships shall have completed approved training in passenger safety, cargo safety and hull integrity as specified in Section A-V/2, paragraph 4, of the STCW Code.
| 8. | Masters, chief mates, chief engineer officers, second engineer officers and any person having responsibility for the safety of passengers in emergency situations on board ro-ro passenger ships shall have completed approved training in crisis management and human behaviour as specified in Section A-V/2, paragraph 5, of the STCW Code.
| 9. | Administrations shall ensure that documentary evidence of the training which has been completed is issued to every person found qualified under the provisions of this Regulation.Regulation V/3Mandatory minimum requirements for the training and qualifications of masters, officers, ratings and other personnel on passenger ships other than ro-ro passenger ships
| 1. | This Regulation applies to masters, officers, ratings and other personnel serving on board passenger ships, other than ro-ro passenger ships, engaged on international voyages. Administrations shall determine the applicability of these requirements to personnel serving on passenger ships engaged on domestic voyages.
| 2. | Prior to being assigned shipboard duties on board passenger ships, seafarers shall have completed the training required by points 4 to 8 in accordance with their capacity, duties and responsibilities.
| 3. | Seafarers who are required to be trained in accordance with points 4, 7 and 8 shall, at intervals not exceeding five years, undertake appropriate refresher training or be required to provide evidence of having achieved the required standard of competence within the previous five years.
| 4. | Personnel designated on muster lists to assist passengers in emergency situations on board passenger ships shall have completed training in crowd management as specified in Section A-V/3, paragraph 1, of the STCW Code.
| 5. | Masters, officers and other personnel assigned specific duties and responsibilities on board passenger ships shall have completed the familiarisation training specified in Section A-V/3, paragraph 2, of the STCW Code.
| 6. | Personnel providing direct service to passengers on board passenger ships in passenger spaces shall have completed the safety training specified in Section A-V/3, paragraph 3, of the STCW Code.
| 7. | Masters, chief mates and every person assigned immediate responsibility for embarking and disembarking passengers shall have completed approved training in passenger safety as specified in Section A-V/3, paragraph 4, of the STCW Code.
| 8. | Masters, chief mates, chief engineer officers, second engineer officers and any person having responsibility for the safety of passengers in emergency situations on board passenger ships shall have completed approved training in crisis management and human behaviour as specified in Section A-V/3, paragraph 5, of the STCW Code.
| 9. | Administrations shall ensure that documentary evidence of the training which has been completed is issued for every person found qualified under the provisions of this Regulation.CHAPTER VIEMERGENCY, OCCUPATIONAL SAFETY, MEDICAL CARE AND SURVIVAL FUNCTIONSRegulation VI/1Mandatory minimum requirements for familiarisation, basic safety training and instruction for all seafarersSeafarers shall receive familiarisation and basic safety training or instruction in accordance with Section A-VI/1 of the STCW Code and shall meet the appropriate standard of competence specified therein.
Regulation VI/2Mandatory minimum requirements for the issue of certificates of proficiency in survival craft, rescue boats and fast rescue boats
| 1. | Every candidate for a certificate of proficiency in survival craft and rescue boats other than fast rescue boats shall:1.1.be not less than 18 years of age;1.2.have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months;1.3.meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code. | 1.1. | be not less than 18 years of age; | 1.2. | have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months; | 1.3. | meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code.
1.1. | be not less than 18 years of age;
1.2. | have approved seagoing service of not less than 12 months or have attended an approved training course and have approved seagoing service of not less than six months;
1.3. | meet the standard of competence for certificates of proficiency in survival craft and rescue boats set out in Section A-VI/2, paragraphs 1 to 4, of the STCW Code.
| 2. | Every candidate for a certificate of proficiency in fast rescue boats shall:2.1.be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats;2.2.have attended an approved training course;2.3.meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code. | 2.1. | be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats; | 2.2. | have attended an approved training course; | 2.3. | meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code.
2.1. | be the holder of a certificate of proficiency in survival craft and rescue boats other than fast rescue boats;
2.2. | have attended an approved training course;
2.3. | meet the standard of competence for certificates of proficiency in fast rescue boats set out in Section A-VI/2, paragraphs 5 to 8, of the STCW Code.Regulation VI/3Mandatory minimum requirements for training in advanced firefighting
| 1. | Seafarers designated to control firefighting operations shall have successfully completed advanced training in techniques for fighting fire with particular emphasis on organisation, tactics and command in accordance with the provisions of Section A-VI/3 of the STCW Code and shall meet the standard of competence specified therein.
| 2. | Where training in advanced firefighting is not included in the qualifications for the certificate to be issued, a special certificate or documentary evidence, as appropriate, shall be issued indicating that the holder has attended a course of training in advanced firefighting.Regulation VI/4Mandatory minimum requirements relating to medical first aid and medical care
| 1. | Seafarers designated to provide medical first aid on board ship shall meet the standard of competence in medical first aid specified in Section A-VI/4, paragraphs 1, 2 and 3, of the STCW Code.
| 2. | Seafarers designated to take charge of medical care on board ship shall meet the standard of competence in medical care on board ships specified in Section A-VI/4, paragraphs 4, 5 and 6, of the STCW Code.
| 3. | Where training in medical first aid or medical care is not included in the qualifications for the certificate to be issued, a special certificate or documentary evidence, as appropriate, shall be issued indicating that the holder has attended a course of training in medical first aid or in medical care.CHAPTER VIIALTERNATIVE CERTIFICATIONRegulation VII/1Issue of alternative certificates
| 1. | Notwithstanding the requirements for certification laid down in Chapters II and III of this Annex, Member States may elect to issue or authorise the issue of certificates other than those mentioned in the regulations of those chapters, provided that:1.1.the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code;1.2.the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements;1.3.the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code;1.4.the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;1.5.the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code. | 1.1. | the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code; | 1.2. | the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements; | 1.3. | the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code; | 1.4. | the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations; | 1.5. | the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code.
1.1. | the associated functions and levels of responsibility to be stated on the certificates and in the endorsements are selected from and identical to those appearing in Sections A-II/1, A-II/2, A-II/3, A-II/4, A-III/1, A-III/2, A-III/3, A-III/4 and A-IV/2 of the STCW Code;
1.2. | the candidates have completed approved education and training and meet the requirements for standards of competence, prescribed in the relevant sections of the STCW Code and as set forth in Section A-VII/1 of this Code, for the functions and levels that are to be stated on the certificates and in the endorsements;
1.3. | the candidates have completed approved seagoing service appropriate to the performance of the functions and levels that are to be stated on the certificate. The minimum duration of seagoing service shall be equivalent to the duration of seagoing service prescribed in Chapters II and III of this Annex. However, the minimum duration of seagoing service shall be not less than as prescribed in Section A-VII/2 of the STCW Code;
1.4. | the candidates for certification who are to perform the function of navigation at the operational level shall meet the applicable requirements of the regulations in Chapter IV, as appropriate, for performing designated radio duties in accordance with the Radio Regulations;
1.5. | the certificates are issued in accordance with the requirements of Article 11 and the provisions set forth in Chapter VII of the STCW Code.
| 2. | No certificate shall be issued under this chapter unless the Member State has communicated the information required by the STCW Convention to the Commission.Regulation VII/2Certification of seafarersEvery seafarer who performs any function or group of functions specified in Tables, A-II/1, A-II/2, A-II/3 or AII/4 of Chapter II or in Tables A-III/1, A-III/2, A-III/4 of Chapter III or A-IV/2 of Chapter IV of the STCW Code, shall hold an appropriate certificate.
Regulation VII/3Principles governing the issue of alternative certificates
| 1. | A Member State which elects to issue or authorise the issue of alternative certificates shall ensure that the following principles are observed:1.1.no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters;1.2.any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters. | 1.1. | no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters; | 1.2. | any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters.
1.1. | no alternative certification system shall be implemented unless it ensures a degree of safety at sea and has a preventive effect as regards pollution at least equivalent to that provided by the other chapters;
1.2. | any arrangement for alternative certification issued under this chapter shall provide for the interchangeability of certificates with those issued under the other chapters.
| 2. | The principle of interchangeability in point 1 shall ensure that:2.1.seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation;2.2.seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere. | 2.1. | seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation; | 2.2. | seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere.
2.1. | seafarers certificated under the arrangements of Chapters II and/or III and those certificated under Chapter VII are able to serve on ships which have either traditional or other forms of shipboard organisation;
2.2. | seafarers are not trained for specific shipboard arrangements in such a way as would impair their ability to take their skills elsewhere.
| 3. | In issuing any certificate under the provisions of this chapter the following principles shall be taken into account:3.1.the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;3.2.the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification. | 3.1. | the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; | 3.1.1. | to reduce the number of crew on board; | 3.1.2. | to lower the integrity of the profession or ‘deskill’ seafarers; or | 3.1.3. | to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; | 3.2. | the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification.
3.1. | the issue of alternative certificates shall not be used in itself:3.1.1.to reduce the number of crew on board;3.1.2.to lower the integrity of the profession or ‘deskill’ seafarers; or3.1.3.to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch; | 3.1.1. | to reduce the number of crew on board; | 3.1.2. | to lower the integrity of the profession or ‘deskill’ seafarers; or | 3.1.3. | to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.1.1. | to reduce the number of crew on board;
3.1.2. | to lower the integrity of the profession or ‘deskill’ seafarers; or
3.1.3. | to justify the assignment of the combined duties of the engine and check watchkeeping officers to a single certificate holder during any particular watch;
3.2. | the person in command shall be designated as the master and the legal position and authority of the master and others shall not be adversely affected by the implementation of any arrangement for alternative certification.
| 4. | The principles contained in points 1 and 2 shall ensure that the competency of both deck and engineer officers is maintained.

CRITERIA FOR THE RECOGNITION OF THIRD COUNTRIES THAT HAVE ISSUED A CERTIFICATE OR UNDER THE AUTHORITY OF WHICH WAS ISSUED A CERTIFICATE, REFERRED TO IN ARTICLE 19(2)

ANNEX II
| 1. | The third country must be a Party to the STCW Convention.
| 2. | The third country must have been identified by the Maritime Safety Committee as having demonstrated that full and complete effect is given to the provisions of the STCW Convention.
| 3. | The Commission, assisted by the European Maritime Safety Agency and with the possible involvement of any Member State concerned, must have confirmed, through all necessary measures, which may include the inspection of facilities and procedures, that the requirements concerning the standard of competence, the issue and endorsement of certificates and record keeping are fully complied with, and that a quality standards system has been established pursuant to Regulation I/8 of the STCW Convention.
| 4. | The Member State is in the process of agreeing an undertaking with the third country concerned that prompt notification will be given of any significant change in the arrangements for training and certification provided in accordance with the STCW Convention.
| 5. | The Member State has introduced measures to ensure that seafarers who present for recognition certificates for functions at management level have an appropriate knowledge of the maritime legislation of the Member State relevant to the functions they are permitted to perform.
| 6. | If a Member State wishes to supplement assessment of compliance of a third country by evaluating certain maritime training institutes, it shall proceed according to the provisions of section A-I/6 of the STCW Code.

PART A

ANNEX IIIRepealed Directive with list of its successive amendments(referred to in Article 32)
Directive 2001/25/EC of the European Parliament and of the Council(OJ L 136, 18.5.2001, p. 17). |
Directive 2002/84/EC of the European Parliament and of the Council(OJ L 324, 29.11.2002, p. 53). | only Article 11
Directive 2003/103/EC of the European Parliament and of the Council(OJ L 326, 13.12.2003, p. 28). |
Commission Directive 2005/23/EC(OJ L 62, 9.3.2005, p. 14). |
Directive 2005/45/EC of the European Parliament and of the Council(OJ L 255, 30.9.2005, p. 160). | only Article 4PART BList of time limits for transposition into national law(referred to in Article 32)
Directive | Deadline for transposition
2002/84/EC | 23 November 2003
2003/103/EC | 14 May 2005
2005/23/EC | 29 September 2005
2005/45/EC | 20 October 2007
ANNEX IVCORRELATION TABLE
Directive 2001/25/EC | This Directive
Article 1 | Article 1
Article 2, introductory words | Article 2, introductory words
Article 2, first to fourth indent | Article 2(a) to (d)
Articles 3 to 7 | Articles 3 to 7
Article 7a | Article 8
Article 8 | Article 9
Article 9(1) introductory wording | Article 10(1) first subparagraph introductory wording
Article 9(1)(a) and (b) | Article 10(1) first subparagraph (a) and (b)
Article 9(1)(c) first sentence | Article 10(1) first subparagraph (c)
Article 9(1)(c) second sentence | Article 10(1) second subparagraph
Article 9(1)(d) | Article 10(1) first subparagraph (d)
Article 9(2) and (3) | Article 10(2) and (3)
Article 10 | Article 11
Article 11 | Article 12
Article 12 | Article 13
Article 13 | Article 14
Article 14 | Article 15
Article 15 | Article 16
Article 16(1), introductory phrase | Article 17(1), introductory phrase
Article 16(1), first indent to fourth indent | Article 17(1)(a) to (d)
Article 16(2), introductory wording | Article 17(2), introductory wording
Article 16(2)(a)(1) and (2) | Article 17(2)(a)(i) and (ii)
Article 16(2)(b) and (c) | Article 17(2)(b) and (c)
Article 16(2)(d)(1) and (2) | Article 17(2)(d)(i) and (ii)
Article 16(2)(d)(3)(i) and (ii) | Article 17(2)(d)(iii), first and second indent
Article 16(2)(e) | Article 17(2)(e)
Article 16(2)(f)(1) to (5) | Article 17(2)(f)(i) to (v)
Article 16(2)(g) | Article 17(2)(g)
Article 17 | Article 18
Article 18(1) and (2) | –
Article 18(3), introductory phrase | Article 19(1)
Article 18(3)(a) | Article 19(2)
Article 18(3)(b) | Article 19(3), first subparagraph
Article 18(3)(c) | Article 19(3), second subparagraph
Article 18(3)(d) | Article 19(4)
Article 18(3)(e) | Article 19(5)
Article 18(3)(f) | Article 19(6)
Article 18(4) | Article 19(7)
Article 18a(1), first and second sentence | Article 20(1), first and second subparagraph
Article 18a(2), first and second sentence | Article 20(2), first and second subparagraph
Article 18a(3) to (5) | Article 20(3) to (5)
Article 18a(6), first and second sentence | Article 20(6), first and second subparagraph
Article 18a(7) | Article 20(7)
Article 18b | Article 21
Article 19 | Article 22
Article 20(1), introductory words | Article 23(1), introductory words
Article 20(1), first and second indent | Article 23(1)(a) and (b)
Article 20(2), introductory words | Article 23(2), introductory words
Article 20(2), first to sixth indent | Article 23(2)(a) to (f)
Article 20(3) | Article 23(3)
Article 21 | Article 24
Article 21a | Article 25
– | Article 26(1)
Article 21b, first sentence | Article 26(2), first subparagraph
Article 21b, second sentence | Article 26(2), second subparagraph
Article 22(1), first sentence | Article 27(1), first subparagraph
Article 22(1) second sentence | Article 27(1), second subparagraph
– | Article 27(1), third subparagraph
Article 22(3) and (4) | Article 27(2) and (3)
Article 23(1) and (2) | Article 28(1) and (2)
– | Article 28(3)
Article 23(3) | –
Article 24(1) and (2) | –
Article 24(3)(1) and (2) | Article 29(a) and (b)
Article 25 | Article 30
Article 26, first sentence | Article 31, first paragraph
Article 26, second sentence | Article 31, second paragraph
Article 27 | Article 32
Article 28 | Article 33
Article 29 | Article 34
Annexes I and II | Annexes I and II
Annex III | –
Annex IV | –
– | Annex III
– | Annex IV

Pending: 32008L0100

January 16, 2026
29.10.2008 EN Official Journal of the European Union L 285/9
(1) Directive 90/496/EEC specifies that fibre should be defined.
(2) Conditions for nutrition claims such as ‘source of fibre’ or ‘high fibre’ are laid down in the Annex to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods(2).
(3) For reasons of clarity and coherence with other Community legislation that refers to that notion, it is necessary to provide a definition of ‘fibre’.
(4) The definition of fibre should take into account relevant work by the Codex Alimentarius and the statement related to dietary fibre, expressed on the 6 July 2007, by the European Food Safety Authority Scientific Panel on Dietetic Products, Nutrition and Allergies.
(5) Fibre has been traditionally consumed as plant material and has one or more beneficial physiological effects such as: decrease intestinal transit time, increase stool bulk, is fermentable by colonic microflora, reduce blood total cholesterol, reduce blood LDL cholesterol levels, reduce post-prandial blood glucose, or reduce blood insulin levels. Recent scientific evidence has shown that similar beneficial physiological effects may be obtained from other carbohydrate polymers that are not digestible and not naturally occurring in the food as consumed. Therefore it is appropriate that the definition of fibre should include carbohydrate polymers with one or more beneficial physiological effects.
(6) The carbohydrate polymers of plant origin that meet the definition of fibre may be closely associated in the plant with lignin or other non-carbohydrate components such as phenolic compounds, waxes, saponins, phytates, cutin, phytosterols. These substances when closely associated with carbohydrate polymers of plant origin and extracted with the carbohydrate polymers for analysis of fibre may be considered as fibre. However, when separated from the carbohydrate polymers and added to a food these substances should not be considered as fibre.
(7) In order to take account of new scientific and technological developments, there is a need to amend the list of energy conversion factors.
(8) The FAO report of a technical workshop on food energy — methods of analysis and conversion factors indicates that 70 percent of the fibre in traditional foods is assumed to be fermentable. Therefore, it is appropriate that the average energy value for fibre should be 8 kJ/g (2 kcal/g).
(9) Erythritol can be used in a wide variety of foods and its use is, among others, as a replacement for nutrients such as sugar where lower energy value is desired.
(10) Erythritol is a polyol, and according to the current rules as provided for in Article 5(1) of Directive 90/496/EEC, its energy would be calculated using the conversion factor for polyols, namely 10 kJ/g (2,4 kcal/g). Using this energy conversion factor would not fully inform the consumer about the reduced energy value of a product achieved by the use of erythritol in its manufacture. The Scientific Committee on Food in its opinion on erythritol, expressed on 5 March 2003, noted that the energy provided by erythritol was less than 0,9 kJ/g (less than 0,2 kcal/g). Therefore it is appropriate to adopt a suitable energy conversion factor for erythritol.
(11) The Annex to Directive 90/496/EEC lists the vitamins and minerals which may be declared as part of the nutrition labelling, specifies their recommended daily allowances (RDAs) and defines a rule of what constitutes a significant amount. The purpose of this RDA list is to provide values for nutrition labelling and the calculation of what constitutes a significant amount.
(12) The rule on significant amount as defined in the Annex to Directive 90/496/EEC constitutes a reference in other Community legislation, in particular in Article 8(3) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(3), in the Annex to Regulation (EC) No 1924/2006 and in Article 6(6) of Regulation (EC) No 1925/2006 of the European Parliament and the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods(4).
(13) The RDAs listed in the Annex to Directive 90/496/EEC are based on the recommendation of the FAO/WHO expert consultation meeting in Helsinki in 1988.
(14) In order to ensure coherence with other Community legislation, the current list of vitamins and minerals and their RDAs should be updated in the light of scientific developments since 1988.
(15) The Scientific Committee on Food in its opinion on the revision of reference values for nutrition labelling, expressed on 5 March 2003, included reference labelling values for adults. This opinion covers the vitamins and minerals listed in Annex I to Directive 2002/46/EC and in Annex I to Regulation (EC) No 1925/2006.
(16) The Annex to Directive 90/496/EEC should therefore be amended accordingly.
(17) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
1. In Article 1(4)(j) the following sentence is added:‘The definition of the material and if necessary the methods of analysis shall be included in Annex II;’;
2. The following indents are added in Article 5(1):‘—fibre 2 kcal/g — 8 kJ/g—erythritol 0 kcal/g — 0 kJ/g.’; ‘— fibre 2 kcal/g — 8 kJ/g — erythritol 0 kcal/g — 0 kJ/g.’;
‘— fibre 2 kcal/g — 8 kJ/g
— erythritol 0 kcal/g — 0 kJ/g.’;
‘— fibre 2 kcal/g — 8 kJ/g
— erythritol 0 kcal/g — 0 kJ/g.’;
3. The Annex is replaced by the text in Annex I to this Directive;
4. The text in Annex II to this Directive is added.
Vitamin A (μg) 800
Vitamin D (μg) 5
Vitamin E (mg) 12
Vitamin K (μg) 75
Vitamin C (mg) 80
Thiamin (mg) 1,1
Riboflavin (mg) 1,4
Niacin (mg) 16
Vitamin B6 (mg) 1,4
Folic acid (μg) 200
Vitamin B12 (μg) 2,5
Biotin (μg) 50
Pantothenic acid (mg) 6
Potassium (mg) 2 000
Chloride (mg) 800
Calcium (mg) 800
Phosphorus (mg) 700
Magnesium (mg) 375
Iron (mg) 14
Zinc (mg) 10
Copper (mg) 1
Manganese (mg) 2
Fluoride (mg) 3,5
Selenium (μg) 55
Chromium (μg) 40
Molybdenum (μg) 50
Iodine (μg) 150
— edible carbohydrate polymers naturally occurring in the food as consumed;
— edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and which have a beneficial physiological effect demonstrated by generally accepted scientific evidence;
— edible synthetic carbohydrate polymers which have a beneficial physiological effect demonstrated by generally accepted scientific evidence.’
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(1), and in particular Article 1(4)(a) and (j) and Article 5(2) thereof,
After consulting the European Food Safety Authority,
(1) Directive 90/496/EEC specifies that fibre should be defined.
(2) Conditions for nutrition claims such as ‘source of fibre’ or ‘high fibre’ are laid down in the Annex to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods(2).
(3) For reasons of clarity and coherence with other Community legislation that refers to that notion, it is necessary to provide a definition of ‘fibre’.
(4) The definition of fibre should take into account relevant work by the Codex Alimentarius and the statement related to dietary fibre, expressed on the 6 July 2007, by the European Food Safety Authority Scientific Panel on Dietetic Products, Nutrition and Allergies.
(5) Fibre has been traditionally consumed as plant material and has one or more beneficial physiological effects such as: decrease intestinal transit time, increase stool bulk, is fermentable by colonic microflora, reduce blood total cholesterol, reduce blood LDL cholesterol levels, reduce post-prandial blood glucose, or reduce blood insulin levels. Recent scientific evidence has shown that similar beneficial physiological effects may be obtained from other carbohydrate polymers that are not digestible and not naturally occurring in the food as consumed. Therefore it is appropriate that the definition of fibre should include carbohydrate polymers with one or more beneficial physiological effects.
(6) The carbohydrate polymers of plant origin that meet the definition of fibre may be closely associated in the plant with lignin or other non-carbohydrate components such as phenolic compounds, waxes, saponins, phytates, cutin, phytosterols. These substances when closely associated with carbohydrate polymers of plant origin and extracted with the carbohydrate polymers for analysis of fibre may be considered as fibre. However, when separated from the carbohydrate polymers and added to a food these substances should not be considered as fibre.
(7) In order to take account of new scientific and technological developments, there is a need to amend the list of energy conversion factors.
(8) The FAO report of a technical workshop on food energy — methods of analysis and conversion factors indicates that 70 percent of the fibre in traditional foods is assumed to be fermentable. Therefore, it is appropriate that the average energy value for fibre should be 8 kJ/g (2 kcal/g).
(9) Erythritol can be used in a wide variety of foods and its use is, among others, as a replacement for nutrients such as sugar where lower energy value is desired.
(10) Erythritol is a polyol, and according to the current rules as provided for in Article 5(1) of Directive 90/496/EEC, its energy would be calculated using the conversion factor for polyols, namely 10 kJ/g (2,4 kcal/g). Using this energy conversion factor would not fully inform the consumer about the reduced energy value of a product achieved by the use of erythritol in its manufacture. The Scientific Committee on Food in its opinion on erythritol, expressed on 5 March 2003, noted that the energy provided by erythritol was less than 0,9 kJ/g (less than 0,2 kcal/g). Therefore it is appropriate to adopt a suitable energy conversion factor for erythritol.
(11) The Annex to Directive 90/496/EEC lists the vitamins and minerals which may be declared as part of the nutrition labelling, specifies their recommended daily allowances (RDAs) and defines a rule of what constitutes a significant amount. The purpose of this RDA list is to provide values for nutrition labelling and the calculation of what constitutes a significant amount.
(12) The rule on significant amount as defined in the Annex to Directive 90/496/EEC constitutes a reference in other Community legislation, in particular in Article 8(3) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(3), in the Annex to Regulation (EC) No 1924/2006 and in Article 6(6) of Regulation (EC) No 1925/2006 of the European Parliament and the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods(4).
(13) The RDAs listed in the Annex to Directive 90/496/EEC are based on the recommendation of the FAO/WHO expert consultation meeting in Helsinki in 1988.
(14) In order to ensure coherence with other Community legislation, the current list of vitamins and minerals and their RDAs should be updated in the light of scientific developments since 1988.
(15) The Scientific Committee on Food in its opinion on the revision of reference values for nutrition labelling, expressed on 5 March 2003, included reference labelling values for adults. This opinion covers the vitamins and minerals listed in Annex I to Directive 2002/46/EC and in Annex I to Regulation (EC) No 1925/2006.
(16) The Annex to Directive 90/496/EEC should therefore be amended accordingly.
(17) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Directive 90/496/EEC is amended as follows:
1.
In Article 1(4)(j) the following sentence is added:
‘The definition of the material and if necessary the methods of analysis shall be included in Annex II;’;
2.
The following indents are added in Article 5(1):
‘—
fibre 2 kcal/g — 8 kJ/g
—
erythritol 0 kcal/g — 0 kJ/g.’;
3.
The Annex is replaced by the text in Annex I to this Directive;
4.
The text in Annex II to this Directive is added.

Article 2
1. Member States shall bring into force by 31 October 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions in such a way as to prohibit, with effect from 31 October 2012, the trade in products which do not comply with Directive 90/496/EEC, as amended by this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs(1), and in particular Article 1(4)(a) and (j) and Article 5(2) thereof,
After consulting the European Food Safety Authority,
(1) Directive 90/496/EEC specifies that fibre should be defined.
(2) Conditions for nutrition claims such as ‘source of fibre’ or ‘high fibre’ are laid down in the Annex to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods(2).
(3) For reasons of clarity and coherence with other Community legislation that refers to that notion, it is necessary to provide a definition of ‘fibre’.
(4) The definition of fibre should take into account relevant work by the Codex Alimentarius and the statement related to dietary fibre, expressed on the 6 July 2007, by the European Food Safety Authority Scientific Panel on Dietetic Products, Nutrition and Allergies.
(5) Fibre has been traditionally consumed as plant material and has one or more beneficial physiological effects such as: decrease intestinal transit time, increase stool bulk, is fermentable by colonic microflora, reduce blood total cholesterol, reduce blood LDL cholesterol levels, reduce post-prandial blood glucose, or reduce blood insulin levels. Recent scientific evidence has shown that similar beneficial physiological effects may be obtained from other carbohydrate polymers that are not digestible and not naturally occurring in the food as consumed. Therefore it is appropriate that the definition of fibre should include carbohydrate polymers with one or more beneficial physiological effects.
(6) The carbohydrate polymers of plant origin that meet the definition of fibre may be closely associated in the plant with lignin or other non-carbohydrate components such as phenolic compounds, waxes, saponins, phytates, cutin, phytosterols. These substances when closely associated with carbohydrate polymers of plant origin and extracted with the carbohydrate polymers for analysis of fibre may be considered as fibre. However, when separated from the carbohydrate polymers and added to a food these substances should not be considered as fibre.
(7) In order to take account of new scientific and technological developments, there is a need to amend the list of energy conversion factors.
(8) The FAO report of a technical workshop on food energy — methods of analysis and conversion factors indicates that 70 percent of the fibre in traditional foods is assumed to be fermentable. Therefore, it is appropriate that the average energy value for fibre should be 8 kJ/g (2 kcal/g).
(9) Erythritol can be used in a wide variety of foods and its use is, among others, as a replacement for nutrients such as sugar where lower energy value is desired.
(10) Erythritol is a polyol, and according to the current rules as provided for in Article 5(1) of Directive 90/496/EEC, its energy would be calculated using the conversion factor for polyols, namely 10 kJ/g (2,4 kcal/g). Using this energy conversion factor would not fully inform the consumer about the reduced energy value of a product achieved by the use of erythritol in its manufacture. The Scientific Committee on Food in its opinion on erythritol, expressed on 5 March 2003, noted that the energy provided by erythritol was less than 0,9 kJ/g (less than 0,2 kcal/g). Therefore it is appropriate to adopt a suitable energy conversion factor for erythritol.
(11) The Annex to Directive 90/496/EEC lists the vitamins and minerals which may be declared as part of the nutrition labelling, specifies their recommended daily allowances (RDAs) and defines a rule of what constitutes a significant amount. The purpose of this RDA list is to provide values for nutrition labelling and the calculation of what constitutes a significant amount.
(12) The rule on significant amount as defined in the Annex to Directive 90/496/EEC constitutes a reference in other Community legislation, in particular in Article 8(3) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements(3), in the Annex to Regulation (EC) No 1924/2006 and in Article 6(6) of Regulation (EC) No 1925/2006 of the European Parliament and the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods(4).
(13) The RDAs listed in the Annex to Directive 90/496/EEC are based on the recommendation of the FAO/WHO expert consultation meeting in Helsinki in 1988.
(14) In order to ensure coherence with other Community legislation, the current list of vitamins and minerals and their RDAs should be updated in the light of scientific developments since 1988.
(15) The Scientific Committee on Food in its opinion on the revision of reference values for nutrition labelling, expressed on 5 March 2003, included reference labelling values for adults. This opinion covers the vitamins and minerals listed in Annex I to Directive 2002/46/EC and in Annex I to Regulation (EC) No 1925/2006.
(16) The Annex to Directive 90/496/EEC should therefore be amended accordingly.
(17) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Directive 90/496/EEC is amended as follows:
1.
In Article 1(4)(j) the following sentence is added:
‘The definition of the material and if necessary the methods of analysis shall be included in Annex II;’;
2.
The following indents are added in Article 5(1):
‘—
fibre 2 kcal/g — 8 kJ/g
—
erythritol 0 kcal/g — 0 kJ/g.’;
3.
The Annex is replaced by the text in Annex I to this Directive;
4.
The text in Annex II to this Directive is added.
1. Member States shall bring into force by 31 October 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions in such a way as to prohibit, with effect from 31 October 2012, the trade in products which do not comply with Directive 90/496/EEC, as amended by this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX IThe Annex to Directive 90/496/EEC is replaced by the following:

‘ANNEX I
Vitamins and minerals which may be declared and their recommended daily allowances (RDAs)
Vitamin A (μg)
800
Vitamin D (μg)
5
Vitamin E (mg)
12
Vitamin K (μg)
75
Vitamin C (mg)
80
Thiamin (mg)
1,1
Riboflavin (mg)
1,4
Niacin (mg)
16
Vitamin B6 (mg)
1,4
Folic acid (μg)
200
Vitamin B12 (μg)
2,5
Biotin (μg)
50
Pantothenic acid (mg)
6
Potassium (mg)
2 000
Chloride (mg)
800
Calcium (mg)
800
Phosphorus (mg)
700
Magnesium (mg)
375
Iron (mg)
14
Zinc (mg)
10
Copper (mg)
1
Manganese (mg)
2
Fluoride (mg)
3,5
Selenium (μg)
55
Chromium (μg)
40
Molybdenum (μg)
50
Iodine (μg)
150
As a rule, 15 % of the recommended allowance specified in this Annex supplied by 100 g or 100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount.’

ANNEX IIThe following Annex II is added to Directive 90/496/EEC:

‘ANNEX II
Definition of the material constituting fibre and methods of analysis as referred to in Article 1(4)(j) Definition of the material constituting fibre
For the purposes of this Directive “fibre” means carbohydrate polymers with three or more monomeric units, which are neither digested nor absorbed in the human small intestine and belong to the following categories:
—
edible carbohydrate polymers naturally occurring in the food as consumed;
—
edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and which have a beneficial physiological effect demonstrated by generally accepted scientific evidence;
—
edible synthetic carbohydrate polymers which have a beneficial physiological effect demonstrated by generally accepted scientific evidence.’

Pending: 32008L0088

January 16, 2026
24.9.2008 EN Official Journal of the European Union L 256/12
(1) Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, replaced by the Scientific Committee on Consumer Products (SCCP), by Commission Decision 2004/210/EC(2), concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.
(2) The Scientific Committee on Consumer Products further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.
(3) Following the opinions of the SCCP, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCP.
(4) Substances for which no updated safety files are submitted allowing an adequate risk assessment should be included in Annex II to Directive 76/768/EEC.
(5) Some hair dye substances have already been banned, either as a result of opinions by the SCCP or due to lack of safety data. The substances currently under consideration were carefully selected to be regulated together since they are listed in Annex IV. As no safety files on these substances for their use in hair dye products were submitted to the SCCP for a risk assessment by the agreed deadlines, there is no evidence that these substances, when used in hair dye products, can be considered safe for human health.
(6) Substances without safety files 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salt; 1,4-Dihydroxybenzene (Hydroquinone); [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammoniumchloride (Basic Blue 26); Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulpho-nate (Ponceau SX) and 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14), currently listed as colorants in Annex IV and as hair dye substances in Annex III, Part 1 and Part 2, shall be deleted from Annex III and banned for use in hair dye products in Annex II.
(7) Directive 76/768/EEC should therefore be amended accordingly.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
1. in Annex II, the following reference numbers 1329 to 1369 are added:Reference NoChemical name/INCI-name‘13294-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products13304-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products13313-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products13322-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products13334′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products13342-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products1335Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products13363′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products13372′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products13381-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products13391,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products1340[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products1341Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products1342Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products13434-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products13444-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products13451-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products13463-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products1347N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products1348Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products1349Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products1350Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products13512,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products13522,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products13531-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products1354Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products1355Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products1356Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products1357Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products13581,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products1359Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products13608,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products13611,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products1362Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products13631-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products13641,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products13656-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products13665,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products1367(29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products1368Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products1369Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’ Reference No Chemical name/INCI-name ‘1329 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products 1330 4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products 1331 3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products 1332 2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products 1333 4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products 1334 2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products 1335 Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products 1336 3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products 1337 2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products 1338 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products 1339 1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products 1340 [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products 1341 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products 1342 Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products 1343 4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products 1344 4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products 1345 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products 1346 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products 1347 N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products 1348 Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products 1349 Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products 1350 Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products 1351 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products 1352 2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products 1353 1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products 1354 Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products 1355 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products 1356 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products 1357 Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products 1358 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products 1359 Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products 1360 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products 1361 1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products 1362 Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products 1363 1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products 1364 1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products 1365 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products 1366 5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products 1367 (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products 1368 Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products 1369 Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’
Reference No Chemical name/INCI-name
‘1329 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products
1330 4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products
1331 3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products
1332 2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products
1333 4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products
1334 2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products
1335 Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products
1336 3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products
1337 2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products
1338 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products
1339 1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products
1340 [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products
1341 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products
1342 Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products
1343 4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products
1344 4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products
1345 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products
1346 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products
1347 N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products
1348 Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products
1349 Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products
1350 Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products
1351 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products
1352 2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products
1353 1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products
1354 Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products
1355 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products
1356 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products
1357 Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products
1358 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products
1359 Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products
1360 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products
1361 1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products
1362 Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products
1363 1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products
1364 1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products
1365 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products
1366 5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products
1367 (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products
1368 Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products
1369 Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’
Reference No Chemical name/INCI-name
‘1329 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products
1330 4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products
1331 3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products
1332 2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products
1333 4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products
1334 2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products
1335 Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products
1336 3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products
1337 2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products
1338 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products
1339 1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products
1340 [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products
1341 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products
1342 Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products
1343 4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products
1344 4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products
1345 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products
1346 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products
1347 N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products
1348 Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products
1349 Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products
1350 Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products
1351 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products
1352 2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products
1353 1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products
1354 Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products
1355 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products
1356 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products
1357 Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products
1358 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products
1359 Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products
1360 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products
1361 1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products
1362 Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products
1363 1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products
1364 1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products
1365 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products
1366 5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products
1367 (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products
1368 Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products
1369 Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’
2. Annex III is amended as follows:(a)in Part 1, reference number 10 is deleted;(b)in Part 1, column c of reference number 14, item (a) is deleted;(c)in Part 2, reference numbers 57, 59 and 60 are deleted. (a) in Part 1, reference number 10 is deleted; (b) in Part 1, column c of reference number 14, item (a) is deleted; (c) in Part 2, reference numbers 57, 59 and 60 are deleted.
(a) in Part 1, reference number 10 is deleted;
(b) in Part 1, column c of reference number 14, item (a) is deleted;
(c) in Part 2, reference numbers 57, 59 and 60 are deleted.
(a) in Part 1, reference number 10 is deleted;
(b) in Part 1, column c of reference number 14, item (a) is deleted;
(c) in Part 2, reference numbers 57, 59 and 60 are deleted.
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Consumer Products,
(1) Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, replaced by the Scientific Committee on Consumer Products (SCCP), by Commission Decision 2004/210/EC(2), concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.
(2) The Scientific Committee on Consumer Products further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.
(3) Following the opinions of the SCCP, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCP.
(4) Substances for which no updated safety files are submitted allowing an adequate risk assessment should be included in Annex II to Directive 76/768/EEC.
(5) Some hair dye substances have already been banned, either as a result of opinions by the SCCP or due to lack of safety data. The substances currently under consideration were carefully selected to be regulated together since they are listed in Annex IV. As no safety files on these substances for their use in hair dye products were submitted to the SCCP for a risk assessment by the agreed deadlines, there is no evidence that these substances, when used in hair dye products, can be considered safe for human health.
(6) Substances without safety files 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salt; 1,4-Dihydroxybenzene (Hydroquinone); [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammoniumchloride (Basic Blue 26); Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulpho-nate (Ponceau SX) and 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14), currently listed as colorants in Annex IV and as hair dye substances in Annex III, Part 1 and Part 2, shall be deleted from Annex III and banned for use in hair dye products in Annex II.
(7) Directive 76/768/EEC should therefore be amended accordingly.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE:

Article 1
Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.

Article 2
1. Member States shall adopt and publish, by 14 February 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 14 August 2009.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3
This Directive shall enter into force on the 20th day following that of its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Consumer Products,
(1) Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, replaced by the Scientific Committee on Consumer Products (SCCP), by Commission Decision 2004/210/EC(2), concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.
(2) The Scientific Committee on Consumer Products further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.
(3) Following the opinions of the SCCP, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCP.
(4) Substances for which no updated safety files are submitted allowing an adequate risk assessment should be included in Annex II to Directive 76/768/EEC.
(5) Some hair dye substances have already been banned, either as a result of opinions by the SCCP or due to lack of safety data. The substances currently under consideration were carefully selected to be regulated together since they are listed in Annex IV. As no safety files on these substances for their use in hair dye products were submitted to the SCCP for a risk assessment by the agreed deadlines, there is no evidence that these substances, when used in hair dye products, can be considered safe for human health.
(6) Substances without safety files 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salt; 1,4-Dihydroxybenzene (Hydroquinone); [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammoniumchloride (Basic Blue 26); Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulpho-nate (Ponceau SX) and 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14), currently listed as colorants in Annex IV and as hair dye substances in Annex III, Part 1 and Part 2, shall be deleted from Annex III and banned for use in hair dye products in Annex II.
(7) Directive 76/768/EEC should therefore be amended accordingly.
(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS DIRECTIVE:
Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
1. Member States shall adopt and publish, by 14 February 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions from 14 August 2009.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
This Directive shall enter into force on the 20th day following that of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEXDirective 76/768/EEC is amended as follows:

1. | in Annex II, the following reference numbers 1329 to 1369 are added:Reference NoChemical name/INCI-name‘13294-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products13304-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products13313-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products13322-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products13334′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products13342-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products1335Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products13363′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products13372′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products13381-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products13391,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products1340[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products1341Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products1342Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products13434-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products13444-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products13451-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products13463-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products1347N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products1348Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products1349Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products1350Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products13512,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products13522,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products13531-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products1354Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products1355Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products1356Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products1357Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products13581,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products1359Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products13608,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products13611,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products1362Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products13631-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products13641,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products13656-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products13665,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products1367(29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products1368Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products1369Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’ | Reference No | Chemical name/INCI-name | ‘1329 | 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products | 1330 | 4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products | 1331 | 3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products | 1332 | 2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products | 1333 | 4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products | 1334 | 2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products | 1335 | Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products | 1336 | 3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products | 1337 | 2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products | 1338 | 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products | 1339 | 1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products | 1340 | [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products | 1341 | Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products | 1342 | Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products | 1343 | 4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products | 1344 | 4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products | 1345 | 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products | 1346 | 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products | 1347 | N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products | 1348 | Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products | 1349 | Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products | 1350 | Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products | 1351 | 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products | 1352 | 2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products | 1353 | 1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products | 1354 | Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products | 1355 | Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products | 1356 | Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products | 1357 | Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products | 1358 | 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products | 1359 | Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products | 1360 | 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products | 1361 | 1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products | 1362 | Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products | 1363 | 1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products | 1364 | 1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products | 1365 | 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products | 1366 | 5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products | 1367 | (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products | 1368 | Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products | 1369 | Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’
Reference No | Chemical name/INCI-name
‘1329 | 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS 221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6) when used as a substance in hair dye products
1330 | 4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its sodium salt (Acid Orange 6; CI 14270) (CAS 547-57-9; EINECS 208-924-8) when used as a substance in hair dye products
1331 | 3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt (Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair dye products
1332 | 2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8) and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0), when used as a substance in hair dye products
1333 | 4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) (CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370) (CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products
1334 | 2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380) (CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake) (CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products
1335 | Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190) (CAS 6252-76-2; EINECS 228-377-9) when used as a substance in hair dye products
1336 | 3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS 38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9; EINECS 251-419-2) when used as a substance in hair dye products
1337 | 2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51; CI 45430) (CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt (Pigment Red 172 Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products
1338 | 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its dihydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a substance in hair dye products
1339 | 1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance in hair dye products
1340 | [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a substance in hair dye products
1341 | Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products
1342 | Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) (Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye products
1343 | 4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its salts, when used as a substance in hair dye products
1344 | 4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and its salts, when used as a substance in hair dye products
1345 | 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-562-2) and its salts when used as a substance in hair dye products
1346 | 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye products
1347 | N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its salts when used as a substance in hair dye products
1348 | Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products
1349 | Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) (CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products
1350 | Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products
1351 | 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair dye products
1352 | 2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products
1353 | 1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4) when used as a substance in hair dye products
1354 | Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) (CAS 2118-39-0; EINECS 218-326-9) when used as a substance in hair dye products
1355 | Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) (CAS 129-17-9; EINECS 204-934-1) when used as a substance in hair dye products
1356 | Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) (CAS 3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products
1357 | Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye products
1358 | 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products
1359 | Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products
1360 | 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products
1361 | 1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when used as a substance in hair dye products
1362 | Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS 228-783-6) when used as a substance in hair dye products
1363 | 1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-353-5), when used as a substance in hair dye products
1364 | 1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5) when used as a substance in hair dye products
1365 | 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair dye products
1366 | 5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS 213-879-2) when used as a substance in hair dye products
1367 | (29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-8; EINECS 205-685-1) when used as a substance in hair dye products
1368 | Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products
1369 | Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7) when used as a substance in hair dye products’
2. | Annex III is amended as follows:(a)in Part 1, reference number 10 is deleted;(b)in Part 1, column c of reference number 14, item (a) is deleted;(c)in Part 2, reference numbers 57, 59 and 60 are deleted. | (a) | in Part 1, reference number 10 is deleted; | (b) | in Part 1, column c of reference number 14, item (a) is deleted; | (c) | in Part 2, reference numbers 57, 59 and 60 are deleted.
(a) | in Part 1, reference number 10 is deleted;
(b) | in Part 1, column c of reference number 14, item (a) is deleted;
(c) | in Part 2, reference numbers 57, 59 and 60 are deleted.

Pending: 32008L0084

January 16, 2026
20.9.2008 EN Official Journal of the European Union L 253/1
(1) Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners(4).
(3) It is necessary to take into account the specifications and analytical techniques for additives as set out in theCodex Alimentariusas drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B,
Definition
Chemical name Sorbic acid
Trans, trans-2,4-hexadienoic acid
Einecs 203-768-7
Chemical formula C6H8O2
Molecular weight 112,12
Assay Content not less than 99 % on the anhydrous basis
Description Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105oC
Identification
A.Melting range A. Melting range Between 133oC and 135oC, after vacuum drying for four hours in a sulphuric acid desiccator
A. Melting range
B.Spectrometry B. Spectrometry An isopropanol solution (1 in 4 000 000 ) shows absorbance maximum at 254 ± 2 nm
B. Spectrometry
C.Positive test for double bonds C. Positive test for double bonds
C. Positive test for double bonds
D.Sublimation point D. Sublimation point 80oC
D. Sublimation point
Purity
Water content Not more than 0,5  % (Karl Fischer method)
Sulphated ash Not more than 0,2  %
Aldehydes Not more than 0,1  % (as formaldehyde)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Spectrometry
C. Positive test for double bonds
D. Sublimation point
Definition
Chemical name Potassium sorbate
Potassium (E, E)-2,4-hexadienoate
Potassium salt of trans, trans 2,4-hexadienoic acid
Einecs 246-376-1
Chemical formula C6H7O2K
Molecular weight 150,22
Assay Content not less than 99 % on the dried basis
Description White crystalline powder showing no change in colour after heating for 90 minutes at 105oC
Identification
A.Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator A. Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
A. Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
B.Positive tests for potassium and for double bonds B. Positive tests for potassium and for double bonds
B. Positive tests for potassium and for double bonds
Purity
Loss on drying Not more than 1,0  % (105oC, 3h)
Acidity or alkalinity Not more than about 1,0  % (as sorbic acid or K2CO3)
Aldehydes Not more than 0,1  %, calculated as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
B. Positive tests for potassium and for double bonds
Definition
Chemical name Calcium sorbate
Calcium salts of trans, trans-2,4-hexadienoic acid
Einecs 231-321-6
Chemical formula C12H14O4Ca
Molecular weight 262,32
Assay Content not less than 98 % on the dried basis
Description Fine white crystalline powder not showing any change in colour after heating at 105oC for 90 minutes
Identification
A.Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator A. Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
A. Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
B.Positive tests for calcium and for double bonds B. Positive tests for calcium and for double bonds
B. Positive tests for calcium and for double bonds
Purity
Loss on drying Not more than 2,0  %, determined by vacuum drying for four hours in a sulphuric acid desiccator
Aldehydes Not more than 0,1  % (as formaldehyde)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
B. Positive tests for calcium and for double bonds
Definition
Chemical name Benzoic acid
Benzenecarboxylic acid
Phenylcarboxylic acid
Einecs 200-618-2
Chemical formula C7H6O2
Molecular weight 122,12
Assay Content not less than 99,5  % on the anhydrous basis
Description White crystalline powder
Identification
A.Melting range A. Melting range 121,5oC to 123,5oC
A. Melting range
B.Positive sublimation test and test for benzoate B. Positive sublimation test and test for benzoate
B. Positive sublimation test and test for benzoate
Purity
Loss on drying Not more than 0,5  % after drying for three hours over sulphuric acid
pH About 4 (solution in water)
Sulphated ash Not more than 0,05  %
Chlorinated organic compounds Not more than 0,07  % expressed as chloride corresponding to 0,3  % expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5  ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1  N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1  N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5  ml should be required
Readily carbonisable substances A cold solution of 0,5  g of benzoic acid in 5 ml of 94,5 to 95,5  % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2  ml of cobalt chloride TSC(2), 0,3  ml of ferric chloride TSC(3), 0,1  ml of copper sulphate TSC(4)and 4,4  ml of water
Polycyclic acids On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Positive sublimation test and test for benzoate
Definition
Chemical name Sodium benzoate
Sodium salt of benzenecarboxylic acid
Sodium salt of phenylcarboxylic acid
Einecs 208-534-8
Chemical formula C7H5O2Na
Molecular weight 144,11
Assay Not less than 99 % of C7H5O2Na, after drying at 105oC for four hours
Description A white, almost odourless, crystalline powder or granules
Identification
A.Solubility A. Solubility Freely soluble in water, sparingly soluble in ethanol
A. Solubility
B.Melting range for benzoic acid B. Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after drying in a sulphuric acid desiccator
B. Melting range for benzoic acid
C.Positive tests for benzoate and for sodium C. Positive tests for benzoate and for sodium
C. Positive tests for benzoate and for sodium
Purity
Loss on drying Not more than 1,5  % after drying at 105oC for four hours
Readily oxidisable substances Add 1,5  ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1  N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1  N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5  ml should be required
Polycyclic acids On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Chlorinated organic compounds Not more than 0,06  % expressed as chloride, corresponding to 0,25  % expressed as monochlorobenzoic acid
Degree of acidity or alkalinity Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25  ml of 0,1  N NaOH or 0,1  N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Melting range for benzoic acid
C. Positive tests for benzoate and for sodium
Definition
Chemical name Potassium benzoate
Potassium salt of benzenecarboxylic acid
Potassium salt of phenylcarboxylic acid
Einecs 209-481-3
Chemical formula C7H5KO2·3H2O
Molecular weight 214,27
Assay Content not less than 99 % C7H5KO2after drying at 105oC to constant weight
Description White crystalline powder
Identification
A.Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
B.Positive tests for benzoate and for potassium B. Positive tests for benzoate and for potassium
B. Positive tests for benzoate and for potassium
Purity
Loss on drying Not more than 26,5  %, determined by drying at 105oC
Chlorinated organic compounds Not more than 0,06  % expressed as chloride, corresponding to 0,25  % expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5  ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1  N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1  N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5  ml should be required
Readily carbonisable substances A cold solution of 0,5  g of benzoic acid in 5 ml 94,5 to 95,5  % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2  ml of cobalt chloride TSC, 0,3  ml of ferric chloride TSC, 0,1  ml of copper sulphate TSC and 4,4  ml of water
Polycyclic acids On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Degree of acidity or alkalinity Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25  ml of 0,1  N NaOH or 0,1  N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
B. Positive tests for benzoate and for potassium
Synonyms Monocalcium benzoate
Definition
Chemical name Calcium benzoate
Calcium dibenzoate
Einecs 218-235-4
Chemical formula Anhydrous: C14H10O4Ca
Monohydrate: C14H10O4Ca· H2O
Trihydrate: C14H10O4Ca· 3H2O
Molecular weight Anhydrous: 282,31
Monohydrate: 300,32
Trihydrate: 336,36
Assay Content not less than 99 % after drying at 105oC
Description White or colourless crystals, or white powder
Identification
A.Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
B.Positive tests for benzoate and for calcium B. Positive tests for benzoate and for calcium
B. Positive tests for benzoate and for calcium
Purity
Loss on drying Not more than 17,5  % determined by drying at 105oC to constant weight
Water insoluble matter Not more than 0,3  %
Chlorinated organic compounds Not more than 0,06  % expressed as chloride, corresponding to 0,25  % expressed as monochlorobenzoic acids
Readily oxidisable substances Add 1,5  ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1  N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1  N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5  ml should be required
Readily carbonisable substances Cold solution of 0,5  g of benzoic acid in 5 ml of 94,5 to 95,5  % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2  ml of cobalt chloride TSC, 0,3  ml of ferric chloride TSC, 0,1  ml of copper sulphate TSC and 4,4  ml of water
Polycyclic acids On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
Degree of acidity or alkalinity Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25  ml of 0,1  N NaOH or 0,1  N HCl
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
B. Positive tests for benzoate and for calcium
Synonyms Ethylparaben
Ethylp-oxybenzoate
Definition
Chemical name Ethyl-p-hydroxybenzoate
Ethyl ester ofp-hydroxybenzoic acid
Einecs 204-399-4
Chemical formula C9H10O3
Molecular weight 166,8
Assay Content not less than 99,5  % after drying for two hours at 80oC
Description Almost odourless, small, colourless crystals or a white, crystalline powder
Identification
A.Melting range A. Melting range 115oC to 118oC
A. Melting range
B.Positive test forp-hydroxybenzoate B. Positive test forp-hydroxybenzoate Melting range ofp-hydroxybenzoic acid isolated by acidification and not recrystallised: 213oC to 217oC, after vacuum drying in a sulphuric acid desiccator
B. Positive test forp-hydroxybenzoate
C.Positive test for alcohol C. Positive test for alcohol
C. Positive test for alcohol
Purity
Loss on drying Not more than 0,5  % after drying for two hours at 80oC
Sulphated ash Not more than 0,05  %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35  % expressed asp-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Positive test forp-hydroxybenzoate
C. Positive test for alcohol
Definition
Chemical name Sodium ethylp-hydroxybenzoate
Sodium compound of the ethyl ester ofp-hydroxybenzoic acid
Einecs 252-487-6
Chemical formula C9H9O3Na
Molecular weight 188,8
Assay Content of ethylester ofp-hydroxybenzoic acid not less than 83 % on the anhydrous basis
Description White, crystalline hygroscopic powder
Identification
A.Melting range A. Melting range 115oC to 118oC, after vacuum drying in a sulphuric acid desiccator
A. Melting range
B.Positive test forp-hydroxybenzoate B. Positive test forp-hydroxybenzoate Melting range ofp-hydroxybenzoic acid derived from the sample is 213oC to 217oC
B. Positive test forp-hydroxybenzoate
C.Positive test for sodium C. Positive test for sodium
C. Positive test for sodium
D.pH of a 0,1  % aqueous solution must be between 9,9 and 10,3 D. pH of a 0,1  % aqueous solution must be between 9,9 and 10,3
D. pH of a 0,1  % aqueous solution must be between 9,9 and 10,3
Purity
Loss on drying Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator
Sulphated ash 37 to 39 %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35  % expressed asp-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Positive test forp-hydroxybenzoate
C. Positive test for sodium
D. pH of a 0,1  % aqueous solution must be between 9,9 and 10,3
Synonyms Methylparaben
Methyl-p-oxybenzoate
Definition
Chemical name Methylp-hydroxybenzoate
Methyl ester ofp-hydroxybenzoic acid
Einecs 243-171-5
Chemical formula C8H8O3
Molecular weight 152,15
Assay Content not less than 99 % after drying for two hours at 80oC
Description Almost odourless, small colourless crystals or white crystalline powder
Identification
A.Melting range A. Melting range 125oC to 128oC
A. Melting range
B.Positive test forp-hydroxybenzoate B. Positive test forp-hydroxybenzoate Melting range ofp-hydroxybenzoic acid derived from the sample is 213oC to 217oC after drying for two hours at 80oC
B. Positive test forp-hydroxybenzoate
Purity
Loss on drying Not more than 0,5  %, after drying for two hours at 80oC
Sulphated ash Not more than 0,05  %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35  % expressed asp-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Positive test forp-hydroxybenzoate
Definition
Chemical name Sodium methylp-hydroxybenzoate
Sodium compound of the methylester ofp-hydroxybenzoic acid
Chemical formula C8H7O3Na
Molecular weight 174,15
Assay Content not less than 99,5  % on the anhydrous basis
Description White, hygroscopic powder
Identification
A.The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC A. The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC
A. The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC
B.Positive test for sodium B. Positive test for sodium
B. Positive test for sodium
C.pH of a 0,1  % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3 C. pH of a 0,1  % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
C. pH of a 0,1  % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash 40 % to 44,5  % on the anhydrous basis
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35  % expressed asp-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC
B. Positive test for sodium
C. pH of a 0,1  % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
Definition
Chemical name Sulphur dioxide
Sulphurous acid anhydride
Einecs 231-195-2
Chemical formula SO2
Molecular weight 64,07
Assay Content not less than 99 %
Description Colourless, non-flammable gas with strong pungent suffocating odour
Identification
A.Positive test for sulphurous substances A. Positive test for sulphurous substances
A. Positive test for sulphurous substances
Purity
Water content Not more than 0,05  %
Non-volatile residue Not more than 0,01  %
Sulphur trioxide Not more than 0,1  %
Selenium Not more than 10 mg/kg
Other gases not normally present in the air No trace
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive test for sulphurous substances
Definition
Chemical name Sodium sulphite (anhydrous or heptahydrate)
Einecs 231-821-4
Chemical formula Anhydrous: Na2SO3
Heptahydrate: Na2SO37H2O
Molecular weight Anhydrous: 126,04
Heptahydrate: 252,16
Assay Anhydrous: Not less than 95 % of Na2SO3and not less than 48 % of SO2
Heptahydrate: Not less than 48 % of Na2SO3and not less than 24 % of SO2
Description White crystalline powder or colourless crystals
Identification
A.Positive tests for sulphite and for sodium A. Positive tests for sulphite and for sodium
A. Positive tests for sulphite and for sodium
B.pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5 B. pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
B. pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
Purity
Thiosulphate Not more than 0,1  % based on the SO2content
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for sodium
B. pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
Definition
Chemical name Sodium bisulphite
Sodium hydrogen sulphite
Einecs 231-921-4
Chemical formula NaHSO3in aqueous solution
Molecular weight 104,06
Assay Content not less than 32 % w/w NaHSO3
Description A clear, colourless to yellow solution
Identification
A.Positive tests for sulphite and for sodium A. Positive tests for sulphite and for sodium
A. Positive tests for sulphite and for sodium
B.pH of a 10 % aqueous solution between 2,5 and 5,5 B. pH of a 10 % aqueous solution between 2,5 and 5,5
B. pH of a 10 % aqueous solution between 2,5 and 5,5
Purity
Iron Not more than 50 mg/kg of Na2SO3based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for sodium
B. pH of a 10 % aqueous solution between 2,5 and 5,5
Synonyms Pyrosulphite
Sodium pyrosulphite
Definition
Chemical name Sodium disulphite
Disodium pentaoxodisulphate
Einecs 231-673-0
Chemical formula Na2S2O5
Molecular weight 190,11
Assay Content not less than 95 % Na2S2O5and not less than 64 % of SO2
Description White crystals or crystalline powder
Identification
A.Positive tests for sulphite and for sodium A. Positive tests for sulphite and for sodium
A. Positive tests for sulphite and for sodium
B.pH of a 10 % aqueous solution between 4,0 and 5,5 B. pH of a 10 % aqueous solution between 4,0 and 5,5
B. pH of a 10 % aqueous solution between 4,0 and 5,5
Purity
Thiosulphate Not more than 0,1  % based on the SO2content
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for sodium
B. pH of a 10 % aqueous solution between 4,0 and 5,5
Synonyms Potassium pyrosulphite
Definition
Chemical name Potassium disulphite
Potassium pentaoxo disulphate
Einecs 240-795-3
Chemical formula K2S2O5
Molecular weight 222,33
Assay Content not less than 90 % of K2S2O5and not less than 51,8  % of SO2, the remainder being composed almost entirely of potassium sulphate
Description Colourless crystals or white crystalline powder
Identification
A.Positive tests for sulphite and for potassium A. Positive tests for sulphite and for potassium
A. Positive tests for sulphite and for potassium
Purity
Thiosulphate Not more than 0,1  % based on the SO2content
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for potassium
Definition
Chemical name Calcium sulphite
Einecs 218-235-4
Chemical formula CaSO3·2H2O
Molecular weight 156,17
Assay Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2
Description White crystals or white crystalline powder
Identification
A.Positive tests for sulphite and for calcium A. Positive tests for sulphite and for calcium
A. Positive tests for sulphite and for calcium
Purity
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for calcium
Definition
Chemical name Calcium bisulphite
Calcium hydrogen sulphite
Einecs 237-423-7
Chemical formula Ca(HSO3)2
Molecular weight 202,22
Assay 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5  % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]
Description Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
Identification
A.Positive tests for sulphite and for calcium A. Positive tests for sulphite and for calcium
A. Positive tests for sulphite and for calcium
Purity
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for calcium
Definition
Chemical name Potassium bisulphite
Potassium hydrogen sulphite
Einecs 231-870-1
Chemical formula KHSO3in aqueous solution
Molecular weight 120,17
Assay Content not less than 280 g KHSO3per litre (or 150 g SO2per litre)
Description Clear colourless aqueous solution
Identification
A.Positive tests for sulphite and for potassium A. Positive tests for sulphite and for potassium
A. Positive tests for sulphite and for potassium
Purity
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sulphite and for potassium
Synonyms Diphenyl
Definition
Chemical name 1,1′-biphenyl
Phenylbenzene
Einecs 202-163-5
Chemical formula C12H10
Molecular weight 154,20
Assay Content not less than 99,8  %
Description White or pale yellow to amber crystalline solid having a characteristic odour
Identification
A.Melting range A. Melting range 68,5oC to 70,5oC
A. Melting range
B.Distillation range B. Distillation range It distils completely within a 2,5oC range between 252,5oC and 257,5oC
B. Distillation range
Purity
Benzene Not more than 10 mg/kg
Aromatic amines Not more than 2 mg/kg (as aniline)
Phenol derivatives Not more than 5 mg/kg (as phenol)
Readily carbonisable substances Cold solution of 0,5  g of biphenyl in 5 ml of 94,5 to 95,5  % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2  ml of cobalt chloride TSC, 0,3  ml of ferric chloride TSC, 0,1  ml of copper sulphate TSC and 4,4  ml of water
Terphenyl and higher polyphenyl derivatives Not more than 0,2  %
Polycyclic aromatic hydrocarbons Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Distillation range
Synonyms Orthoxenol
Definition
Chemical name (1,1'-Biphenyl)-2-ol
2-Hydroxydiphenyl
o-Hydroxydiphenyl
Einecs 201-993-5
Chemical formula C12H10O
Molecular weight 170,20
Assay Content not less than 99 %
Description White or slightly yellowish crystalline powder
Identification
A.Melting range A. Melting range 56oC to 58oC
A. Melting range
B.Positive test for phenolate B. Positive test for phenolate An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution
B. Positive test for phenolate
Purity
Sulphated ash Not more than 0,05  %
Diphenyl ether Not more than 0,3  %
p-Phenylphenol Not more than 0,1  %
1-Naphthol Not more than 0,01  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Positive test for phenolate
Synonyms Sodium orthophenylphenate
Sodium salt ofo-phenylphenol
Definition
Chemical name Sodium orthophenylphenol
Einecs 205-055-6
Chemical formula C12H9ONa· 4H2O
Molecular weight 264,26
Assay Content not less than 97 % of C12H9ONa· 4H2O
Description White or slightly yellowish crystalline powder
Identification
A.Positive tests for phenolate and for sodium A. Positive tests for phenolate and for sodium
A. Positive tests for phenolate and for sodium
B.Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator B. Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator
B. Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator
C.pH of a 2 % aqueous solution must be between 11,1 and 11,8 C. pH of a 2 % aqueous solution must be between 11,1 and 11,8
C. pH of a 2 % aqueous solution must be between 11,1 and 11,8
Purity
Diphenylether Not more than 0,3  %
p-phenylphenol Not more than 0,1  %
1-naphthol Not more than 0,01  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for phenolate and for sodium
B. Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator
C. pH of a 2 % aqueous solution must be between 11,1 and 11,8
Definition
Chemical name 4-(2-benzimidazolyl)thiazole
2-(4-thiazolyl)-1H-benzimidazole
Einecs 205-725-8
Chemical formula C10H7N3S
Molecular weight 201,26
Assay Content not less than 98 % on the anhydrous basis
Description White, or almost white, odourless powder
Identification
A.Melting range A. Melting range 296oC to 303oC
A. Melting range
B.Spectrometry B. Spectrometry Absorption maxima in 0,1  N HCl (0,0005  % w/v) at 302 nm, 258 nm and 243 nm
B. Spectrometry
at 302 nm ± 2 nm: approximately 1 230
at 258 nm ± 2 nm: approximately 200
at 243 nm ± 2 nm: approximately 620
Ratio of absorption 243 nm/302 nm = 0,47 to 0,53
Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
Purity
Water content Not more than 0,5  % (Karl Fischer method)
Sulphated ash Not more than 0,2  %
Selenium Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Spectrometry
Definition Nisin consists of several closely related polypeptides produced by natural strains ofStreptococcus lactis, Lancefield group N
Einecs 215-807-5
Chemical formula C143H230N42O37S7
Molecular weight 3 354 ,12
Assay Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %
Description White powder
Purity
Loss on drying Not more than 3 % when dried to constant weight at 102oC to 103oC
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Synonyms Pimaricin
Definition Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains ofStreptomyces natalensisor ofStreptococcus lactis
Einecs 231-683-5
Chemical formula C33H47O13N
Molecular weight 665,74
Assay Content not less than 95 % on the anhydrous basis
Description White to creamy-white crystalline powder
Identification
A.Colour reactions A. Colour reactions On adding a few crystals of natamycin on a spot plate, to a drop of:—concentrated hydrochloric acid, a blue colour develops,—concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes — concentrated hydrochloric acid, a blue colour develops, — concentrated phosphoric acid, a green colour develops,
A. Colour reactions
— concentrated hydrochloric acid, a blue colour develops,
— concentrated phosphoric acid, a green colour develops,
B.Spectrometry B. Spectrometry A 0,0005  % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5  nm and 311 nm
B. Spectrometry
C.pH C. pH 5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
C. pH
D.Specific rotation D. Specific rotation [α]D20= + 250oto + 295o(a 1 % w/v solution in glacial acetic acid, at 20oC and calculated with reference to the dried material)
D. Specific rotation
Purity
Loss on drying Not more than 8 % (over P2O5, in vacuum at 60oC to constant weight)
Sulphated ash Not more than 0,5  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria: total viable count Not more than 100/g
A. Colour reactions
— concentrated hydrochloric acid, a blue colour develops,
— concentrated phosphoric acid, a green colour develops,
B. Spectrometry
C. pH
D. Specific rotation
Synonyms Hexamine
Methenamine
Definition
Chemical name 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
Einecs 202-905-8
Chemical formula C6H12N4
Molecular weight 140,19
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline powder
Identification
A.Positive tests for formaldehyde and for ammonia A. Positive tests for formaldehyde and for ammonia
A. Positive tests for formaldehyde and for ammonia
B.Sublimation point approximately 260oC B. Sublimation point approximately 260oC
B. Sublimation point approximately 260oC
Purity
Loss on drying Not more than 0,5  % after drying at 105oC in vacuum over P2O5for two hours
Sulphated ash Not more than 0,05  %
Sulphates Not more than 0,005  % expressed as SO4
Chlorides Not more than 0,005  % expressed as Cl
Ammonium salts Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for formaldehyde and for ammonia
B. Sublimation point approximately 260oC
Synonyms DMDC
Dimethyl pyrocarbonate
Definition
Chemical name Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Einecs 224-859-8
Chemical formula C4H6O5
Molecular weight 134,09
Assay Content not less than 99,8  %
Description Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion
Identification
A.Decomposition A. Decomposition After dilution positive tests for CO2and methanol
A. Decomposition
B.Melting point B. Melting point 17oC
B. Melting point
Boiling point 172oC with decomposition
C.Density 20oC C. Density 20oC Approximately 1,25 g/cm3
C. Density 20oC
D.Infrared spectrum D. Infrared spectrum Maxima at 1 156 and 1 832 cm-1
D. Infrared spectrum
Purity
Dimethyl carbonate Not more than 0,2  %
Chlorine, total Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Decomposition
B. Melting point
C. Density 20oC
D. Infrared spectrum
Definition
Chemical name Potassium nitrite
Einecs 231-832-4
Chemical formula KNO2
Molecular weight 85,11
Assay Content not less than 95 % on the anhydrous basis(5)
Description White or slightly yellow, deliquescent granules
Identification
A.Positive tests for nitrite and for potassium A. Positive tests for nitrite and for potassium
A. Positive tests for nitrite and for potassium
B.pH of a 5 % solution: B. pH of a 5 % solution: Not less than 6,0 and not more than 9,0
B. pH of a 5 % solution:
Purity
Loss on drying Not more than 3 % after drying for four hours over silica gel
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for nitrite and for potassium
B. pH of a 5 % solution:
Definition
Chemical name Sodium nitrite
Einecs 231-555-9
Chemical formula NaNO2
Molecular weight 69,00
Assay Content not less than 97 % on the anhydrous basis(6)
Description White crystalline powder or yellowish lumps
Identification
A.Positive tests for nitrite and for sodium A. Positive tests for nitrite and for sodium
A. Positive tests for nitrite and for sodium
Purity
Loss on drying Not more than 0,25  % after drying over silica gel for four hours
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for nitrite and for sodium
Synonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Sodium nitrate
Einecs 231-554-3
Chemical formula NaNO3
Molecular weight 85,00
Assay Content not less than 99 % after drying
Description White crystalline, slightly hygroscopic powder
Identification
A.Positive tests for nitrate and for sodium A. Positive tests for nitrate and for sodium
A. Positive tests for nitrate and for sodium
B.pH of a 5 % solution B. pH of a 5 % solution Not less than 5,5 and more than 8,3
B. pH of a 5 % solution
Purity
Loss on drying Not more than 2 % after drying at 105oC for four hours
Nitrites Not more than 30 mg/kg expressed as NaNO2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for nitrate and for sodium
B. pH of a 5 % solution
Definition Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
Chemical name Sodium nitrate
Einecs 231-554-3
Chemical formula NaNO3
Molecular weight 85,00
Assay Content between 33,5  % and 40,0  % of NaNO3
Description Clear colourless liquid
Identification
A.Positive tests for nitrate and for sodium A. Positive tests for nitrate and for sodium
A. Positive tests for nitrate and for sodium
B.pH B. pH Not less than 1,5 and not more than 3,5
B. pH
Purity
Free nitric acid Not more than 0,01  %
Nitrites Not more than 10 mg/kg expressed as NaNO2
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 0,3  mg/kg
This specification refers to a 35 % aqueous solution
A. Positive tests for nitrate and for sodium
B. pH
Synonyms Chile saltpetreCubic or soda nitre
Definition
Chemical name Potassium nitrate
Einecs 231-818-8
Chemical formula KNO3
Molecular weight 101,11
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline powder or transparent prisms having a cooling, saline, pungent taste
Identification
A.Positive tests for nitrate and for potassium A. Positive tests for nitrate and for potassium
A. Positive tests for nitrate and for potassium
B.pH of a 5 % solution B. pH of a 5 % solution Not less than 4,5 and not more than 8,5
B. pH of a 5 % solution
Purity
Loss on drying Not more than 1 % after drying at 105oC for four hours
Nitrites Not more than 20 mg/kg expressed as KNO2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for nitrate and for potassium
B. pH of a 5 % solution
Definition
Chemical name Acetic acid
Ethanoic acid
Einecs 200-580-7
Chemical formula C2H4O2
Molecular weight 60,05
Assay Content not less than 99,8  %
Description Clear, colourless liquid having a pungent, characteristic odour
Identification
A.Boiling point A. Boiling point 118oC at 760 mm pressure (of mercury)
A. Boiling point
B.Specific gravity B. Specific gravity About 1,049
B. Specific gravity
C.A one in three solution gives positive tests for acetate C. A one in three solution gives positive tests for acetate
C. A one in three solution gives positive tests for acetate
D.Solidification point D. Solidification point Not lower than 14,5oC
D. Solidification point
Purity
Non-volatile residue Not more than 100 mg/kg
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Readily oxidisable substances Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1  ml of 0,1  N potassium permanganate. The pink colour does not change to brown within 30 minutes
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Boiling point
B. Specific gravity
C. A one in three solution gives positive tests for acetate
D. Solidification point
Definition
Chemical name Potassium acetate
Einecs 204-822-2
Chemical formula C2H3O2K
Molecular weight 98,14
Assay Content not less than 99 % on the anhydrous basis
Description Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
Identification
A.pH of a 5 % aqueous solution A. pH of a 5 % aqueous solution Not less than 7,5 and not more than 9,0
A. pH of a 5 % aqueous solution
B.Positive tests for acetate and for potassium B. Positive tests for acetate and for potassium
B. Positive tests for acetate and for potassium
Purity
Loss on drying Not more than 8 % after drying at 150oC for two hours
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. pH of a 5 % aqueous solution
B. Positive tests for acetate and for potassium
Definition
Chemical name Sodium acetate
Einecs 204-823-8
Chemical formula C2H3NaO2·nH2O (n = 0 or 3)
Molecular weight Anhydrous: 82,03
Trihydrate: 136,08
Assay Content (for both of anhydrous and trihydrate form) not less than 98,5  % on the anhydrous basis
Description Anhydrous: White, odourless, granular, hygroscopic powder
Trihydrate: Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
Identification
A.pH of a 1 % aqueous solution A. pH of a 1 % aqueous solution Not less than 8,0 and not more than 9,5
A. pH of a 1 % aqueous solution
B.Positive tests for acetate and for sodium B. Positive tests for acetate and for sodium
B. Positive tests for acetate and for sodium
Purity
Loss on drying Anhydrous: Not more than 2 % (120oC, 4 hours)
Trihydrate: Between 36 and 42 % (120oC, 4 hours)
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. pH of a 1 % aqueous solution
B. Positive tests for acetate and for sodium
Definition Sodium diacetate is a molecular compound of sodium acetate and acetic acid
Chemical name Sodium hydrogen diacetate
Einecs 204-814-9
Chemical formula C4H7NaO4·nH2O (n = 0 or 3)
Molecular weight 142,09 (anhydrous)
Assay Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
Description White, hygroscopic crystalline solid with an acetic odour
Identification
A.pH of a 10 % aqueous solution A. pH of a 10 % aqueous solution Not less than 4,5 and not more than 5,0
A. pH of a 10 % aqueous solution
B.Positive tests for acetate and for sodium B. Positive tests for acetate and for sodium
B. Positive tests for acetate and for sodium
Purity
Water content Not more than 2 % (Karl Fischer method)
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. pH of a 10 % aqueous solution
B. Positive tests for acetate and for sodium
Definition
Chemical name Calcium acetate
Einecs 200-540-9
Chemical formula Anhydrous: C4H6O4Ca
Monohydrate: C4H6O4Ca· H2O
Molecular weight Anhydrous: 158,17
Monohydrate: 176,18
Assay Content not less than 98 % on the anhydrous basis
Description Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
Identification
A.pH of a 10 % aqueous solution A. pH of a 10 % aqueous solution Not less than 6,0 and not more than 9,0
A. pH of a 10 % aqueous solution
B.Positive tests for acetate and for calcium B. Positive tests for acetate and for calcium
B. Positive tests for acetate and for calcium
Purity
Loss on drying Not more than 11 % after drying (155oC to constant weight, for the monohydrate)
Water insoluble matter Not more than 0,3  %
Formic acid, formates and other oxidisable substances Not more than 1 000  mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. pH of a 10 % aqueous solution
B. Positive tests for acetate and for calcium
Definition
Chemical name Lactic acid
2-Hydroxypropionic acid
1-Hydroxyethane-1-carboxylic acid
Einecs 200-018-0
Chemical formula C3H6O3
Molecular weight 90,08
Assay Content not less than 76 % and not more than 84 %
Description Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically
Note:Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid
Identification
A.Positive test for lactate A. Positive test for lactate
A. Positive test for lactate
Purity
Sulphated ash Not more than 0,1  %
Chloride Not more than 0,2  %
Sulphate Not more than 0,25  %
Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Note:This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content
A. Positive test for lactate
Definition
Chemical name Propionic acid
Propanoic acid
Einecs 201-176-3
Chemical formula C3H6O2
Molecular weight 74,08
Assay Content not less than 99,5  %
Description Colourless or slightly yellowish, oily liquid with a slightly pungent odour
Indentification
A.Melting point A. Melting point – 22oC
A. Melting point
B.Distillation range B. Distillation range 138,5oC to 142,5oC
B. Distillation range
Purity
Non-volatile residue Not more than 0,01  % when dried at 140oC to constant weight
Aldehydes Not more than 0,1  % expressed as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting point
B. Distillation range
Definition
Chemical name Sodium propionate
Sodium propanoate
Einecs 205-290-4
Chemical formula C3H5O2Na
Molecular weight 96,06
Assay Content not less than 99 % after drying for two hours at 105oC
Description White crystalline hygroscopic powder, or a fine white powder
Identification
A.Positive tests for propionate and for sodium A. Positive tests for propionate and for sodium
A. Positive tests for propionate and for sodium
B.pH of a 10 % aqueous solution B. pH of a 10 % aqueous solution Not less than 7,5 and not more than 10,5
B. pH of a 10 % aqueous solution
Purity
Loss on drying Not more than 4 % determined by drying for two hours at 105oC
Water insolubles Not more than 0,1  %
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for propionate and for sodium
B. pH of a 10 % aqueous solution
Definition
Chemical name Calcium propionate
Einecs 223-795-8
Chemical formula C6H10O4Ca
Molecular weight 186,22
Assay Content not less than 99 %, after drying for two hours at 105oC
Description White crystalline powder
Identification
A.Positive tests for propionate and for calcium A. Positive tests for propionate and for calcium
A. Positive tests for propionate and for calcium
B.pH of a 10 % aqueous solution B. pH of a 10 % aqueous solution Between 6,0 and 9,0
B. pH of a 10 % aqueous solution
Purity
Loss on drying Not more than 4 %, determined by drying for two hours at 105oC
Water insolubles Not more than 0,3  %
Iron Not more than 50 mg/kg
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for propionate and for calcium
B. pH of a 10 % aqueous solution
Definition
Chemical name Potassium propionate
Potassium propanoate
Einecs 206-323-5
Chemical formula C3H5KO2
Molecular weight 112,17
Assay Content not less than 99 % after drying for two hours at 105oC
Description White crystalline powder
Identification
A.Positive tests for propionate and for potassium A. Positive tests for propionate and for potassium
A. Positive tests for propionate and for potassium
Purity
Loss on drying Not more than 4 %, determined by drying for two hours at 105oC
Water-insoluble substances Not more than 0,3  %
Iron Not more than 30 mg/kg
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for propionate and for potassium
Synonyms Boracic acid
Orthoboric acid
Borofax
Definition
Einecs 233-139-2
Chemical formula H3BO3
Molecular weight 61,84
Assay Content not less than 99,5  %
Description Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite
Identification
A.Melting point A. Melting point At approximately 171oC
A. Melting point
B.Burns with a nice green flame B. Burns with a nice green flame
B. Burns with a nice green flame
C.pH of a 3,3  % aqueous solution C. pH of a 3,3  % aqueous solution Between 3,8 and 4,8
C. pH of a 3,3  % aqueous solution
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting point
B. Burns with a nice green flame
C. pH of a 3,3  % aqueous solution
Synonyms Sodium borate
Definition
Chemical name Sodium tetraborate
Sodium biborate
Sodium pyroborate
Anhydrous tetraborate
Einecs 215-540-4
Chemical formula Na2B4O7
Na2B4O7·10H2O
Molecular weight 201,27
Description Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
Identification
A.Melting range A. Melting range Between 171oC and 175oC with decomposition
A. Melting range
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
Synonyms Carbonic acid gas
Dry ice (solid form)
Carbonic anhydride
Definition
Chemical name Carbon dioxide
Einecs 204-696-9
Chemical formula CO2
Molecular weight 44,01
Assay Content not less than 99 % v/v on the gaseous basis
Description A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
Identification
A.Precipitation (Precipitate formation) A. Precipitation (Precipitate formation) When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid
A. Precipitation (Precipitate formation)
Purity
Acidity 915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen phosphide and sulphide 915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution
Carbon monoxide Not more than 10 μl/l
Oil content Not more than 0,1  mg/l
A. Precipitation (Precipitate formation)
Synonyms DL-Malic acid, pomalous acid
Definition
Chemical name DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
Einecs 230-022-8
Chemical formula C4H6O5
Molecular weight 134,09
Assay Content not less than 99,0  %
Description White or nearly white crystalline powder or granules
Identification
A.Melting range between 127oC and 132oC A. Melting range between 127oC and 132oC
A. Melting range between 127oC and 132oC
B.Positive test for malate B. Positive test for malate
B. Positive test for malate
C.Solutions of this substance are optically inactive in all concentrations C. Solutions of this substance are optically inactive in all concentrations
C. Solutions of this substance are optically inactive in all concentrations
Purity
Sulphated ash Not more than 0,1  %
Fumaric acid Not more than 1,0  %
Maleic acid Not more than 0,05  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range between 127oC and 132oC
B. Positive test for malate
C. Solutions of this substance are optically inactive in all concentrations
Definition
Chemical name Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
Einecs 203-743-0
Chemical formula C4H4O4
Molecular weight 116,07
Assay Content not less than 99,0  % on the anhydrous basis
Description White crystalline powder or granules
Identification
A.Melting range A. Melting range 286oC-302oC (closed capillary, rapid heating)
A. Melting range
B.Positive tests for double bonds and for 1,2-dicarboxylic acid B. Positive tests for double bonds and for 1,2-dicarboxylic acid
B. Positive tests for double bonds and for 1,2-dicarboxylic acid
C.pH of a 0,05  % solution at 25oC C. pH of a 0,05  % solution at 25oC 3,0 -3,2
C. pH of a 0,05  % solution at 25oC
Purity
Loss on drying Not more than 0,5  % (120oC, 4h)
Sulphated ash Not more than 0,1  %
Maleic acid Not more than 0,1  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range
B. Positive tests for double bonds and for 1,2-dicarboxylic acid
C. pH of a 0,05  % solution at 25oC
Definition
Chemical name L-ascorbic acid
Ascorbic acid
2,3-Didehydro-L-threo-hexono-1,4-lactone
3-Keto-L-gulofuranolactone
Einecs 200-066-2
Chemical formula C6H8O6
Molecular weight 176,13
Assay Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6
Description White to pale yellow, odourless crystalline solid
Identification
A.Melting range A. Melting range Between 189oC and 193oC with decomposition
A. Melting range
B.Positive tests for ascorbic acid B. Positive tests for ascorbic acid
B. Positive tests for ascorbic acid
Purity
Loss on drying Not more than 0,4  % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Sulphated ash Not more than 0,1  %
Specific rotation [α]D20between +20,5oand +21,5o(10 % w/v aqueous solution)
pH of a 2 % aqueous solution Between 2,4 and 2,8
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
B. Positive tests for ascorbic acid
Definition
Chemical name Sodium ascorbate
Sodium L-ascorbate
2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate
3-Keto-L-gulofurano-lactone sodium enolate
Einecs 205-126-1
Chemical formula C6H7O6Na
Molecular weight 198,11
Assay Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na
Description White or almost white, odourless crystalline solid which darkens on exposure to light
Identification
A.Positive tests for ascorbate and for sodium A. Positive tests for ascorbate and for sodium
A. Positive tests for ascorbate and for sodium
Purity
Loss on drying Not more than 0,25  % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation [α]D20between + 103oand + 106o(10 % w/v aqueous solution)
pH of 10 % aqueous solution Between 6,5 and 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for ascorbate and for sodium
Definition
Chemical name Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs 227-261-5
Chemical formula C12H14O12Ca· 2H2O
Molecular weight 426,35
Assay Content not less than 98 % on a volatile matter-free basis
Description White to slightly pale greyish-yellow odourless crystalline powder
Identification
A.Positive tests for ascorbate and for calcium A. Positive tests for ascorbate and for calcium
A. Positive tests for ascorbate and for calcium
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Specific rotation [α]D20between + 95oand + 97o(5 % w/v aqueous solution)
pH of 10 % aqueous solution Between 6,0 and 7,5
Volatile matter Not more than 0,3  % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for ascorbate and for calcium
Definition
Chemical name Ascorbyl palmitate
L-ascorbyl palmitate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate
6-palmitoyl-3-keto-L-gulofuranolactone
Einecs 205-305-4
Chemical formula C22H38O7
Molecular weight 414,55
Assay Content not less than 98 % on the dried basis
Description White or yellowish-white solid with a citrus-like odour
Identification
A.Melting range A. Melting range Between 107oC and 117oC
A. Melting range
Purity
Loss on drying Not more than 2,0  % after drying in a vacuum oven at 56oC and 60oC for one hour
Sulphated ash Not more than 0,1  %
Specific rotation [α]D20between + 21oand + 24o(5 % w/v in methanol solution)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting range
Definition
Chemical name Ascorbyl stearate
L-ascorbyl stearate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate
6-stearoyl-3-keto-L-gulofuranolactone
Einecs 246-944-9
Chemical formula C24H42O7
Molecular weight 442,6
Assay Content not less than 98 %
Description White or yellowish, white solid with a citrus-like odour
Identification
A.Melting point A. Melting point About 116oC
A. Melting point
Purity
Loss on drying Not more than 2,0  % after drying in a vacuum oven at 56oC to 60oC for one hour
Sulphated ash Not more than 0,1  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Melting point
Definition Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols
Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols
Molecular weight 430,71 (d-α-tocopherol)
Assay Content not less than 34 % of total tocopherols
Description Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form
Identification
A.By suitable gas liquid chromatographic method A. By suitable gas liquid chromatographic method
A. By suitable gas liquid chromatographic method
B.Solubility tests B. Solubility tests Insoluble in water. Soluble in ethanol. Miscible in ether
B. Solubility tests
Purity
Sulphated ash Not more than 0,1  %
Specific rotation [α]D20not less than + 20o
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. By suitable gas liquid chromatographic method
B. Solubility tests
Synonyms DL-α-Tocopherol
Definition
Chemical name DL-5,7,8-Trimethyltocol
DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs 233-466-0
Chemical formula C29H50O2
Molecular weight 430,71
Assay Content not less than 96 %
Description Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light
Identification
A.Solubility tests A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether
A. Solubility tests
B.Spectro-photometry B. Spectro-photometry In absolute ethanol the maximum absorption is about 292 nm
B. Spectro-photometry
Purity
Refractive index nD201,503 -1,507
Specific absorptionin ethanol (292 nm) 72-76(0,01  g in 200 ml of absolute ethanol)
Sulphated ash Not more than 0,1  %
Specific rotation [α]D250o±0,05o(1 in 10 solution in chloroform)
Lead Not more than 2 mg/kg
A. Solubility tests
B. Spectro-photometry
Synonyms dl-γ-Tocopherol
Definition
Chemical name 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs 231-523-4
Chemical formula C28H48O2
Molecular weight 416,69
Assay Content not less than 97 %
Description Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light
Identification
A.Spectrometry A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
A. Spectrometry
Purity
Specific absorptionin ethanol (298 nm) between 91 and 97
(257 nm) between 5,0 and 8,0
Refractive index 1,503 -1,507
Sulphated ash Not more than 0,1  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Spectrometry
Definition
Chemical name 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs 204-299-0
Chemical formula C27H46O2
Molecular weight 402,7
Assay Content not less than 97 %
Description Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light
Identification
A.Spectrometry A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
A. Spectrometry
Purity
Specific absorptionin ethanol (298 nm) between 89 and 95
(257 nm) between 3,0 and 6,0
Refractive index 1,500 -1,504
Sulphated ash Not more than 0,1  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Spectrometry
Definition
Chemical name Propyl gallate
Propyl ester of gallic acid
n-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 204-498-2
Chemical formula C10H12O5
Molecular weight 212,20
Assay Content not less than 98 % on the anhydrous basis
Description White to creamy-white, crystalline, odourless solid
Identification
A.Solubility tests A. Solubility tests Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
A. Solubility tests
B.Melting range B. Melting range Between 146oC and 150oC after drying at 110oC for four hours
B. Melting range
Purity
Loss on drying Not more than 1,0  % (110oC, four hours)
Sulphated ash Not more than 0,1  %
Free acid Not more than 0,5  % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as C1)
Specific absorptionin ethanol (275 nm) not less than 485 and not more than 520
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility tests
B. Melting range
Definition
Chemical name Octyl gallate
Octyl ester of gallic acid
n-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 213-853-0
Chemical formula C15H22O5
Molecular weight 282,34
Assay Content not less than 98 % after drying at 90oC for six hours
Description White to creamy-white odourless solid
Identification
A.Solubility tests A. Solubility tests Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
A. Solubility tests
B.Melting range B. Melting range Between 99oC and 102oC after drying at 90oC for six hours
B. Melting range
Purity
Loss on drying Not more than 0,5  % (90oC, six hours)
Sulphated ash Not more than 0,05  %
Free acid Not more than 0,5  % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as C1)
Specific absorptionin ethanol (275 nm) not less than 375 and not more than 390
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility tests
B. Melting range
Synonyms Lauryl gallate
Definition
Chemical name Dodecyl gallate
n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid
Dodecyl ester of gallic acid
Einecs 214-620-6
Chemical formula C19H30O5
Molecular weight 338,45
Assay Content not less than 98 % after drying at 90oC for six hours
Description White or creamy-white odourless solid
Identification
A.Solubility tests A. Solubility tests Insoluble in water, freely soluble in ethanol and ether
A. Solubility tests
B.Melting range B. Melting range Between 95oC and 98oC after drying at 90oC for six hours
B. Melting range
Purity
Loss on drying Not more than 0,5  % (90oC, six hours)
Sulphated ash Not more than 0,05  %
Free acid Not more than 0,5  % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as Cl)
Specific absorptionin ethanol (275 nm) not less than 300 and not more than 325
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 30 mg/kg
A. Solubility tests
B. Melting range
Synonyms Isoascorbic acid
D-Araboascorbic acid
Definition
Chemical name D-Erythro-hex-2-enoic acid γ-lactone
Isoascorbic acid
D-Isoascorbic acid
Einecs 201-928-0
Chemical formula C6H8O6
Molecular weight 176,13
Assay Content not less than 98 % on the anhydrous basis
Description White to slightly yellow crystalline solid which darkens gradually on exposure to light
Identification
A.Melting range A. Melting range About 164oC to 172oC with decomposition
A. Melting range
B.Positive test for ascorbic acid/colour reaction B. Positive test for ascorbic acid/colour reaction
B. Positive test for ascorbic acid/colour reaction
Purity
Loss on drying Not more than 0,4  % after drying under reduced pressure on silica gel for 3 hours
Sulphated ash Not more than 0,3  %
Specific rotation [α]10 % (w/v) aqueous solution between -16,5oto -18,0o
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
Lead Not more than 2 mg/kg
A. Melting range
B. Positive test for ascorbic acid/colour reaction
Synonyms Sodium isoascorbate
Definition
Chemical name Sodium isoascorbate
Sodium D-isoascorbic acid
Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone
3-keto-D-gulofurano-lactone sodium enolate monohydrate
Einecs 228-973-9
Chemical formula C6H7O6Na· H2O
Molecular weight 216,13
Assay Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis
Description White crystalline solid
Identification
A.Solubility tests A. Solubility tests Freely soluble in water, very slightly soluble in ethanol
A. Solubility tests
B.Positive test for ascorbic acid/colour reaction B. Positive test for ascorbic acid/colour reaction
B. Positive test for ascorbic acid/colour reaction
C.Positive test for sodium C. Positive test for sodium
C. Positive test for sodium
Purity
Loss on drying Not more than 0,25  % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation [α]10 % (w/v) aqueous solution between + 95oand + 98o
pH of a 10 % aqueous solution 5,5 to 8,0
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility tests
B. Positive test for ascorbic acid/colour reaction
C. Positive test for sodium
Synonyms TBHQ
Definition
Chemical names Tert-butyl-1,4-benzenediol
2-(1,1-Dimethylethyl)-1,4-benzenediol
Einecs 217-752-2
Chemical formula C10H14O2
Molecular weight 166,22
Assay Content not less than 99 % of C10H14O2
Description White crystalline solid having a characteristic odour
Identification
A.Solubility A. Solubility Practically insoluble in water; soluble in ethanol
A. Solubility
B.Melting point B. Melting point Not less than 126,5oC
B. Melting point
C.Phenolics C. Phenolics Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5  ml of dimethylamine solution (1 in 4). A red to pink colour is produced
C. Phenolics
Purity
Tertiary-Butyl-p-benzoquinone Not more than 0,2  %
2,5-Di-tertiary-butyl hydroquinone Not more than 0,2  %
Hydroxyquinone Not more than 0,1  %
Toluene Not more than 25 mg/kg
Lead Not more than 2 mg/kg
A. Solubility
B. Melting point
C. Phenolics
Synonyms BHA
Definition
Chemical names 3-Tertiary-butyl-4-hydroxyanisole
A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
Einecs 246-563-8
Chemical formula C11H16O2
Formula weight 180,25
Assay Content not less than 98,5  % of C11H16O2and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
Description White or slightly yellow crystals or waxy solid with a slight aromatic smell
Identification
A.Solubility A. Solubility Insoluble in water, freely soluble in ethanol
A. Solubility
B.Melting range B. Melting range Between 48 °C and 63 °C
B. Melting range
C.Colour reaction C. Colour reaction Passes test for phenol groups
C. Colour reaction
Purity
Sulphated ash Not more than 0,05  % after calcination at 800 ± 25 °C
Phenolic impurities Not more than 0,5  %
Specific absorption (290 nm) not less than 190 and not more than 210
Specific absorption (228 nm) not less than 326 and not more than 345
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Melting range
C. Colour reaction
Synonyms BHT
Definition
Chemical name 2,6-Ditertiary-butyl-p-cresol
4-Methyl-2,6-ditertiarybutylphenol
Einecs 204-881-4
Chemical formula C15H24O
Molecular weight 220,36
Assay Content not less than 99 %
Description White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour
Identification
A.Solubility tests A. Solubility tests Insoluble in water and propane- 1,2-diol
A. Solubility tests
Freely soluble in ethanol
B.Melting point B. Melting point At 70oC
B. Melting point
C.Absorbance maximum C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
C. Absorbance maximum
Purity
Sulphated ash Not more than 0,005  %
Phenolic impurities Not more than 0,5  %
Specific absorptionin ethanol (278 nm) not less than 81 and not more than 88
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility tests
B. Melting point
C. Absorbance maximum
Synonyms Phosphatides
Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
Einecs 232-307-2
Assay —Lecithins: not less than 60,0  % of substances insoluble in acetone — Lecithins: not less than 60,0  % of substances insoluble in acetone
— Lecithins: not less than 60,0  % of substances insoluble in acetone
—Hydrolysed lecithins: not less than 56,0  % of substances insoluble in acetone — Hydrolysed lecithins: not less than 56,0  % of substances insoluble in acetone
— Hydrolysed lecithins: not less than 56,0  % of substances insoluble in acetone
Description —Lecithins: brown liquid or viscous semi-liquid or powder — Lecithins: brown liquid or viscous semi-liquid or powder
— Lecithins: brown liquid or viscous semi-liquid or powder
—Hydrolysed lecithins: light brown to brown viscous liquid or paste — Hydrolysed lecithins: light brown to brown viscous liquid or paste
— Hydrolysed lecithins: light brown to brown viscous liquid or paste
Identification
A.Positive tests for choline, for phosphorus and fatty acids A. Positive tests for choline, for phosphorus and fatty acids
A. Positive tests for choline, for phosphorus and fatty acids
B.Test for hydrolysed lecithin B. Test for hydrolysed lecithin To a 800 ml beaker add 500 ml of water (30oC-35oC). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
B. Test for hydrolysed lecithin
Purity
Loss on drying Not more than 2,0  % determined by drying at 105oC for one hour
Toluene-insoluble matter Not more than 0,3  %
Acid value —Lecithins: not more than 35 mg of potassium hydroxide per gram — Lecithins: not more than 35 mg of potassium hydroxide per gram
— Lecithins: not more than 35 mg of potassium hydroxide per gram
—Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram — Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
— Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
Peroxide value Equal to or less than 10
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
— Lecithins: not less than 60,0  % of substances insoluble in acetone
— Hydrolysed lecithins: not less than 56,0  % of substances insoluble in acetone
— Lecithins: brown liquid or viscous semi-liquid or powder
— Hydrolysed lecithins: light brown to brown viscous liquid or paste
A. Positive tests for choline, for phosphorus and fatty acids
B. Test for hydrolysed lecithin
— Lecithins: not more than 35 mg of potassium hydroxide per gram
— Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
Definition
Chemical name Sodium lactate
Sodium 2-hydroxypropanoate
Einecs 200-772-0
Chemical formula C3H5NaO3
Molecular weight 112,06 (anhydrous)
Assay Content not less than 57 % and not more than 66 %
Description Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour
Identification
A.Positive test for lactate A. Positive test for lactate
A. Positive test for lactate
B.Positive test for sodium B. Positive test for sodium
B. Positive test for sodium
Purity
Acidity Not more than 0,5  % after drying expressed as lactic acid
pH of a 20 % aqueous solution 6,5 to 7,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Reducing substances No reduction of Fehling's solution
Note:This specification refers to a 60 % aqueous solution
A. Positive test for lactate
B. Positive test for sodium
Definition
Cheminal name Potassium lactate
Potassium 2-hydroxypropanoate
Einecs 213-631-3
Chemical formula C3H5O3K
Molecular weight 128,17 (anhydrous)
Assay Content not less than 57 % and not more than 66 %
Description Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour
Identification
A.Ignition A. Ignition Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
A. Ignition
B.Colour reaction B. Colour reaction Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
B. Colour reaction
C.Positive tests for potassium and for lactate C. Positive tests for potassium and for lactate
C. Positive tests for potassium and for lactate
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Acidity Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1  N sodium hydroxide. Not more than 0,2  ml should be required
Reducing substances Potassium lactate solution shall not cause any reduction of Fehling's solution
Note:This specification refers to a 60 % aqueous solution
A. Ignition
B. Colour reaction
C. Positive tests for potassium and for lactate
Definition
Chemical name Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs 212-406-7
Chemical formula (C3H5O2)2Ca· nH2O (n = 0-5)
Molecular weight 218,22 (anhydrous)
Assay Content not less than 98 % on the anhydrous basis
Description Almost odourless, white crystalline powder or granules
Identification
A.Positive tests for lactate and for calcium A. Positive tests for lactate and for calcium
A. Positive tests for lactate and for calcium
B.Solubility tests B. Solubility tests Soluble in water and practically insoluble in ethanol
B. Solubility tests
Purity
Loss on drying Determined by drying at 120oC for four hours:
—anhydrous: not more than 3,0  % — anhydrous: not more than 3,0  %
— anhydrous: not more than 3,0  %
—with 1 molecule of water: not more than 8,0  % — with 1 molecule of water: not more than 8,0  %
— with 1 molecule of water: not more than 8,0  %
—with 3 molecules of water: not more than 20,0  % — with 3 molecules of water: not more than 20,0  %
— with 3 molecules of water: not more than 20,0  %
—with 4,5 molecules of water: not more than 27,0  % — with 4,5 molecules of water: not more than 27,0  %
— with 4,5 molecules of water: not more than 27,0  %
Acidity Not more than 0,5  % of the dry matter expressed as lactic acid
Fluoride Not more than 30 mg/kg (expressed as fluorine)
pH of a 5 % solution Between 6,0 and 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Reducing substances No reduction of Fehling's solution
A. Positive tests for lactate and for calcium
B. Solubility tests
— anhydrous: not more than 3,0  %
— with 1 molecule of water: not more than 8,0  %
— with 3 molecules of water: not more than 20,0  %
— with 4,5 molecules of water: not more than 27,0  %
Definition
Chemical name Citric acid
2-Hydroxy-1,2,3-propanetricarboxylic acid
β-Hydroxytricarballytic acid
Einecs 201-069-1
Chemical formula (a)C6H8O7(anhydrous) (a) C6H8O7(anhydrous)
(a) C6H8O7(anhydrous)
(b)C6H8O7·H2O (monohydrate) (b) C6H8O7·H2O (monohydrate)
(b) C6H8O7·H2O (monohydrate)
Molecular weight (a)192,13 (anhydrous) (a) 192,13 (anhydrous)
(a) 192,13 (anhydrous)
(b)210,15 (monohydrate) (b) 210,15 (monohydrate)
(b) 210,15 (monohydrate)
Assay Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5  % of C6H8O7, calculated on the anhydrous basis
Description Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air
Identification
A.Solubility tests A. Solubility tests Very soluble in water; freely soluble in ethanol; soluble in ether
A. Solubility tests
Purity
Water content Anhydrous citric acid contains not more than 0,5  % water; citric acid monohydrate contains not more than 8,8  % water (Karl Fischer method)
Sulphated ash Not more than 0,05  % after calcination at 800 ± 25oC
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
Oxalates Not more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonisable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90oC in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)
(a) C6H8O7(anhydrous)
(b) C6H8O7·H2O (monohydrate)
(a) 192,13 (anhydrous)
(b) 210,15 (monohydrate)
A. Solubility tests
Synonyms Monosodium citrateMonobasic sodium citrate
Definition
Chemical name Monosodium citrate
Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Chemical formula (a)C6H7O7Na (anhydrous) (a) C6H7O7Na (anhydrous)
(a) C6H7O7Na (anhydrous)
(b)C6H7O7Na· H2O (monohydrate) (b) C6H7O7Na· H2O (monohydrate)
(b) C6H7O7Na· H2O (monohydrate)
Molecular weight (a)214,11 (anhydrous) (a) 214,11 (anhydrous)
(a) 214,11 (anhydrous)
(b)232,23 (monohydrate) (b) 232,23 (monohydrate)
(b) 232,23 (monohydrate)
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A.Positive tests for citrate and for sodium A. Positive tests for citrate and for sodium
A. Positive tests for citrate and for sodium
Purity
Loss on drying Determined by drying at 180oC for four hours:—anhydrous: not more than 1,0  % — anhydrous: not more than 1,0  %
— anhydrous: not more than 1,0  %
—monohydrate: not more than 8,8  % — monohydrate: not more than 8,8  %
— monohydrate: not more than 8,8  %
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
(a) C6H7O7Na (anhydrous)
(b) C6H7O7Na· H2O (monohydrate)
(a) 214,11 (anhydrous)
(b) 232,23 (monohydrate)
A. Positive tests for citrate and for sodium
— anhydrous: not more than 1,0  %
— monohydrate: not more than 8,8  %
Synonyms Disodium citrateDibasic sodium citrate
Definition
Chemical name Disodium citrate
Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Disodium salt of citric acid with 1,5 molecules of water
Einecs 205-623-3
Chemical formula C6H6O7Na2·1,5H2O
Molecular weight 263,11
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A.Positive tests for citrate and for sodium A. Positive tests for citrate and for sodium
A. Positive tests for citrate and for sodium
Purity
Loss on drying Not more than 13,0  % by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 4,9 and 5,2
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
A. Positive tests for citrate and for sodium
Synonyms Trisodium citrateTribasic sodium citrate
Definition
Chemical name Trisodium citrate
Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form
Einecs 200-675-3
Chemical formula Anhydrous: C6H5O7Na3
Hydrated: C6H5O7Na3·nH2O (n = 2 or 5)
Molecular weight 258,07 (anhydrous)
Assay Not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A.Positive tests for citrate and for sodium A. Positive tests for citrate and for sodium
A. Positive tests for citrate and for sodium
Purity
Loss on drying Determined by drying at 180oC for four hours:
—anhydrous: — anhydrous: not more than 1,0  %
— anhydrous:
—dihydrate: — dihydrate: not more than 13,5  %
— dihydrate:
—pentahydrate: — pentahydrate: not more than 30,3  %
— pentahydrate:
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution Between 7,5 and 9,0
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
A. Positive tests for citrate and for sodium
— anhydrous:
— dihydrate:
— pentahydrate:
Synonyms Monopotassium citrateMonobasic potassium citrate
Definition
Chemical name Monopotassium citrate
Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Anhydrous monopotassium salt of citric acid
Einecs 212-753-4
Chemical formula C6H7O7K
Molecular weight 230,21
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification
A.Positive tests for citrate and for potassium A. Positive tests for citrate and for potassium
A. Positive tests for citrate and for potassium
Purity
Loss on drying Not more than 1,0  % determined by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
A. Positive tests for citrate and for potassium
Synonyms Tripotassium citrateTribasic potassium citrate
Definition
Chemical name Tripotassium citrate
Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrated tripotassium salt of citric acid
Einecs 212-755-5
Chemical formula C6H5O7K3·H2O
Molecular weight 324,42
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification
A.Positive tests for citrate and for potassium A. Positive tests for citrate and for potassium
A. Positive tests for citrate and for potassium
Purity
Loss on drying Not more than 6,0  % determined by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution Between 7,5 and 9,0
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
A. Positive tests for citrate and for potassium
Synonyms Monocalcium citrateMonobasic calcium citrate
Definition
Chemical name Monocalcium citrate
Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrate monocalcium salt of citric acid
Chemical formula (C6H7O7)2Ca· H2O
Molecular weight 440,32
Assay Content not less than 97,5  % on the anhydrous basis
Description Fine white powder
Identification
A.Positive tests for citrate and for calcium A. Positive tests for citrate and for calcium
A. Positive tests for citrate and for calcium
Purity
Loss on drying Not more than 7,0  % determined by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 3,2 and 3,5
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
A. Positive tests for citrate and for calcium
Synonyms Dicalcium citrateDibasic calcium citrate
Definition
Chemical name Dicalcium citrate
Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Trihydrated dicalcium salt of citric acid
Chemical formula (C6H7O7)2Ca2·3H2O
Molecular weight 530,42
Assay Not less than 97,5  % on the anhydrous basis
Description Fine white powder
Identification
A.Positive tests for citrate and for calcium A. Positive tests for citrate and for calcium
A. Positive tests for citrate and for calcium
Purity
Loss on drying Not more than 20,0  % determined by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
A. Positive tests for citrate and for calcium
Synonyms Tricalcium citrateTribasic calcium citrate
Definition
Chemical name Tricalcium citrate
Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Tetrahydrated tricalcium salt of citric acid
Einecs 212-391-7
Chemical formula (C6H6O7)2Ca3·4H2O
Molecular weight 570,51
Assay Not less than 97,5  % on the anhydrous basis
Description Fine white powder
Identification
A.Positive tests for citrate and for calcium A. Positive tests for citrate and for calcium
A. Positive tests for citrate and for calcium
Purity
Loss on drying Not more than 14,0  % determined by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
A. Positive tests for citrate and for calcium
Definition
Chemical name L-tartaric acid
L-2,3-dihydroxybutanedioic acid
d-α, β-dihydroxysuccinic acid
Einecs 201-766-0
Chemical formula C4H6O6
Molecular weight 150,09
Assay Content not less than 99,5  % on the anhydrous basis
Description Colourless or translucent crystalline solid or white crystalline powder
Identification
A.Melting range A. Melting range Between 168oC and 170oC
A. Melting range
B.Positive test for tartrate B. Positive test for tartrate
B. Positive test for tartrate
Purity
Loss on drying Not more than 0,5  % (over P2O5, three hours)
Sulphated ash Not more than 1 000  mg/kg after calcination at 800 ± 25oC
Specific optical rotation of a 20 % w/v aqueous solution [α]20Dbetween +11,5oand +13,5o
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
A. Melting range
B. Positive test for tartrate
Synonyms Monosodium salt of L-(+)-tartaric acid
Definition
Chemical name Monosodium salt of L-2,3-dihydroxybutanedioic acid
Monohydrated monosodium salt of L-(+)-tartaric acid
Chemical formula C4H5O6Na· H2O
Molecular weight 194,05
Assay Content not less than 99 % on the anhydrous basis
Description Transparent colourless crystals
Identification
A.Positive tests for tartrate and for sodium A. Positive tests for tartrate and for sodium
A. Positive tests for tartrate and for sodium
Purity
Loss on drying Not more than 10,0  % determined by drying at 105oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for tartrate and for sodium
Definition
Chemical name Disodium L-tartrate
Disodium (+)-tartrate
Disodium (+)-2,3-dihydroxybutanedioic acid
Dihydrated disodium salt of L-(+)-tartaric acid
Einecs 212-773-3
Chemical formula C4H4O6Na2·2H2O
Molecular weight 230,8
Assay Content not less than 99 % on the anhydrous basis
Description Transparent, colourless crystals
Identification
A.Positive tests for tartrate and for sodium A. Positive tests for tartrate and for sodium
A. Positive tests for tartrate and for sodium
B.Solubility tests B. Solubility tests 1 gram is insoluble in 3 ml of water. Insoluble in ethanol
B. Solubility tests
Purity
Loss on drying Not more than 17,0  % determined by drying at 150oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 7,0 and 7,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for tartrate and for sodium
B. Solubility tests
Synonyms Monobasic potassium tartrate
Definition
Chemical name Anhydrous monopotassium salt of L-(+)-tartaric acid
Monopotassium salt of L-2,3-dihydroxybutanedioic acid
Chemical formula C4H5O6K
Molecular weight 188,16
Assay Content not less than 98 % on the anhydrous basis
Description White crystalline or granulated powder
Identification
A.Positive tests for tartrate and for potassium A. Positive tests for tartrate and for potassium
A. Positive tests for tartrate and for potassium
B.Melting point B. Melting point 230oC
B. Melting point
Purity
pH of a 1 % aqueous solution 3,4
Loss on drying Not more than 1,0  % determined by drying at 105oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for tartrate and for potassium
B. Melting point
Synonyms Dibasic potassium tartrate
Definition
Chemical name Dipotassium salt of L-2,3-dihydroxybutanedioic acid
Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
Einecs 213-067-8
Chemical formula C4H4O6K2·1/2H2O
Molecular weight 235,2
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline or granulated powder
Identification
A.Positive tests for tartrate and for potassium A. Positive tests for tartrate and for potassium
A. Positive tests for tartrate and for potassium
Purity
pH of a 1 % aqueous solution Between 7,0 and 9,0
Loss on drying Not more than 4,0  % determined by drying at 150oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for tartrate and for potassium
Synonyms Potassium sodium L-(+)-tartrate
Rochelle salt
Seignette salt
Definition
Chemical name Potassium sodium salt of L-2,3-dihydroxybutanedioic acid
Potassium sodium L-(+)-tartrate
Einecs 206-156-8
Chemical formula C4H4O6KNa· 4H2O
Molecular weight 282,23
Assay Content not less than 99 % on the anhydrous basis
Description Colourless crystals or white crystalline powder
Identification
A.Positive tests for tartrate, for potassium and for sodium A. Positive tests for tartrate, for potassium and for sodium
A. Positive tests for tartrate, for potassium and for sodium
B.Solubility tests B. Solubility tests 1 gram is soluble in 1 ml of water, insoluble in ethanol
B. Solubility tests
C.Melting range C. Melting range Between 70 and 80oC
C. Melting range
Purity
Loss on drying Not more than 26,0  % and not less than 21,0  % determined by drying at 150oC for three hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of 1 % aqueous solution Between 6,5 and 8,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for tartrate, for potassium and for sodium
B. Solubility tests
C. Melting range
Synonyms Orthophosphoric acid
Monophosphoric acid
Definition
Chemical name Phosphoric acid
Einecs 231-633-2
Chemical formula H3PO4
Molecular weight 98,00
Assay Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0  % and not more than 85,7  %.
Description Clear, colourless, viscous liquid
Identification
A.Positive tests for acid and for phosphate A. Positive tests for acid and for phosphate
A. Positive tests for acid and for phosphate
Purity
Volatile acids Not more than 10 mg/kg (as acetic acid)
Chlorides Not more than 200 mg/kg (expressed as chlorine)
Nitrates Not more than 5 mg/kg (as NaNO3)
Sulphates Not more than 1 500  mg/kg (as CaSO4)
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
Note:This specification refers to a 75 % aqueous solution
A. Positive tests for acid and for phosphate
Synonyms Monosodium monophosphate
Acid monosodium monophosphate
Monosodium orthophosphate
Monobasic sodium phosphate
Sodium dihydrogen monophosphate
Definition
Chemical name Sodium dihydrogen monophosphate
Einecs 231-449-2
Chemical formula Anhydrous: NaH2PO4
Monohydrate: NaH2PO4· H2O
Dihydrate: NaH2PO4· 2H2O
Molecular weight Anhydrous: 119,98
Monohydrate: 138,00
Dihydrate: 156,01
Assay After drying at 60oC for one hour and then at 105oC for four hours, contains not less than 97 % of NaH2PO4
P2O5content Between 58,0  % and 60,0  % on the anhydrous basis
Description A white odourless, slightly deliquescent powder, crystals or granules
Identification
A.Positive tests for sodium and for phosphate A. Positive tests for sodium and for phosphate
A. Positive tests for sodium and for phosphate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol or ether
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 4,1 and 5,0
C. pH of a 1 % solution
Purity
Loss on drying The anhydrous salt loses not more than 2,0  %, the monohydrate not more than 15,0  %, and the dihydrate not more than 25 % when dried first at 60oC for one hour, then at 105oC for four hours
Water-insoluble substances Not more than 0,2  % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Disodium monophosphate
Secondary sodium phosphate
Disodium orthophosphate
Acid disodium phosphate
Definition
Chemical name Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs 231-448-7
Chemical formula Anhydrous: Na2HPO4
Hydrat: Na2HPO4· nH2O (n = 2,7 or 12)
Molecular weight 141,98 (anhydrous)
Assay After drying at 40oC for three hours and subsequently at 105oC for five hours, contains not less than 98 % of Na2HPO4
P2O5content Between 49 % and 51 % on the anhydrous basis
Description Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
Identification
A.Positive tests for sodium and for phosphate A. Positive tests for sodium and for phosphate
A. Positive tests for sodium and for phosphate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 8,4 and 9,6
C. pH of a 1 % solution
Purity
Loss on drying When dried at 40oC for three hours and then at 105oC for five hours, the losses in weight are as follows: anhydrous not more than 5,0  %, dihydrate not more than 22,0  %, heptahydrate not more than 50,0  %, dodecahydrate not more than 61,0  %
Water-insoluble substances Not more than 0,2  % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains 1/4 molecule of NaOH
Chemical name Trisodium monophosphate
Trisodium phosphate
Trisodium orthophosphate
Einecs 231-509-8
Chemical formula Anhydrous: Na3PO4
Hydrated: Na3PO4· nH2O (n = 1/2, 1, 6, 8, or 12)
Molecular weight 163,94 (anhydrous)
Assay Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0  % of Na3PO4calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0  % of Na3PO4calculated on the ignited basis
P2O5content Between 40,5  % and 43,5  % on the anhydrous basis
Description White odourless crystals, granules or crystalline powder
Identification
A.Positive tests for sodium and for phosphate A. Positive tests for sodium and for phosphate
A. Positive tests for sodium and for phosphate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 11,5 and 12,5
C. pH of a 1 % solution
Purity
Loss on ignition When dried at 120oC for two hours and then ignited at about 800oC for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0  %, monohydrate not more than 11,0  %, dodecahydrate: between 45,0  % and 58,0  %
Water insoluble substances Not more than 0,2  % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Monobasic potassium phosphate
Monopotassium monophosphate
Potassium orthophosphate
Definition
Chemical name Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs 231-913-4
Chemical formula KH2PO4
Molecular weight 136,09
Assay Content not less than 98,0  % after drying at 105oC for four hours
P2O5content Between 51,0  % and 53,0  % on the anhydrous basis
Description Odourless, colourless crystals or white granular or crystalline powder, hygroscopic
Identification
A.Positive tests for potassium and for phosphate A. Positive tests for potassium and for phosphate
A. Positive tests for potassium and for phosphate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 4,2 and 4,8
C. pH of a 1 % solution
Purity
Loss on drying Not more than 2,0  % determined by drying at 105oC for four hours
Water-insoluble substances Not more than 0,2  % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Dipotassium monophosphate
Secondary potassium phosphate
Dipotassium acid phosphate
Dipotassium orthophosphate
Dibasic potassium phosphate
Definition
Chemical name Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphate
Dipotassium hydrogen orthophosphate
Einecs 231-834-5
Chemical formula K2HPO4
Molecular weight 174,18
Assay Content not less than 98 % after drying at 105oC for four hours
P2O5content Between 40,3  % and 41,5  % on the anhydrous basis
Description Colourless or white granular powder, crystals or masses; deliquescent substance
Identification
A.Positive tests for potassium and for phosphate A. Positive tests for potassium and for phosphate
A. Positive tests for potassium and for phosphate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 8,7 and 9,4
C. pH of a 1 % solution
Purity
Loss on drying Not more than 2,0  % determined by drying at 105oC for four hours
Water-insoluble substances Not more than 0,2  % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Potassium phosphate
Tribasic potassium phosphate
Tripotassium orthophosphate
Definition
Chemical name Tripotassium monophosphate
Tripotassium phosphate
Tripotassium orthophosphate
Einecs 231-907-1
Chemical formula Anhydrous: K3PO4
Hydrated: K3PO4· nH2O (n = 1 or 3)
Molecular weight 212,27 (anhydrous)
Assay Content not less than 97 % calculated on the ignited basis
P2O5content Between 30,5  % and 33,0  % on the ignited basis
Description Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
Identification
A.Positive tests for potassium and for phosphate A. Positive tests for potassium and for phosphate
A. Positive tests for potassium and for phosphate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 11,5 and 12,3
C. pH of a 1 % solution
Purity
Loss on ignition Anhydrous: not more than 3,0  %; hydrated: not more than 23,0  %. Determined by drying at 105oC for one hour and then ignite at about 800oC ± 25oC for 30 minutes
Water insoluble substances Not more than 0,2  % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Monobasic calcium phosphate
Monocalcium orthophosphate
Definition
Chemical name Calcium dihydrogen phosphate
Einecs 231-837-1
Chemical formula Anhydrous: Ca(H2PO4)2
Monohydrate: Ca(H2PO4)2· H2O
Molecular weight 234,05 (anhydrous)
252,08 (monohydrate)
Assay Content not less than 95 % on the dried basis
P2O5content Between 55,5  % and 61,1  % on the anhydrous basis
Description Granular powder or white, deliquescent crystals or granules
Identification
A.Positive tests for calcium and for phosphate A. Positive tests for calcium and for phosphate
A. Positive tests for calcium and for phosphate
B.CaO content B. CaO content Between 23,0  % and 27,5  % (anhydrous)
B. CaO content
Between 19,0  % and 24,8  % (monohydrate)
Purity
Loss on drying Not more than 14 % determined by drying at 105oC for four hours (anhydrous)
Not more than 17,5  % determined by drying at 60oC for one hour, then at 105oC for four hours (monohydrate)
Loss on ignition Not more than 17,5  % after ignition at 800oC ± 25oC for 30 minutes (anhydrous)
Not more than 25,0  % determined by drying at 105oC for one hour, then ignite at 800oC ± 25oC for 30 minutes (monohydrate)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for phosphate
B. CaO content
Synonyms Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate
Einecs 231-826-1
Chemical formula Anhydrous: CaHPO4
Dihydrate: CaHPO4· 2H2O
Molecular weight 136,06 (anhydrous)
172,09 (dihydrate)
Assay Dicalcium phosphate, after drying at 200oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4
P2O5content Between 50,0  % and 52,5  % on the anhydrous basis
Description White crystals or granules, granular powder or powder
Identification
A.Positive tests for calcium and for phosphate A. Positive tests for calcium and for phosphate
A. Positive tests for calcium and for phosphate
B.Solubility tests B. Solubility tests Sparingly soluble in water. Insoluble in ethanol
B. Solubility tests
Purity
Loss on ignition Not more than 8,5  % (anhydrous), or 26,5  % (dihydrate) after ignition at 800oC ± 25oC for 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for phosphate
B. Solubility tests
Synonyms Calcium phosphate, tribasic
Calcium orthophosphate
Pentacalcium hydroxy monophosphate
Calcium hydroxyapatite
Definition Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5· H2O
Chemical name Pentacalcium hydroxy monophosphate
Tricalcium monophosphate
Einecs 235-330-6 (Pentacalcium hydroxy monophosphate)
231-840-8 (Calcium orthophosphate)
Chemical formula Ca5(PO4)3· OH or Ca3(PO4)2
Molecular weight 502 or 310
Assay Content not less than 90 % calculated on the ignited basis
P2O5 content Between 38,5  % and 48,0  % on the anhydrous basis
Description A white, odourless powder which is stable in air
Identification
A.Positive tests for calcium and for phosphate A. Positive tests for calcium and for phosphate
A. Positive tests for calcium and for phosphate
B.Solubility B. Solubility Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid
B. Solubility
Purity
Loss on ignition Not more than 8 % after ignition at 800oC ± 25oC, to constant weight
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for phosphate
B. Solubility
Synonyms Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasic
Monomagnesium orthophosphate
Definition
Chemical name Monomagnesiumdihydrogenmonophosphate
Einecs 236-004-6
Chemical formula Mg(H2PO4)2· nH2O (where n = 0 to 4)
Molecular weight 218,30 (anhydrous)
Assay Not less than 51,0  % after ignition
Description White, odourless, crystalline powder, slightly soluble in water
Identification
A.Positive test for magnesium and for phosphate A. Positive test for magnesium and for phosphate
A. Positive test for magnesium and for phosphate
B.MgO content B. MgO content Not less than 21,5  % after ignition
B. MgO content
Purity
Fluoride Not more than 10 mg/kg (as fluorine)
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for magnesium and for phosphate
B. MgO content
Synonyms Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasic
Dimagnesium orthophosphate
Secondary magnesiumphosphate
Definition
Chemical name Dimagnesiummonohydrogenmonophosphate
Einecs 231-823-5
Chemical formula MgHPO4· nH2O (where n = 0-3)
Molecular weight 120,30 (anhydrous)
Assay Not less than 96 % after ignition
Description White, odourless, crystalline powder, slightly soluble in water
Identification
A.Positive test for magnesium and for phosphate A. Positive test for magnesium and for phosphate
A. Positive test for magnesium and for phosphate
B.MgO content: B. MgO content: Not less than 33,0  % calculated on an anhydrous basis
B. MgO content:
Purity
Fluoride Not more than 10 mg/kg (as fluorine)
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for magnesium and for phosphate
B. MgO content:
Synonyms Sodium salt of malic acid
Definition
Chemical name Disodium DL-malate, disodium salt of hydroxybutanedioic acid
Chemical formula Hemihydrate: C4H4Na2O5· 1/2 H2O
Trihydrate: C4H4Na2O5· 3H2O
Molecular weight Hemihydrate: 187,05
Trihydrate: 232,10
Assay Content not less than 98,0  % on the anhydrous basis
Description White crystalline powder or lumps
Identification
A.Positive tests for 1,2-dicarboxylic acid and for sodium A. Positive tests for 1,2-dicarboxylic acid and for sodium
A. Positive tests for 1,2-dicarboxylic acid and for sodium
B.Azo dye formation B. Azo dye formation Positive
B. Azo dye formation
C.Solubility C. Solubility Freely soluble in water
C. Solubility
Purity
Loss on drying Not more than 7,0  % (130oC, 4h) for the hemihydrate, or 20,5  %-23,5  % (130oC, 4h) for the trihydrate
Alkalinity Not more than 0,2  % as Na2CO3
Fumaric acid Not more than 1,0  %
Maleic acid Not more than 0,05  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for 1,2-dicarboxylic acid and for sodium
B. Azo dye formation
C. Solubility
Synonyms Monosodium salt of DL-malic acid
Definition
Chemical name Monosodium DL-malate, monosodium 2-DL-hydroxy succinate
Chemical formula C4H5NaO5
Molecular weight 156,07
Assay Content not less than 99,0  % on the anhydrous basis
Description White powder
Identification
A.Positive tests for 1,2-dicarboxylic acid and for sodium A. Positive tests for 1,2-dicarboxylic acid and for sodium
A. Positive tests for 1,2-dicarboxylic acid and for sodium
B.Azo dye formation B. Azo dye formation Positive
B. Azo dye formation
Purity
Loss on drying Not more than 2,0  % (110oC, 3h)
Maleic acid Not more than 0,05  %
Fumaric acid Not more than 1,0  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for 1,2-dicarboxylic acid and for sodium
B. Azo dye formation
Synonyms Potassium salt of malic acid
Definition
Chemical name Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid
Chemical formula C4H4K2O5
Molecular weight 210,27
Assay Content not less than 59,5  %
Description Colourless or almost colourless aqueous solution
Identification
A.Positive tests for 1,2-dicarboxylic acid and for potassium A. Positive tests for 1,2-dicarboxylic acid and for potassium
A. Positive tests for 1,2-dicarboxylic acid and for potassium
B.Azo dye formation B. Azo dye formation Positive
B. Azo dye formation
Purity
Alkalinity Not more than 0,2  % as K2CO3
Fumaric acid Not more than 1,0  %
Maleic acid Not more than 0,05  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for 1,2-dicarboxylic acid and for potassium
B. Azo dye formation
Synonyms Calcium salt of malic acid
Definition
Chemical name Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid
Chemical formula C4H5CaO5
Molecular weight 172,14
Assay Content not less than 97,5  % on the anhydrous basis
Description White powder
Identification
A.Positive tests for malate, 1,2-dicarboxylic acid and for calcium A. Positive tests for malate, 1,2-dicarboxylic acid and for calcium
A. Positive tests for malate, 1,2-dicarboxylic acid and for calcium
B.Azo dye formation B. Azo dye formation Positive
B. Azo dye formation
C.Solubility C. Solubility Slightly soluble in water
C. Solubility
Purity
Loss on drying Not more than 2 % (100oC, 3h)
Alkalinity Not more than 0,2  % as CaCO3
Maleic acid Not more than 0,05  %
Fumaric acid Not more than 1,0  %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for malate, 1,2-dicarboxylic acid and for calcium
B. Azo dye formation
C. Solubility
Synonyms Monocalcium salt of DL-malic acid
Definition
Chemical name Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
Chemical formula (C4H5O5)2Ca
Assay Content not less than 97,5  % on the anhydrous basis
Description White powder
Identification
A.Positive tests for 1,2-dicarboxylic acid and for calcium A. Positive tests for 1,2-dicarboxylic acid and for calcium
A. Positive tests for 1,2-dicarboxylic acid and for calcium
B.Azo dye formation B. Azo dye formation Positive
B. Azo dye formation
Purity
Loss on drying Not more than 2,0  % (110oC, 3h)
Maleic acid Not more than 0,05  %
Fumaric acid Not more than 1,0  %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for 1,2-dicarboxylic acid and for calcium
B. Azo dye formation
Synonyms Ditartaric acid
Definition
Chemical name Metatartaric acid
Chemical formula C4H6O6
Assay Not less than 99,5  %
Description Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel
Identification
A. Very soluble in water and ethanol
B. Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150oC, an intense violet coloration appears
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Synonyms L-Calcium tartrate
Definition
Chemical name Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical formula C4H4CaO6· 2H2O
Molecular weight 224,18
Assay Not less than 98,0  %
Description Fine crystalline powder with a white or off-white colour
Identification
A.Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids A. Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
A. Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
B.Specific rotation [α]20D B. Specific rotation [α]20D +7,0oto +7,4o(0,1  % in a 1N de HCl solution)
B. Specific rotation [α]20D
C.pH of a 5 % slurry C. pH of a 5 % slurry Between 6,0 and 9,0
C. pH of a 5 % slurry
Purity
Sulphates (as H2SO4) Not more than 1 g/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
B. Specific rotation [α]20D
C. pH of a 5 % slurry
Definition
Chemical name Hexanedioic acid, 1,4-butanedicarboxylic acid
Einecs 204-673-3
Chemical formula C6H10O4
Molecular weight 146,14
Assay Content not less than 99,6  %
Description White odourless crystals or crystalline powder
Identification
A.Melting range A. Melting range 151,5oC-154,0oC
A. Melting range
B.Solubility B. Solubility Slightly soluble in water. Freely soluble in ethanol
B. Solubility
Purity
Water Not more than 0,2  % (Karl Fischer method)
Sulphated ash Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range
B. Solubility
Definition
Chemical name Sodium adipate
Einecs 231-293-5
Chemical formula C6H8Na2O4
Molecular weight 190,11
Assay Content not less than 99,0  % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
A.Melting range A. Melting range 151oC-152oC (for adipic acid)
A. Melting range
B.Solubility B. Solubility Approximately 50 g/100 ml water (20oC)
B. Solubility
C.Positive test for sodium C. Positive test for sodium
C. Positive test for sodium
Purity
Water Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range
B. Solubility
C. Positive test for sodium
Definition
Chemical name Potassium adipate
Einecs 242-838-1
Chemical formula C6H8K2O4
Molecular weight 222,32
Assay Content not less than 99,0  % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
A.Melting range A. Melting range 151oC-152oC (for adipic acid)
A. Melting range
B.Solubility B. Solubility Approximately 60 g/100 ml water (20oC)
B. Solubility
C.Positive test for potassium C. Positive test for potassium
C. Positive test for potassium
Purity
Water Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range
B. Solubility
C. Positive test for potassium
Definition
Chemical name Butanedioic acid
Einecs 203-740-4
Chemical formula C4H6O4
Molecular weight 118,09
Assay Content no less than 99,0  %
Description Colourless or white, odourless crystals
Identification
A.Melting range A. Melting range Between 185,0oC and 190,0oC
A. Melting range
Purity
Residue on ignition Not more than 0,025  % (800oC, 15 min)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range
Synonyms Tribasic ammonium citrate
Definition
Chemical name Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid
Einecs 222-394-5
Chemical formula C6H17N3O7
Molecular weight 243,22
Assay Content not less than 97,0  %
Description White to off-white crystals or powder
Identification
A.Positive tests for ammonium and for citrate A. Positive tests for ammonium and for citrate
A. Positive tests for ammonium and for citrate
B.Solubility B. Solubility Freely soluble in water
B. Solubility
Purity
Oxalate Not more than 0,04  % (as oxalic acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for ammonium and for citrate
B. Solubility
Synonyms Calcium disodium EDTA
Calcium disodium edetate
Definition
Chemical name N, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium
Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate
Einecs 200-529-9
Chemical formula C10H12O8CaN2Na2·2H2O
Molecular weight 410,31
Assay Content not less than 97 % on the anhydrous basis
Description White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic
Identification
A.Positive tests for sodium and for calcium A. Positive tests for sodium and for calcium
A. Positive tests for sodium and for calcium
B.Chelating activity to metal ions positive B. Chelating activity to metal ions positive
B. Chelating activity to metal ions positive
C.pH of a 1 % solution between 6,5 and 7,5 C. pH of a 1 % solution between 6,5 and 7,5
C. pH of a 1 % solution between 6,5 and 7,5
Purity
Water content 5 to 13 % (Karl Fischer method)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sodium and for calcium
B. Chelating activity to metal ions positive
C. pH of a 1 % solution between 6,5 and 7,5
Definition Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)
Einecs 232-680-1
Chemical formula (C6H8O6)n
Molecular weight 10 000 -600 000 (typical average)
Assay Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5  % of alginic acid (C6H8O6)n(calculted on equivalent weight basis of 200)
Description Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
Identification
A.Solubility A. Solubility Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
A. Solubility
B.Calcium chloride precipitation test B. Calcium chloride precipitation test To a 0,5  % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5  % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum
B. Calcium chloride precipitation test
C.Ammonium sulphate precipitation test C. Ammonium sulphate precipitation test To a 0,5  % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch
C. Ammonium sulphate precipitation test
D.Colour reaction D. Colour reaction Dissolve as completely as possible 0,01  g of the sample by shaking with 0,15  ml of 0,1  N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple
D. Colour reaction
Purity
pH of a 3 % suspension Between 2,0 and 3,5
Loss on drying Not more than 15 % (105oC, 4 hours)
Sulphated ash Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble matter
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Solubility
B. Calcium chloride precipitation test
C. Ammonium sulphate precipitation test
D. Colour reaction
Definition
Chemical name Sodium salt of alginic acid
Chemical formula (C6H7NaO6)n
Molecular weight 10 000 -600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8  % and not more than 106,0  % of sodium alginate (calculated on equivalent weight basis of 222)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A.Positive test for sodium and alginic acid A. Positive test for sodium and alginic acid
A. Positive test for sodium and alginic acid
Purity
Loss on drying Not more than 15 % (105oC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive test for sodium and alginic acid
Definition
Chemical name Potassium salt of alginic acid
Chemical formula (C6H7KO6)n
Molecular weight 10 000 -600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 16,5  % and not more than 19,5  % of carbon dioxide corresponding to not less than 89,2  % and not more than 105,5  % of potassium alginate (calculated on an equivalent weight basis of 238)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A.Positive test for potassium and for alginic acid A. Positive test for potassium and for alginic acid
A. Positive test for potassium and for alginic acid
Purity
Loss on drying Not more than 15 % (105oC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E.coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive test for potassium and for alginic acid
Definition
Chemical name Ammonium salt of alginic acid
Chemical formula (C6H11NO6)n
Molecular weight 10 000 — 600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7  % and not more than 103,6  % ammonium alginate (calculated on an equivalent weight basis of 217)
Description White to yellowish fibrous or granular powder
Identification
A.Positive test for ammonium and alginic acid A. Positive test for ammonium and alginic acid
A. Positive test for ammonium and alginic acid
Purity
Loss on drying Not more than 15 % (105oC, 4 hours)
Sulphated ash Not more than 7 % on the dried basis
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive test for ammonium and alginic acid
Synonyms Calcium salt of alginate
Definition
Chemical name Calcium salt of alginic acid
Chemical formula (C6H7Ca1/2O6)n
Molecular weight 10 000 -600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6  % and not more than 104,5  % of calcium alginate (calculated on an equivalent weight basis of 219)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A.Positive test for calcium and alginic acid A. Positive test for calcium and alginic acid
A. Positive test for calcium and alginic acid
Purity
Loss on drying Not more than 15,0  % (105oC, 4 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive test for calcium and alginic acid
Synonyms Hydroxypropyl alginate
1,2-propanediol ester of alginic acid
Propylene glycol alginate
Definition
Chemical name Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule
Chemical formula (C9H14O7)n(esterified)
Molecular weight 10 000 -600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2of carbon dioxide
Description Nearly odourless, white to yellowish brown fibrous or granular powder
Identification
A.Positive test for 1,2-propanediol and alginic acid after hydrolysis A. Positive test for 1,2-propanediol and alginic acid after hydrolysis
A. Positive test for 1,2-propanediol and alginic acid after hydrolysis
Purity
Loss on drying Not more than 20 % (105oC, 4 hours)
Total propane-1,2-diol content Not less than 15 % and not more than 45 %
Free propane-1,2-diol content Not more than 15 %
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive test for 1,2-propanediol and alginic acid after hydrolysis
Synonyms Gelose
Japan agar
Bengal, Ceylon, Chinese or Japanese isinglass
Layor Carang
Definition
Chemical name Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the familiesGelidiaceaeandSphaerococcaceaeand related red algae of the classRhodophyceae
Einecs 232-658-1
Assay The threshold gel concentration should not be higher than 0,25  %
Description Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
Identification
A.Solubility A. Solubility Insoluble in cold water; soluble in boiling water
A. Solubility
Purity
Loss on drying Not more than 22 % (105oC, 5 hours)
Ash Not more than 6,5  % on the anhydrous basis determined at 550oC
Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid) Not more than 0,5  % determined at 550oC on the anhydrous basis
Insoluble matter (in hot water) Not more than 1,0  %
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Gelatin and other proteins Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50oC. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
Water absorption Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25oC for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
A. Solubility
Synonyms Products of commerce are sold under different names such as:
Irish moss gelose
Eucheuman (fromEucheumaspp.)
Iridophycan (fromIridaeaspp.)
Hypnean (fromHypneaspp.)
Furcellaran or Danish agar (fromFurcellaria fastigiata)
Carrageenan (fromChondrusandGigartinaspp.)
Definition Carrageenan is obtained by aqueous extraction of natural strains of seaweeds ofGigartinaceae,Solieriaceae,HypneaceaeandFurcellariaceae, families of the classRhodophyceae(red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
Einecs 232-524-2
Description Yellowish to colourless, coarse to fine powder which is practically odourless
Identification
A.Positive tests for galactose, for anhydrogalactose and for sulphate A. Positive tests for galactose, for anhydrogalactose and for sulphate
A. Positive tests for galactose, for anhydrogalactose and for sulphate
Purity
Methanol, ethanol propane-2-ol content Not more than 0,1  % singly or in combination
Viscosity of a 1,5  % solution at 75oC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105oC, four hours)
Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO4)
Ash Not less than 15 % and not more than 40 % determined on the dried basis at 550oC
Acid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matter Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) Not more than 5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive tests for galactose, for anhydrogalactose and for sulphate
Synonyms PES (acronym for processed eucheuma seaweed)
Definition Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweedsEucheuma cottoniiandEucheuma spinosum, of the classRhodophyceae(red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
Description Tan to yellowish, coarse to fine powder which is practically odourless
Identification
A.Positive tests for galactose, for anhydrogalactose and for sulphate A. Positive tests for galactose, for anhydrogalactose and for sulphate
A. Positive tests for galactose, for anhydrogalactose and for sulphate
B.Solubility B. Solubility Forms cloudy viscous suspensions in water. Insoluble in ethanol
B. Solubility
Purity
Methanol, ethanol, propane-2-ol content Not more than 0,1  % singly or in combination
Viscosity of a 1,5  % solution at 75oC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105oC, four hours)
Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO4)
Ash Not less than 15 % and not more than 40 % determined on the dried basis at 550oC
Acid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matter Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) Not more than 5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Positive tests for galactose, for anhydrogalactose and for sulphate
B. Solubility
Synonyms Carob bean gum
Algaroba gum
Definition Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree,Cerationia siliqua(L.) Taub. (familyLeguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Molecular weight 50 000 -3 000 000
Einecs 232-541-5
Assay Galactomannan content not less than 75 %
Description White to yellowish-white, nearly odourless powder
Identification
A.Positive tests for galactose mannose A. Positive tests for galactose mannose
A. Positive tests for galactose mannose
B.Microscopic examination B. Microscopic examination Place some ground sample in an aqueous solution containing 0,5  % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
B. Microscopic examination
C.Solubility C. Solubility Soluble in hot water, insoluble in ethanol
C. Solubility
Purity
Loss on drying Not more than 15 % (105oC, 5 hours)
Ash Not more than 1,2  % determined at 800oC
Protein (N × 6,25 ) Not more than 7 %
Acid-insoluble matter Not more than 4 %
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Ethanol and propane-2-ol Not more than 1 %, single or in combination
A. Positive tests for galactose mannose
B. Microscopic examination
C. Solubility
Synonyms Gum cyamopsis
Guar flour
Definition Guar gum is the ground endosperm of the seeds of natural strains of the guar plant,Cyamopsis tetragonolobus(L.) Taub. (familyLeguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Einecs 232-536-0
Molecular weight 50 000 -8 000 000
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification
A.Positive tests for galactose and for mannose A. Positive tests for galactose and for mannose
A. Positive tests for galactose and for mannose
B.Solubility B. Solubility Soluble in cold water
B. Solubility
Purity
Loss on drying Not more than 15 % (105oC, 5 hours)
Ash Not more than 1,5  % determined at 800oC
Acid-insoluble matter Not more than 7 %
Protein (N × 6,25 ) Not more than 10 %
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
A. Positive tests for galactose and for mannose
B. Solubility
Synonyms Tragacanth gum
Tragant
Definition Tragacanth is a dried exudation obtained from the stems and branches of natural strains ofAstragalus gummiferLabillardiere and other Asiatic species ofAstragalus(familyLeguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
Molecular weight Approximately 800 000
Einecs 232-252-5
Description Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5 -2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
Identification
A.Solubility A. Solubility 1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
A. Solubility
Purity
Negative test for Karaya gum Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
Loss on drying Not more than 16 % (105oC, 5 hours)
Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5  %
Acid insoluble matter Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Salmonellaspp. Negative in 10 g
E. coli Negative in 5 g
A. Solubility
Synonyms Gum arabic
Definition Acacia gum is a dried exudation obtained from the stems and branches of natural strains ofAcacia senegal(L) Willdenow or closely related species of Acacia (familyLeguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
Molecular weight Approximately 350 000
Einecs 232-519-5
Description Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.
Identification
A.Solubility A. Solubility 1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol
A. Solubility
Purity
Loss on drying Not more than 17 % (105oC, 5 hours) for granular and not more than 10 % (105oC, 4 hours) for spray-dried material
Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5  %
Acid insoluble matter Not more than 1 %
Starch or dextrin Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced
Tannin To 10 ml of a 1 in 50 solution add about 0,1  ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Hydrolysis products Mannose, xylose and galacturonic acid are absent (determined by chromatography)
Salmonellaspp. Negative in 10 g
E. coli Negative in 5 g
A. Solubility
Definition Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains ofXanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
Molecular weight Approximately 1 000 000
Einecs 234-394-2
Assay Yields, on dried basis, not less than 4,2  % and not more than 5 % of CO2corresponding to between 91 % and 108 % of xanthan gum
Description Cream-coloured powder
Identification
A.Solubility A. Solubility Soluble in water. Insoluble in ethanol
A. Solubility
Purity
Loss on drying Not more than 15 % (105oC, 21/2 hours)
Total ash Not more than 16 % on the anhydrous basis determined at 650oC after drying at 105oC for four hours
Pyruvic acid Not less than 1,5  %
Nitrogen Not more than 1,5  %
Ethanol and propan-2-ol Not more than 500 mg/kg singly or in combination
Lead Not more than 2 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and mould Not more than 300 colonies per gram
E. coli Absent in 5 g
Salmonellaspp. Absent in 10 g
Xanthomonas campestris Viable cells absent in 1 g
A. Solubility
Synonyms Katilo
Kadaya
Gumsterculia
Sterculia
Karaya, gum karaya
Kullo
Kuterra
Definition Karaya gum is a dried exudation from the stems and branches of natural strains of:Sterculia urensRoxburgh and other species ofSterculia(familySterculiaceae) or fromCochlospermum gossypiumA.P. De Candolle or other species ofCochlospermum(familyBixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid
Einecs 232-539-4
Description Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
Identification
A.Solubility A. Solubility Insoluble in ethanol
A. Solubility
B.Swelling in ethanol solution B. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it from other gums
B. Swelling in ethanol solution
Purity
Loss on drying Not more than 20 % (105oC, 5 hours)
Total ash Not more than 8 %
Acid insoluble ash Not more than 1 %
Acid insoluble matter Not more than 3 %
Volatile acid Not less than 10 % (as acetic acid)
Starch Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Salmonellaspp. Negative in 10 g
E. coli Negative in 5 g
A. Solubility
B. Swelling in ethanol solution
Definition Tara gum is obtained by grinding the endosperm of the seeds of natural strains ofCaesalpinia spinosa(familyLeguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
Einecs 254-409-6
Description A white to white-yellow odourless powder
Identification
A.Solubility A. Solubility Soluble in water
A. Solubility
Insoluble in ethanol
B.Gel formation B. Gel formation To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
B. Gel formation
Purity
Loss on drying Not more than 15 %
Ash Not more than 1,5  %
Acid insoluble matter Not more than 2 %
Protein Not more than 3,5  % (factor N × 5,7 )
Starch Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
A. Solubility
B. Gel formation
Definition Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains ofPseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt
Einecs 275-117-5
Molecular weight Approximately 500 000
Assay Yields, on the dried basis, not less than 3,3  % and not more than 6,8  % of CO2
Description An off-white powder
Identification
A.Solubility A. Solubility Soluble in water, forming a viscous solution.
A. Solubility
Insoluble in ethanol
Purity
Loss on drying Not more than 15 % after drying (105oC, 21/2 hours)
Nitrogen Not more than 3 %
Propane-2-ol Not more than 750 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 10 000 colonies per gram
Yeast and mould Not more than 400 colonies per gram
E. coli Negative in 5 g
Salmonellaspp. Negative in 10 g
A. Solubility
Synonyms Glycerin
Glycerine
Definition
Chemical names 1,2,3-propanetriol
Glycerol
Trihydroxypropane
Einecs 200-289-5
Chemical formula C3H8O3
Molecular weight 92,10
Assay Content not less than 98 % of glycerol on the anhydrous basis
Description Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable
Identification
A.Acrolein formation on heating A. Acrolein formation on heating Heat a few drops of the sample in a test tube with about 0,5  g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved
A. Acrolein formation on heating
B.Specific gravity (25/25oC) B. Specific gravity (25/25oC) Not less than 1,257
B. Specific gravity (25/25oC)
C.Refractive index [n]D20 C. Refractive index [n]D20 Between 1,471 and 1,474
C. Refractive index [n]D20
Purity
Water Not more than 5 % (Karl Fischer method)
Sulphated ash Not more than 0,01  % determined at 800 ± 25oC
Butanetriols Not more than 0,2  %
Acrolein, glucose and ammonium compounds Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60oC for five minutes. It neither becomes yellow nor emits an odour of ammonia
Fatty acids and esters Not more than 0,1  % calculated as butyric acid
Chlorinated compounds Not more than 30 mg/kg (as chlorine)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
A. Acrolein formation on heating
B. Specific gravity (25/25oC)
C. Refractive index [n]D20
Definition Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plantAmorphophallus konjac.The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6 :1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units
Molecular weight The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000
Assay Not less than 75 % carbohydrate
Description A white to cream to light tan powder
Identification
A.Solubility A. Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
A. Solubility
B.Gel formation B. Gel formation Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms
B. Gel formation
C.Formation of heat-stable gel C. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
C. Formation of heat-stable gel
D.Viscosity (1 % solution) D. Viscosity (1 % solution) Not less than 3 kgm-1s-1at 25oC
D. Viscosity (1 % solution)
Purity
Loss on drying Not more than 12 % (105oC, 5 h)
Starch Not more than 3 %
Protein Not more than 3 % (N × 5,7 )
Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble material Not more than 0,1  %
Total ash Not more than 5,0  % (800oC, 3 to 4h)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Salmonellaspp. Absent in 12,5 g
E. coli Absent in 5 g
A. Solubility
B. Gel formation
C. Formation of heat-stable gel
D. Viscosity (1 % solution)
Definition Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plantAmorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6 :1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated
Molecular weight 500 000 to 2 000 000
Assay Total dietary fibre: not less than 95 % on a dry weight basis
Description White to slightly brownish fine particle size, free flowing and odourless powder
Identification
A.Solubility A. Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0 . Solubility is increased by heat and mechanical agitation
A. Solubility
B.Formation of heat-stable gel B. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
B. Formation of heat-stable gel
C.Viscosity (1 % solution) C. Viscosity (1 % solution) Not less than 20 kgm-1s-1at 25oC
C. Viscosity (1 % solution)
Purity
Loss on drying Not more than 8 % (105oC, 3h)
Starch Not more than 1 %
Protein Not more than 1,5  % (N × 5,7 )
Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble material Not more than 0,5  %
Sulphite (as SO2) Not more than 4 mg/kg
Chloride Not more than 0,02  %
50 % Alcohol-soluble Not more than 2,0  % material
Total ash Not more than 2,0  % (800oC, 3 to 4h)
Lead Not more than 1 mg/kg
Salmonellaspp. Absent in 12,5 g
E. coli Absent in 5 g
A. Solubility
B. Formation of heat-stable gel
C. Viscosity (1 % solution)
Definition Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction
Chemical names Water soluble soybean polysaccharides
Water soluble soybean fibre
Assay Not less than 74 % carbohydrate
Description Free flowing spray-dried white powder
Identification
A.Solubility pH of 1 % solution A. Solubility pH of 1 % solution Soluble in hot and cold water without gel formation
A. Solubility pH of 1 % solution
5,5 ±1,5
B.Viscosity of 10 % solution B. Viscosity of 10 % solution Not more than 200 mPa.s
B. Viscosity of 10 % solution
Purity
Loss on drying Not more than 7 % (105oC, 4h)
Protein Not more than 14 %
Total ash Not more than 9,5  % (600oC, 4h)
Arsenic Not more than 2 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Standard plate count Not more than 3 000 colonies per gram
Yeast and mould Not more than 100 colonies per gram
E. coli Negative in 10 g
A. Solubility pH of 1 % solution
B. Viscosity of 10 % solution
Synonyms Polyoxyl (40) stearate
polyoxyethylene (40) monostearate
Definition A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
Assay Content not less than 97,5  % on the anhydrous basis
Description Cream-coloured flakes or waxy solid at 25oC with a faint odour
Identification
A.Solubility A. Solubility Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
A. Solubility
B.Congealing range B. Congealing range 39oC-44oC
B. Congealing range
C.Infrared absorption spectrum C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
C. Infrared absorption spectrum
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 1
Saponification value Not less than 25 and not more than 35
Hydroxyl value Not less than 27 and not more than 40
1,4-Dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2  mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Congealing range
C. Infrared absorption spectrum
Synonyms Polysorbate 20
Polyoxyethylene (20) sorbitan monolaurate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3  % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25oC with a faint characteristic odour
Identification
A.Solubility A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
A. Solubility
B.Infrared absorption spectrum B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. Infrared absorption spectrum
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 40 and not more than 50
Hydroxyl value Not less than 96 and not more than 108
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2  mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Infrared absorption spectrum
Synonyms Polysorbate 80
Polyoxyethylene (20) sorbitan monooleate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5  % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25oC with a faint characteristic odour
Identification
A.Solubility A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
A. Solubility
B.Infrared absorption spectrum B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. Infrared absorption spectrum
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 65 and not more than 80
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2  mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Infrared absorption spectrum
Synonyms Polysorbate 40
Polyoxyethylene (20) sorbitan monopalmitate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25oC with a faint characteristic odour
Identification
A.Solubility A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
A. Solubility
B.Infrared absorption spectrum B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. Infrared absorption spectrum
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 41 and not more than 52
Hydroxyl value Not less than 90 and not more than 107
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2  mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Infrared absorption spectrum
Synonyms Polysorbate 60
Polyoxyethylene (20) sorbitan monostearate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25oC with a faint characteristic odour
Identification
A.Solubility A. Solubility Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
A. Solubility
B.Infrared absorption spectrum B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. Infrared absorption spectrum
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 81 and not more than 96
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2  mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Infrared absorption spectrum
Synonyms Polysorbate 65
Polyoxyethylene (20) sorbitan tristearate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
Description A tan-coloured, waxy solid at 25oC with a faint characteristic odour
Identification
A.Solubility A. Solubility Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
A. Solubility
B.Congealing range B. Congealing range 29-33oC
B. Congealing range
C.Infrared absorption spectrum C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
C. Infrared absorption spectrum
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 88 and not more than 98
Hydroxyl value Not less than 40 and not more than 60
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2  mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Congealing range
C. Infrared absorption spectrum
Definition Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Einecs 232-553-0
Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description White, light yellow, light grey or light brown powder
Identification
A.Solubility A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
A. Solubility
Purity
Loss on drying Not more than 12 % (105oC, 2 hours)
Acid insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 1,0  % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol Not more than 1 %, singly or in combination, on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
A. Solubility
Definition Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description White, light yellow, light greyish or light brownish powder
Identification
A.Solubility A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
A. Solubility
Purity
Loss on drying Not more than 12 % (105oC, 2 hours)
Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidation Not more than 25 % of total carboxyl groups
Sulphur dioxide residue Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 2,5  % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol Not more than 1 % single or in combination, on a volatile matter-free basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
A. Solubility
Synonyms Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides
Definition A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
Assay The phosphorus content is not less than 3 % and not more than 3,4  % by weight; the ammonium content is not less than 1,2  % and not more than 1,5  % (calculated as N)
Description Unctuous semi-solid
Identification
A.Solubility A. Solubility Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
A. Solubility
B.Positive tests for glycerol, for fatty acid and for phosphate B. Positive tests for glycerol, for fatty acid and for phosphate
B. Positive tests for glycerol, for fatty acid and for phosphate
Purity
Petroleum ether insoluble matter Not more than 2,5  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Positive tests for glycerol, for fatty acid and for phosphate
Synonyms SAIB
Definition Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
Einecs 204-771-6
Chemical name Sucrose diacetate hexaisobutyrate
Chemical formulae C40H62O19
Molecular weight 832-856 (approximate), C40H62O19: 846,9
Assay Content not less than 98,8  % and not more than 101,9  % of C40H62O19
Description A pale straw-coloured liquid, clear and free of sediment and having a bland odour
Identification
A.Solubility A. Solubility Insoluble in water. Soluble in most organic solvents
A. Solubility
B.Refractive index B. Refractive index [n]40D: 1,4492 -1,4504
B. Refractive index
C.Specific gravity C. Specific gravity [d]25D: 1,141 -1,151
C. Specific gravity
Purity
Triacetin Not more than 0,1  %
Acid value Not more than 0,2
Saponification value Not less than 524 and not more than 540
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
A. Solubility
B. Refractive index
C. Specific gravity
Synonyms Ester gum
Definition A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
Description Hard, yellow to pale amber-coloured solid
Identification
A.Solubility A. Solubility Insoluble in water, soluble in acetone
A. Solubility
B.Infrared absorption spectrum B. Infrared absorption spectrum Characteristic of the compound
B. Infrared absorption spectrum
Purity
Specific gravity of solution [d]2025not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5 -176oC, d204: 0,84 )
Ring and ball softening range Between 82oC and 90oC
Acid value Not less than 3 and not more than 9
Hydroxyl value Not less than 15 and not more than 45
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Test for absence of tall oil rosin (sulphur test) When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin
A. Solubility
B. Infrared absorption spectrum
Synonyms Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphate
Sodium acid pyrophosphate
Disodium pyrophosphate
Definition
Chemical name Disodium dihydrogen diphosphate
Einecs 231-835-0
Chemical formula Na2H2P2O7
Molecular weight 221,94
Assay Content not less than 95 % of disodium diphosphate
P2O5Content Not less than 63,0  % and not more than 64,5  %
Description White powder or grains
Identification
A.Positive tests for sodium and for phosphate A. Positive tests for sodium and for phosphate
A. Positive tests for sodium and for phosphate
B.Solubility B. Solubility Soluble in water
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 3,7 and 5,0
C. pH of a 1 % solution
Purity
Loss on drying Not more than 0,5  % (105oC, four hours)
Water-insoluble matter Not more than 1 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Acid trisodium pyrophosphate
Trisodium monohydrogen diphosphate
Definition
Einecs 238-735-6
Chemical formula Monohydrate: Na3HP2O7· H2O
Anhydrous: Na3HP2O7
Molecular weight Monohydrate: 261,95
Anhydrous: 243,93
Assay Content not less than 95 % on the anhydrous basis
P2O5content Not less than 57 % and not more than 59 %
Description White powder or grains, occurs anhydrous or as a monohydrate
Identification
A.Positive tests for sodium and for phosphate A. Positive tests for sodium and for phosphate
A. Positive tests for sodium and for phosphate
B.Solubility B. Solubility Soluble in water
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 6,7 and 7,5
C. pH of a 1 % solution
Purity
Loss on ignition Not more than 4,5  % on the anhydrous compound
Not more than 11,5  % on the monohydrous basis
Loss on drying Not more than 0,5  % (105oC, four hours)
Water-insoluble matter Not more than 0,2  %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition
Chemical name Tetrasodium diphosphate
Einecs 231-767-1
Chemical formula Anhydrous: Na4P2O7
Decahydrate: Na4P2O7· 10H2O
Molecular weight Anhydrous: 265,94
Decahydrate: 446,09
Assay Content not less than 95 % of Na4P2O7on the ignited basis
P2O5content Not less than 52,5  % and not more than 54,0  %
Description Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air
Identification
A.Positive tests for sodium and for phosphate A. Positive tests for sodium and for phosphate
A. Positive tests for sodium and for phosphate
B.Solubility B. Solubility Soluble in water. Insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 9,8 and 10,8
C. pH of a 1 % solution
Purity
Loss on ignition Not more than 0,5  % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105oC for four hours, followed by ignition at 550oC for 30 minutes
Water-insoluble matter Not more than 0,2  %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition
Chemical name Tetrapotassium diphosphate
Einecs 230-785-7
Chemical formula K4P2O7
Molecular weight 330,34 (anhydrous)
Assay Content not less than 95 % on the ignited basis
P2O5content Not less than 42,0  % and not more than 43,7  % on the anhydrous basis
Description Colourless crystals or white, very hygroscopic powder
Identification
A.Positive tests for potassium and for phosphate A. Positive tests for potassium and for phosphate
A. Positive tests for potassium and for phosphate
B.Solubility B. Solubility Soluble in water, insoluble in ethanol
B. Solubility
C.pH of a 1 % solution C. pH of a 1 % solution Between 10,0 and 10,8
C. pH of a 1 % solution
Purity
Loss on ignition Not more than 2 % after drying at 105oC for four hours and then ignition at 550oC for 30 minutes
Water-insoluble substances Not more than 0,2  %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for phosphate
B. Solubility
C. pH of a 1 % solution
Synonyms Calcium pyrophosphate
Definition
Chemical name Dicalcium diphosphate
Dicalcium pyrophosphate
Einecs 232-221-5
Chemical formula Ca2P2O7
Molecular weight 254,12
Assay Content not less than 96 %
P2O5content Not less than 55 % and not more than 56 %
Description A fine, white, odourless powder
Identification
A.Positive tests for calcium and for phosphate A. Positive tests for calcium and for phosphate
A. Positive tests for calcium and for phosphate
B.Solubility B. Solubility Insoluble in water. Soluble in dilute hydrochloric and nitric acids
B. Solubility
C.pH of a 10 % suspension in water C. pH of a 10 % suspension in water Between 5,5 and 7,0
C. pH of a 10 % suspension in water
Purity
Loss on ignition Not more than 1,5  % at 800oC ± 25oC for 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for phosphate
B. Solubility
C. pH of a 10 % suspension in water
Synonyms Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition
Chemical name Calcium dihydrogen diphosphate
Einecs 238-933-2
Chemical formula CaH2P2O7
Molecular weight 215,97
Assay Content not less than 90 % on the anhydrous basis
P2O5content Not less than 61 % and not more than 64 %
Description White crystals or powder
Identification
A.Positive tests for calcium and for phosphate A. Positive tests for calcium and for phosphate
A. Positive tests for calcium and for phosphate
Purity
Acid-insoluble matter Not more than 0,4  %
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for phosphate
Synonyms Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition
Chemical name Pentasodium triphosphate
Einecs 231-838-7
Chemical formula Na5O10P3· nH2O (n = 0 or 6)
Molecular weight 367,86
Assay Content not less than 85,0  % (anhydrous) or 65,0  % (hexahydrate)
P2O5content Not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)
Description White, slightly hygroscopic granules or powder
Identification
A.Solubility A. Solubility Freely soluble in water. Insoluble in ethanol
A. Solubility
B.Positive tests for sodium and for phosphate B. Positive tests for sodium and for phosphate
B. Positive tests for sodium and for phosphate
C.pH of a 1 % solution C. pH of a 1 % solution Between 9,1 and 10,2
C. pH of a 1 % solution
Purity
Loss on drying Anhydrous: Not more than 0,7  % (105oC, one hour)
Hexahydrate: Not more than 23,5  % (60oC, one hour, followed by drying at 105oC, four hours)
Water-insoluble substances Not more than 0,1  %
Higher polyphosphates Not more than 1 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Positive tests for sodium and for phosphate
C. pH of a 1 % solution
Synonyms Pentapotassium tripolyphosphate
Potassium triphosphate
Potassium tripolyphosphate
Definition
Chemical name Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs 237-574-9
Chemical formula K5O10P3
Molecular weight 448,42
Assay Content not less than 85 % on the anhydrous basis
P2O5content Not less than 46,5  % and not more than 48 %
Description White, very hygroscopic powder or granules
Identification
A.Solubility A. Solubility Very soluble in water
A. Solubility
B.Positive tests for potassium and for phosphate B. Positive tests for potassium and for phosphate
B. Positive tests for potassium and for phosphate
C.pH of a 1 % solution C. pH of a 1 % solution Between 9,2 and 10,5
C. pH of a 1 % solution
Purity
Loss on ignition Not more than 0,4  % (after drying at 105oC, four hours, followed by ignition at 550oC, 30 minutes)
Water-insoluble matter Not more than 2 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Positive tests for potassium and for phosphate
C. pH of a 1 % solution
Synonyms Sodium hexametaphosphate
Sodium tetrapolyphosphate
Graham's salt
Sodium polyphosphates, glassy
Sodium polymetaphosphate
Sodium metaphosphate
Definition Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)xwhere x ≥ 2, terminated by Na2PO4groups. These substances are usually identified by their Na2O/P2O5ratio or their P2O5content. The Na2O/P2O5ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
Chemical name Sodium polyphosphate
Einecs 272-808-3
Chemical formula Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight (102)n
Assay P2O5content Not less than 60 % and not more than 71 % on the ignited basis
Description Colourless or white, transparent platelets, granules, or powders
Identification
A.Solubility A. Solubility Very soluble in water
A. Solubility
B.Positive tests for sodium and for phosphate B. Positive tests for sodium and for phosphate
B. Positive tests for sodium and for phosphate
C.pH of a 1 % solution C. pH of a 1 % solution Between 3,0 and 9,0
C. pH of a 1 % solution
Purity
Loss on ignition Not more than 1 %
Water-insoluble matter Not more than 0,1  %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Positive tests for sodium and for phosphate
C. pH of a 1 % solution
Synonyms Insoluble sodium metaphosphate
Maddrell's salt
Insoluble sodium polyphosphate, IMP
Definition Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)xthat spiral in opposite directions about a common axis. The Na2O/P2O5ratio is about 1,0 . The pH of 1 in 3 suspension in water is about 6,5
Chemical name Sodium polyphosphate
Einecs 272-808-3
Chemical formula Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight (102)n
P2O5content Not less than 68,7  % and not more than 70,0  %
Description White crystalline powder
Identification
A.Solubility A. Solubility Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
A. Solubility
B.Positive tests for sodium and for phosphate B. Positive tests for sodium and for phosphate
B. Positive tests for sodium and for phosphate
C.pH of 1 in 3 suspension in water C. pH of 1 in 3 suspension in water About 6,5
C. pH of 1 in 3 suspension in water
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Positive tests for sodium and for phosphate
C. pH of 1 in 3 suspension in water
Synonyms Potassium metaphosphate
Potassium polymetaphosphate
Kurrol salt
Definition
Chemical name Potassium polyphosphate
Einecs 232-212-6
Chemical formula (KPO3)n
Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight (118)n
P2O5content Not less than 53,5  % and not more than 61,5  % on the ignited basis
Description Fine white powder or crystals or colourless glassy platelets
Identification
A.Solubility A. Solubility 1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
A. Solubility
B.Positive tests for potassium and for phosphate B. Positive tests for potassium and for phosphate
B. Positive tests for potassium and for phosphate
C.pH of a 1 % suspension C. pH of a 1 % suspension Not more than 7,8
C. pH of a 1 % suspension
Purity
Loss on ignition Not more than 2 % (105oC, four hours followed by ignition at 550oC, 30 minutes)
Cyclic phosphate Not more than 8 % on P2O5content
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Positive tests for potassium and for phosphate
C. pH of a 1 % suspension
Synonym Sodium calcium polyphosphate, glassy
Definition
Chemical name Sodium calcium polyphosphate
Einecs 233-782-9
Chemical formula (NaPO3)nCaO where n is typically 5
Assay Not less than 61 % and not more than 69 % as P2O5
Description White glassy crystals, spheres
Identification
A.pH of a 1 % m/m slurry A. pH of a 1 % m/m slurry Approximately 5 to 7
A. pH of a 1 % m/m slurry
B.CaO content B. CaO content 7 %-15 % m/m
B. CaO content
Purity
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
A. pH of a 1 % m/m slurry
B. CaO content
Synonyms Calcium metaphosphate
Calcium polymetaphosphate
Definition
Chemical name Calcium polyphosphate
Einecs 236-769-6
Chemical formula (CaP2O6)n
Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1)where ‘n’ is not less than 2
Molecular weight (198)n
P2O5content Not less than 71 % and not more than 73 % on the ignited basis
Description Odourless, colourless crystals or white powder
Identification
A.Solubility A. Solubility Usually sparingly soluble in water. Soluble in acid medium
A. Solubility
B.Positive tests for calcium and for phosphate B. Positive tests for calcium and for phosphate
B. Positive tests for calcium and for phosphate
C.CaO content C. CaO content 27 to 29,5  %
C. CaO content
Purity
Loss on ignition Not more than 2 % (105oC, four hours followed by ignition at 550oC, 30 minutes)
Cyclic phosphate Not more than 8 % on P2O5content
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
A. Solubility
B. Positive tests for calcium and for phosphate
C. CaO content
Definition Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained fromBacillus circulans, Paenibacillus maceransor recombinantBacillus licheniformisstrain SJ1608 on partially hydrolysed starch
Chemical name Cycloheptaamylose
Einecs 231-493-2
Chemical formula (C6H10O5)7
Molecular weight 1 135
Assay Content not less than 98,0  % of (C6H10O5)7on an anhydrous basis
Description Virtually odourless white or almost white crystalline solid
Identification
A.Solubility A. Solubility Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
A. Solubility
B.Specific rotation B. Specific rotation [α]25D: + 160oto + 164o(1 % solution)
B. Specific rotation
Purity
Water Not more than 14 % (Karl Fischer method)
Other cyclodextrins Not more than 2 % on an anhydrous basis
Residual solvents (toluene and trichloroethylene) Not more than 1 mg/kg for each solvent
Sulphated ash Not more than 0,1  %
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
A. Solubility
B. Specific rotation
Synonyms Cellulose gel
Definition Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
Chemical name Cellulose
Einecs 232-674-9
Chemical formula (C6H10O5)n
Molecular weight About 36 000
Assay Not less than 97 % calculated as cellulose on the anhydrous basis
Description A fine white or almost white odourless powder
Identification
A.Solubility A. Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
A. Solubility
B.Colour reaction B. Colour reaction To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced
B. Colour reaction
C.To be identified by IR spectroscopy C. To be identified by IR spectroscopy
C. To be identified by IR spectroscopy
D.Suspension test D. Suspension test Mix 30 g of the sample with 270 ml of water in a high-speed (12 000  rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
D. Suspension test
Purity
Loss on drying Not more than 7 % (105oC, 3 hours)
Water-soluble matter Not more than 0,24  %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5
Starch Not detectable
To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Particle size Not less than 5μm (not more than 10 % of particles of less than 5μm)
Carboxyl groups Not more than 1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Colour reaction
C. To be identified by IR spectroscopy
D. Suspension test
Definition Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials
Chemical name Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs 232-674-9
Chemical formula (C6H10O5)n
Molecular weight (162)n(n is predominantly 1 000 and greater)
Assay Content not less than 92 %
Description A white, odourless powder
Identification
A.Solubility A. Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
A. Solubility
B.Suspension test B. Suspension test Mix 30 g of the sample with 270 ml of water in a high-speed (12 000  rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settle and a supernatant liquid appears
B. Suspension test
Purity
Loss on drying Not more than 7 % (105oC, 3 hours)
Water-soluble matter Not more than 1,0  %
Sulphated ash Not more than 0,3  % determined at 800 ± 25oC
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5
Starch Not detectable
To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Particle size Not less than 5μm (not more than 10 % of particles of less than 5μm)
A. Solubility
B. Suspension test
Synonyms Cellulose methyl ether
Definition Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups
Chemical name Methyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3each may be one of the following:—H—CH3—or CH2CH3 — H — CH3 — or CH2CH3
— H
— CH3
— or CH2CH3
Molecular weight From about 20 000 to 380 000
Assay Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
A.Solubility A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution.
A. Solubility
Insoluble in ethanol, ether and chloroform.
Soluble in glacial acetic acid
Purity
Loss on drying Not more than 10 % (105oC, 3 hours)
Sulphated ash Not more than 1,5  % determined at 800 ± 25oC
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
— H
— CH3
— or CH2CH3
A. Solubility
Synonyms Cellulose ethyl ether
Definition Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
Chemical name Ethyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2) where R1and R2may be any of the following:—H—CH2CH3 — H — CH2CH3
— H
— CH2CH3
Assay Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)
Description Slightly hygroscopic white to off-white, odourless and tasteless powder
Identification
A.Solubility A. Solubility Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate
A. Solubility
B.Film forming test B. Film forming test Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable
B. Film forming test
Purity
Loss on drying Not more than 3 % (105oC, 2 hours)
Sulphated ash Not more than 0,4  %
pH of a 1 % colloidal solution Neutral to litmus
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
— H
— CH2CH3
A. Solubility
B. Film forming test
Synonyms Cellulose hydroxypropyl ether
Definition Hydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups
Chemical name Hydroxypropyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3each may be one of the following:—H—CH2CHOHCH3—CH2CHO(CH2CHOHCH3)CH3—CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3 — H — CH2CHOHCH3 — CH2CHO(CH2CHOHCH3)CH3 — CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
— H
— CH2CHOHCH3
— CH2CHO(CH2CHOHCH3)CH3
— CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weight From about 30 000 to 1 000 000
Assay Content not less than 80,5  % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
A.Solubility A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
A. Solubility
B.Gas chromatography B. Gas chromatography Determine the substituents by gas chromotography
B. Gas chromatography
Purity
Loss on drying Not more than 10 % (105oC, 3 hours)
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Propylene chlorohydrins Not more than 0,1  mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
— H
— CH2CHOHCH3
— CH2CHO(CH2CHOHCH3)CH3
— CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
A. Solubility
B. Gas chromatography
Definition Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
Chemical name 2-Hydroxypropyl ether of methylcellulose
Chemical formula The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2R3each may be one of the following:—H—CH3—CH2CHOHCH3—CH2CHO (CH2CHOHCH3) CH3—CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3 — H — CH3 — CH2CHOHCH3 — CH2CHO (CH2CHOHCH3) CH3 — CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
— H
— CH3
— CH2CHOHCH3
— CH2CHO (CH2CHOHCH3) CH3
— CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
Molecular weight From about 13 000 to 200 000
Assay Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
A.Solubility A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
A. Solubility
B.Gas chromatography B. Gas chromatography Determine the substituents by gas chromatography
B. Gas chromatography
Purity
Loss on drying Not more than 10 % (105oC, 3 hours)
Sulphated ash Not more than 1,5  % for products with viscosities of 50 mPa.s or above
Not more than 3 % for products with viscosities below 50 mPa.s
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Propylene chlorohydrins Not more than 0,1  mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
— H
— CH3
— CH2CHOHCH3
— CH2CHO (CH2CHOHCH3) CH3
— CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
A. Solubility
B. Gas chromatography
Synonyms Methylethylcellulose
Definition Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups
Chemical name Ethyl methyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2R3each may be one of the following:—H—CH3—CH2CH3 — H — CH3 — CH2CH3
— H
— CH3
— CH2CH3
Molecular weight From about 30 000 to 40 000
Assay Content on the anhydrous basis not less than 3,5  % and not more than 6,5  % of methoxyl groups (-OCH3) and not less than 14,5  % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2  % and not more than 19,6  % of total alkoxyl groups, calculated as methoxyl
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
A.Solubility A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
A. Solubility
Purity
Loss on drying Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105oC to constant weight)
Sulphated ash Not more than 0,6  %
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
— H
— CH3
— CH2CH3
A. Solubility
Synonyms Carboxy methyl cellulose
CMC
NaCMC
Sodium CMC
Cellulose gum
Definition Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material
Chemical name Sodium salt of the carboxymethyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2R3each may be one of the following:—H—CH2COONa—CH2COOH — H — CH2COONa — CH2COOH
— H
— CH2COONa
— CH2COOH
Molecular weight Higher than approximately 17 000 (degree of polymerisation approximately 100)
Assay Content on the anhydrous basis not less than 99,5  %
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
A.Solubility A. Solubility Yields a viscous colloidal solution with water. Insoluble in ethanol
A. Solubility
B.Foam test B. Foam test A 0,1  % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)
B. Foam test
C.Precipitate formation C. Precipitate formation To 5 ml of a 0,5  % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
C. Precipitate formation
D.Colour reaction D. Colour reaction Add 0,5  g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
D. Colour reaction
Purity
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit
Loss on drying Not more than 12 % (105oC to constant weight)
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total glycolate Not more than 0,4  %, calculated as sodium glycolate on the anhydrous basis
Sodium Not more than 12,4  % on the anhydrous basis
— H
— CH2COONa
— CH2COOH
A. Solubility
B. Foam test
C. Precipitate formation
D. Colour reaction
Synonyms Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum
Definition Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
Chemical name Sodium salt of the cross-linked carboxymethyl ether cellulose
Chemical formula The polymers containing substituted anhydroglucose units with the general formula:
C6H7O2(OR1)(OR2)(OR3)
where R1, R2and R3may be any of the following:—H—CH2COONa—CH2COOH — H — CH2COONa — CH2COOH
— H
— CH2COONa
— CH2COOH
Description Slightly hygroscopic, white to off white, odourless powder
Identification
A. Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
B. Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05  ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
C. It gives the reaction of sodium
Purity
Loss on drying Not more than 6 % (105oC, 3h)
Water solubles Not more than 10 %
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
pH of 1 % Not less than 5,0 and not more than 7,0
Sodium content Not more than 12,4  % on anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
— H
— CH2COONa
— CH2COOH
Synonyms Sodium carboxymethyl cellulose, enzymatically hydrolysed
Definition Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced byTrichoderma longibrachiatum(formerlyT. reesei)
Chemical name Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed
Chemical formula Sodium salts of polymers containing substituted anhydroglucose units with the general formula:
[C6H7O2(OH)x(OCH2COONa)y]n
where n is the degree of polymerisation
x = 1,50 to 2,80
y = 0,2 to 1,50
x + y = 3,0
(y = degree of substitution)
Formula weight 178,14 where y = 0,20
282,18 where y = 1,50
Macromolecules: Not less than 800 (n about 4)
Assay Not less than 99,5  %, including mono- and disaccharides, on the dried basis
Description White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder
Identification
A.Solubility A. Solubility Soluble in water, insoluble in ethanol
A. Solubility
B.Foam test B. Foam test Vigorously shake a 0,1  % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums
B. Foam test
C.Precipitate formation C. Precipitate formation To 5 ml of a 0,5  % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
C. Precipitate formation
D.Colour reaction D. Colour reaction Add 0,5  g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
D. Colour reaction
E.Viscosity (60 % solids) E. Viscosity (60 % solids) Not less than 2,500 kgm-1s-1at 25oC corresponding to an average molecule weight of 5 000 D
E. Viscosity (60 % solids)
Purity
Loss on drying Not more than 12 % (105oC to constant weight)
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis
pH of a 1 % colloidal solution Not less than 6,0 and not more than 8,5
Sodium chloride and sodium glycolate Not more than 0,5  % singly or in combination
Residual enzyme activity Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose
Lead Not more than 3 mg/kg
A. Solubility
B. Foam test
C. Precipitate formation
D. Colour reaction
E. Viscosity (60 % solids)
Definition Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy white light powders, flakes or semi-solids
Identification
A.Solubility A. Solubility Sodium and potassium salts: soluble in water and ethanol calcium salts:
A. Solubility
insoluble in water, ethanol and ether
B.Positive tests for cations and for fatty acids B. Positive tests for cations and for fatty acids
B. Positive tests for cations and for fatty acids
Purity
Sodium Not less than 9 % and not more than 14 % expressed as Na2O
Potassium Not less than 13 % and not more than 21,5  % expressed as K2O
Calcium Not less than 8,5  % and not more than 13 % expressed as CaO
Unsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Free alkali Not more than 0,1  % expressed as NaOH
Matter insoluble in alcohol Not more than 0,2  % (sodium and potassium salts only)
A. Solubility
B. Positive tests for cations and for fatty acids
Definition Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy-white light powders, flakes or semi-solids
Identification
A.Solubility A. Solubility Insoluble in water, partially soluble in ethanol and ether
A. Solubility
B.Positive tests for magnesium and for fatty acids B. Positive tests for magnesium and for fatty acids
B. Positive tests for magnesium and for fatty acids
Purity
Magnesium Not less than 6,5  % and not more than 11 % expressed as MgO
Free alkali Not more than 0,1  % expressed as MgO
Unsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Positive tests for magnesium and for fatty acids
Synonyms Glyceryl monostearate
Glyceryl monopalmitate
Glyceryl monooleate, etc.
Monostearin, monopalmitin, monoolein, etc.
GMS (for glyceryl monostearate)
Definition Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
Assay Content of mono- and diesters: not less than 70 %
Description The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads
Identification
A.Infrared spectrum A. Infrared spectrum Characteristic of a partial fatty acid ester of a polyol
A. Infrared spectrum
B.Positive tests for glycerol and for fatty acids B. Positive tests for glycerol and for fatty acids
B. Positive tests for glycerol and for fatty acids
C.Solubility C. Solubility Insoluble in water, soluble in ethanol and toluene
C. Solubility
Purity
Water content Not more than 2 % (Karl Fischer method)
Acid value Not more than 6
Free glycerol Not more than 7 %
Polyglycerols Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total glycerol Not less than 16 % and not more than 33 %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Infrared spectrum
B. Positive tests for glycerol and for fatty acids
C. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Acetic acid esters of mono- and diglycerides
Acetoglycerides
Acetylated mono- and diglycerides
Acetic and fatty acid esters of glycerol
Definition Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides
Description Clear, mobile liquids to solids, from white to pale yellow in colour
Identification
A.Positive tests for glycerol, for fatty acids and for acetic acid A. Positive tests for glycerol, for fatty acids and for acetic acid
A. Positive tests for glycerol, for fatty acids and for acetic acid
B.Solubility B. Solubility Insoluble in water. Soluble in ethanol
B. Solubility
Purity
Acids other than acetic and fatty acids Not detectable
Free glycerol Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total acetic acid Not less than 9 % and not more than 32 %
Free fatty acids (and acetic acid) Not more than 3 % estimated as oleic acid
Total glycerol Not less than 14 % and not more than 31 %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for fatty acids and for acetic acid
B. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Lactic acid esters of mono- and diglycerides
Lactoglycerides
Mono- and diglycerides of fatty acids esterified with lactic acid
Definition Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
Description Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
Identification
A.Positive tests for glycerol, for fatty acids and for lactic acid A. Positive tests for glycerol, for fatty acids and for lactic acid
A. Positive tests for glycerol, for fatty acids and for lactic acid
B.Solubility B. Solubility Insoluble in cold water but dispersible in hot water
B. Solubility
Purity
Acids other than lactic and fatty acids Not detectable
Free glycerol Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total lactic acid Not less than 13 % and not more than 45 %
Free fatty acids (and lactic acid) Not more than 3 % estimated as oleic acid
Total glycerol Not less than 13 % and not more than 30 %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for fatty acids and for lactic acid
B. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Citrem
Citric acid esters of mono- and diglycerides
Citroglycerides
Mono- and diglycerides of fatty acids esterified with citric acid
Definition Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide
Description Yellowish or light brown liquids to waxy solids or semi-solids
Identification
A.Positive tests for glycerol, for fatty acids and for citric acid A. Positive tests for glycerol, for fatty acids and for citric acid
A. Positive tests for glycerol, for fatty acids and for citric acid
B.Solubility B. Solubility Insoluble in cold water
B. Solubility
Dispersible in hot water
Soluble in oils and fats
Insoluble in cold ethanol
Purity
Acids other than citric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 8 % and not more than 33 %
Total citric acid Not less than 13 % and not more than 50 %
Sulphated ash (determined at 800 ± 25oC) Non-neutralised products: not more than 0,5  %
Partially or wholly neutralised products: not more than 10 %
Lead Not more than 2 mg/kg
Free fatty acids Not more than 3 % estimated as oleic acid
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for fatty acids and for citric acid
B. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Tartaric acid esters of mono- and diglycerides
Mono- and diglycerides of fatty acids esterified with tartaric acid
Definition Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
Description Sticky viscous yellowish liquids to hard yellow waxes
Identification
A.Positive tests for glycerol, for fatty acids and for tartaric acid A. Positive tests for glycerol, for fatty acids and for tartaric acid
A. Positive tests for glycerol, for fatty acids and for tartaric acid
Purity
Acids other than tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 29 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total tartaric acid Not less than 15 % and not more than 50 %
Free fatty acids Not more than 3 % estimated as oleic acid
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for fatty acids and for tartaric acid
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Diacetyltartaric acid esters of mono- and diglycerides
Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid
Diacetyltartaric and fatty acid esters of glycerol
Definition Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
Description Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
Identification
A.Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Purity
Acids other than acetic, tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 11 % and not more than 28 %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total tartaric acid Not less than 10 % and not more than 40 %
Total acetic acid Not less than 8 % and not more than 32 %
Free fatty acids Not more than 3 % estimated as oleic acid
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid
Definition Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
Description Sticky liquids to solids, from white to pale-yellow in colour
Identification
A.Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Purity
Acids other than acetic, tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 27 %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total acetic acid Not less than 10 % and not more than 20 %
Total tartaric acid Not less than 20 % and not more than 40 %
Free fatty acids Not more than 3 % estimated as oleic acid
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Sucroesters
Sugar esters
Definition Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation
Assay Content not less than 80 %
Description Stiff gels, soft solids or white to slightly greyish-white powders
Identification
A.Positive tests for sugar for fatty acids A. Positive tests for sugar for fatty acids
A. Positive tests for sugar for fatty acids
B.Solubility B. Solubility Sparingly soluble in water
B. Solubility
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25oC
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylsulphoxide Not more than 2 mg/kg
Dimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kg
Ethylacetate Not more than 350 mg/kg, singly or in combination
Propane-2-ol
Prolyleneglycol
Methyl ethyl ketone Not more than 10 mg/kg
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for sugar for fatty acids
B. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Sugar glycerides
Definition Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol
Assay Content not less than 40 % and not more than 60 % of sucrose fatty acid esters
Description Soft solid masses, stiff gels or white to off-white powders
Identification
A.Positive tests for sugar and for fatty acids A. Positive tests for sugar and for fatty acids
A. Positive tests for sugar and for fatty acids
B.Solubility B. Solubility Insoluble in cold water
B. Solubility
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25oC
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kg, single or in combination
Cyclohexane
Ethylacetate Not more than 350 mg/kg, single or in combination
Propane-2-ol
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for sugar and for fatty acids
B. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Polyglycerol fatty acid esters
Polyglycerin esters of fatty acid esters
Definition Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Assay Content of total fatty acid ester not less than 90 %
Description Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids
Identification
A.Positive tests for glycerol, for polyglycerols and for fatty acids A. Positive tests for glycerol, for polyglycerols and for fatty acids
A. Positive tests for glycerol, for polyglycerols and for fatty acids
B.Solubility B. Solubility The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils
B. Solubility
Purity
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Acids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acid
Total glycerol and polyglycerol Not less than 18 % and not more than 60 %
Free glycerol and polyglycerol Not more than 7 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for glycerol, for polyglycerols and for fatty acids
B. Solubility
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms Glycerol esters of condensed castor oil fatty acids
Polyglycerol esters of polycondensed fatty acids from castor oil
Polyglycerol esters of interesterified ricinoleic acid
PGPR
Definition Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids
Description Clear, highly viscous liquid
Identification
A.Solubility A. Solubility Insoluble in water and in ethanol.
A. Solubility
Soluble in ether, hydrocarbons and halogenated hydrocarbons
B.Positive tests for glycerol, polyglycerol and for ricinoleic acid B. Positive tests for glycerol, polyglycerol and for ricinoleic acid
B. Positive tests for glycerol, polyglycerol and for ricinoleic acid
C.Refractive index [n]65 C. Refractive index [n]65 Between 1,4630 and 1,4665
C. Refractive index [n]65
Purity
Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100
Acid value Not more than 6
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Positive tests for glycerol, polyglycerol and for ricinoleic acid
C. Refractive index [n]65
Synonyms Propylene glycol esters of fatty acids
Definition Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent
Assay Content of total fatty acid ester not less than 85 %
Description Clear liquids or waxy white flakes, beads or solids having a bland odour
Identification
A.Positive tests for propylene glycol and for fatty acids A. Positive tests for propylene glycol and for fatty acids
A. Positive tests for propylene glycol and for fatty acids
Purity
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Acids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acid
Total propane-1,2-diol Not less than 11 % and not more than 31 %
Free propane-1,2-diol Not more than 5 %
Dimer and trimer of propylene glycol Not more than 0,5  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
A. Positive tests for propylene glycol and for fatty acids
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Synonyms TOSOM
Definition Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans
Description Pale yellow to light brown a waxy or solid consistency
Identification
A.Solubility A. Solubility Insoluble in water. Soluble in hot oil or fat
A. Solubility
Purity
Melting range 55-65oC
Free fatty acids Not more than 1,5  % estimated as oleic acid
Free glycerol Not more than 2 %
Total fatty acids 83-90 %
Total glycerol 16-22 %
Fatty acid methyl esters, not forming adduct with urea Not more than 9 % of total fatty acid methyl esters
Fatty acids, insoluble in petroleum ether Not more than 2 % of total fatty acids
Peroxide value Not more than 3
Epoxides Not more than 0,03  % oxirane oxygen
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
Synonyms Sodium stearoyl lactylate
Sodium stearoyl lactate
Definition A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Chemical names Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs 246-929-7
Chemical formula (major components) C21H39O4Na
C19H35O4Na
Description White or slightly yellowish powder or brittle solid with a characteristic odour
Identification
A.Positive tests for sodium, for fatty acids and for lactic acid A. Positive tests for sodium, for fatty acids and for lactic acid
A. Positive tests for sodium, for fatty acids and for lactic acid
B.Solubility B. Solubility Insoluble in water. Soluble in ethanol
B. Solubility
Purity
Sodium Not less than 2,5  % and not more than 5 %
Ester value Not less than 90 and not more than 190
Acid value Not less than 60 and not more than 130
Total lactic acid Not less than 15 % and not more than 40 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for sodium, for fatty acids and for lactic acid
B. Solubility
Synonyms Calcium stearoyl lactate
Definition A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs 227-335-7
Chemical formula C42H78O8Ca
C38H70O8Ca
Description White or slightly yellowish powder or brittle solid with a characteristic odour
Identification
A.Positive tests for calcium, for fatty acids and for lactid acid A. Positive tests for calcium, for fatty acids and for lactid acid
A. Positive tests for calcium, for fatty acids and for lactid acid
B.Solubility B. Solubility Slightly soluble in hot water
B. Solubility
Purity
Calcium Not less than 1 % and not more than 5,2  %
Ester value Not less than 125 and not more than 190
Total lactic acid Not less than 15 % and not more than 40 %
Acid value Not less than 50 and not more than 130
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Positive tests for calcium, for fatty acids and for lactid acid
B. Solubility
Synonyms Stearyl palmityl tartrate
Definition Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
Chemical name Distearyl tartrate
Dipalmityl tartrate
Chemical formula C38H74O6to C40H78O6
Molecular weight 627 to 655
Assay Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180
Description Cream-coloured unctuous solid (at 25oC)
Identification
A.Positive tests for tartare A. Positive tests for tartare
A. Positive tests for tartare
B.Melting range B. Melting range Between 67oC and 77oC. After saponification the saturated long chain fatty alcohols have a melting range of 49oC to 55oC
B. Melting range
Purity
Hydroxyl value Not less than 200 and not more than 220
Acid value Not more than 5,6
Total tartaric acid content Not less than 18 % and not more than 35 %
Sulphated ash Not more than 0,5  % determined at 800 ± 25oC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Unsaponifiable matter Not less than 77 % and not more than 83 %
Iodine value Not more than 4 (Wijs method)
A. Positive tests for tartare
B. Melting range
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs 215-664-9
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification
A.Solubility A. Solubility Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50oC in mineral oil and ethyl acetate
A. Solubility
B.Congealing range B. Congealing range 50-52oC
B. Congealing range
C.Infrared absorption spectrum C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
C. Infrared absorption spectrum
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5  %
Acid value Not more than 10
Saponification value Not less than 147 and not more than 157
Hydroxyl value Not less than 235 and not more than 260
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Congealing range
C. Infrared absorption spectrum
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs 247-891-4
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour
Identification
A.Solubility A. Solubility Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol
A. Solubility
B.Congealing range B. Congealing range 47-50oC
B. Congealing range
C.Infrared absorption spectrum C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
C. Infrared absorption spectrum
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5  %
Acid value Not more than 15
Saponification value Not less than 176 and not more than 188
Hydroxyl value Not less than 66 and not more than 80
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Congealing range
C. Infrared absorption spectrum
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
Einecs 215-663-3
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour
Identification
A.Solubility A. Solubility Dispersible in hot and cold water
A. Solubility
B.Infrared absorption spectrum B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
B. Infrared absorption spectrum
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5  %
Acid value Not more than 7
Saponification value Not less than 155 and not more than 170
Hydroxyl value Not less than 330 and not more than 358
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Infrared absorption spectrum
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
Einecs 215-665-4
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters
Description Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification
A.Solubility A. Solubility Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water
A. Solubility
B.Iodine value B. Iodine value The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100
B. Iodine value
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5  %
Acid value Not more than 8
Saponification value Not less than 145 and not more than 160
Hydroxyl value Not less than 193 and not more than 210
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Iodine value
Synonyms Sorbitan palmitate
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid
Einecs 247-568-8
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification
A.Solubility A. Solubility Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water
A. Solubility
B.Congealing range B. Congealing range 45-47oC
B. Congealing range
C.Infrared absorption spectrum C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyol
C. Infrared absorption spectrum
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphate ash Not more than 0,5  %
Acid value Not more than 7,5
Saponification value Not less than 140 and not more than 150
Hydroxyl value Not less than 270 and not more than 305
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Congealing range
C. Infrared absorption spectrum
Synonyms Soda ash
Definition
Chemical name Sodium carbonate
Einecs 207-838-8
Chemical formula Na2CO3· nH2O (n = 0, 1 or 10)
Molecular weight 106,00 (anhydrous)
Assay Content not less than 99 % of Na2CO3on the anhydrous basis
Description Colourless crystals or white, granular or crystalline powder
The anhydrous form is hygroscopic, the decahydrate efflorescent
Identification
A.Positive tests for sodium and for carbonate A. Positive tests for sodium and for carbonate
A. Positive tests for sodium and for carbonate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
Purity
Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70oC raising gradually to 300oC, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for carbonate
B. Solubility
Synonyms Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking soda
Definition
Chemical name Sodium hydrogen carbonate
Einecs 205-633-8
Chemical formula NaHCO3
Molecular weight 84,01
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline masses or crystalline powder
Identification
A.Positive tests for sodium and for carbonate A. Positive tests for sodium and for carbonate
A. Positive tests for sodium and for carbonate
B.pH of a 1 % solution B. pH of a 1 % solution Between 8,0 and 8,6
B. pH of a 1 % solution
C.Solubility C. Solubility Soluble in water. Insoluble in ethanol
C. Solubility
Purity
Loss on drying Not more than 0,25  % (over silica gel, 4h)
Ammonium salts No odour of ammonia detectable after heating
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for carbonate
B. pH of a 1 % solution
C. Solubility
Definition
Chemical name Sodium monohydrogen dicarbonate
Einecs 208-580-9
Chemical formula Na2(CO)3· NaHCO3· 2H2O
Molecular weight 226,03
Assay Content between 35,0  % and 38,6  % of NaHCO3and between 46,4  % and 50,0  % of Na2CO3
Description White flakes, crystals or crystalline powder
Identification
A.Positive tests for sodium and for carbonate A. Positive tests for sodium and for carbonate
A. Positive tests for sodium and for carbonate
B.Solubility B. Solubility Freely soluble in water
B. Solubility
Purity
Sodium chloride Not more than 0,5  %
Iron Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for carbonate
B. Solubility
Definition
Chemical name Potassium carbonate
Einecs 209-529-3
Chemical formula K2CO3· nH2O (n = 0 or 1,5 )
Molecular weight 138,21 (anhydrous)
Assay Content not less than 99,0  % on the anhydrous basis
Description White, very deliquescent powder.
The hydrate occurs as small, white, translucent crystals or granules
Identification
A.Positive tests for potassium and for carbonate A. Positive tests for potassium and for carbonate
A. Positive tests for potassium and for carbonate
B.Solubility B. Solubility Very soluble in water. Insoluble in ethanol
B. Solubility
Purity
Loss on drying Not more than 5 % (anhydrous) or 18 % (hydrate) (180oC, 4h)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for carbonate
B. Solubility
Synonyms Potassium bicarbonate, acid potassium carbonate
Definition
Chemical name Potassium hydrogen carbonate
Einecs 206-059-0
Chemical formula KHCO3
Molecular weight 100,11
Assay Content not less than 99,0  % and not more than 101,0  % KHCO3on the anhydrous basis
Description Colourless crystals or white powder or granules
Identification
A.Positive tests for potassium and for carbonate A. Positive tests for potassium and for carbonate
A. Positive tests for potassium and for carbonate
B.Solubility B. Solubility Freely soluble in water. Insoluble in ethanol
B. Solubility
Purity
Loss on drying Not more than 0,25  % (over silica gel, 4h)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for carbonate
B. Solubility
Definition Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
Chemical name Ammonium carbonate
Einecs 233-786-0
Chemical formula CH6N2O2, CH8N2O3and CH5NO3
Molecular weight Ammonium carbamate 78,06 ; ammonium carbonate 98,73 ; ammonium hydrogen carbonate 79,06
Assay Content not less than 30,0  % and not more than 34,0  % of NH3
Description White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide
Identification
A.Positive tests for ammonium and for carbonate A. Positive tests for ammonium and for carbonate
A. Positive tests for ammonium and for carbonate
B.pH of a 5 % solution B. pH of a 5 % solution about 8,6
B. pH of a 5 % solution
C.Solubility C. Solubility Soluble in water
C. Solubility
Purity
Non-volatile matter Not more than 500 mg/kg
Chlorides Not more than 30 mg/kg
Sulphate Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for ammonium and for carbonate
B. pH of a 5 % solution
C. Solubility
Synonyms Ammonium bicarbonate
Definition
Chemical name Ammonium hydrogen carbonate
Einecs 213-911-5
Chemical formula CH5NO3
Molecular weight 79,06
Assay Content not less than 99,0  %
Description White crystals or crystalline powder
Identification
A.Positive tests for ammonium and for carbonate A. Positive tests for ammonium and for carbonate
A. Positive tests for ammonium and for carbonate
B.pH of a 5 % solution B. pH of a 5 % solution about 8,0
B. pH of a 5 % solution
C.Solubility C. Solubility Freely soluble in water. Insoluble in ethanol
C. Solubility
Purity
Non-volatile matter Not more than 500 mg/kg
Chlorides Not more than 30 mg/kg
Sulphate Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for ammonium and for carbonate
B. pH of a 5 % solution
C. Solubility
Synonyms Magnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxide
Definition
Chemical name Magnesium carbonate hydroxide hydrated
Einecs 235-192-7
Chemical formula 4MgCO3Mg(OH)25H2O
Molecular weight 485
Assay Mg content not less than 40,0  % and not more than 45,0  % calculated as MgO
Description Light, white friable mass or bulky white powder
Identification
A.Positive tests for magnesium and for carbonate A. Positive tests for magnesium and for carbonate
A. Positive tests for magnesium and for carbonate
B.Solubility B. Solubility Practically insoluble in water. Insoluble in ethanol
B. Solubility
Purity
Acid insoluble matter Not more than 0,05  %
Water soluble matter Not more than 1,0  %
Calcium Not more than 1,0  %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for magnesium and for carbonate
B. Solubility
Synonyms Hydrogen chloride, muriatic acid
Definition
Chemical name Hydrochloric acid
Einecs 231-595-7
Chemical formula HCl
Molecular weight 36,46
Assay Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0  % HCl
Description Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour
Identification
A.Positive tests for acid and for chloride A. Positive tests for acid and for chloride
A. Positive tests for acid and for chloride
B.Solubility B. Solubility Soluble in water and in ethanol
B. Solubility
Purity
Total organic compounds Total organic compounds (non-fluorine containing): not more than 5 mg/kg
Benzene: not more than 0,05  mg/kg
Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter Not more than 0,5  %
Reducing substances Not more than 70 mg/kg (as SO2)
Oxidising substances Not more than 30 mg/kg (as Cl2)
Sulphate Not more than 0,5  %
Iron Not more than 5 mg/kg
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for acid and for chloride
B. Solubility
Synonyms Sylvine
Sylvite
Definition
Chemical name Potassium chloride
Einecs 231-211-8
Chemical formulae KCl
Molecular weight 74,56
Assay Content not less than 99 % on the dried basis
Description Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless
Identification
A.Solubility A. Solubility Freely soluble in water. Insoluble in ethanol
A. Solubility
B.Positive tests for potassium and for chloride B. Positive tests for potassium and for chloride
B. Positive tests for potassium and for chloride
Purity
Loss on drying Not more than 1 % (105oC, 2 hours)
Sodium Negative test
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
A. Solubility
B. Positive tests for potassium and for chloride
Definition
Chemical name Calcium chloride
Einecs 233-140-8
Chemical formula CaCl2· nH2O (n = 0,2 or 6)
Molecular weight 110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)
Assay Content not less than 93,0  % on the anhydrous basis
Description White, odourless, hygroscopic powder or deliquescent crystals
Identification
A.Positive tests for calcium and for chloride A. Positive tests for calcium and for chloride
A. Positive tests for calcium and for chloride
B.Solubility B. Solubility Anhydrous calcium chloride: freely soluble in water and ethanol
B. Solubility
Dihydrate: freely soluble in water, soluble in ethanol
Hexahydrate: very soluble in water and ethanol
Purity
Magnesium and alkali salts Not more than 5 % on the anhydrous basis
Fluoride Not more than 40 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for chloride
B. Solubility
Definition
Chemical name Magnesium chloride
Einecs 232-094-6
Chemical formula MgCl2· 6H2O
Molecular weight 203,30
Assay Content not less than 99,0  %
Description Colourless, odourless, very deliquescent flakes or crystals
Identification
A.Positive tests for magnesium and for chloride A. Positive tests for magnesium and for chloride
A. Positive tests for magnesium and for chloride
B.Solubility B. Solubility Very soluble in water, freely soluble in ethanol
B. Solubility
Purity
Ammonium Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for magnesium and for chloride
B. Solubility
Synonyms Tin chloride, tin dichloride
Definition
Chemical name Stannous chloride dihydrate
Einecs 231-868-0
Chemical formula SnCl2· 2H2O
Molecular weight 225,63
Assay Content not less than 98,0  %
Description Colourless or white crystals
May have a slight odour of hydrochloric acid
Identification
A.Positive tests for tin (II) and for chloride A. Positive tests for tin (II) and for chloride
A. Positive tests for tin (II) and for chloride
B.Solubility B. Solubility Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water
B. Solubility
Ethanol: soluble
Purity
Sulphate Not more than 30 mg/kg
Arsenic Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Lead Not more than 5 mg/kg
A. Positive tests for tin (II) and for chloride
B. Solubility
Synonyms Oil of vitriol, dihydrogen sulphate
Definition
Chemical name Sulphuric acid
Einecs 231-639-5
Chemical formula H2SO4
Molecular weight 98,07
Assay Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0  %
Description Clear, colourless or slightly brown, very corrosive oily liquid
Identification
A.Positive tests for acid and for sulphate A. Positive tests for acid and for sulphate
A. Positive tests for acid and for sulphate
B.Solubility B. Solubility Miscible with water, with generation of much heat, also with ethanol
B. Solubility
Purity
Ash Not more than 0,02  %
Reducing matter Not more than 40 mg/kg (as SO2)
Nitrate Not more than 10 mg/kg (on H2SO4basis)
Chloride Not more than 50 mg/kg
Iron Not more than 20 mg/kg
Selenium Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for acid and for sulphate
B. Solubility
Definition
Chemical name Sodium sulphate
Chemical formula Na2SO4· nH2O (n = 0 or 10)
Molecular weight 142,04 (anhydrous)
322,04 (decahydrate)
Assay Content not less than 99,0  % on the anhydrous basis
Description Colourless crystals or a fine, white, crystalline powder
The decahydrate is efflorescent
Identification
A.Positive tests for sodium and for sulphate A. Positive tests for sodium and for sulphate
A. Positive tests for sodium and for sulphate
B.Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper B. Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
B. Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
Purity
Loss on drying Not more than 1,0  % (anhydrous) or not more than 57 % (decahydrate) at 130 °C
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for sulphate
B. Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
Synonyms Acid sodium sulphate, sodium bisulphate, nitre cake
Definition
Chemical name Sodium hydrogen sulphate
Chemical formula NaHSO4
Molecular weight 120,06
Assay Content not less than 95,2  %
Description White, odourless crystals or granules
Identification
A.Positive tests for sodium and for sulphate A. Positive tests for sodium and for sulphate
A. Positive tests for sodium and for sulphate
B.Solutions are strongly acidic B. Solutions are strongly acidic
B. Solutions are strongly acidic
Purity
Loss on drying Not more than 0,8  %
Water insoluble Not more than 0,05  %
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium and for sulphate
B. Solutions are strongly acidic
Definition
Chemical name Potassium sulphate
Chemical formula K2SO4
Molecular weight 174,25
Assay Content not less than 99,0  %
Description Colourless or white crystals or crystalline powder
Identification
A.Positive tests for potassium and for sulphate A. Positive tests for potassium and for sulphate
A. Positive tests for potassium and for sulphate
B.pH of a 5 % solution B. pH of a 5 % solution Between 5,5 and 8,5
B. pH of a 5 % solution
C.Solubility C. Solubility Freely soluble in water, insoluble in ethanol
C. Solubility
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium and for sulphate
B. pH of a 5 % solution
C. Solubility
Definition
Synonyms Potassium bisulphate, potassium acid sulphate
Chemical name Potassium hydrogen sulphate
Chemical formula KHSO4
Molecular weight 136,17
Assay Content not less than 99 %
Melting point 197oC
Description White deliquescent crystals, pieces or granules
Identification
A.Positive test for potassium A. Positive test for potassium
A. Positive test for potassium
B.Solubility B. Solubility Freely soluble in water, insoluble in ethanol
B. Solubility
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for potassium
B. Solubility
Synonyms Gypsum, selenite, anhydrite
Definition
Chemical name Calcium sulphate
Einecs 231-900-3
Chemical formula CaSO4· nH2O (n = 0 or 2)
Molecular weight 136,14 (anhydrous), 172,18 (dihydrate)
Assay Content not less than 99,0  % on the anhydrous basis
Description Fine, white to slightly yellowish-white odourless powder
Identification
A.Positive tests for calcium and for sulphate A. Positive tests for calcium and for sulphate
A. Positive tests for calcium and for sulphate
B.Solubility B. Solubility Slightly soluble in water, insoluble in ethanol
B. Solubility
Purity
Loss on drying Anhydrous: not more than 1,5  % (250oC, constant weight)
Dihydrate: not more than 23 % (ibid.)
Fluoride Not more than 30 mg/kg
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for calcium and for sulphate
B. Solubility
Definition
Chemical name Ammonium sulphate
Einecs 231-984-1
Chemical formula (NH4)2SO4
Molecular weight 132,14
Assay Content not less than 99,0  % and not more than 100,5  %
Description White powder, shining plates or crystalline fragments
Identification
A.Positive tests for ammonium and for sulphate A. Positive tests for ammonium and for sulphate
A. Positive tests for ammonium and for sulphate
B.Solubility B. Solubility Freely soluble in water, insoluble in ethanol
B. Solubility
Purity
Loss on ignition Not more than 0,25  %
Selenium Not more than 30 mg/kg
Lead Not more than 5 mg/kg
A. Positive tests for ammonium and for sulphate
B. Solubility
Synonyms Alum
Definition
Chemical name Aluminium sulphate
Einecs 233-135-0
Chemical formula Al2(SO4)3
Molecular weight 342,13
Assay Content not less than 99,5  % on the ignited basis
Description White powder, shining plates or crystalline fragments
Identification
A.Positive tests for aluminium and for sulphateB.pH of a 5 % solution 2,9 or above A. Positive tests for aluminium and for sulphate B. pH of a 5 % solution 2,9 or above
A. Positive tests for aluminium and for sulphate
B. pH of a 5 % solution 2,9 or above
C.Solubility C. Solubility Freely soluble in water, insoluble in ethanol
C. Solubility
Purity
Loss on ignition Not more than 5 % (500oC, 3h)
Alkalies and alkaline earths Not more than 0,4  %
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for aluminium and for sulphate
B. pH of a 5 % solution 2,9 or above
C. Solubility
Synonyms Soda alum, sodium alum
Definition
Chemical name Aluminium sodium sulphate
Einecs 233-277-3
Chemical formula AlNa(SO4)2· nH2O (n = 0 or 12)
Molecular weight 242,09 (anhydrous)
Assay Content on the anhydrous basis not less than 96,5  % (anhydrous) and 99,5  % (dodecahydrate)
Description Transparent crystals or white crystalline powder
Identification
A.Positive tests for aluminium, for sodium and for sulphate A. Positive tests for aluminium, for sodium and for sulphate
A. Positive tests for aluminium, for sodium and for sulphate
B.Solubility B. Solubility Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol
B. Solubility
Purity
Loss on drying Anhydrous form: not more than 10,0  % (220oC, 16h)
Dodecahydrate: not more than 47,2  % (50oC-55oC, 1h then 200oC, 16h)
Ammonium salts No odour of ammonia detectable after heating
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for aluminium, for sodium and for sulphate
B. Solubility
Synonyms Potassium alum, potash alum
Definition
Chemical name Aluminium potassium sulphate dodecahydrate
Einecs 233-141-3
Chemical formula AlK(SO4)2· 12 H2O
Molecular weight 474,38
Assay Content not less than 99,5  %
Description Large, transparent crystals or white crystalline powder
Identification
A.Positive tests for aluminium, for potassium and for sulphate A. Positive tests for aluminium, for potassium and for sulphate
A. Positive tests for aluminium, for potassium and for sulphate
B.pH of a 10 % solution between 3,0 and 4,0 B. pH of a 10 % solution between 3,0 and 4,0
B. pH of a 10 % solution between 3,0 and 4,0
C.Solubility C. Solubility Freely soluble in water, insoluble in ethanol
C. Solubility
Purity
Ammonium salts No odour of ammonia detectable after heating
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for aluminium, for potassium and for sulphate
B. pH of a 10 % solution between 3,0 and 4,0
C. Solubility
Synonyms Ammonium alum
Definition
Chemical name Aluminium ammonium sulphate
Einecs 232-055-3
Chemical formula AlNH4(SO4)2· 12 H2O
Molecular weight 453,32
Assay Content not less than 99,5  %
Description Large, colourless crystals or white powder
Identification
A.Positive tests for aluminium, for ammonium and for sulphate A. Positive tests for aluminium, for ammonium and for sulphate
A. Positive tests for aluminium, for ammonium and for sulphate
B.Solubility B. Solubility Freely soluble in water, soluble in ethanol
B. Solubility
Purity
Alkali metals and alkaline earths Not more than 0,5  %
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for aluminium, for ammonium and for sulphate
B. Solubility
Synonyms Caustic soda, lye
Definition
Chemical name Sodium hydroxide
Einecs 215-185-5
Chemical formula NaOH
Molecular weight 40,0
Assay Content of solid forms not less than 98,0  % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
Identification
A.Positive tests for sodium A. Positive tests for sodium
A. Positive tests for sodium
B.A 1 % solution is strongly alkaline B. A 1 % solution is strongly alkaline
B. A 1 % solution is strongly alkaline
C.Solubility C. Solubility Very soluble in water. Freely soluble in ethanol
C. Solubility
Purity
Water insoluble and organic matter A 5 % solution is completely clear and colourless to slightly coloured
Carbonate Not more than 0,5  % (as Na2CO3)
Arsenic Not more than 3 mg/kg
Lead Not more than 0,5  mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for sodium
B. A 1 % solution is strongly alkaline
C. Solubility
Synonyms Caustic potash
Definition
Chemical name Potassium hydroxide
Einecs 215-181-3
Chemical formula KOH
Molecular weight 56,11
Assay Content not less than 85,0  % of alkali calculated as KOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms
Identification
A.Positive tests for potassium A. Positive tests for potassium
A. Positive tests for potassium
B.A 1 % solution is strongly alkaline B. A 1 % solution is strongly alkaline
B. A 1 % solution is strongly alkaline
C.Solubility C. Solubility Very soluble in water. Freely soluble in ethanol
C. Solubility
Purity
Water insoluble matter A 5 % solution is completely clear and colourless
Carbonate Not more than 3,5  % (as K2CO3)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for potassium
B. A 1 % solution is strongly alkaline
C. Solubility
Synonyms Slaked lime, hydrated lime
Definition
Chemical name Calcium hydroxide
Einecs 215-137-3
Chemical formula Ca(OH)2
Molecular weight 74,09
Assay Content not less than 92,0  %
Description White powder
Identification
A.Positive tests for alkali and for calcium A. Positive tests for alkali and for calcium
A. Positive tests for alkali and for calcium
B.Solubility B. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
B. Solubility
Purity
Acid insoluble ash Not more than 1,0  %
Magnesium and alkali salts Not more than 1,0  %
Barium Not more than 300 mg/kg
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
A. Positive tests for alkali and for calcium
B. Solubility
Synonyms Aqua ammonia, strong ammonia solution
Definition
Chemical name Ammonium hydroxide
Chemical formula NH4OH
Molecular weight 35,05
Assay Content not less than 27 % of NH3
Description Clear, colourless solution, having an exceedingly pungent, characteristic odour
Identification
A.Positive tests for ammonia A. Positive tests for ammonia
A. Positive tests for ammonia
Purity
Non-volatile matter Not more than 0,02  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
A. Positive tests for ammonia
Definition
Chemical name Magnesium hydroxide
Einecs 215-170-3
Chemical formula Mg(OH)2
Molecular weight 58,32
Assay Content not less than 95,0  % on the anhydrous basis
Description Odourless, white bulky powder
Identification
A.Positive test for magnesium and for alkali A. Positive test for magnesium and for alkali
A. Positive test for magnesium and for alkali
B.Solubility B. Solubility Practically insoluble in water and in ethanol
B. Solubility
Purity
Loss on drying Not more than 2,0  % (105oC, 2h)
Loss on ignition Not more than 33 % (800oC to constant weight)
Calcium oxide Not more than 1,5  %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
A. Positive test for magnesium and for alkali
B. Solubility
Synonyms Burnt lime
Definition
Chemical name Calcium oxide
Einecs 215-138-9
Chemical formula CaO
Molecular weight 56,08
Assay Content not less than 95,0  % on the ignited basis
Description Odourless, hard, white or greyish white masses of granules, or white to greyish powder
Identification
A.Positive test for alkali and for calcium A. Positive test for alkali and for calcium
A. Positive test for alkali and for calcium
B.Heat is generated on moistening the sample with water B. Heat is generated on moistening the sample with water
B. Heat is generated on moistening the sample with water
C.Solubility C. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
C. Solubility
Purity
Loss on ignition Not more than 10,0  % (ca 800oC to constant weight)
Acid insoluble matter Not more than 1,0  %
Barium Not more than 300 mg/kg
Magnesium and alkali salts Not more than 1,5  %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
A. Positive test for alkali and for calcium
B. Heat is generated on moistening the sample with water
C. Solubility
Definition
Chemical name Magnesium oxide
Einecs 215-171-9
Chemical formula MgO
Molecular weight 40,31
Assay Content not less than 98,0  % on the ignited basis
Description A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml
Identification
A.Positive test for alkali and for magnesium A. Positive test for alkali and for magnesium
A. Positive test for alkali and for magnesium
B.Solubility B. Solubility Practically insoluble in water. Insoluble in ethanol
B. Solubility
Purity
Loss on ignition Not more than 5,0  % (ca 800oC to constant weight)
Calcium oxide Not more than 1,5  %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
A. Positive test for alkali and for magnesium
B. Solubility
Synonyms Yellow prussiate of soda, sodium hexacyanoferrate
Definition
Chemical name Sodium ferrocyanide
Einecs 237-081-9
Chemical formula Na4Fe(CN)6· 10 H2O
Molecular weight 484,1
Assay Content not less than 99,0  %
Description Yellow crystals or crystalline powder
Identification
A.Positive test for sodium and for ferrocyanide A. Positive test for sodium and for ferrocyanide
A. Positive test for sodium and for ferrocyanide
Purity
Free moisture Not more than 1,0  %
Water insoluble matter Not more than 0,03  %
Chloride Not more than 0,2  %
Sulphate Not more than 0,1  %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
A. Positive test for sodium and for ferrocyanide
Synonyms Yellow prussiate of potash, potassium hexacyanoferrate
Definition
Chemical name Potassium ferrocyanide
Einecs 237-722-2
Chemical formula K4Fe(CN)6· 3 H2O
Molecular weight 422,4
Assay Content not less than 99,0  %
Description Lemon yellow crystals
Identification
A.Positive test for potassium and for ferrocyanide A. Positive test for potassium and for ferrocyanide
A. Positive test for potassium and for ferrocyanide
Purity
Free moisture Not more than 1,0  %
Water insoluble matter Not more than 0,03  %
Chloride Not more than 0,2  %
Sulphate Not more than 0,1  %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
A. Positive test for potassium and for ferrocyanide
Synonyms Yellow prussiate of lime, calcium hexacyanoferrate
Definition
Chemical name Calcium ferrocyanide
Einecs 215-476-7
Chemical formula Ca2Fe(CN)6· 12H2O
Molecular weight 508,3
Assay Content not less than 99,0  %
Description Yellow crystals or crystalline powder
Identification
A.Positive test for calcium and for ferrocyanide A. Positive test for calcium and for ferrocyanide
A. Positive test for calcium and for ferrocyanide
Purity
Free moisture Not more than 1,0  %
Water insoluble matter Not more than 0,03  %
Chloride Not more than 0,2  %
Sulphate Not more than 0,1  %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
A. Positive test for calcium and for ferrocyanide
Synonyms SALP
Definition
Chemical name Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or
Trisodium dialuminium pentadecahydrogen octaphosphate (B)
Einecs 232-090-4
Chemical formula NaAl3H14(PO4)8· 4H2O (A)
Na3Al2H15(PO4)8(B)
Molecular weight 949,88 (A)
897,82 (B)
Assay Content not less than 95,0  % (both forms)
Description White odourless powder
Identification
A.Positive test for sodium, for aluminium and for phosphate A. Positive test for sodium, for aluminium and for phosphate
A. Positive test for sodium, for aluminium and for phosphate
B.pH B. pH Acid to litmus
B. pH
C.Solubility C. Solubility Insoluble in water. Soluble in hydrochloric acid
C. Solubility
Purity
Loss on ignition 19,5  %-21,0  % (A) } (750oC-800oC, 2h)
15 %-16 % (B) } (750oC-800oC, 2h)
Fluoride Not more than 25 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for sodium, for aluminium and for phosphate
B. pH
C. Solubility
Synonyms Silica, silicium dioxide
Definition Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
Chemical name Silicon dioxide
Einecs 231-545-4
Chemical formula (SiO2)n
Molecular weight 60,08 (SiO2)
Assay Content after ignition not less than 99,0  % (fumed silica) or 94,0  % (hydrated forms)
Description White, fluffy powder or granules
Hygroscopic
Identification
A.Positive test for silica A. Positive test for silica
A. Positive test for silica
Purity
Loss on drying Not more than 2,5  % (fumed silica, 105oC, 2h)
Not more than 8,0  % (precipitated silica and silica gel, 105oC, 2h)
Not more than 70 % (hydrous silica, 105oC, 2h)
Loss on ignition Not more than 2,5  % after drying (1 000oC, fumed silica)
Not more than 8,5  % after drying (1 000oC, hydrated forms)
Soluble ionisable salts Not more than 5,0  % (as Na2SO4)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for silica
Definition Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2
Chemical name Calcium silicate
Einecs 215-710-8
Assay Content on the anhydrous basis:—as SiO2not less than 50 % and not more than 95 %—as CaO not less than 3 % and not more than 35 % — as SiO2not less than 50 % and not more than 95 % — as CaO not less than 3 % and not more than 35 %
— as SiO2not less than 50 % and not more than 95 %
— as CaO not less than 3 % and not more than 35 %
Description White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids
Identification
A.Positive test for silicate and for calcium A. Positive test for silicate and for calcium
A. Positive test for silicate and for calcium
B.Forms a gel with mineral acids B. Forms a gel with mineral acids
B. Forms a gel with mineral acids
Purity
Loss on drying Not more than 10 % (105oC, 2h)
Loss on ignition Not less than 5 % and not more than 14 % (1 000oC, constant weight)
Sodium Not more than 3 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
— as SiO2not less than 50 % and not more than 95 %
— as CaO not less than 3 % and not more than 35 %
A. Positive test for silicate and for calcium
B. Forms a gel with mineral acids
Definition Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
Assay Content not less than 15 % of MgO and not less than 67 % of SiO2on the ignited basis
Description Very fine, white, odourless powder, free from grittiness
Identification
A.Positive test for magnesium and for silicate A. Positive test for magnesium and for silicate
A. Positive test for magnesium and for silicate
B.pH of a 10 % slurry B. pH of a 10 % slurry Between 7,0 and 10,8
B. pH of a 10 % slurry
Purity
Loss on drying Not more than 15 % (105oC, 2h)
Loss on ignition Not more than 15 % after drying (1 000oC, 20 min)
Water soluble salts Not more than 3 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for magnesium and for silicate
B. pH of a 10 % slurry
Definition
Chemical name Magnesium trisilicate
Chemical formula Mg2Si3O8· xH2O (approximate composition)
Einecs 239-076-7
Assay Content not less than 29,0  % of MgO and not less than 65,0  % of SiO2both on the ignited basis
Description Fine, white powder, free from grittiness
Identification
A.Positive test for magnesium and for silicate A. Positive test for magnesium and for silicate
A. Positive test for magnesium and for silicate
B.pH of a 5 % slurry B. pH of a 5 % slurry Between 6,3 and 9,5
B. pH of a 5 % slurry
Purity
Loss on ignition Not less than 17 % and not more than 34 % (1 000oC)
Water soluble salts Not more than 2 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for magnesium and for silicate
B. pH of a 5 % slurry
Synonyms Talcum
Definition Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite
Chemical name Magnesium hydrogen metasilicate
Einecs 238-877-9
Chemical formula Mg3(Si4O10)(OH)2
Molecular weight 379,22
Description Light, homogeneous, white or almost white powder, greasy to the touch
Identification
A.IR absorption A. IR absorption Characteristic peaks at 3 677 , 1 018 and 669 cm-1
A. IR absorption
B.X-ray diffraction B. X-ray diffraction Peaks at 9,34 /4,66/3,12 Å
B. X-ray diffraction
C.Solubility C. Solubility Insoluble in water and ethanol
C. Solubility
Purity
Loss on drying Not more than 0,5  % (105oC, 1h)
Acid-soluble matter Not more than 6 %
Water-soluble matter Not more than 0,2  %
Acid-soluble iron Not detectable
Arsenic Not more than 10 mg/kg
Lead Not more than 5 mg/kg
A. IR absorption
B. X-ray diffraction
C. Solubility
Synonyms Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate
Definition
Chemical name Sodium aluminium silicate
Assay Content on the anhydrous basis:—as SiO2not less than 66,0  % and not more than 88,0  %—as Al2O3not less than 5,0  % and not more than 15,0  % — as SiO2not less than 66,0  % and not more than 88,0  % — as Al2O3not less than 5,0  % and not more than 15,0  %
— as SiO2not less than 66,0  % and not more than 88,0  %
— as Al2O3not less than 5,0  % and not more than 15,0  %
Description Fine white amorphous powder or beads
Identification
A.Positive tests for sodium, for aluminium and for silicate A. Positive tests for sodium, for aluminium and for silicate
A. Positive tests for sodium, for aluminium and for silicate
B.pH of a 5 % slurry B. pH of a 5 % slurry Between 6,5 and 11,5
B. pH of a 5 % slurry
Purity
Loss on drying Not more than 8,0  % (105oC, 2h)
Loss on ignition Not less than 5,0  % and not more than 11,0  % on the anhydrous basis (1 000oC, constant weight)
Sodium Not less than 5 % and not more than 8,5  % (as Na2O) on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
— as SiO2not less than 66,0  % and not more than 88,0  %
— as Al2O3not less than 5,0  % and not more than 15,0  %
A. Positive tests for sodium, for aluminium and for silicate
B. pH of a 5 % slurry
Synonyms Mica
Definition Natural mica consists of mainly potassium aluminium silicate (muscovite)
Einecs 310-127-6
Chemical name Potassium aluminium silicate
Chemical formulae KAl2[AlSi3O10](OH)2
Molecular weight 398
Assay Content not less than 98 %
Description Light grey to white crystalline platelets or powder
Identification
A.Solubility A. Solubility Insoluble in water, diluted acids and alkali and organic solvents
A. Solubility
Purity
Loss on drying Not more than 0,5  % (105oC, 2h)
Antimony Not more than 20 mg/kg
Zinc Not more than 25 mg/kg
Barium Not more than 25 mg/kg
Chromium Not more than 100 mg/kg
Copper Not more than 25 mg/kg
Nickel Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 2 mg/kg
Lead Not more than 10 mg/kg
A. Solubility
Synonyms Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate
Definition
Chemical name Calcium aluminium silicate
Assay Content on the anhydrous basis:—as SiO2not less than 44,0  % and not more than 50,0  %—as Al2O3not less than 3,0  % and not more than 5,0  %—as CaO not less than 32,0  % and not more than 38,0  % — as SiO2not less than 44,0  % and not more than 50,0  % — as Al2O3not less than 3,0  % and not more than 5,0  % — as CaO not less than 32,0  % and not more than 38,0  %
— as SiO2not less than 44,0  % and not more than 50,0  %
— as Al2O3not less than 3,0  % and not more than 5,0  %
— as CaO not less than 32,0  % and not more than 38,0  %
Description Fine white, free-flowing powder
Identification
A.Positive tests for calcium, for aluminium and for silicate A. Positive tests for calcium, for aluminium and for silicate
A. Positive tests for calcium, for aluminium and for silicate
Purity
Loss on drying Not more than 10,0  % (105oC, 2h)
Loss on ignition Not less than 14,0  % and not more than 18,0 on the anhydrous basis (1 000oC, constant weight)
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
— as SiO2not less than 44,0  % and not more than 50,0  %
— as Al2O3not less than 3,0  % and not more than 5,0  %
— as CaO not less than 32,0  % and not more than 38,0  %
A. Positive tests for calcium, for aluminium and for silicate
Definition Bentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite
Einecs 215-108-5
Chemical formula (Al, Mg)8(Si4O10)4(OH)8· 12H2O
Molecular weight 819
Assay Montmorillonite content not less than 80 %
Description Very fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)
Identification
A.Methylene blue test A. Methylene blue test
A. Methylene blue test
B.X-Ray diffraction B. X-Ray diffraction Characteristic peaks at 12,5 /15 A
B. X-Ray diffraction
C.IR absorption C. IR absorption Peaks at 428/470/530/1 110 -1 020 /3 750 — 3 400 cm-1
C. IR absorption
Purity
Loss on drying Not more than 15,0  % (105oC, 2h)
Arsenic Not more than 2 mg/kg
Lead Not more than 20 mg/kg
A. Methylene blue test
B. X-Ray diffraction
C. IR absorption
Synonyms Kaolin, light or heavy
Definition Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption
Einecs 215-286-4 (kaolinite)
Chemical formula Al2Si2O5(OH)4(kaolinite)
Molecular weight 264
Assay Content not less than 90 % (sum of silica and alumina, after ignition)
Silica (SiO2) Between 45 % and 55 %
Alumina (Al2O3) Between 30 % and 39 %
Description Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes
Identification
A.Positive tests for alumina and for silicate A. Positive tests for alumina and for silicate
A. Positive tests for alumina and for silicate
B.X-ray diffraction: B. X-ray diffraction: Characteristic peaks at 7,18 /3,58/2,38/1,78 Å
B. X-ray diffraction:
C.IR absorption: C. IR absorption: Peaks at 3 700 and 3 620 cm-1
C. IR absorption:
Purity
Loss on ignition Between 10 and 14 % (1 000oC, constant weight)
Water soluble matter Not more than 0,3  %
Acid soluble matter Not more than 2 %
Iron Not more than 5 %
Potassium oxide (K2O) Not more than 5 %
Carbon Not more than 0,5  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive tests for alumina and for silicate
B. X-ray diffraction:
C. IR absorption:
Definition Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
Chemical name octanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1)
Assay Not less than 98 % by chromatography
Description A colourless liquid or white solid obtained from oils and fats
Identification
A.Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight A. Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight
A. Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight
Purity
Residue on ignition Not more than 0,1  %
Unsaponifiable matter Not more than 1,5  %
Water Not more than 0,2  % (Karl Fischer method)
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
A. Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight
Synonyms D-gluconic acid, dextronic acid
Definition Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone
Chemical name Gluconic acid
Chemical formula C6H12O7(gluconic acid)
Molecular weight 196,2
Assay Content not less than 50,0  % (as gluconic acid)
Description Colourless to light yellow, clear syrupy liquid
Identification
A.Formation of phenylhydrazine derivative positive A. Formation of phenylhydrazine derivative positive Compound formed melts between 196oC and 202oC with decomposition
A. Formation of phenylhydrazine derivative positive
Purity
Residue on ignition Not more than 1,0  %
Reducing matter Not more than 0,75  % (as D-glucose)
Chloride Not more than 350 mg/kg
Sulphate Not more than 240 mg/kg
Sulphite Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Formation of phenylhydrazine derivative positive
Synonyms Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone
Definition Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones
Chemical name D-Glucono-1,5 -lactone
Einecs 202-016-5
Chemical formula C6H10O6
Molecular weight 178,14
Assay Content not less than 99,0  % on the anhydrous basis
Description Fine, white, nearly odourless, crystalline powder
Identification
A.Formation of phenylhydrazine derivative of gluconic acid positive A. Formation of phenylhydrazine derivative of gluconic acid positive Compound formed melts between 196oC and 202oC with decomposition
A. Formation of phenylhydrazine derivative of gluconic acid positive
B.Solubility B. Solubility Freely soluble in water. Sparingly soluble in ethanol
B. Solubility
C.Melting point C. Melting point 152oC ± 2oC
C. Melting point
Purity
Water Not more than 1,0  % (Karl Fischer method)
Reducing substances Not more than 0,75  % (as D-glucose)
Lead Not more than 2 mg/kg
A. Formation of phenylhydrazine derivative of gluconic acid positive
B. Solubility
C. Melting point
Synonyms Sodium salt of D-gluconic acid
Definition
Chemical name Sodium D-gluconate
Einecs 208-407-7
Chemical formula C6H11NaO7(anhydrous)
Molecular weight 218,14
Assay Content not less than 98,0  %
Description White to tan, granular to fine, crystalline powder
Identification
A.Positive test for sodium and for gluconate A. Positive test for sodium and for gluconate
A. Positive test for sodium and for gluconate
B.Solubility B. Solubility Very soluble in water. Sparingly soluble in ethanol
B. Solubility
C.pH of a 10 % solution C. pH of a 10 % solution Between 6,5 and 7,5
C. pH of a 10 % solution
Purity
Reducing matter Not more than 1,0  % (as D-glucose)
Lead Not more than 2 mg/kg
A. Positive test for sodium and for gluconate
B. Solubility
C. pH of a 10 % solution
Synonyms Potassium salt of D-gluconic acid
Definition
Chemical name Potassium D-gluconate
Einecs 206-074-2
Chemical formula C6H11KO7(anhydrous)
C6H11KO7· H2O (monohydrate)
Molecular weight 234,25 (anhydrous)
252,26 (monohydrate)
Assay Content not less than 97,0  % and not more than 103,0  % on dried basis
Description Odourless, free flowing white to yellowish white, crystalline powder or granules
Identification
A.Positive test for potassium and for gluconate A. Positive test for potassium and for gluconate
A. Positive test for potassium and for gluconate
B.pH of a 10 % solution B. pH of a 10 % solution Between 7,0 and 8,3
B. pH of a 10 % solution
Purity
Loss on drying Anhydrous: not more than 3,0  % (105oC, 4h, vacuum)Monohydrate: not less than 6 % and not more than 7,5  % (105oC, 4h, vacuum)
Reducing substances Not more than 1,0  % (as D-glucose)
Lead Not more than 2 mg/kg
A. Positive test for potassium and for gluconate
B. pH of a 10 % solution
Synonyms Calcium salt of D-gluconic acid
Definition
Chemical name Calcium di-D-gluconate
Einecs 206-075-8
Chemical formula C12H22CaO14(anhydrous)
C12H22CaO14· H2O (monohydrate)
Molecular weight 430,38 (anhydrous form)
448,39 (monohydrate)
Assay Content not less than 98,0  % and not more than 102 % on the anhydrous and monohydrate basis
Description Odourless, white crystalline granules or powder, stable in air
Identification
A.Positive test for calcium and for gluconate A. Positive test for calcium and for gluconate
A. Positive test for calcium and for gluconate
B.Solubility B. Solubility Soluble in water, insoluble in ethanol
B. Solubility
C.pH of a 5 % solution C. pH of a 5 % solution Between 6,0 and 8,0
C. pH of a 5 % solution
Purity
Loss on drying Not more than 3,0  % (105oC, 16h) (anhydrous)
Not more than 2,0  % (105oC, 16h) (monohydrate)
Reducing substances Not more than 1,0  % (as D-glucose)
Lead Not more than 2 mg/kg
A. Positive test for calcium and for gluconate
B. Solubility
C. pH of a 5 % solution
Definition
Chemical name Ferrous di-D-gluconate dihydrate
Iron(II) di-gluconate dihydrate
Einecs 206-076-3
Chemical formulae C12H22FeO14·2H2O
Molecular weight 482,17
Assay Content not less than 95 % on the dried basis
Description Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar
Identification
A.Solubility A. Solubility Soluble with slight heating in water. Practically insoluble in ethanol
A. Solubility
B.Positive test for ferrous ion B. Positive test for ferrous ion
B. Positive test for ferrous ion
C.Formation of phenylhy-drazine derivative of gluconic acid positive C. Formation of phenylhy-drazine derivative of gluconic acid positive
C. Formation of phenylhy-drazine derivative of gluconic acid positive
D.pH of a 10 % solution D. pH of a 10 % solution Between 4 and 5,5
D. pH of a 10 % solution
Purity
Loss on drying Not more than 10 % (105oC, 16 hours)
Oxalic acid Not detectable
Iron (Fe III) Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Reducing substances Not more than 0,5  % expressed as glucose
A. Solubility
B. Positive test for ferrous ion
C. Formation of phenylhy-drazine derivative of gluconic acid positive
D. pH of a 10 % solution
Synonyms Iron(II) lactate
Iron(II) 2-hydroxy propanoate
Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Definition
Chemical name Ferrous 2-hydroxy propanoate
Einecs 227-608-0
Chemical formulae C6H10FeO6·xH2O (x = 2 or 3)
Molecular weight 270,02 (dihydrate)
288,03 (trihydrate)
Assay Content not less than 96 % on the dried basis
Description Greenish-white crystals or light green powder having a characteristic smell
Identification
A.Solubility A. Solubility Soluble in water. Practically insoluble in ethanol
A. Solubility
B.Positive test for ferrous ion and for lactate B. Positive test for ferrous ion and for lactate
B. Positive test for ferrous ion and for lactate
C.pH of a 2 % solution C. pH of a 2 % solution Between 4 and 6
C. pH of a 2 % solution
Purity
Loss on drying Not more than 18 % (100oC, under vacuum, approximately 700 mm Hg)
Iron (Fe III) Not more than 0,6  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
A. Solubility
B. Positive test for ferrous ion and for lactate
C. pH of a 2 % solution
Synonyms 4-Hexyl-1,3-benzenediol
Hexylresorcinol
Definition
Chemical name 4-Hexylresorcinol
Einecs 205-257-4
Chemical formula C12H18O2
Molecular weight 197,24
Assay Not less than 98 % on the dried basis
Description White powder
Identification
A.Solubility A. Solubility Freely soluble in ether and acetone; very slightly soluble in water
A. Solubility
B.Nitric acid test B. Nitric acid test To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears
B. Nitric acid test
C.Bromine test C. Bromine test To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution
C. Bromine test
D.Melting range D. Melting range 62 to 67oC
D. Melting range
Purity
Acidity Not more than 0,05  %
Sulphated ash Not more than 0,1  %
Resorcinol and other phenols Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced
Nickel Not more than 2 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 3 mg/kg
A. Solubility
B. Nitric acid test
C. Bromine test
D. Melting range
Synonyms L-Glutamic acid, L-α-aminoglutaric acid
Definition
Chemical name L-Glutamic acid, L-2-amino-pentanedioic acid
Einecs 200-293-7
Chemical formula C5H9NO4
Molecular weight 147,13
Assay Content not less than 99,0  % and not more than 101,0  % on the anhydrous basis
Description White crystals or crystalline powder
Identification
A.Positive test for glutamic acid by thin layer chromatography A. Positive test for glutamic acid by thin layer chromatography
A. Positive test for glutamic acid by thin layer chromatography
B.Specific rotation [α]D20 B. Specific rotation [α]D20 Between +31,5oand +32,2o
B. Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
C.pH of a saturated solution C. pH of a saturated solution Between 3,0 and 3,5
C. pH of a saturated solution
Purity
Loss on drying Not more than 0,2  % (80oC, 3h)
Sulphated ash Not more than 0,2  %
Chloride Not more than 0,2  %
Pyrrolidone carboxylic acid Not more than 0,2  %
Lead Not more than 2 mg/kg
A. Positive test for glutamic acid by thin layer chromatography
B. Specific rotation [α]D20
C. pH of a saturated solution
Synonyms Sodium glutamate, MSG
Definition
Chemical name Monosodium L-glutamate monohydrate
Einecs 205-538-1
Chemical formula C5H8NaNO4· H2O
Molecular weight 187,13
Assay Content not less than 99,0  % and not more than 101,0  % on the anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A.Positive test for sodium A. Positive test for sodium
A. Positive test for sodium
B.Positive test for glutamic acid by thin-layer chromatography B. Positive test for glutamic acid by thin-layer chromatography
B. Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20 C. Specific rotation [α]D20 Between +24,8oand +25,3o
C. Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 5 % solution D. pH of a 5 % solution Between 6,7 and 7,2
D. pH of a 5 % solution
Purity
Loss on drying Not more than 0,5  % (98oC, 5h)
Chloride Not more than 0,2  %
Pyrrolidone carboxylic acid Not more than 0,2  %
Lead Not more than 2 mg/kg
A. Positive test for sodium
B. Positive test for glutamic acid by thin-layer chromatography
C. Specific rotation [α]D20
D. pH of a 5 % solution
Synonyms Potassium glutamate, MPG
Definition
Chemical name Monopotassium L-glutamate monohydrate
Einecs 243-094-0
Chemical formula C5H8KNO4· H2O
Molecular weight 203,24
Assay Content not less than 99,0  % and not more than 101,0  % on the anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A.Positive test for potassium A. Positive test for potassium
A. Positive test for potassium
B.Positive test for glutamic acid by thin-layer chromatog-raphy B. Positive test for glutamic acid by thin-layer chromatog-raphy
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 C. Specific rotation [α]D20 Between +22,5oand +24,0o
C. Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 2 % solution D. pH of a 2 % solution Between 6,7 and 7,3
D. pH of a 2 % solution
Purity
Loss on drying Not more than 0,2  % (80oC, 5h)
Chloride Not more than 0,2  %
Pyrrolidone carboxylic acid Not more than 0,2  %
Lead Not more than 2 mg/kg
A. Positive test for potassium
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C. Specific rotation [α]D20
D. pH of a 2 % solution
Synonyms Calcium glutamate
Definition
Chemical name Monocalcium di-L-glutamate
Einecs 242-905-5
Chemical formula C10H16CaN2O8· x H2O (x = 0, 1, 2 or 4)
Molecular weight 332,32 (anhydrous)
Assay Content not less than 98,0  % and not more than 102,0  % on the anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A.Positive test for calcium A. Positive test for calcium
A. Positive test for calcium
B.Positive test for glutamic acid by thin-layer chromatog-raphy B. Positive test for glutamic acid by thin-layer chromatog-raphy
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 C. Specific rotation [α]D20 Between +27,4 and +29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
C. Specific rotation [α]D20
Purity
Water Not more than 19,0  % (for calcium diglutamate with x = 4) (Karl Fischer)
Chloride Not more than 0,2  %
Pyrrolidone carboxylic acid Not more than 0,2  %
Lead Not more than 2 mg/kg
A. Positive test for calcium
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C. Specific rotation [α]D20
Synonyms Ammonium glutamate
Definition
Chemical name Monoammonium L-glutamate monohydrate
Einecs 231-447-1
Chemical formula C5H12N2O4· H2O
Molecular weight 182,18
Assay Content not less than 99,0  % and not more 101,0  % on the anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A.Positive test for ammonium A. Positive test for ammonium
A. Positive test for ammonium
B.Positive test for glutamic acid by thin-layer chromatog-raphy B. Positive test for glutamic acid by thin-layer chromatog-raphy
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 C. Specific rotation [α]D20 Between +25,4oand +26,4o
C. Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 5 % solution D. pH of a 5 % solution Between 6,0 and 7,0
D. pH of a 5 % solution
Purity
Loss on drying Not more than 0,5  % (50oC, 4h)
Sulphated ash Not more than 0,1  %
Pyrrolidone carboxylic acid Not more than 0,2  %
Lead Not more than 2 mg/kg
A. Positive test for ammonium
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C. Specific rotation [α]D20
D. pH of a 5 % solution
Synonyms Magnesium glutamate
Definition
Chemical name Monomagnesium di-L-glutamate tetrahydrate
Einecs 242-413-0
Chemical formula C10H16MgN2O8· 4H2O
Molecular weight 388,62
Assay Content not less than 95,0  % and not more than 105,0  % on the anhydrous basis
Description Odourless, white or off-white crystals or powder
Identification
A.Positive test for magnesium A. Positive test for magnesium
A. Positive test for magnesium
B.Positive test for glutamic acid by thin-layer chromatog-raphy B. Positive test for glutamic acid by thin-layer chromatog-raphy
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 C. Specific rotation [α]D20 Between +23,8oand +24,4o
C. Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 10 % solution D. pH of a 10 % solution Between 6,4 and 7,5
D. pH of a 10 % solution
Purity
Water Not more than 24 % (Karl Fischer)
Chloride Not more than 0,2  %
Pyrrolidone carboxylic acid Not more than 0,2  %
Lead Not more than 2 mg/kg
A. Positive test for magnesium
B. Positive test for glutamic acid by thin-layer chromatog-raphy
C. Specific rotation [α]D20
D. pH of a 10 % solution
Synonyms Guanylic acid
Definition
Chemical name Guanosine-5'-monophosphoric acid
Einecs 201-598-8
Chemical formula C10H14N5O8P
Molecular weight 363,22
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or white crystalline powder
Identification
A.Positive test for ribose and for organic phosphate A. Positive test for ribose and for organic phosphate
A. Positive test for ribose and for organic phosphate
B.pH of a 0,25  % solution B. pH of a 0,25  % solution Between 1,5 and 2,5
B. pH of a 0,25  % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. Spectrometry:
Purity
Loss on drying Not more than 1,5  % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose and for organic phosphate
B. pH of a 0,25  % solution
C. Spectrometry:
Synonyms Sodium guanylate, sodium 5'-guanylate
Definition
Chemical name Disodium guanosine-5'-monophosphate
Einecs 221-849-5
Chemical formula C10H12N5Na2O8P· x H2O (x = ca. 7)
Molecular weight 407,19 (anhydrous)
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or white crystalline powder
Identification
A.Positive test for ribose, for organic phosphate, and for sodium A. Positive test for ribose, for organic phosphate, and for sodium
A. Positive test for ribose, for organic phosphate, and for sodium
B.pH of a 5 % solution B. pH of a 5 % solution Between 7,0 and 8,5
B. pH of a 5 % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. Spectrometry:
Purity
Loss on drying Not more than 25 % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, for organic phosphate, and for sodium
B. pH of a 5 % solution
C. Spectrometry:
Synonyms Potassium guanylate, potassium 5'-guanylate
Definition
Chemical name Dipotassium guanosine-5'-monophosphate
Einecs 226-914-1
Chemical formula C10H12K2N5O8P
Molecular weight 439,40
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or white crystalline powder
Identification
A.Positive test for ribose, for organic phosphate, and for potassium A. Positive test for ribose, for organic phosphate, and for potassium
A. Positive test for ribose, for organic phosphate, and for potassium
B.pH of a 5 % solution B. pH of a 5 % solution Between 7,0 and 8,5
B. pH of a 5 % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. Spectrometry:
Purity
Loss on drying Not more than 5 % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, for organic phosphate, and for potassium
B. pH of a 5 % solution
C. Spectrometry:
Synonyms Calcium 5'-guanylate
Definition
Chemical name Calcium guanosine-5'-monophosphate
Chemical formula C10H12CaN5O8P· nH2O
Molecular weight 401,20 (anhydrous)
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, white or off-white crystals or powder
Identification
A.Positive test for ribose, for organic phosphate, and for calcium A. Positive test for ribose, for organic phosphate, and for calcium
A. Positive test for ribose, for organic phosphate, and for calcium
B.pH of a 0,05  % solution B. pH of a 0,05  % solution Between 7,0 and 8,0
B. pH of a 0,05  % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. Spectrometry:
Purity
Loss on drying Not more than 23,0  % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, for organic phosphate, and for calcium
B. pH of a 0,05  % solution
C. Spectrometry:
Synonyms 5'-Inosinic acid
Definition
Chemical name Inosine-5'-monophosphoric acid
Einecs 205-045-1
Chemical formula C10H13N4O8P
Molecular weight 348,21
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A.Positive test for ribose, and for organic phosphate A. Positive test for ribose, and for organic phosphate
A. Positive test for ribose, and for organic phosphate
B.pH of a 5 % solution B. pH of a 5 % solution Between 1,0 and 2,0
B. pH of a 5 % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. Spectrometry:
Purity
Loss on drying Not more than 3,0  % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, and for organic phosphate
B. pH of a 5 % solution
C. Spectrometry:
Synonyms Sodium inosinate, sodium 5'-inosinate
Definition
Chemical name Disodium inosine-5'-monophosphate
Einecs 225-146-4
Chemical formula C10H11N4Na2O8P· H2O
Molecular weight 392,17 (anhydrous)
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A.Positive test for ribose, and for organic phosphate and for sodium A. Positive test for ribose, and for organic phosphate and for sodium
A. Positive test for ribose, and for organic phosphate and for sodium
B.pH of a 5 % solution B. pH of a 5 % solution Between 7,0 and 8,5
B. pH of a 5 % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. Spectrometry:
Purity
Water Not more than 28,5  % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, and for organic phosphate and for sodium
B. pH of a 5 % solution
C. Spectrometry:
Synonyms Potassium inosinate, potassium 5'-inosinate
Definition
Chemical name Dipotassium inosine-5'-monophosphate
Einecs 243-652-3
Chemical formula C10H11K2N4O8P
Molecular weight 424,39
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A.Positive test for ribose, and for organic phosphate and for potassium A. Positive test for ribose, and for organic phosphate and for potassium
A. Positive test for ribose, and for organic phosphate and for potassium
B.pH of a 5 % solution B. pH of a 5 % solution Between 7,0 and 8,5
B. pH of a 5 % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. Spectrometry:
Purity
Water Not more than 10,0  % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, and for organic phosphate and for potassium
B. pH of a 5 % solution
C. Spectrometry:
Synonyms Calcium 5'-inosinate
Definition
Chemical name Calcium inosine-5'-monophosphate
Chemical formula C10H11CaN4O8P· nH2O
Molecular weight 386,19 (anhydrous)
Assay Content not less than 97,0  % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A.Positive test for ribose, and for organic phosphate and for calcium A. Positive test for ribose, and for organic phosphate and for calcium
A. Positive test for ribose, and for organic phosphate and for calcium
B.pH of a 0,05  % solution B. pH of a 0,05  % solution Between 7,0 and 8,0
B. pH of a 0,05  % solution
C.Spectrometry: C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. Spectrometry:
Purity
Water Not more than 23,0  % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, and for organic phosphate and for calcium
B. pH of a 0,05  % solution
C. Spectrometry:
Definition
Chemical name Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate
Chemical formula C10H11N4CaO8P· nH2O y
C10H12N5CaO8P· nH2O
Assay Content of both major components not less than 97,0  %, and of each component not less than 47,0  % and not more than 53 %, in every case on the anhydrous basis
Description Odourless, white or nearly white crystals or powder
Identification
A.Positive test for ribose, and for organic phosphate and for calcium A. Positive test for ribose, and for organic phosphate and for calcium
A. Positive test for ribose, and for organic phosphate and for calcium
B.pH of a 0,05  % solution B. pH of a 0,05  % solution Between 7,0 and 8,0
B. pH of a 0,05  % solution
Purity
Water Not more than 23,0  % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, and for organic phosphate and for calcium
B. pH of a 0,05  % solution
Synonyms Sodium 5'-ribonucleotide
Definition
Chemical name Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate
Chemical formula C10H11N4Na2O8P · nH2O and
C10H12N5Na2O8P· nH2O
Assay Content of both major components not less than 97,0  %, and of each component not less than 47,0  % and not more than 53 %, in every case on the anhydrous basis
Description Odourless, white or nearly white crystals or powder
Identification
A.Positive test for ribose, and for organic phosphate and for sodium A. Positive test for ribose, and for organic phosphate and for sodium
A. Positive test for ribose, and for organic phosphate and for sodium
B.pH of a 5 % solution B. pH of a 5 % solution Between 7,0 and 8,5
B. pH of a 5 % solution
Purity
Water Not more than 26,0  % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
A. Positive test for ribose, and for organic phosphate and for sodium
B. pH of a 5 % solution
Synonyms(gly) Aminoacetic acid, glycocoll
(Na salt) Sodium glycinate
Definition
Chemical name (gly) Aminoacetic acid
(Na salt) Sodium glycinate
Chemical formula (gly) C2H5NO2
(Na salt) C2H5NO2Na
Einecs (gly) 200-272-2
(Na salt) 227-842-3
Molecular weight (gly) 75,07
(Na salt) 98
Assay Content not less than 98,5  % on the anhydrous basis
Description White crystals or crystalline powder
Identification
A.Positive test for amino acid (gly and Na salt) A. Positive test for amino acid (gly and Na salt)
A. Positive test for amino acid (gly and Na salt)
B.Positive test for sodium (Na salt) B. Positive test for sodium (Na salt)
B. Positive test for sodium (Na salt)
Purity
Loss on drying (gly) Not more than 0,2  % (105oC, 3h)
(Na salt) Not more than 0,2  % (105oC, 3h)
Residue on ignition (gly) Not more than 0,1  %
(Na salt) Not more than 0,1  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Positive test for amino acid (gly and Na salt)
B. Positive test for sodium (Na salt)
Synonyms Acetic acid, zinc salt, dihydrate
Definition
Chemical name Zinc acetate dihydrate
Chemical formula C4H6O4Zn· 2H2O
Molecular weight 219,51
Assay Content not less than 98 % and not more than 102 % of C4H6O4Zn · 2H2O
Description Colourless crystals or fine, off-white powder
Identification
A.Positive tests for acetate and for zinc A. Positive tests for acetate and for zinc
A. Positive tests for acetate and for zinc
B.pH of a 5 % solution B. pH of a 5 % solution Between 6,0 and 8,0
B. pH of a 5 % solution
Purity
Insoluble matter Not more than 0,005  %
Chlorides Not more than 50 mg/kg
Sulphates Not more than 100 mg/kg
Alkalines and alkaline earths Not more than 0,2  %
Organic volatile impurities Passes test
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 20 mg/kg
Cadmium Not more than 5 mg/kg
A. Positive tests for acetate and for zinc
B. pH of a 5 % solution
Synonyms Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone
Definition Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3SiO
Chemical name Siloxanes and silicones, di-methyl
Chemical formula (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3
Assay Content of total silicon not less than 37,3  % and not more than 38,5  %
Description Clear, colourless, viscous liquid
Identification
A.Specific gravity (25o/25oC) A. Specific gravity (25o/25oC) Between 0,964 and 0,977
A. Specific gravity (25o/25oC)
B.Refractive index [n]D25 B. Refractive index [n]D25 Between 1,400 and 1,405
B. Refractive index [n]D25
C.Infrared spectrum characteristic of the compound C. Infrared spectrum characteristic of the compound
C. Infrared spectrum characteristic of the compound
Purity
Loss on drying Not more than 0,5  % (150oC, 4h)
Viscosity Not less than 1,00 · 10-4m2s-1at 25oC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Specific gravity (25o/25oC)
B. Refractive index [n]D25
C. Infrared spectrum characteristic of the compound
Synonyms White wax, yellow wax
Definition Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee,Apis melliferaL., with hot water and removing foreign matter
White beeswax is obtained by bleaching yellow beeswax
Einecs 232-383-7 (beeswax)
Description Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour
Identification
A.Melting range A. Melting range Between 62oC and 65oC
A. Melting range
B.Specific gravity B. Specific gravity About 0,96
B. Specific gravity
C.Solubility C. Solubility Insoluble in water
C. Solubility
Sparingly soluble in alcohol
Very soluble in chloroform and ether
Purity
Acid value Not less than 17 and not more than 24
Saponification value 87-104
Peroxide value Not more than 5
Glycerol and other polyols Not more than 0,5  % (as glycerol)
Ceresin, paraffins and certain other waxes Absent
Fats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Melting range
B. Specific gravity
C. Solubility
Definition Candelilla wax is a purified wax obtained from the leaves of the candelilla plant,Euphorbia antisyphilitica
Einecs 232-347-0
Description Hard, yellowish brown, opaque to translucent wax
Identification
A.Specific gravity A. Specific gravity About 0,983
A. Specific gravity
B.Melting range B. Melting range Between 68,5oC and 72,5oC
B. Melting range
C.Solubility C. Solubility Insoluble in water
C. Solubility
Soluble in chloroform and toluene
Purity
Acid value Not less than 12 and not more than 22
Saponification value Not less than 43 and not more than 65
Glycerol and other polyols Not more than 0,5  % (as glycerol)
Ceresin, paraffins and certain other waxes Absent
Fats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Specific gravity
B. Melting range
C. Solubility
Definition Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm,Copernicia cerifera
Einecs 232-399-4
Description Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
Identification
A.Specific gravity A. Specific gravity About 0,997
A. Specific gravity
B.Melting range B. Melting range Between 82oC and 86oC
B. Melting range
C.Solubility C. Solubility Insoluble in water
C. Solubility
Partly soluble in boiling ethanol
Soluble in chloroform and diethyl ether
Purity
Sulphated ash Not more than 0,25  %
Acid value Not less than 2 and not more than 7
Ester value Not less than 71 and not more than 88
Unsaponifiable matter Not less than 50 % and not more than 55 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. Specific gravity
B. Melting range
C. Solubility
Synonyms Bleached shellac, white shellac
Definition Shellac is the purified and bleached lac, the resinous secretion of the insectLaccifer (Tachardia) laccaKerr (Fam.Coccidae)
Einecs 232-549-9
Description Bleached shellac — off-white, amorphous, granular resin
Wax-free bleached shellac — light yellow, amorphous, granular resin
Identification
A.Solubility A. Solubility Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
A. Solubility
B.Acid value B. Acid value Between 60 and 89
B. Acid value
Purity
Loss on drying Not more than 6,0  % (40oC, over silica gel, 15h)
Rosin Absent
Wax Bleached shellac: not more than 5,5  %
Wax-free bleached shellac: not more than 0,2  %
Lead Not more than 2 mg/kg
A. Solubility
B. Acid value
Synonyms Petroleum wax
Definition Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum
Description White to amber, odourless wax
Identification
A.Solubility A. Solubility Insoluble in water, very slightly soluble in ethanol
A. Solubility
B.Refractive Index B. Refractive Index nD1001,434 -1,448
B. Refractive Index
Purity
Molecular weight Average not less than 500
Viscosity at 100oC Not less than 1,1 · 10-5m2s-1
Residue on ignition Not more than 0,1  %
Carbon number at 5 % distillation point Not more than 5 % of molecules with carbon number less than 25
Colour Passes test
Sulphur Not more than 0,4  %
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Polycyclic aromatic compounds The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:
nm Maximum absorbance per cm path length
280-289 0,15
290-299 0,12
300-359 0,08
360-400 0,02
A. Solubility
B. Refractive Index
Synonyms Hydrogenated polydec-1-ene
Hydrogenated poly-alpha-olefin
Definition
Chemical formula C10nH20n+2where n = 3-6
Molecular weight 560 (average)
Assay Not less than 98,5  % of hydrogenated poly-1-decene, having the following oligomer distribution:
C30: 13-37 %
C40: 35-70 %
C50: 9-25 %
C60: 1-7 %
Description
Identification
A.Solubility A. Solubility Insoluble in water; slightly soluble in ethanol; soluble in toluene
A. Solubility
B.Burning B. Burning Burns with a bright flame and a paraffin-like characteristic smell
B. Burning
Purity
Viscosity Between 5,7 × 10-6and 6,1 × 10-6m2s-1at 100oC
Compounds with carbon number less than 30 Not more than 1,5  %
Readily carbonisable substances After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour
Nickel Not more than 1 mg/kg
Lead Not more than 1 mg/kg
A. Solubility
B. Burning
Definition Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
Chemical name Montan acid esters
Description Almost white to yellowish flakes, powder, granules or pellets
Identification
A.Density (20oC) A. Density (20oC) Between 0,98 and 1,05
A. Density (20oC)
B.Drop point B. Drop point Greater than 77oC
B. Drop point
Purity
Acid value Not more than 40
Glycerol Not more than 1 % (by gas chromatography)
Other polyols Not more than 1 % (by gas chromatography)
Other wax types Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
Arsenic Not more than 2 mg/kg
Chromium Not more than 3 mg/kg
Lead Not more than 2 mg/kg
A. Density (20oC)
B. Drop point
Definition Polar reaction products from mild oxidation of polyethylene
Chemical name Oxidised polyethylene
Description Almost white flakes, powder, granules or pellets
Identification
A.Density (20oC) A. Density (20oC) Between 0,92 and 1,05
A. Density (20oC)
B.Drop point B. Drop point Greater than 95oC
B. Drop point
Purity
Acid value Not more than 70
Viscosity at 120oC Not less than 8,1 · 10-5m2s-1
Other wax types Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
Oxygen Not more than 9,5  %
Chromium Not more than 5 mg/kg
Lead Not more than 2 mg/kg
A. Density (20oC)
B. Drop point
Definition L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance
Einecs 200-157-7 (anhydrous)
Chemical formula C3H7NO2S· HCl· n H20 (where n = 0 or 1)
Molecular weight 157,62 (anhydrous)
Assay Content not less than 98,0  % and not more than 101,5  % on the anhydrous basis
Description White powder or colourless crystals
Identification
A.Solubility A. Solubility Freely soluble in water and in ethanol
A. Solubility
B.Melting range B. Melting range Anhydrous form melts at about 175oC
B. Melting range
C.Specific rotation C. Specific rotation [α]20D: between +5,0oand +8,0oor
C. Specific rotation
[α]25D: between +4,9oand 7,9o
Purity
Loss on drying Between 8,0  % and 12,0  %
Not more than 2,0  % (anhydrous form)
Residue on ignition Not more than 0,1  %
Ammonium-ion Not more than 200 mg/kg
Arsenic Not more than 1,5  mg/kg
Lead Not more than 5 mg/kg
A. Solubility
B. Melting range
C. Specific rotation
Synonyms Urea
Definition
Einecs 200-315-5
Chemical formula CH4N2O
Molecular weight 60,06
Assay Content not less than 99,0  % on the anhydrous basis
Description Colourless to white, prismatic, crystalline powder or small, white pellets
Identification
A.Solubility A. Solubility Very soluble in water
A. Solubility
Soluble in ethanol
B.Precipitation with nitric acid B. Precipitation with nitric acid To pass the test a white, crystalline precipitate is formed
B. Precipitation with nitric acid
C.Colour reaction C. Colour reaction To pass the test a reddish-violet colour is produced
C. Colour reaction
D.Melting range D. Melting range 132oC to 135oC
D. Melting range
Purity
Loss on drying Not more than 1,0  % (105oC, 1h)
Sulphated ash Not more than 0,1  %
Ethanol-insoluble matter Not more than 0,04  %
Alkalinity Passes test
Ammonium-ion Not more than 500 mg/kg
Biuret Not more than 0,1  %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
A. Solubility
B. Precipitation with nitric acid
C. Colour reaction
D. Melting range
Definition
Chemical name Argon
Einecs 231-147-0
Chemical formula Ar
Molecular weight 40
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05  %
Methane and other hydrocarbons calculated as methane Not more than 100 μl/l
Definition
Chemical name Helium
Einecs 231-168-5
Chemical formula He
Molecular weight 4
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05  %
Methane and other hydrocarbons calculated as methane Not more than 100 μl/l
Definition
Chemical name Nitrogen
Einecs 231-783-9
Chemical formula N2
Molecular weight 28
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05  %
Carbon monoxide Not more than 10 μl/l
Methane and other hydrocarbons calculated as methane Not more than 100 μl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 μl/l
Oxygen Not more than 1 %
Definition
Chemical name Nitrous oxide
Einecs 233-032-0
Chemical formula N2O
Molecular weight 44
Assay Not less than 99 %
Description Colourless, non-flammable gas, sweetish odour
Purity
Water Not more than 0,05  %
Carbon monoxide Not more than 30 μl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 μl/l
Synonyms n-Butane
Definition
Chemical name Butane
Chemical formula CH3CH2CH2CH3
Molecular weight 58,12
Assay Content not less than 96 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
A.Vapour pressure A. Vapour pressure 108,935 kPa at 20oC
A. Vapour pressure
Purity
Methane Not more than 0,15  % v/v
Ethane Not more than 0,5  % v/v
Propane Not more than 1,5  % v/v
Isobutane Not more than 3,0  % v/v
1,3-butadiene Not more than 0,1  % v/v
Moisture Not more than 0,005  %
A. Vapour pressure
Synonyms 2-methyl propane
Definition
Chemical name 2-methyl propane
Chemical formula (CH3)2CH CH3
Molecular weight 58,12
Assay Content not less than 94 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
A.Vapour pressure A. Vapour pressure 205,465 kPa at 20oC
A. Vapour pressure
Purity
Methane Not more than 0,15  % v/v
Ethane Not more than 0,5  % v/v
Propane Not more than 2,0  % v/v
n-Butane Not more than 4,0  % v/v
1,3 -butadiene Not more than 0,1  % v/v
Moisture Not more than 0,005  %
A. Vapour pressure
Definition
Chemical name Propane
Chemical formula CH3CH2CH3
Molecular weight 44,09
Assay Content not less than 95 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
A.Vapour pressure A. Vapour pressure 732,910 kPa at 20oC
A. Vapour pressure
Purity
Methane Not more than 0,15  % v/v
Ethane Not more than 1,5  % v/v
Isobutane Not more than 2,0  % v/v
n-Butane Not more than 1,0  % v/v
1,3-butadiene Not more than 0,1  % v/v
Moisture Not more than 0,005  %
A. Vapour pressure
Definition
Chemical name Oxygen
Einecs 231-956-9
Chemical formula O2
Molecular weight 32
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05  %
Methane and other hydrocarbons calculated as methane Not more than 100 μl/l
Definition
Chemical name Hydrogen
Einecs 215-605-7
Chemical formula H2
Molecular weight 2
Assay Content not less than 99,9  %
Description Colourless, odourless, highly flammable gas
Purity
Water Not more than 0,005  % v/v
Oxygen Not more than 0,001  % v/v
Nitrogen Not more than 0,75  % v/v
Synonyms Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract
Definition Quillaia extract is obtained by aqueous extraction ofQuillaia saponariaMolina, or otherQuillaiaspecies, trees of the familyRosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components
Description Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
Identification
A.pH of a 2,5  % solution A. pH of a 2,5  % solution Between 4,5 and 5,5
A. pH of a 2,5  % solution
Purity
Water Not more than 6,0  % (Karl Fischer method) (powder form only)
Arsenic Not more than 2 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
A. pH of a 2,5  % solution
Definition Invertase is produced fromSaccharomyces cerevisiae
Systematic name β-D-Fructofuranoside fructohydrolase
Enzyme Commission No EC 3.2.1.26
Einecs 232-615-7
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 0,5  mg/kg
Total bacterial count Not more than 50 000 /g
Salmonellaspp. Absent by test in 25 g
Coliforms Not more than 30/g
E. coli Absent by test in 25 g
Synonyms Lysozyme hydrochloride
Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride
Chemical name Enzyme Commission (EC) No: 3.2.1.17
Einecs 232-620-4
Molecular weight About 14 000
Assay Content not less than 950 mg/g on the anhydrous basis
Description White, odourless powder having a slightly sweet taste
Identification
A.Isoelectric point 10,7 A. Isoelectric point 10,7
A. Isoelectric point 10,7
B.pH of a 2 % aqueous solution between 3,0 and 3,6 B. pH of a 2 % aqueous solution between 3,0 and 3,6
B. pH of a 2 % aqueous solution between 3,0 and 3,6
C.Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm C. Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
C. Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Purity
Water content Not more than 6,0  % (Karl Fischer method) (powder form only)
Residue on ignition Not more than 1,5  %
Nitrogen Not less than 16,8  % and not more than 17,8  %
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria
Total bacterial count Not more than 5 × 104col/g
Salmonellae Absent in 25 g
Staphylococcus aureus Absent in 1 g
Escherichia coli Absent in 1 g
A. Isoelectric point 10,7
B. pH of a 2 % aqueous solution between 3,0 and 3,6
C. Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Synonyms Modified polydextroses
Definition Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose
Assay Content not less than 90 % of polymer on the ash free and anhydrous basis
Description White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution
Identification
A.Positive tests for sugar and for reducing sugar A. Positive tests for sugar and for reducing sugar
A. Positive tests for sugar and for reducing sugar
B.pH of a 10 % solution B. pH of a 10 % solution Between 2,5 and 7,0 for polydextrose
B. pH of a 10 % solution
Between 5,0 and 6,0 for polydextrose-N
Purity
Water Not more than 4,0  % (Karl Fischer method)
Sulphated ash Not more than 0,3  % (polydextrose)
Not more than 2,0  % (polydextrose N)
Nickel Not more than 2 mg/kg for hydrogenated polydextroses
1,6-Anhydro-D-glucose Not more than 4,0  % on the ash-free and the dried basis
Glucose and sorbitol Not more than 6,0  % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately
Molecular weight limit Negative test for polymers of molecular weight greater than 22 000
5-Hydroxy-methylfurfural Not more than 0,1  % (polydextrose)
Not more than 0,05  % (polydextrose-N)
Lead Not more than 0,5  mg/kg
A. Positive tests for sugar and for reducing sugar
B. pH of a 10 % solution
Synonyms Povidone
PVP
Soluble polyvinylpyrrolidone
Definition
Chemical name Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula (C6H9NO)n
Molecular weight Not less than 25 000
Assay Content not less than 11,5  % and not more than 12,8  % of nitrogen (N) on the anhydrous basis
Description White or nearly white powder
Identification
A.Solubility A. Solubility Soluble in water and in ethanol. Insoluble in ether
A. Solubility
B.pH of a 5 % solution B. pH of a 5 % solution Between 3,0 and 7,0
B. pH of a 5 % solution
Purity
Water Not more than 5 % (Karl Fischer)
Total ash Not more than 0,1  %
Aldehyde Not more than 500 mg/kg (as acetaldehyde)
Free-N-vinylpyrrolidone Not more than 10 mg/kg
Hydrazine Not more than 1 mg/kg
Lead Not more than 5 mg/kg
A. Solubility
B. pH of a 5 % solution
Synonyms Crospovidone
Cross linked polyvidone
Insoluble polyvinylpyrrolidone
Definition Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination
Chemical name Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula (C6H9NO)n
Assay Content not less than 11 % and not more than 12,8  % nitrogen (N) on the anhydrous basis
Description A white hygroscopic powder with a faint, non-objectionable odour
Identification
A.Solubility A. Solubility Insoluble in water, ethanol and ether
A. Solubility
B.pH of a 1 % suspension in water B. pH of a 1 % suspension in water Between 5,0 and 8,0
B. pH of a 1 % suspension in water
Purity
Water Not more than 6 % (Karl Fischer)
Sulphated ash Not more than 0,4  %
Water-soluble matter Not more than 1 %
Free-N-vinylpyrrolidone Not more than 10 mg/kg
Free-N, N'-divinyl-imidazolidone Not more than 2 mg/kg
Lead Not more than 5 mg/kg
A. Solubility
B. pH of a 1 % suspension in water
Definition Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain ofAureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography
Einecs 232-945-1
Chemical formula (C6H10O5)x
Assay Not less than 90 % of glucan on the dried basis
Description White to off-white odourless powder
Identification
A.Solubility A. Solubility Soluble in water, practically insoluble in ethanol
A. Solubility
B.pH of 10 % solution B. pH of 10 % solution 5,0 to 7,0
B. pH of 10 % solution
C.Precipitation with polyethylene glycol 600 C. Precipitation with polyethylene glycol 600 Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed
C. Precipitation with polyethylene glycol 600
D.Depoly-merisation with pullulanase D. Depoly-merisation with pullulanase Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1  ml pullulanase solution having activity 10 units/g to one test tube, and 0,1  ml water to the other. After incubation at about 25oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
D. Depoly-merisation with pullulanase
Purity
Loss on drying Not more than 6 % (90oC, pressure not more than 50 mm Hg, 6 h)
Mono-, di- and oligosaccharides Not more than 10 % expressed as glucose
Viscosity 100 to 180 mm2/s (10 % w/w aqueous solution at 30oC)
Lead Not more than 1 mg/kg
Yeast and moulds Not more than 100 colonies per gram
Coliforms Absent in 25 g
Salmonella Absent in 25 g
A. Solubility
B. pH of 10 % solution
C. Precipitation with polyethylene glycol 600
D. Depoly-merisation with pullulanase
Definition Oxidised starch is starch treated with sodium hypochlorite
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Carboxyl groups Not more than 1,1  %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Residual phosphate Not more than 0,5  % (as P) for wheat or potato starch
Not more than 0,4  % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Residual phosphate Not more than 0,5  % (as P) for wheat or potato starch
Not more than 0,4  % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Residual phosphate Not more than 0,5  % (as P) for wheat or potato starch
Not more than 0,4  % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Acetyl groups Not more than 2,5  %
Residual phosphate Not more than 0,14  % (as P) for wheat or potato starch
Not more than 0,04  % (as P) for other starches
Vinyl acetate Not more than 0,1  mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Synonyms Starch acetate
Definition Acetylated starch is starch esterified with acetic anhydride or vinyl acetate
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Acetyl groups Not more than 2,5  %
Vinyl acetate Not more than 0,1  mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Acetyl groups Not more than 2,5  %
Adipate groups Not more than 0,135  %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Hydroxypropyl starch is starch etherified with propylene oxide
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Hydroxypropyl groups Not more than 7,0  %
Propylene chlorohydrin Not more than 1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Hydroxypropyl groups Not more than 7,0  %
Residual phosphate Not more than 0,14  % (as P) for wheat or potato starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin Not more than 1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Synonyms SSOS
Definition Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Octenylsuccinyl groups Not more than 3 %
Octenylsuccinic acid residue Not more than 0,3  %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Definition Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 15,0  % for cereal starch
Not more than 21,0  % for potato starch
Not more than 18,0  % for other starches
Carboxyl groups Not more than 1,3  %
Acetyl groups Not more than 2,5  %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Synonyms SAOS
Definition Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.If not pregelatinised: by microscopic observation A. If not pregelatinised: by microscopic observation
A. If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) B. Iodine staining positive (dark blue to light red colour)
B. Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying)
Loss on drying Not more than 21,0  %
Octenylsuccinyl groups Not more than 3 %
Octenylsuccinic acid residue Not more than 0,3  %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for the other modified starches, unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1  mg/kg
Aluminium Not more than 0,3  %
A. If not pregelatinised: by microscopic observation
B. Iodine staining positive (dark blue to light red colour)
Synonyms Ethyl citrate
Definition
Chemical name Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
Einecs 201-070-7
Chemical formula C12H20O7
Molecular weight 276,29
Assay Content not less than 99,0  %
Description Odourless, practically colourless, oily liquid
Identification
A.Specific gravity A. Specific gravity d2525: 1,135 -1,139
A. Specific gravity
B.Refractive index B. Refractive index [n]D20: 1,439 -1,441
B. Refractive index
Purity
Water Not more than 0,25  % (Karl Fischer method)
Acidity Not more than 0,02  % (as citric acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
A. Specific gravity
B. Refractive index
Synonyms Diacetin
Definition Glyceryl diacetate consist predominantly of a mixture of the 1,2 – and 1,3 -diacetates of glycerol, with minor amounts of the mono- and tri-esters
Chemical names Glyceryl diacetate
1, 2, 3-propanetriol diacetate
Chemical formula C7H12O5
Molecular weight 176,17
Assay Not less than 94,0  %
Description Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour
Identification
A.Solubility A. Solubility Soluble in water. Miscible with ethanol
A. Solubility
B.Positive tests for glycerol and acetate B. Positive tests for glycerol and acetate
B. Positive tests for glycerol and acetate
C.Specific gravity C. Specific gravity d2020: 1,175 -1,195
C. Specific gravity
D.Boiling range D. Boiling range Between 259 and 261oC
D. Boiling range
Purity
Total ash Not more than 0,02  %
Acidity Not more than 0,4  % (as ascetic acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
A. Solubility
B. Positive tests for glycerol and acetate
C. Specific gravity
D. Boiling range
Synonyms Triacetin
Definition
Chemical name Glyceryl triacetate
Einecs 203-051-9
Chemical formula C9H14O6
Molecular weight 218,21
Assay Content not less than 98,0  %
Description Colourless, somewhat oily liquid having a slightly fatty odour
Identification
A.Positive tests for acetate and for glycerol A. Positive tests for acetate and for glycerol
A. Positive tests for acetate and for glycerol
B.Refractive index B. Refractive index Between 1,429 and 1,431 at 25oC
B. Refractive index
C.Specific gravity (25oC/25oC) C. Specific gravity (25oC/25oC) Between 1,154 and 1,158
C. Specific gravity (25oC/25oC)
D.Boiling range D. Boiling range Between 258 and 270oC
D. Boiling range
Purity
Water Not more than 0,2  % (Karl Fischer method)
Sulphated ash Not more than 0,02  % (as citric acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
A. Positive tests for acetate and for glycerol
B. Refractive index
C. Specific gravity (25oC/25oC)
D. Boiling range
Synonyms Phenylcarbinol
Phenylmethyl alcohol
Benzenemethanol
Alpha-hydroxytoluene
Definition
Chemical names Benzyl alcohol
Phenylmethanol
Chemical formula C7H8O
Molecular weight 108,14
Assay Not less than 98,0  %
Description Colourless, clear liquid with a faint, aromatic odour
Identification
A.Solubility A. Solubility Soluble in water, ethanol and ether
A. Solubility
B.Refractive index B. Refractive index [n]D20: 1,538 -1,541
B. Refractive index
C.Specific gravity C. Specific gravity d2525: 1,042 -1,047
C. Specific gravity
D.Positive test for peroxides D. Positive test for peroxides
D. Positive test for peroxides
Purity
Distillation range Not less than 95 % v/v distils between 202 and 208oC
Acid value Not more than 0,5
Aldehydes Not more than 0,2  % v/v (as bezaldehyde)
Lead Not more than 5 mg/kg
A. Solubility
B. Refractive index
C. Specific gravity
D. Positive test for peroxides
Synonyms Propylene glycol
Definition
Chemical names 1,2-dihydroxypropane
Einecs 200-338-0
Chemical formula C3H8O2
Molecular weight 76,10
Assay Content not less than 99,5  % on the anhydrous basis
Description Clear, colourless, hygroscopic, viscous liquid
Identification
A.Solubility A. Solubility Soluble in water, ethanol and acetone
A. Solubility
B.Specific gravity B. Specific gravity d2020: 1,035 -1,040
B. Specific gravity
C.Refractive index C. Refractive index [n]20D: 1,431 -1,433
C. Refractive index
Purity
Distillation range 99 % v/v distils between 185oC-189oC
Sulphated ash Not more than 0,07  %
Water Not more than 1,0  % (Karl Fischer method)
Lead Not more than 5 mg/kg
A. Solubility
B. Specific gravity
C. Refractive index
Synonyms PEG 6000
Macrogol 6000
Definition Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000
Chemical formula (C2H4O)nH2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000 , about 140)
Molecular weight 5 600 -7 000
Assay Not less than 90,0  % and not more than 110,0  %
Description A white or almost white solid with a waxy or paraffin-like appearance
Identification
A.Solubility A. Solubility Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils
A. Solubility
B.Melting range B. Melting range Between 55oC and 61oC
B. Melting range
Purity
Viscosity Between 0,220 and 0,275 kgm-1s-1at 20oC
Hydroxyl value Between 16 and 22
Sulphated ash Not more than 0,2  %
Ethylene oxide Not more than 0,2  mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
A. Solubility
B. Melting range
Commission Directive 96/77/ECCommission Directive 98/86/ECCommission Directive 2000/63/ECCommission Directive 2001/30/ECCommission Directive 2002/82/ECCommission Directive 2003/95/ECCommission Directive 2004/45/ECCommission Directive 2006/129/EC Commission Directive 98/86/EC Commission Directive 2000/63/EC Commission Directive 2001/30/EC Commission Directive 2002/82/EC Commission Directive 2003/95/EC Commission Directive 2004/45/EC Commission Directive 2006/129/EC (OJ L 339, 30.12.1996, p. 1)(OJ L 334, 9.12.1998, p. 1)(OJ L 277, 30.10.2000, p. 1)(OJ L 146, 31.5.2001, p. 1)(OJ L 292, 28.10.2002, p. 1)(OJ L 283, 31.10.2003, p. 71)(OJ L 113, 20.4.2004, p. 19)(OJ L 346, 9.12.2006, p. 15) (OJ L 334, 9.12.1998, p. 1) (OJ L 277, 30.10.2000, p. 1) (OJ L 146, 31.5.2001, p. 1) (OJ L 292, 28.10.2002, p. 1) (OJ L 283, 31.10.2003, p. 71) (OJ L 113, 20.4.2004, p. 19) (OJ L 346, 9.12.2006, p. 15)
Commission Directive 98/86/EC
Commission Directive 2000/63/EC
Commission Directive 2001/30/EC
Commission Directive 2002/82/EC
Commission Directive 2003/95/EC
Commission Directive 2004/45/EC
Commission Directive 2006/129/EC
(OJ L 334, 9.12.1998, p. 1)
(OJ L 277, 30.10.2000, p. 1)
(OJ L 146, 31.5.2001, p. 1)
(OJ L 292, 28.10.2002, p. 1)
(OJ L 283, 31.10.2003, p. 71)
(OJ L 113, 20.4.2004, p. 19)
(OJ L 346, 9.12.2006, p. 15)
Commission Directive 98/86/EC
Commission Directive 2000/63/EC
Commission Directive 2001/30/EC
Commission Directive 2002/82/EC
Commission Directive 2003/95/EC
Commission Directive 2004/45/EC
Commission Directive 2006/129/EC
(OJ L 334, 9.12.1998, p. 1)
(OJ L 277, 30.10.2000, p. 1)
(OJ L 146, 31.5.2001, p. 1)
(OJ L 292, 28.10.2002, p. 1)
(OJ L 283, 31.10.2003, p. 71)
(OJ L 113, 20.4.2004, p. 19)
(OJ L 346, 9.12.2006, p. 15)
Directive Time-limit for transposition
96/77/EC 1 July 1997(1)
98/86/EC 1 July 1999(2)
2000/63/EC 31 March 2001(3)
2001/30/EC 1 June 2002(4)
2002/82/EC 31 August 2003
2003/95/EC 1 November 2004(5)
2004/45/EC 1 April 2005(6)
2006/129/EC 15 February 2008
Directive 96/77/EC This Directive
Article 1 Article 1
Article 2 —
Article 3 —
— Article 2
Article 4 Article 3
Article 5 Article 4
Annex Annex I
— Annex II
— Annex III
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof,
(1) Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners(4).
(3) It is necessary to take into account the specifications and analytical techniques for additives as set out in theCodex Alimentariusas drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B,
HAS ADOPTED THIS DIRECTIVE:

Article 1
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in Annex I to this Directive.

Article 2
Directive 96/77/EC, as amended by the Directives listed in Annex II, part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law set out in Annex II, part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Article 4
This Directive is addressed to the Member States.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption(1), and in particular Article 3(3)(a) thereof,
(1) Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners(4).
(3) It is necessary to take into account the specifications and analytical techniques for additives as set out in theCodex Alimentariusas drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B,
HAS ADOPTED THIS DIRECTIVE:
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in Annex I to this Directive.
Directive 96/77/EC, as amended by the Directives listed in Annex II, part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law set out in Annex II, part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.

E 170 (i) CALCIUM CARBONATE

ANNEX IEthylene oxide may not be used for sterilising purposes in food additives.
Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC(1).
E 200 SORBIC ACID
Definition |
Chemical name | Sorbic acid
Trans, trans-2,4-hexadienoic acid
Einecs | 203-768-7
Chemical formula | C6H8O2
Molecular weight | 112,12
Assay | Content not less than 99 % on the anhydrous basis
Description | Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105oC
Identification |
A.Melting range | A. | Melting range | Between 133oC and 135oC, after vacuum drying for four hours in a sulphuric acid desiccator
A. | Melting range
B.Spectrometry | B. | Spectrometry | An isopropanol solution (1 in 4 000 000 ) shows absorbance maximum at 254 ± 2 nm
B. | Spectrometry
C.Positive test for double bonds | C. | Positive test for double bonds |
C. | Positive test for double bonds
D.Sublimation point | D. | Sublimation point | 80oC
D. | Sublimation point
Purity |
Water content | Not more than 0,5 % (Karl Fischer method)
Sulphated ash | Not more than 0,2 %
Aldehydes | Not more than 0,1 % (as formaldehyde)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 202 POTASSIUM SORBATE
Definition |
Chemical name | Potassium sorbate
Potassium (E, E)-2,4-hexadienoate
Potassium salt of trans, trans 2,4-hexadienoic acid
Einecs | 246-376-1
Chemical formula | C6H7O2K
Molecular weight | 150,22
Assay | Content not less than 99 % on the dried basis
Description | White crystalline powder showing no change in colour after heating for 90 minutes at 105oC
Identification |
A.Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator | A. | Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator |
A. | Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
B.Positive tests for potassium and for double bonds | B. | Positive tests for potassium and for double bonds |
B. | Positive tests for potassium and for double bonds
Purity |
Loss on drying | Not more than 1,0 % (105oC, 3h)
Acidity or alkalinity | Not more than about 1,0 % (as sorbic acid or K2CO3)
Aldehydes | Not more than 0,1 %, calculated as formaldehyde
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 203 CALCIUM SORBATE
Definition |
Chemical name | Calcium sorbate
Calcium salts of trans, trans-2,4-hexadienoic acid
Einecs | 231-321-6
Chemical formula | C12H14O4Ca
Molecular weight | 262,32
Assay | Content not less than 98 % on the dried basis
Description | Fine white crystalline powder not showing any change in colour after heating at 105oC for 90 minutes
Identification |
A.Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator | A. | Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator |
A. | Melting range of sorbic acid isolated by acidification and not recrystallised 133oC to 135oC after vacuum drying in a sulphuric acid desiccator
B.Positive tests for calcium and for double bonds | B. | Positive tests for calcium and for double bonds |
B. | Positive tests for calcium and for double bonds
Purity |
Loss on drying | Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator
Aldehydes | Not more than 0,1 % (as formaldehyde)
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 210 BENZOIC ACID
Definition |
Chemical name | Benzoic acid
Benzenecarboxylic acid
Phenylcarboxylic acid
Einecs | 200-618-2
Chemical formula | C7H6O2
Molecular weight | 122,12
Assay | Content not less than 99,5 % on the anhydrous basis
Description | White crystalline powder
Identification |
A.Melting range | A. | Melting range | 121,5oC to 123,5oC
A. | Melting range
B.Positive sublimation test and test for benzoate | B. | Positive sublimation test and test for benzoate |
B. | Positive sublimation test and test for benzoate
Purity |
Loss on drying | Not more than 0,5 % after drying for three hours over sulphuric acid
pH | About 4 (solution in water)
Sulphated ash | Not more than 0,05 %
Chlorinated organic compounds | Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid
Readily oxidisable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances | A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC(2), 0,3 ml of ferric chloride TSC(3), 0,1 ml of copper sulphate TSC(4)and 4,4 ml of water
Polycyclic acids | On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
E 211 SODIUM BENZOATE
Definition |
Chemical name | Sodium benzoate
Sodium salt of benzenecarboxylic acid
Sodium salt of phenylcarboxylic acid
Einecs | 208-534-8
Chemical formula | C7H5O2Na
Molecular weight | 144,11
Assay | Not less than 99 % of C7H5O2Na, after drying at 105oC for four hours
Description | A white, almost odourless, crystalline powder or granules
Identification |
A.Solubility | A. | Solubility | Freely soluble in water, sparingly soluble in ethanol
A. | Solubility
B.Melting range for benzoic acid | B. | Melting range for benzoic acid | Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after drying in a sulphuric acid desiccator
B. | Melting range for benzoic acid
C.Positive tests for benzoate and for sodium | C. | Positive tests for benzoate and for sodium |
C. | Positive tests for benzoate and for sodium
Purity |
Loss on drying | Not more than 1,5 % after drying at 105oC for four hours
Readily oxidisable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Polycyclic acids | On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Chlorinated organic compounds | Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Degree of acidity or alkalinity | Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 212 POTASSIUM BENZOATE
Definition |
Chemical name | Potassium benzoate
Potassium salt of benzenecarboxylic acid
Potassium salt of phenylcarboxylic acid
Einecs | 209-481-3
Chemical formula | C7H5KO2·3H2O
Molecular weight | 214,27
Assay | Content not less than 99 % C7H5KO2after drying at 105oC to constant weight
Description | White crystalline powder
Identification |
A.Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator | A. | Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator |
A. | Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
B.Positive tests for benzoate and for potassium | B. | Positive tests for benzoate and for potassium |
B. | Positive tests for benzoate and for potassium
Purity |
Loss on drying | Not more than 26,5 %, determined by drying at 105oC
Chlorinated organic compounds | Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
Readily oxidisable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances | A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids | On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Degree of acidity or alkalinity | Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 213 CALCIUM BENZOATE
Synonyms | Monocalcium benzoate
Definition |
Chemical name | Calcium benzoate
Calcium dibenzoate
Einecs | 218-235-4
Chemical formula | Anhydrous: | C14H10O4Ca
Monohydrate: | C14H10O4Ca· H2O
Trihydrate: | C14H10O4Ca· 3H2O
Molecular weight | Anhydrous: | 282,31
Monohydrate: | 300,32
Trihydrate: | 336,36
Assay | Content not less than 99 % after drying at 105oC
Description | White or colourless crystals, or white powder
Identification |
A.Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator | A. | Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator |
A. | Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator
B.Positive tests for benzoate and for calcium | B. | Positive tests for benzoate and for calcium |
B. | Positive tests for benzoate and for calcium
Purity |
Loss on drying | Not more than 17,5 % determined by drying at 105oC to constant weight
Water insoluble matter | Not more than 0,3 %
Chlorinated organic compounds | Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids
Readily oxidisable substances | Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances | Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids | On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
Degree of acidity or alkalinity | Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 214 ETHYL p-HYDROXYBENZOATE
Synonyms | Ethylparaben
Ethylp-oxybenzoate
Definition |
Chemical name | Ethyl-p-hydroxybenzoate
Ethyl ester ofp-hydroxybenzoic acid
Einecs | 204-399-4
Chemical formula | C9H10O3
Molecular weight | 166,8
Assay | Content not less than 99,5 % after drying for two hours at 80oC
Description | Almost odourless, small, colourless crystals or a white, crystalline powder
Identification |
A.Melting range | A. | Melting range | 115oC to 118oC
A. | Melting range
B.Positive test forp-hydroxybenzoate | B. | Positive test forp-hydroxybenzoate | Melting range ofp-hydroxybenzoic acid isolated by acidification and not recrystallised: 213oC to 217oC, after vacuum drying in a sulphuric acid desiccator
B. | Positive test forp-hydroxybenzoate
C.Positive test for alcohol | C. | Positive test for alcohol |
C. | Positive test for alcohol
Purity |
Loss on drying | Not more than 0,5 % after drying for two hours at 80oC
Sulphated ash | Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed asp-hydroxybenzoic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 215 SODIUM ETHYL p-HYDROXYBENZOATE
Definition |
Chemical name | Sodium ethylp-hydroxybenzoate
Sodium compound of the ethyl ester ofp-hydroxybenzoic acid
Einecs | 252-487-6
Chemical formula | C9H9O3Na
Molecular weight | 188,8
Assay | Content of ethylester ofp-hydroxybenzoic acid not less than 83 % on the anhydrous basis
Description | White, crystalline hygroscopic powder
Identification |
A.Melting range | A. | Melting range | 115oC to 118oC, after vacuum drying in a sulphuric acid desiccator
A. | Melting range
B.Positive test forp-hydroxybenzoate | B. | Positive test forp-hydroxybenzoate | Melting range ofp-hydroxybenzoic acid derived from the sample is 213oC to 217oC
B. | Positive test forp-hydroxybenzoate
C.Positive test for sodium | C. | Positive test for sodium |
C. | Positive test for sodium
D.pH of a 0,1 % aqueous solution must be between 9,9 and 10,3 | D. | pH of a 0,1 % aqueous solution must be between 9,9 and 10,3 |
D. | pH of a 0,1 % aqueous solution must be between 9,9 and 10,3
Purity |
Loss on drying | Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator
Sulphated ash | 37 to 39 %
p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed asp-hydroxybenzoic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 218 METHYL p-HYDROXYBENZOATE
Synonyms | Methylparaben
Methyl-p-oxybenzoate
Definition |
Chemical name | Methylp-hydroxybenzoate
Methyl ester ofp-hydroxybenzoic acid
Einecs | 243-171-5
Chemical formula | C8H8O3
Molecular weight | 152,15
Assay | Content not less than 99 % after drying for two hours at 80oC
Description | Almost odourless, small colourless crystals or white crystalline powder
Identification |
A.Melting range | A. | Melting range | 125oC to 128oC
A. | Melting range
B.Positive test forp-hydroxybenzoate | B. | Positive test forp-hydroxybenzoate | Melting range ofp-hydroxybenzoic acid derived from the sample is 213oC to 217oC after drying for two hours at 80oC
B. | Positive test forp-hydroxybenzoate
Purity |
Loss on drying | Not more than 0,5 %, after drying for two hours at 80oC
Sulphated ash | Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed asp-hydroxybenzoic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 219 SODIUM METHYL p-HYDROXYBENZOATE
Definition |
Chemical name | Sodium methylp-hydroxybenzoate
Sodium compound of the methylester ofp-hydroxybenzoic acid
Chemical formula | C8H7O3Na
Molecular weight | 174,15
Assay | Content not less than 99,5 % on the anhydrous basis
Description | White, hygroscopic powder
Identification |
A.The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC | A. | The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC |
A. | The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80oC for two hours, have a melting range of 125oC to 128oC
B.Positive test for sodium | B. | Positive test for sodium |
B. | Positive test for sodium
C.pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3 | C. | pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3 |
C. | pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
Purity |
Water content | Not more than 5 % (Karl Fischer method)
Sulphated ash | 40 % to 44,5 % on the anhydrous basis
p-Hydroxybenzoic acid and salicylic acid | Not more than 0,35 % expressed asp-hydroxybenzoic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 220 SULPHUR DIOXIDE
Definition |
Chemical name | Sulphur dioxide
Sulphurous acid anhydride
Einecs | 231-195-2
Chemical formula | SO2
Molecular weight | 64,07
Assay | Content not less than 99 %
Description | Colourless, non-flammable gas with strong pungent suffocating odour
Identification |
A.Positive test for sulphurous substances | A. | Positive test for sulphurous substances |
A. | Positive test for sulphurous substances
Purity |
Water content | Not more than 0,05 %
Non-volatile residue | Not more than 0,01 %
Sulphur trioxide | Not more than 0,1 %
Selenium | Not more than 10 mg/kg
Other gases not normally present in the air | No trace
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 221 SODIUM SULPHITE
Definition |
Chemical name | Sodium sulphite (anhydrous or heptahydrate)
Einecs | 231-821-4
Chemical formula | Anhydrous: | Na2SO3
Heptahydrate: | Na2SO37H2O
Molecular weight | Anhydrous: | 126,04
Heptahydrate: | 252,16
Assay | Anhydrous: | Not less than 95 % of Na2SO3and not less than 48 % of SO2
Heptahydrate: | Not less than 48 % of Na2SO3and not less than 24 % of SO2
Description | White crystalline powder or colourless crystals
Identification |
A.Positive tests for sulphite and for sodium | A. | Positive tests for sulphite and for sodium |
A. | Positive tests for sulphite and for sodium
B.pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5 | B. | pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5 |
B. | pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
Purity |
Thiosulphate | Not more than 0,1 % based on the SO2content
Iron | Not more than 50 mg/kg based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 222 SODIUM BISULPHITE
Definition |
Chemical name | Sodium bisulphite
Sodium hydrogen sulphite
Einecs | 231-921-4
Chemical formula | NaHSO3in aqueous solution
Molecular weight | 104,06
Assay | Content not less than 32 % w/w NaHSO3
Description | A clear, colourless to yellow solution
Identification |
A.Positive tests for sulphite and for sodium | A. | Positive tests for sulphite and for sodium |
A. | Positive tests for sulphite and for sodium
B.pH of a 10 % aqueous solution between 2,5 and 5,5 | B. | pH of a 10 % aqueous solution between 2,5 and 5,5 |
B. | pH of a 10 % aqueous solution between 2,5 and 5,5
Purity |
Iron | Not more than 50 mg/kg of Na2SO3based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 223 SODIUM METABISULPHITE
Synonyms | Pyrosulphite
Sodium pyrosulphite
Definition |
Chemical name | Sodium disulphite
Disodium pentaoxodisulphate
Einecs | 231-673-0
Chemical formula | Na2S2O5
Molecular weight | 190,11
Assay | Content not less than 95 % Na2S2O5and not less than 64 % of SO2
Description | White crystals or crystalline powder
Identification |
A.Positive tests for sulphite and for sodium | A. | Positive tests for sulphite and for sodium |
A. | Positive tests for sulphite and for sodium
B.pH of a 10 % aqueous solution between 4,0 and 5,5 | B. | pH of a 10 % aqueous solution between 4,0 and 5,5 |
B. | pH of a 10 % aqueous solution between 4,0 and 5,5
Purity |
Thiosulphate | Not more than 0,1 % based on the SO2content
Iron | Not more than 50 mg/kg based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 224 POTASSIUM METABISULPHITE
Synonyms | Potassium pyrosulphite
Definition |
Chemical name | Potassium disulphite
Potassium pentaoxo disulphate
Einecs | 240-795-3
Chemical formula | K2S2O5
Molecular weight | 222,33
Assay | Content not less than 90 % of K2S2O5and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate
Description | Colourless crystals or white crystalline powder
Identification |
A.Positive tests for sulphite and for potassium | A. | Positive tests for sulphite and for potassium |
A. | Positive tests for sulphite and for potassium
Purity |
Thiosulphate | Not more than 0,1 % based on the SO2content
Iron | Not more than 50 mg/kg based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 226 CALCIUM SULPHITE
Definition |
Chemical name | Calcium sulphite
Einecs | 218-235-4
Chemical formula | CaSO3·2H2O
Molecular weight | 156,17
Assay | Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2
Description | White crystals or white crystalline powder
Identification |
A.Positive tests for sulphite and for calcium | A. | Positive tests for sulphite and for calcium |
A. | Positive tests for sulphite and for calcium
Purity |
Iron | Not more than 50 mg/kg based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 227 CALCIUM BISULPHITE
Definition |
Chemical name | Calcium bisulphite
Calcium hydrogen sulphite
Einecs | 237-423-7
Chemical formula | Ca(HSO3)2
Molecular weight | 202,22
Assay | 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]
Description | Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
Identification |
A.Positive tests for sulphite and for calcium | A. | Positive tests for sulphite and for calcium |
A. | Positive tests for sulphite and for calcium
Purity |
Iron | Not more than 50 mg/kg based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 228 POTASSIUM BISULPHITE
Definition |
Chemical name | Potassium bisulphite
Potassium hydrogen sulphite
Einecs | 231-870-1
Chemical formula | KHSO3in aqueous solution
Molecular weight | 120,17
Assay | Content not less than 280 g KHSO3per litre (or 150 g SO2per litre)
Description | Clear colourless aqueous solution
Identification |
A.Positive tests for sulphite and for potassium | A. | Positive tests for sulphite and for potassium |
A. | Positive tests for sulphite and for potassium
Purity |
Iron | Not more than 50 mg/kg based on the SO2content
Selenium | Not more than 10 mg/kg based on the SO2content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 230 BIPHENYL
Synonyms | Diphenyl
Definition |
Chemical name | 1,1′-biphenyl
Phenylbenzene
Einecs | 202-163-5
Chemical formula | C12H10
Molecular weight | 154,20
Assay | Content not less than 99,8 %
Description | White or pale yellow to amber crystalline solid having a characteristic odour
Identification |
A.Melting range | A. | Melting range | 68,5oC to 70,5oC
A. | Melting range
B.Distillation range | B. | Distillation range | It distils completely within a 2,5oC range between 252,5oC and 257,5oC
B. | Distillation range
Purity |
Benzene | Not more than 10 mg/kg
Aromatic amines | Not more than 2 mg/kg (as aniline)
Phenol derivatives | Not more than 5 mg/kg (as phenol)
Readily carbonisable substances | Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Terphenyl and higher polyphenyl derivatives | Not more than 0,2 %
Polycyclic aromatic hydrocarbons | Absent
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 231 ORTHOPHENYLPHENOL
Synonyms | Orthoxenol
Definition |
Chemical name | (1,1′-Biphenyl)-2-ol
2-Hydroxydiphenyl
o-Hydroxydiphenyl
Einecs | 201-993-5
Chemical formula | C12H10O
Molecular weight | 170,20
Assay | Content not less than 99 %
Description | White or slightly yellowish crystalline powder
Identification |
A.Melting range | A. | Melting range | 56oC to 58oC
A. | Melting range
B.Positive test for phenolate | B. | Positive test for phenolate | An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution
B. | Positive test for phenolate
Purity |
Sulphated ash | Not more than 0,05 %
Diphenyl ether | Not more than 0,3 %
p-Phenylphenol | Not more than 0,1 %
1-Naphthol | Not more than 0,01 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 232 SODIUM ORTHOPHENYLPHENOL
Synonyms | Sodium orthophenylphenate
Sodium salt ofo-phenylphenol
Definition |
Chemical name | Sodium orthophenylphenol
Einecs | 205-055-6
Chemical formula | C12H9ONa· 4H2O
Molecular weight | 264,26
Assay | Content not less than 97 % of C12H9ONa· 4H2O
Description | White or slightly yellowish crystalline powder
Identification |
A.Positive tests for phenolate and for sodium | A. | Positive tests for phenolate and for sodium |
A. | Positive tests for phenolate and for sodium
B.Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator | B. | Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator |
B. | Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56oC to 58oC after drying in a sulphuric acid desiccator
C.pH of a 2 % aqueous solution must be between 11,1 and 11,8 | C. | pH of a 2 % aqueous solution must be between 11,1 and 11,8 |
C. | pH of a 2 % aqueous solution must be between 11,1 and 11,8
Purity |
Diphenylether | Not more than 0,3 %
p-phenylphenol | Not more than 0,1 %
1-naphthol | Not more than 0,01 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 233 THIABENDAZOLE
Definition |
Chemical name | 4-(2-benzimidazolyl)thiazole
2-(4-thiazolyl)-1H-benzimidazole
Einecs | 205-725-8
Chemical formula | C10H7N3S
Molecular weight | 201,26
Assay | Content not less than 98 % on the anhydrous basis
Description | White, or almost white, odourless powder
Identification |
A.Melting range | A. | Melting range | 296oC to 303oC
A. | Melting range
B.Spectrometry | B. | Spectrometry | Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm
B. | Spectrometry
at 302 nm ± 2 nm: approximately 1 230
at 258 nm ± 2 nm: approximately 200
at 243 nm ± 2 nm: approximately 620
Ratio of absorption 243 nm/302 nm = 0,47 to 0,53
Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
Purity |
Water content | Not more than 0,5 % (Karl Fischer method)
Sulphated ash | Not more than 0,2 %
Selenium | Not more than 3 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 234 NISIN
Definition | Nisin consists of several closely related polypeptides produced by natural strains ofStreptococcus lactis, Lancefield group N
Einecs | 215-807-5
Chemical formula | C143H230N42O37S7
Molecular weight | 3 354 ,12
Assay | Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %
Description | White powder
Purity |
Loss on drying | Not more than 3 % when dried to constant weight at 102oC to 103oC
Arsenic | Not more than 1 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 235 NATAMYCIN
Synonyms | Pimaricin
Definition | Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains ofStreptomyces natalensisor ofStreptococcus lactis
Einecs | 231-683-5
Chemical formula | C33H47O13N
Molecular weight | 665,74
Assay | Content not less than 95 % on the anhydrous basis
Description | White to creamy-white crystalline powder
Identification |
A.Colour reactions | A. | Colour reactions | On adding a few crystals of natamycin on a spot plate, to a drop of:—concentrated hydrochloric acid, a blue colour develops,—concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes | — | concentrated hydrochloric acid, a blue colour develops, | — | concentrated phosphoric acid, a green colour develops,
A. | Colour reactions
— | concentrated hydrochloric acid, a blue colour develops,
— | concentrated phosphoric acid, a green colour develops,
B.Spectrometry | B. | Spectrometry | A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
B. | Spectrometry
C.pH | C. | pH | 5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
C. | pH
D.Specific rotation | D. | Specific rotation | [α]D20= + 250oto + 295o(a 1 % w/v solution in glacial acetic acid, at 20oC and calculated with reference to the dried material)
D. | Specific rotation
Purity |
Loss on drying | Not more than 8 % (over P2O5, in vacuum at 60oC to constant weight)
Sulphated ash | Not more than 0,5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Microbiological criteria: total viable count | Not more than 100/gE 239 HEXAMETHYLENE TETRAMINE
Synonyms | Hexamine
Methenamine
Definition |
Chemical name | 1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
Einecs | 202-905-8
Chemical formula | C6H12N4
Molecular weight | 140,19
Assay | Content not less than 99 % on the anhydrous basis
Description | Colourless or white crystalline powder
Identification |
A.Positive tests for formaldehyde and for ammonia | A. | Positive tests for formaldehyde and for ammonia |
A. | Positive tests for formaldehyde and for ammonia
B.Sublimation point approximately 260oC | B. | Sublimation point approximately 260oC |
B. | Sublimation point approximately 260oC
Purity |
Loss on drying | Not more than 0,5 % after drying at 105oC in vacuum over P2O5for two hours
Sulphated ash | Not more than 0,05 %
Sulphates | Not more than 0,005 % expressed as SO4
Chlorides | Not more than 0,005 % expressed as Cl
Ammonium salts | Not detectable
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 242 DIMETHYL DICARBONATE
Synonyms | DMDC
Dimethyl pyrocarbonate
Definition |
Chemical name | Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Einecs | 224-859-8
Chemical formula | C4H6O5
Molecular weight | 134,09
Assay | Content not less than 99,8 %
Description | Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion
Identification |
A.Decomposition | A. | Decomposition | After dilution positive tests for CO2and methanol
A. | Decomposition
B.Melting point | B. | Melting point | 17oC
B. | Melting point
Boiling point | 172oC with decomposition
C.Density 20oC | C. | Density 20oC | Approximately 1,25 g/cm3
C. | Density 20oC
D.Infrared spectrum | D. | Infrared spectrum | Maxima at 1 156 and 1 832 cm-1
D. | Infrared spectrum
Purity |
Dimethyl carbonate | Not more than 0,2 %
Chlorine, total | Not more than 3 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 249 POTASSIUM NITRITE
Definition |
Chemical name | Potassium nitrite
Einecs | 231-832-4
Chemical formula | KNO2
Molecular weight | 85,11
Assay | Content not less than 95 % on the anhydrous basis(5)
Description | White or slightly yellow, deliquescent granules
Identification |
A.Positive tests for nitrite and for potassium | A. | Positive tests for nitrite and for potassium |
A. | Positive tests for nitrite and for potassium
B.pH of a 5 % solution: | B. | pH of a 5 % solution: | Not less than 6,0 and not more than 9,0
B. | pH of a 5 % solution:
Purity |
Loss on drying | Not more than 3 % after drying for four hours over silica gel
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 250 SODIUM NITRITE
Definition |
Chemical name | Sodium nitrite
Einecs | 231-555-9
Chemical formula | NaNO2
Molecular weight | 69,00
Assay | Content not less than 97 % on the anhydrous basis(6)
Description | White crystalline powder or yellowish lumps
Identification |
A.Positive tests for nitrite and for sodium | A. | Positive tests for nitrite and for sodium |
A. | Positive tests for nitrite and for sodium
Purity |
Loss on drying | Not more than 0,25 % after drying over silica gel for four hours
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 251 SODIUM NITRATE1. SOLID SODIUM NITRATE
Synonyms | Chile saltpetre
Cubic or soda nitre
Definition |
Chemical name | Sodium nitrate
Einecs | 231-554-3
Chemical formula | NaNO3
Molecular weight | 85,00
Assay | Content not less than 99 % after drying
Description | White crystalline, slightly hygroscopic powder
Identification |
A.Positive tests for nitrate and for sodium | A. | Positive tests for nitrate and for sodium |
A. | Positive tests for nitrate and for sodium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Not less than 5,5 and more than 8,3
B. | pH of a 5 % solution
Purity |
Loss on drying | Not more than 2 % after drying at 105oC for four hours
Nitrites | Not more than 30 mg/kg expressed as NaNO2
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 251 SODIUM NITRATE2. LIQUID SODIUM NITRATE
Definition | Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
Chemical name | Sodium nitrate
Einecs | 231-554-3
Chemical formula | NaNO3
Molecular weight | 85,00
Assay | Content between 33,5 % and 40,0 % of NaNO3
Description | Clear colourless liquid
Identification |
A.Positive tests for nitrate and for sodium | A. | Positive tests for nitrate and for sodium |
A. | Positive tests for nitrate and for sodium
B.pH | B. | pH | Not less than 1,5 and not more than 3,5
B. | pH
Purity |
Free nitric acid | Not more than 0,01 %
Nitrites | Not more than 10 mg/kg expressed as NaNO2
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 0,3 mg/kg
This specification refers to a 35 % aqueous solution | E 252 POTASSIUM NITRATE
Synonyms | Chile saltpetreCubic or soda nitre
Definition |
Chemical name | Potassium nitrate
Einecs | 231-818-8
Chemical formula | KNO3
Molecular weight | 101,11
Assay | Content not less than 99 % on the anhydrous basis
Description | White crystalline powder or transparent prisms having a cooling, saline, pungent taste
Identification |
A.Positive tests for nitrate and for potassium | A. | Positive tests for nitrate and for potassium |
A. | Positive tests for nitrate and for potassium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Not less than 4,5 and not more than 8,5
B. | pH of a 5 % solution
Purity |
Loss on drying | Not more than 1 % after drying at 105oC for four hours
Nitrites | Not more than 20 mg/kg expressed as KNO2
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 260 ACETIC ACID
Definition |
Chemical name | Acetic acid
Ethanoic acid
Einecs | 200-580-7
Chemical formula | C2H4O2
Molecular weight | 60,05
Assay | Content not less than 99,8 %
Description | Clear, colourless liquid having a pungent, characteristic odour
Identification |
A.Boiling point | A. | Boiling point | 118oC at 760 mm pressure (of mercury)
A. | Boiling point
B.Specific gravity | B. | Specific gravity | About 1,049
B. | Specific gravity
C.A one in three solution gives positive tests for acetate | C. | A one in three solution gives positive tests for acetate |
C. | A one in three solution gives positive tests for acetate
D.Solidification point | D. | Solidification point | Not lower than 14,5oC
D. | Solidification point
Purity |
Non-volatile residue | Not more than 100 mg/kg
Formic acid, formates and other oxidisable substances | Not more than 1 000 mg/kg expressed as formic acid
Readily oxidisable substances | Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes
Arsenic | Not more than 1 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 261 POTASSIUM ACETATE
Definition |
Chemical name | Potassium acetate
Einecs | 204-822-2
Chemical formula | C2H3O2K
Molecular weight | 98,14
Assay | Content not less than 99 % on the anhydrous basis
Description | Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
Identification |
A.pH of a 5 % aqueous solution | A. | pH of a 5 % aqueous solution | Not less than 7,5 and not more than 9,0
A. | pH of a 5 % aqueous solution
B.Positive tests for acetate and for potassium | B. | Positive tests for acetate and for potassium |
B. | Positive tests for acetate and for potassium
Purity |
Loss on drying | Not more than 8 % after drying at 150oC for two hours
Formic acid, formates and other oxidisable substances | Not more than 1 000 mg/kg expressed as formic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 262 (i) SODIUM ACETATE
Definition |
Chemical name | Sodium acetate
Einecs | 204-823-8
Chemical formula | C2H3NaO2·nH2O (n = 0 or 3)
Molecular weight | Anhydrous: | 82,03
Trihydrate: | 136,08
Assay | Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis
Description | Anhydrous: | White, odourless, granular, hygroscopic powder
Trihydrate: | Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
Identification |
A.pH of a 1 % aqueous solution | A. | pH of a 1 % aqueous solution | Not less than 8,0 and not more than 9,5
A. | pH of a 1 % aqueous solution
B.Positive tests for acetate and for sodium | B. | Positive tests for acetate and for sodium |
B. | Positive tests for acetate and for sodium
Purity |
Loss on drying | Anhydrous: | Not more than 2 % (120oC, 4 hours)
Trihydrate: | Between 36 and 42 % (120oC, 4 hours)
Formic acid, formates and other oxidisable substances | Not more than 1 000 mg/kg expressed as formic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 262 (ii) SODIUM DIACETATE
Definition | Sodium diacetate is a molecular compound of sodium acetate and acetic acid
Chemical name | Sodium hydrogen diacetate
Einecs | 204-814-9
Chemical formula | C4H7NaO4·nH2O (n = 0 or 3)
Molecular weight | 142,09 (anhydrous)
Assay | Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
Description | White, hygroscopic crystalline solid with an acetic odour
Identification |
A.pH of a 10 % aqueous solution | A. | pH of a 10 % aqueous solution | Not less than 4,5 and not more than 5,0
A. | pH of a 10 % aqueous solution
B.Positive tests for acetate and for sodium | B. | Positive tests for acetate and for sodium |
B. | Positive tests for acetate and for sodium
Purity |
Water content | Not more than 2 % (Karl Fischer method)
Formic acid, formates and other oxidisable substances | Not more than 1 000 mg/kg expressed as formic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 263 CALCIUM ACETATE
Definition |
Chemical name | Calcium acetate
Einecs | 200-540-9
Chemical formula | Anhydrous: | C4H6O4Ca
Monohydrate: | C4H6O4Ca· H2O
Molecular weight | Anhydrous: | 158,17
Monohydrate: | 176,18
Assay | Content not less than 98 % on the anhydrous basis
Description | Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
Identification |
A.pH of a 10 % aqueous solution | A. | pH of a 10 % aqueous solution | Not less than 6,0 and not more than 9,0
A. | pH of a 10 % aqueous solution
B.Positive tests for acetate and for calcium | B. | Positive tests for acetate and for calcium |
B. | Positive tests for acetate and for calcium
Purity |
Loss on drying | Not more than 11 % after drying (155oC to constant weight, for the monohydrate)
Water insoluble matter | Not more than 0,3 %
Formic acid, formates and other oxidisable substances | Not more than 1 000 mg/kg expressed as formic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 270 LACTIC ACID
Definition |
Chemical name | Lactic acid
2-Hydroxypropionic acid
1-Hydroxyethane-1-carboxylic acid
Einecs | 200-018-0
Chemical formula | C3H6O3
Molecular weight | 90,08
Assay | Content not less than 76 % and not more than 84 %
Description | Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically
Note:Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid |
Identification |
A.Positive test for lactate | A. | Positive test for lactate |
A. | Positive test for lactate
Purity |
Sulphated ash | Not more than 0,1 %
Chloride | Not more than 0,2 %
Sulphate | Not more than 0,25 %
Iron | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Note:This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content | E 280 PROPIONIC ACID
Definition |
Chemical name | Propionic acid
Propanoic acid
Einecs | 201-176-3
Chemical formula | C3H6O2
Molecular weight | 74,08
Assay | Content not less than 99,5 %
Description | Colourless or slightly yellowish, oily liquid with a slightly pungent odour
Indentification |
A.Melting point | A. | Melting point | – 22oC
A. | Melting point
B.Distillation range | B. | Distillation range | 138,5oC to 142,5oC
B. | Distillation range
Purity |
Non-volatile residue | Not more than 0,01 % when dried at 140oC to constant weight
Aldehydes | Not more than 0,1 % expressed as formaldehyde
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 281 SODIUM PROPIONATE
Definition |
Chemical name | Sodium propionate
Sodium propanoate
Einecs | 205-290-4
Chemical formula | C3H5O2Na
Molecular weight | 96,06
Assay | Content not less than 99 % after drying for two hours at 105oC
Description | White crystalline hygroscopic powder, or a fine white powder
Identification |
A.Positive tests for propionate and for sodium | A. | Positive tests for propionate and for sodium |
A. | Positive tests for propionate and for sodium
B.pH of a 10 % aqueous solution | B. | pH of a 10 % aqueous solution | Not less than 7,5 and not more than 10,5
B. | pH of a 10 % aqueous solution
Purity |
Loss on drying | Not more than 4 % determined by drying for two hours at 105oC
Water insolubles | Not more than 0,1 %
Iron | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 282 CALCIUM PROPIONATE
Definition |
Chemical name | Calcium propionate
Einecs | 223-795-8
Chemical formula | C6H10O4Ca
Molecular weight | 186,22
Assay | Content not less than 99 %, after drying for two hours at 105oC
Description | White crystalline powder
Identification |
A.Positive tests for propionate and for calcium | A. | Positive tests for propionate and for calcium |
A. | Positive tests for propionate and for calcium
B.pH of a 10 % aqueous solution | B. | pH of a 10 % aqueous solution | Between 6,0 and 9,0
B. | pH of a 10 % aqueous solution
Purity |
Loss on drying | Not more than 4 %, determined by drying for two hours at 105oC
Water insolubles | Not more than 0,3 %
Iron | Not more than 50 mg/kg
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 283 POTASSIUM PROPIONATE
Definition |
Chemical name | Potassium propionate
Potassium propanoate
Einecs | 206-323-5
Chemical formula | C3H5KO2
Molecular weight | 112,17
Assay | Content not less than 99 % after drying for two hours at 105oC
Description | White crystalline powder
Identification |
A.Positive tests for propionate and for potassium | A. | Positive tests for propionate and for potassium |
A. | Positive tests for propionate and for potassium
Purity |
Loss on drying | Not more than 4 %, determined by drying for two hours at 105oC
Water-insoluble substances | Not more than 0,3 %
Iron | Not more than 30 mg/kg
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 284 BORIC ACID
Synonyms | Boracic acid
Orthoboric acid
Borofax
Definition |
Einecs | 233-139-2
Chemical formula | H3BO3
Molecular weight | 61,84
Assay | Content not less than 99,5 %
Description | Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite
Identification |
A.Melting point | A. | Melting point | At approximately 171oC
A. | Melting point
B.Burns with a nice green flame | B. | Burns with a nice green flame |
B. | Burns with a nice green flame
C.pH of a 3,3 % aqueous solution | C. | pH of a 3,3 % aqueous solution | Between 3,8 and 4,8
C. | pH of a 3,3 % aqueous solution
Purity |
Peroxides | No colour develops with added KI-solution
Arsenic | Not more than 1 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 285 SODIUM TETRABORATE (BORAX)
Synonyms | Sodium borate
Definition |
Chemical name | Sodium tetraborate
Sodium biborate
Sodium pyroborate
Anhydrous tetraborate
Einecs | 215-540-4
Chemical formula | Na2B4O7
Na2B4O7·10H2O
Molecular weight | 201,27
Description | Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
Identification |
A.Melting range | A. | Melting range | Between 171oC and 175oC with decomposition
A. | Melting range
Purity |
Peroxides | No colour develops with added KI-solution
Arsenic | Not more than 1 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 290 CARBON DIOXIDE
Synonyms | Carbonic acid gas
Dry ice (solid form)
Carbonic anhydride
Definition |
Chemical name | Carbon dioxide
Einecs | 204-696-9
Chemical formula | CO2
Molecular weight | 44,01
Assay | Content not less than 99 % v/v on the gaseous basis
Description | A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
Identification |
A.Precipitation (Precipitate formation) | A. | Precipitation (Precipitate formation) | When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid
A. | Precipitation (Precipitate formation)
Purity |
Acidity | 915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen phosphide and sulphide | 915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution
Carbon monoxide | Not more than 10 μl/l
Oil content | Not more than 0,1 mg/lE 296 MALIC ACID
Synonyms | DL-Malic acid, pomalous acid
Definition |
Chemical name | DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
Einecs | 230-022-8
Chemical formula | C4H6O5
Molecular weight | 134,09
Assay | Content not less than 99,0 %
Description | White or nearly white crystalline powder or granules
Identification |
A.Melting range between 127oC and 132oC | A. | Melting range between 127oC and 132oC |
A. | Melting range between 127oC and 132oC
B.Positive test for malate | B. | Positive test for malate |
B. | Positive test for malate
C.Solutions of this substance are optically inactive in all concentrations | C. | Solutions of this substance are optically inactive in all concentrations |
C. | Solutions of this substance are optically inactive in all concentrations
Purity |
Sulphated ash | Not more than 0,1 %
Fumaric acid | Not more than 1,0 %
Maleic acid | Not more than 0,05 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 297 FUMARIC ACID
Definition |
Chemical name | Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
Einecs | 203-743-0
Chemical formula | C4H4O4
Molecular weight | 116,07
Assay | Content not less than 99,0 % on the anhydrous basis
Description | White crystalline powder or granules
Identification |
A.Melting range | A. | Melting range | 286oC-302oC (closed capillary, rapid heating)
A. | Melting range
B.Positive tests for double bonds and for 1,2-dicarboxylic acid | B. | Positive tests for double bonds and for 1,2-dicarboxylic acid |
B. | Positive tests for double bonds and for 1,2-dicarboxylic acid
C.pH of a 0,05 % solution at 25oC | C. | pH of a 0,05 % solution at 25oC | 3,0 -3,2
C. | pH of a 0,05 % solution at 25oC
Purity |
Loss on drying | Not more than 0,5 % (120oC, 4h)
Sulphated ash | Not more than 0,1 %
Maleic acid | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 300 ASCORBIC ACID
Definition |
Chemical name | L-ascorbic acid
Ascorbic acid
2,3-Didehydro-L-threo-hexono-1,4-lactone
3-Keto-L-gulofuranolactone
Einecs | 200-066-2
Chemical formula | C6H8O6
Molecular weight | 176,13
Assay | Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6
Description | White to pale yellow, odourless crystalline solid
Identification |
A.Melting range | A. | Melting range | Between 189oC and 193oC with decomposition
A. | Melting range
B.Positive tests for ascorbic acid | B. | Positive tests for ascorbic acid |
B. | Positive tests for ascorbic acid
Purity |
Loss on drying | Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Sulphated ash | Not more than 0,1 %
Specific rotation | [α]D20between +20,5oand +21,5o(10 % w/v aqueous solution)
pH of a 2 % aqueous solution | Between 2,4 and 2,8
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 301 SODIUM ASCORBATE
Definition |
Chemical name | Sodium ascorbate
Sodium L-ascorbate
2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate
3-Keto-L-gulofurano-lactone sodium enolate
Einecs | 205-126-1
Chemical formula | C6H7O6Na
Molecular weight | 198,11
Assay | Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na
Description | White or almost white, odourless crystalline solid which darkens on exposure to light
Identification |
A.Positive tests for ascorbate and for sodium | A. | Positive tests for ascorbate and for sodium |
A. | Positive tests for ascorbate and for sodium
Purity |
Loss on drying | Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation | [α]D20between + 103oand + 106o(10 % w/v aqueous solution)
pH of 10 % aqueous solution | Between 6,5 and 8,0
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 302 CALCIUM ASCORBATE
Definition |
Chemical name | Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs | 227-261-5
Chemical formula | C12H14O12Ca· 2H2O
Molecular weight | 426,35
Assay | Content not less than 98 % on a volatile matter-free basis
Description | White to slightly pale greyish-yellow odourless crystalline powder
Identification |
A.Positive tests for ascorbate and for calcium | A. | Positive tests for ascorbate and for calcium |
A. | Positive tests for ascorbate and for calcium
Purity |
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Specific rotation | [α]D20between + 95oand + 97o(5 % w/v aqueous solution)
pH of 10 % aqueous solution | Between 6,0 and 7,5
Volatile matter | Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 304 (i) ASCORBYL PALMITATE
Definition |
Chemical name | Ascorbyl palmitate
L-ascorbyl palmitate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate
6-palmitoyl-3-keto-L-gulofuranolactone
Einecs | 205-305-4
Chemical formula | C22H38O7
Molecular weight | 414,55
Assay | Content not less than 98 % on the dried basis
Description | White or yellowish-white solid with a citrus-like odour
Identification |
A.Melting range | A. | Melting range | Between 107oC and 117oC
A. | Melting range
Purity |
Loss on drying | Not more than 2,0 % after drying in a vacuum oven at 56oC and 60oC for one hour
Sulphated ash | Not more than 0,1 %
Specific rotation | [α]D20between + 21oand + 24o(5 % w/v in methanol solution)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 304 (ii) ASCORBYL STEARATE
Definition |
Chemical name | Ascorbyl stearate
L-ascorbyl stearate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate
6-stearoyl-3-keto-L-gulofuranolactone
Einecs | 246-944-9
Chemical formula | C24H42O7
Molecular weight | 442,6
Assay | Content not less than 98 %
Description | White or yellowish, white solid with a citrus-like odour
Identification |
A.Melting point | A. | Melting point | About 116oC
A. | Melting point
Purity |
Loss on drying | Not more than 2,0 % after drying in a vacuum oven at 56oC to 60oC for one hour
Sulphated ash | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 306 TOCOPHEROL-RICH EXTRACT
Definition | Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols
Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols
Molecular weight | 430,71 (d-α-tocopherol)
Assay | Content not less than 34 % of total tocopherols
Description | Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form
Identification |
A.By suitable gas liquid chromatographic method | A. | By suitable gas liquid chromatographic method |
A. | By suitable gas liquid chromatographic method
B.Solubility tests | B. | Solubility tests | Insoluble in water. Soluble in ethanol. Miscible in ether
B. | Solubility tests
Purity |
Sulphated ash | Not more than 0,1 %
Specific rotation | [α]D20not less than + 20o
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 307 ALPHA-TOCOPHEROL
Synonyms | DL-α-Tocopherol
Definition |
Chemical name | DL-5,7,8-Trimethyltocol
DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs | 233-466-0
Chemical formula | C29H50O2
Molecular weight | 430,71
Assay | Content not less than 96 %
Description | Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light
Identification |
A.Solubility tests | A. | Solubility tests | Insoluble in water, freely soluble in ethanol, miscible in ether
A. | Solubility tests
B.Spectro-photometry | B. | Spectro-photometry | In absolute ethanol the maximum absorption is about 292 nm
B. | Spectro-photometry
Purity |
Refractive index | nD201,503 -1,507
Specific absorptionin ethanol | (292 nm) 72-76(0,01 g in 200 ml of absolute ethanol)
Sulphated ash | Not more than 0,1 %
Specific rotation | [α]D250o±0,05o(1 in 10 solution in chloroform)
Lead | Not more than 2 mg/kgE 308 GAMMA-TOCOPHEROL
Synonyms | dl-γ-Tocopherol
Definition |
Chemical name | 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs | 231-523-4
Chemical formula | C28H48O2
Molecular weight | 416,69
Assay | Content not less than 97 %
Description | Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light
Identification |
A.Spectrometry | A. | Spectrometry | Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
A. | Spectrometry
Purity |
Specific absorptionin ethanol | (298 nm) between 91 and 97
(257 nm) between 5,0 and 8,0
Refractive index | 1,503 -1,507
Sulphated ash | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 309 DELTA-TOCOPHEROL
Definition |
Chemical name | 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs | 204-299-0
Chemical formula | C27H46O2
Molecular weight | 402,7
Assay | Content not less than 97 %
Description | Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light
Identification |
A.Spectrometry | A. | Spectrometry | Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
A. | Spectrometry
Purity |
Specific absorptionin ethanol | (298 nm) between 89 and 95
(257 nm) between 3,0 and 6,0
Refractive index | 1,500 -1,504
Sulphated ash | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 310 PROPYL GALLATE
Definition |
Chemical name | Propyl gallate
Propyl ester of gallic acid
n-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs | 204-498-2
Chemical formula | C10H12O5
Molecular weight | 212,20
Assay | Content not less than 98 % on the anhydrous basis
Description | White to creamy-white, crystalline, odourless solid
Identification |
A.Solubility tests | A. | Solubility tests | Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
A. | Solubility tests
B.Melting range | B. | Melting range | Between 146oC and 150oC after drying at 110oC for four hours
B. | Melting range
Purity |
Loss on drying | Not more than 1,0 % (110oC, four hours)
Sulphated ash | Not more than 0,1 %
Free acid | Not more than 0,5 % (as gallic acid)
Chlorinated organic compound | Not more than 100 mg/kg (as C1)
Specific absorptionin ethanol | (275 nm) not less than 485 and not more than 520
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 311 OCTYL GALLATE
Definition |
Chemical name | Octyl gallate
Octyl ester of gallic acid
n-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs | 213-853-0
Chemical formula | C15H22O5
Molecular weight | 282,34
Assay | Content not less than 98 % after drying at 90oC for six hours
Description | White to creamy-white odourless solid
Identification |
A.Solubility tests | A. | Solubility tests | Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
A. | Solubility tests
B.Melting range | B. | Melting range | Between 99oC and 102oC after drying at 90oC for six hours
B. | Melting range
Purity |
Loss on drying | Not more than 0,5 % (90oC, six hours)
Sulphated ash | Not more than 0,05 %
Free acid | Not more than 0,5 % (as gallic acid)
Chlorinated organic compound | Not more than 100 mg/kg (as C1)
Specific absorptionin ethanol | (275 nm) not less than 375 and not more than 390
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 312 DODECYL GALLATE
Synonyms | Lauryl gallate
Definition |
Chemical name | Dodecyl gallate
n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid
Dodecyl ester of gallic acid
Einecs | 214-620-6
Chemical formula | C19H30O5
Molecular weight | 338,45
Assay | Content not less than 98 % after drying at 90oC for six hours
Description | White or creamy-white odourless solid
Identification |
A.Solubility tests | A. | Solubility tests | Insoluble in water, freely soluble in ethanol and ether
A. | Solubility tests
B.Melting range | B. | Melting range | Between 95oC and 98oC after drying at 90oC for six hours
B. | Melting range
Purity |
Loss on drying | Not more than 0,5 % (90oC, six hours)
Sulphated ash | Not more than 0,05 %
Free acid | Not more than 0,5 % (as gallic acid)
Chlorinated organic compound | Not more than 100 mg/kg (as Cl)
Specific absorptionin ethanol | (275 nm) not less than 300 and not more than 325
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 30 mg/kgE 315 ERYTHORBIC ACID
Synonyms | Isoascorbic acid
D-Araboascorbic acid
Definition |
Chemical name | D-Erythro-hex-2-enoic acid γ-lactone
Isoascorbic acid
D-Isoascorbic acid
Einecs | 201-928-0
Chemical formula | C6H8O6
Molecular weight | 176,13
Assay | Content not less than 98 % on the anhydrous basis
Description | White to slightly yellow crystalline solid which darkens gradually on exposure to light
Identification |
A.Melting range | A. | Melting range | About 164oC to 172oC with decomposition
A. | Melting range
B.Positive test for ascorbic acid/colour reaction | B. | Positive test for ascorbic acid/colour reaction |
B. | Positive test for ascorbic acid/colour reaction
Purity |
Loss on drying | Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours
Sulphated ash | Not more than 0,3 %
Specific rotation | [α]10 % (w/v) aqueous solution between -16,5oto -18,0o
Oxalate | To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
Lead | Not more than 2 mg/kgE 316 SODIUM ERYTHORBATE
Synonyms | Sodium isoascorbate
Definition |
Chemical name | Sodium isoascorbate
Sodium D-isoascorbic acid
Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone
3-keto-D-gulofurano-lactone sodium enolate monohydrate
Einecs | 228-973-9
Chemical formula | C6H7O6Na· H2O
Molecular weight | 216,13
Assay | Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis
Description | White crystalline solid
Identification |
A.Solubility tests | A. | Solubility tests | Freely soluble in water, very slightly soluble in ethanol
A. | Solubility tests
B.Positive test for ascorbic acid/colour reaction | B. | Positive test for ascorbic acid/colour reaction |
B. | Positive test for ascorbic acid/colour reaction
C.Positive test for sodium | C. | Positive test for sodium |
C. | Positive test for sodium
Purity |
Loss on drying | Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation | [α]10 % (w/v) aqueous solution between + 95oand + 98o
pH of a 10 % aqueous solution | 5,5 to 8,0
Oxalate | To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
Synonyms | TBHQ
Definition |
Chemical names | Tert-butyl-1,4-benzenediol
2-(1,1-Dimethylethyl)-1,4-benzenediol
Einecs | 217-752-2
Chemical formula | C10H14O2
Molecular weight | 166,22
Assay | Content not less than 99 % of C10H14O2
Description | White crystalline solid having a characteristic odour
Identification |
A.Solubility | A. | Solubility | Practically insoluble in water; soluble in ethanol
A. | Solubility
B.Melting point | B. | Melting point | Not less than 126,5oC
B. | Melting point
C.Phenolics | C. | Phenolics | Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced
C. | Phenolics
Purity |
Tertiary-Butyl-p-benzoquinone | Not more than 0,2 %
2,5-Di-tertiary-butyl hydroquinone | Not more than 0,2 %
Hydroxyquinone | Not more than 0,1 %
Toluene | Not more than 25 mg/kg
Lead | Not more than 2 mg/kgE 320 BUTYLATED HYDROXYANISOLE (BHA)
Synonyms | BHA
Definition |
Chemical names | 3-Tertiary-butyl-4-hydroxyanisole
A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
Einecs | 246-563-8
Chemical formula | C11H16O2
Formula weight | 180,25
Assay | Content not less than 98,5 % of C11H16O2and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
Description | White or slightly yellow crystals or waxy solid with a slight aromatic smell
Identification |
A.Solubility | A. | Solubility | Insoluble in water, freely soluble in ethanol
A. | Solubility
B.Melting range | B. | Melting range | Between 48 °C and 63 °C
B. | Melting range
C.Colour reaction | C. | Colour reaction | Passes test for phenol groups
C. | Colour reaction
Purity |
Sulphated ash | Not more than 0,05 % after calcination at 800 ± 25 °C
Phenolic impurities | Not more than 0,5 %
Specific absorption | (290 nm) not less than 190 and not more than 210
Specific absorption | (228 nm) not less than 326 and not more than 345
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 321 BUTYLATED HYDROXYTOLUENE (BHT)
Synonyms | BHT
Definition |
Chemical name | 2,6-Ditertiary-butyl-p-cresol
4-Methyl-2,6-ditertiarybutylphenol
Einecs | 204-881-4
Chemical formula | C15H24O
Molecular weight | 220,36
Assay | Content not less than 99 %
Description | White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour
Identification |
A.Solubility tests | A. | Solubility tests | Insoluble in water and propane- 1,2-diol
A. | Solubility tests
Freely soluble in ethanol
B.Melting point | B. | Melting point | At 70oC
B. | Melting point
C.Absorbance maximum | C. | Absorbance maximum | The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
C. | Absorbance maximum
Purity |
Sulphated ash | Not more than 0,005 %
Phenolic impurities | Not more than 0,5 %
Specific absorptionin ethanol | (278 nm) not less than 81 and not more than 88
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 322 LECITHINS
Synonyms | Phosphatides
Phospholipids
Definition | Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
Einecs | 232-307-2
Assay | —Lecithins: not less than 60,0 % of substances insoluble in acetone | — | Lecithins: not less than 60,0 % of substances insoluble in acetone
— | Lecithins: not less than 60,0 % of substances insoluble in acetone
—Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone | — | Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone
— | Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone
Description | —Lecithins: brown liquid or viscous semi-liquid or powder | — | Lecithins: brown liquid or viscous semi-liquid or powder
— | Lecithins: brown liquid or viscous semi-liquid or powder
—Hydrolysed lecithins: light brown to brown viscous liquid or paste | — | Hydrolysed lecithins: light brown to brown viscous liquid or paste
— | Hydrolysed lecithins: light brown to brown viscous liquid or paste
Identification |
A.Positive tests for choline, for phosphorus and fatty acids | A. | Positive tests for choline, for phosphorus and fatty acids |
A. | Positive tests for choline, for phosphorus and fatty acids
B.Test for hydrolysed lecithin | B. | Test for hydrolysed lecithin | To a 800 ml beaker add 500 ml of water (30oC-35oC). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
B. | Test for hydrolysed lecithin
Purity |
Loss on drying | Not more than 2,0 % determined by drying at 105oC for one hour
Toluene-insoluble matter | Not more than 0,3 %
Acid value | —Lecithins: not more than 35 mg of potassium hydroxide per gram | — | Lecithins: not more than 35 mg of potassium hydroxide per gram
— | Lecithins: not more than 35 mg of potassium hydroxide per gram
—Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram | — | Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
— | Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
Peroxide value | Equal to or less than 10
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 325 SODIUM LACTATE
Definition |
Chemical name | Sodium lactate
Sodium 2-hydroxypropanoate
Einecs | 200-772-0
Chemical formula | C3H5NaO3
Molecular weight | 112,06 (anhydrous)
Assay | Content not less than 57 % and not more than 66 %
Description | Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour
Identification |
A.Positive test for lactate | A. | Positive test for lactate |
A. | Positive test for lactate
B.Positive test for sodium | B. | Positive test for sodium |
B. | Positive test for sodium
Purity |
Acidity | Not more than 0,5 % after drying expressed as lactic acid
pH of a 20 % aqueous solution | 6,5 to 7,5
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Reducing substances | No reduction of Fehling’s solution
Note:This specification refers to a 60 % aqueous solution | E 326 POTASSIUM LACTATE
Definition |
Cheminal name | Potassium lactate
Potassium 2-hydroxypropanoate
Einecs | 213-631-3
Chemical formula | C3H5O3K
Molecular weight | 128,17 (anhydrous)
Assay | Content not less than 57 % and not more than 66 %
Description | Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour
Identification |
A.Ignition | A. | Ignition | Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
A. | Ignition
B.Colour reaction | B. | Colour reaction | Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
B. | Colour reaction
C.Positive tests for potassium and for lactate | C. | Positive tests for potassium and for lactate |
C. | Positive tests for potassium and for lactate
Purity |
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Acidity | Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required
Reducing substances | Potassium lactate solution shall not cause any reduction of Fehling’s solution
Note:This specification refers to a 60 % aqueous solution | E 327 CALCIUM LACTATE
Definition |
Chemical name | Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs | 212-406-7
Chemical formula | (C3H5O2)2Ca· nH2O (n = 0-5)
Molecular weight | 218,22 (anhydrous)
Assay | Content not less than 98 % on the anhydrous basis
Description | Almost odourless, white crystalline powder or granules
Identification |
A.Positive tests for lactate and for calcium | A. | Positive tests for lactate and for calcium |
A. | Positive tests for lactate and for calcium
B.Solubility tests | B. | Solubility tests | Soluble in water and practically insoluble in ethanol
B. | Solubility tests
Purity |
Loss on drying | Determined by drying at 120oC for four hours:
—anhydrous: not more than 3,0 % | — | anhydrous: not more than 3,0 %
— | anhydrous: not more than 3,0 %
—with 1 molecule of water: not more than 8,0 % | — | with 1 molecule of water: not more than 8,0 %
— | with 1 molecule of water: not more than 8,0 %
—with 3 molecules of water: not more than 20,0 % | — | with 3 molecules of water: not more than 20,0 %
— | with 3 molecules of water: not more than 20,0 %
—with 4,5 molecules of water: not more than 27,0 % | — | with 4,5 molecules of water: not more than 27,0 %
— | with 4,5 molecules of water: not more than 27,0 %
Acidity | Not more than 0,5 % of the dry matter expressed as lactic acid
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
pH of a 5 % solution | Between 6,0 and 8,0
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Reducing substances | No reduction of Fehling’s solutionE 330 CITRIC ACID
Definition |
Chemical name | Citric acid
2-Hydroxy-1,2,3-propanetricarboxylic acid
β-Hydroxytricarballytic acid
Einecs | 201-069-1
Chemical formula | (a)C6H8O7(anhydrous) | (a) | C6H8O7(anhydrous)
(a) | C6H8O7(anhydrous)
(b)C6H8O7·H2O (monohydrate) | (b) | C6H8O7·H2O (monohydrate)
(b) | C6H8O7·H2O (monohydrate)
Molecular weight | (a)192,13 (anhydrous) | (a) | 192,13 (anhydrous)
(a) | 192,13 (anhydrous)
(b)210,15 (monohydrate) | (b) | 210,15 (monohydrate)
(b) | 210,15 (monohydrate)
Assay | Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis
Description | Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air
Identification |
A.Solubility tests | A. | Solubility tests | Very soluble in water; freely soluble in ethanol; soluble in ether
A. | Solubility tests
Purity |
Water content | Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)
Sulphated ash | Not more than 0,05 % after calcination at 800 ± 25oC
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kg
Oxalates | Not more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonisable substances | Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90oC in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)E 331 (i) MONOSODIUM CITRATE
Synonyms | Monosodium citrateMonobasic sodium citrate
Definition |
Chemical name | Monosodium citrate
Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Chemical formula | (a)C6H7O7Na (anhydrous) | (a) | C6H7O7Na (anhydrous)
(a) | C6H7O7Na (anhydrous)
(b)C6H7O7Na· H2O (monohydrate) | (b) | C6H7O7Na· H2O (monohydrate)
(b) | C6H7O7Na· H2O (monohydrate)
Molecular weight | (a)214,11 (anhydrous) | (a) | 214,11 (anhydrous)
(a) | 214,11 (anhydrous)
(b)232,23 (monohydrate) | (b) | 232,23 (monohydrate)
(b) | 232,23 (monohydrate)
Assay | Content not less than 99 % on the anhydrous basis
Description | Crystalline white powder or colourless crystals
Identification |
A.Positive tests for citrate and for sodium | A. | Positive tests for citrate and for sodium |
A. | Positive tests for citrate and for sodium
Purity |
Loss on drying | Determined by drying at 180oC for four hours:—anhydrous: not more than 1,0 % | — | anhydrous: not more than 1,0 %
— | anhydrous: not more than 1,0 %
—monohydrate: not more than 8,8 % | — | monohydrate: not more than 8,8 %
— | monohydrate: not more than 8,8 %
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution | Between 3,5 and 3,8
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 331 (ii) DISODIUM CITRATE
Synonyms | Disodium citrateDibasic sodium citrate
Definition |
Chemical name | Disodium citrate
Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Disodium salt of citric acid with 1,5 molecules of water
Einecs | 205-623-3
Chemical formula | C6H6O7Na2·1,5H2O
Molecular weight | 263,11
Assay | Content not less than 99 % on the anhydrous basis
Description | Crystalline white powder or colourless crystals
Identification |
A.Positive tests for citrate and for sodium | A. | Positive tests for citrate and for sodium |
A. | Positive tests for citrate and for sodium
Purity |
Loss on drying | Not more than 13,0 % by drying at 180oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution | Between 4,9 and 5,2
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 331 (iii) TRISODIUM CITRATE
Synonyms | Trisodium citrateTribasic sodium citrate
Definition |
Chemical name | Trisodium citrate
Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form
Einecs | 200-675-3
Chemical formula | Anhydrous: | C6H5O7Na3
Hydrated: | C6H5O7Na3·nH2O (n = 2 or 5)
Molecular weight | 258,07 (anhydrous)
Assay | Not less than 99 % on the anhydrous basis
Description | Crystalline white powder or colourless crystals
Identification |
A.Positive tests for citrate and for sodium | A. | Positive tests for citrate and for sodium |
A. | Positive tests for citrate and for sodium
Purity |
Loss on drying | Determined by drying at 180oC for four hours:
—anhydrous: | — | anhydrous: | not more than 1,0 %
— | anhydrous:
—dihydrate: | — | dihydrate: | not more than 13,5 %
— | dihydrate:
—pentahydrate: | — | pentahydrate: | not more than 30,3 %
— | pentahydrate:
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution | Between 7,5 and 9,0
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 332 (i) MONOPOTASSIUM CITRATE
Synonyms | Monopotassium citrateMonobasic potassium citrate
Definition |
Chemical name | Monopotassium citrate
Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Anhydrous monopotassium salt of citric acid
Einecs | 212-753-4
Chemical formula | C6H7O7K
Molecular weight | 230,21
Assay | Content not less than 99 % on the anhydrous basis
Description | White, hygroscopic, granular powder or transparent crystals
Identification |
A.Positive tests for citrate and for potassium | A. | Positive tests for citrate and for potassium |
A. | Positive tests for citrate and for potassium
Purity |
Loss on drying | Not more than 1,0 % determined by drying at 180oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution | Between 3,5 and 3,8
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 332 (ii) TRIPOTASSIUM CITRATE
Synonyms | Tripotassium citrateTribasic potassium citrate
Definition |
Chemical name | Tripotassium citrate
Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrated tripotassium salt of citric acid
Einecs | 212-755-5
Chemical formula | C6H5O7K3·H2O
Molecular weight | 324,42
Assay | Content not less than 99 % on the anhydrous basis
Description | White, hygroscopic, granular powder or transparent crystals
Identification |
A.Positive tests for citrate and for potassium | A. | Positive tests for citrate and for potassium |
A. | Positive tests for citrate and for potassium
Purity |
Loss on drying | Not more than 6,0 % determined by drying at 180oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution | Between 7,5 and 9,0
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 333 (i) MONOCALCIUM CITRATE
Synonyms | Monocalcium citrateMonobasic calcium citrate
Definition |
Chemical name | Monocalcium citrate
Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrate monocalcium salt of citric acid
Chemical formula | (C6H7O7)2Ca· H2O
Molecular weight | 440,32
Assay | Content not less than 97,5 % on the anhydrous basis
Description | Fine white powder
Identification |
A.Positive tests for citrate and for calcium | A. | Positive tests for citrate and for calcium |
A. | Positive tests for citrate and for calcium
Purity |
Loss on drying | Not more than 7,0 % determined by drying at 180oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution | Between 3,2 and 3,5
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kg
Carbonates | Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubblesE 333 (ii) DICALCIUM CITRATE
Synonyms | Dicalcium citrateDibasic calcium citrate
Definition |
Chemical name | Dicalcium citrate
Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Trihydrated dicalcium salt of citric acid
Chemical formula | (C6H7O7)2Ca2·3H2O
Molecular weight | 530,42
Assay | Not less than 97,5 % on the anhydrous basis
Description | Fine white powder
Identification |
A.Positive tests for citrate and for calcium | A. | Positive tests for citrate and for calcium |
A. | Positive tests for citrate and for calcium
Purity |
Loss on drying | Not more than 20,0 % determined by drying at 180oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kg
Carbonates | Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubblesE 333 (iii) TRICALCIUM CITRATE
Synonyms | Tricalcium citrateTribasic calcium citrate
Definition |
Chemical name | Tricalcium citrate
Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Tetrahydrated tricalcium salt of citric acid
Einecs | 212-391-7
Chemical formula | (C6H6O7)2Ca3·4H2O
Molecular weight | 570,51
Assay | Not less than 97,5 % on the anhydrous basis
Description | Fine white powder
Identification |
A.Positive tests for citrate and for calcium | A. | Positive tests for citrate and for calcium |
A. | Positive tests for citrate and for calcium
Purity |
Loss on drying | Not more than 14,0 % determined by drying at 180oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kg
Carbonates | Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubblesE 334 L(+)-TARTARIC ACID
Definition |
Chemical name | L-tartaric acid
L-2,3-dihydroxybutanedioic acid
d-α, β-dihydroxysuccinic acid
Einecs | 201-766-0
Chemical formula | C4H6O6
Molecular weight | 150,09
Assay | Content not less than 99,5 % on the anhydrous basis
Description | Colourless or translucent crystalline solid or white crystalline powder
Identification |
A.Melting range | A. | Melting range | Between 168oC and 170oC
A. | Melting range
B.Positive test for tartrate | B. | Positive test for tartrate |
B. | Positive test for tartrate
Purity |
Loss on drying | Not more than 0,5 % (over P2O5, three hours)
Sulphated ash | Not more than 1 000 mg/kg after calcination at 800 ± 25oC
Specific optical rotation of a 20 % w/v aqueous solution | [α]20Dbetween +11,5oand +13,5o
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after dryingE 335 (i) MONOSODIUM TARTRATE
Synonyms | Monosodium salt of L-(+)-tartaric acid
Definition |
Chemical name | Monosodium salt of L-2,3-dihydroxybutanedioic acid
Monohydrated monosodium salt of L-(+)-tartaric acid
Chemical formula | C4H5O6Na· H2O
Molecular weight | 194,05
Assay | Content not less than 99 % on the anhydrous basis
Description | Transparent colourless crystals
Identification |
A.Positive tests for tartrate and for sodium | A. | Positive tests for tartrate and for sodium |
A. | Positive tests for tartrate and for sodium
Purity |
Loss on drying | Not more than 10,0 % determined by drying at 105oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 335 (ii) DISODIUM TARTRATE
Definition |
Chemical name | Disodium L-tartrate
Disodium (+)-tartrate
Disodium (+)-2,3-dihydroxybutanedioic acid
Dihydrated disodium salt of L-(+)-tartaric acid
Einecs | 212-773-3
Chemical formula | C4H4O6Na2·2H2O
Molecular weight | 230,8
Assay | Content not less than 99 % on the anhydrous basis
Description | Transparent, colourless crystals
Identification |
A.Positive tests for tartrate and for sodium | A. | Positive tests for tartrate and for sodium |
A. | Positive tests for tartrate and for sodium
B.Solubility tests | B. | Solubility tests | 1 gram is insoluble in 3 ml of water. Insoluble in ethanol
B. | Solubility tests
Purity |
Loss on drying | Not more than 17,0 % determined by drying at 150oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution | Between 7,0 and 7,5
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 336 (i) MONOPOTASSIUM TARTRATE
Synonyms | Monobasic potassium tartrate
Definition |
Chemical name | Anhydrous monopotassium salt of L-(+)-tartaric acid
Monopotassium salt of L-2,3-dihydroxybutanedioic acid
Chemical formula | C4H5O6K
Molecular weight | 188,16
Assay | Content not less than 98 % on the anhydrous basis
Description | White crystalline or granulated powder
Identification |
A.Positive tests for tartrate and for potassium | A. | Positive tests for tartrate and for potassium |
A. | Positive tests for tartrate and for potassium
B.Melting point | B. | Melting point | 230oC
B. | Melting point
Purity |
pH of a 1 % aqueous solution | 3,4
Loss on drying | Not more than 1,0 % determined by drying at 105oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 336 (ii) DIPOTASSIUM TARTRATE
Synonyms | Dibasic potassium tartrate
Definition |
Chemical name | Dipotassium salt of L-2,3-dihydroxybutanedioic acid
Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
Einecs | 213-067-8
Chemical formula | C4H4O6K2·1/2H2O
Molecular weight | 235,2
Assay | Content not less than 99 % on the anhydrous basis
Description | White crystalline or granulated powder
Identification |
A.Positive tests for tartrate and for potassium | A. | Positive tests for tartrate and for potassium |
A. | Positive tests for tartrate and for potassium
Purity |
pH of a 1 % aqueous solution | Between 7,0 and 9,0
Loss on drying | Not more than 4,0 % determined by drying at 150oC for four hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 337 POTASSIUM SODIUM TARTRATE
Synonyms | Potassium sodium L-(+)-tartrate
Rochelle salt
Seignette salt
Definition |
Chemical name | Potassium sodium salt of L-2,3-dihydroxybutanedioic acid
Potassium sodium L-(+)-tartrate
Einecs | 206-156-8
Chemical formula | C4H4O6KNa· 4H2O
Molecular weight | 282,23
Assay | Content not less than 99 % on the anhydrous basis
Description | Colourless crystals or white crystalline powder
Identification |
A.Positive tests for tartrate, for potassium and for sodium | A. | Positive tests for tartrate, for potassium and for sodium |
A. | Positive tests for tartrate, for potassium and for sodium
B.Solubility tests | B. | Solubility tests | 1 gram is soluble in 1 ml of water, insoluble in ethanol
B. | Solubility tests
C.Melting range | C. | Melting range | Between 70 and 80oC
C. | Melting range
Purity |
Loss on drying | Not more than 26,0 % and not less than 21,0 % determined by drying at 150oC for three hours
Oxalates | Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of 1 % aqueous solution | Between 6,5 and 8,5
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 338 PHOSPHORIC ACID
Synonyms | Orthophosphoric acid
Monophosphoric acid
Definition |
Chemical name | Phosphoric acid
Einecs | 231-633-2
Chemical formula | H3PO4
Molecular weight | 98,00
Assay | Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.
Description | Clear, colourless, viscous liquid
Identification |
A.Positive tests for acid and for phosphate | A. | Positive tests for acid and for phosphate |
A. | Positive tests for acid and for phosphate
Purity |
Volatile acids | Not more than 10 mg/kg (as acetic acid)
Chlorides | Not more than 200 mg/kg (expressed as chlorine)
Nitrates | Not more than 5 mg/kg (as NaNO3)
Sulphates | Not more than 1 500 mg/kg (as CaSO4)
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kg
Note:This specification refers to a 75 % aqueous solution | E 339 (i) MONOSODIUM PHOSPHATE
Synonyms | Monosodium monophosphate
Acid monosodium monophosphate
Monosodium orthophosphate
Monobasic sodium phosphate
Sodium dihydrogen monophosphate
Definition |
Chemical name | Sodium dihydrogen monophosphate
Einecs | 231-449-2
Chemical formula | Anhydrous: NaH2PO4
Monohydrate: NaH2PO4· H2O
Dihydrate: NaH2PO4· 2H2O
Molecular weight | Anhydrous: 119,98
Monohydrate: 138,00
Dihydrate: 156,01
Assay | After drying at 60oC for one hour and then at 105oC for four hours, contains not less than 97 % of NaH2PO4
P2O5content | Between 58,0 % and 60,0 % on the anhydrous basis
Description | A white odourless, slightly deliquescent powder, crystals or granules
Identification |
A.Positive tests for sodium and for phosphate | A. | Positive tests for sodium and for phosphate |
A. | Positive tests for sodium and for phosphate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol or ether
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 4,1 and 5,0
C. | pH of a 1 % solution
Purity |
Loss on drying | The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60oC for one hour, then at 105oC for four hours
Water-insoluble substances | Not more than 0,2 % on the anhydrous basis
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 339 (ii) DISODIUM PHOSPHATE
Synonyms | Disodium monophosphate
Secondary sodium phosphate
Disodium orthophosphate
Acid disodium phosphate
Definition |
Chemical name | Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs | 231-448-7
Chemical formula | Anhydrous: Na2HPO4
Hydrat: Na2HPO4· nH2O (n = 2,7 or 12)
Molecular weight | 141,98 (anhydrous)
Assay | After drying at 40oC for three hours and subsequently at 105oC for five hours, contains not less than 98 % of Na2HPO4
P2O5content | Between 49 % and 51 % on the anhydrous basis
Description | Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
Identification |
A.Positive tests for sodium and for phosphate | A. | Positive tests for sodium and for phosphate |
A. | Positive tests for sodium and for phosphate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 8,4 and 9,6
C. | pH of a 1 % solution
Purity |
Loss on drying | When dried at 40oC for three hours and then at 105oC for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %
Water-insoluble substances | Not more than 0,2 % on the anhydrous basis
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 339 (iii) TRISODIUM PHOSPHATE
Synonyms | Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition | Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains 1/4 molecule of NaOH
Chemical name | Trisodium monophosphate
Trisodium phosphate
Trisodium orthophosphate
Einecs | 231-509-8
Chemical formula | Anhydrous: Na3PO4
Hydrated: Na3PO4· nH2O (n = 1/2, 1, 6, 8, or 12)
Molecular weight | 163,94 (anhydrous)
Assay | Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4calculated on the ignited basis
P2O5content | Between 40,5 % and 43,5 % on the anhydrous basis
Description | White odourless crystals, granules or crystalline powder
Identification |
A.Positive tests for sodium and for phosphate | A. | Positive tests for sodium and for phosphate |
A. | Positive tests for sodium and for phosphate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 11,5 and 12,5
C. | pH of a 1 % solution
Purity |
Loss on ignition | When dried at 120oC for two hours and then ignited at about 800oC for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
Water insoluble substances | Not more than 0,2 % on the anhydrous basis
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms | Monobasic potassium phosphate
Monopotassium monophosphate
Potassium orthophosphate
Definition |
Chemical name | Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs | 231-913-4
Chemical formula | KH2PO4
Molecular weight | 136,09
Assay | Content not less than 98,0 % after drying at 105oC for four hours
P2O5content | Between 51,0 % and 53,0 % on the anhydrous basis
Description | Odourless, colourless crystals or white granular or crystalline powder, hygroscopic
Identification |
A.Positive tests for potassium and for phosphate | A. | Positive tests for potassium and for phosphate |
A. | Positive tests for potassium and for phosphate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 4,2 and 4,8
C. | pH of a 1 % solution
Purity |
Loss on drying | Not more than 2,0 % determined by drying at 105oC for four hours
Water-insoluble substances | Not more than 0,2 % on the anhydrous basis
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms | Dipotassium monophosphate
Secondary potassium phosphate
Dipotassium acid phosphate
Dipotassium orthophosphate
Dibasic potassium phosphate
Definition |
Chemical name | Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphate
Dipotassium hydrogen orthophosphate
Einecs | 231-834-5
Chemical formula | K2HPO4
Molecular weight | 174,18
Assay | Content not less than 98 % after drying at 105oC for four hours
P2O5content | Between 40,3 % and 41,5 % on the anhydrous basis
Description | Colourless or white granular powder, crystals or masses; deliquescent substance
Identification |
A.Positive tests for potassium and for phosphate | A. | Positive tests for potassium and for phosphate |
A. | Positive tests for potassium and for phosphate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 8,7 and 9,4
C. | pH of a 1 % solution
Purity |
Loss on drying | Not more than 2,0 % determined by drying at 105oC for four hours
Water-insoluble substances | Not more than 0,2 % on the anhydrous basis
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms | Potassium phosphate
Tribasic potassium phosphate
Tripotassium orthophosphate
Definition |
Chemical name | Tripotassium monophosphate
Tripotassium phosphate
Tripotassium orthophosphate
Einecs | 231-907-1
Chemical formula | Anhydrous: K3PO4
Hydrated: K3PO4· nH2O (n = 1 or 3)
Molecular weight | 212,27 (anhydrous)
Assay | Content not less than 97 % calculated on the ignited basis
P2O5content | Between 30,5 % and 33,0 % on the ignited basis
Description | Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
Identification |
A.Positive tests for potassium and for phosphate | A. | Positive tests for potassium and for phosphate |
A. | Positive tests for potassium and for phosphate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 11,5 and 12,3
C. | pH of a 1 % solution
Purity |
Loss on ignition | Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105oC for one hour and then ignite at about 800oC ± 25oC for 30 minutes
Water insoluble substances | Not more than 0,2 % on the anhydrous basis
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 341 (i) MONOCALCIUM PHOSPHATE
Synonyms | Monobasic calcium phosphate
Monocalcium orthophosphate
Definition |
Chemical name | Calcium dihydrogen phosphate
Einecs | 231-837-1
Chemical formula | Anhydrous: Ca(H2PO4)2
Monohydrate: Ca(H2PO4)2· H2O
Molecular weight | 234,05 (anhydrous)
252,08 (monohydrate)
Assay | Content not less than 95 % on the dried basis
P2O5content | Between 55,5 % and 61,1 % on the anhydrous basis
Description | Granular powder or white, deliquescent crystals or granules
Identification |
A.Positive tests for calcium and for phosphate | A. | Positive tests for calcium and for phosphate |
A. | Positive tests for calcium and for phosphate
B.CaO content | B. | CaO content | Between 23,0 % and 27,5 % (anhydrous)
B. | CaO content
Between 19,0 % and 24,8 % (monohydrate)
Purity |
Loss on drying | Not more than 14 % determined by drying at 105oC for four hours (anhydrous)
Not more than 17,5 % determined by drying at 60oC for one hour, then at 105oC for four hours (monohydrate)
Loss on ignition | Not more than 17,5 % after ignition at 800oC ± 25oC for 30 minutes (anhydrous)
Not more than 25,0 % determined by drying at 105oC for one hour, then ignite at 800oC ± 25oC for 30 minutes (monohydrate)
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 341 (ii) DICALCIUM PHOSPHATE
Synonyms | Dibasic calcium phosphate
Dicalcium orthophosphate
Definition |
Chemical name | Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate
Einecs | 231-826-1
Chemical formula | Anhydrous: CaHPO4
Dihydrate: CaHPO4· 2H2O
Molecular weight | 136,06 (anhydrous)
172,09 (dihydrate)
Assay | Dicalcium phosphate, after drying at 200oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4
P2O5content | Between 50,0 % and 52,5 % on the anhydrous basis
Description | White crystals or granules, granular powder or powder
Identification |
A.Positive tests for calcium and for phosphate | A. | Positive tests for calcium and for phosphate |
A. | Positive tests for calcium and for phosphate
B.Solubility tests | B. | Solubility tests | Sparingly soluble in water. Insoluble in ethanol
B. | Solubility tests
Purity |
Loss on ignition | Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800oC ± 25oC for 30 minutes
Fluoride | Not more than 50 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 341 (iii) TRICALCIUM PHOSPHATE
Synonyms | Calcium phosphate, tribasic
Calcium orthophosphate
Pentacalcium hydroxy monophosphate
Calcium hydroxyapatite
Definition | Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5· H2O
Chemical name | Pentacalcium hydroxy monophosphate
Tricalcium monophosphate
Einecs | 235-330-6 (Pentacalcium hydroxy monophosphate)
231-840-8 (Calcium orthophosphate)
Chemical formula | Ca5(PO4)3· OH or Ca3(PO4)2
Molecular weight | 502 or 310
Assay | Content not less than 90 % calculated on the ignited basis
P2O5 content | Between 38,5 % and 48,0 % on the anhydrous basis
Description | A white, odourless powder which is stable in air
Identification |
A.Positive tests for calcium and for phosphate | A. | Positive tests for calcium and for phosphate |
A. | Positive tests for calcium and for phosphate
B.Solubility | B. | Solubility | Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid
B. | Solubility
Purity |
Loss on ignition | Not more than 8 % after ignition at 800oC ± 25oC, to constant weight
Fluoride | Not more than 50 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 343(i) MONOMAGNESIUM PHOSPHATE
Synonyms | Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasic
Monomagnesium orthophosphate
Definition |
Chemical name | Monomagnesiumdihydrogenmonophosphate
Einecs | 236-004-6
Chemical formula | Mg(H2PO4)2· nH2O (where n = 0 to 4)
Molecular weight | 218,30 (anhydrous)
Assay | Not less than 51,0 % after ignition
Description | White, odourless, crystalline powder, slightly soluble in water
Identification |
A.Positive test for magnesium and for phosphate | A. | Positive test for magnesium and for phosphate |
A. | Positive test for magnesium and for phosphate
B.MgO content | B. | MgO content | Not less than 21,5 % after ignition
B. | MgO content
Purity |
Fluoride | Not more than 10 mg/kg (as fluorine)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 4 mg/kg
Cadmium | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 343(ii) DIMAGNESIUM PHOSPHATE
Synonyms | Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasic
Dimagnesium orthophosphate
Secondary magnesiumphosphate
Definition |
Chemical name | Dimagnesiummonohydrogenmonophosphate
Einecs | 231-823-5
Chemical formula | MgHPO4· nH2O (where n = 0-3)
Molecular weight | 120,30 (anhydrous)
Assay | Not less than 96 % after ignition
Description | White, odourless, crystalline powder, slightly soluble in water
Identification |
A.Positive test for magnesium and for phosphate | A. | Positive test for magnesium and for phosphate |
A. | Positive test for magnesium and for phosphate
B.MgO content: | B. | MgO content: | Not less than 33,0 % calculated on an anhydrous basis
B. | MgO content:
Purity |
Fluoride | Not more than 10 mg/kg (as fluorine)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 4 mg/kg
Cadmium | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 350 (i) SODIUM MALATE
Synonyms | Sodium salt of malic acid
Definition |
Chemical name | Disodium DL-malate, disodium salt of hydroxybutanedioic acid
Chemical formula | Hemihydrate: C4H4Na2O5· 1/2 H2O
Trihydrate: C4H4Na2O5· 3H2O
Molecular weight | Hemihydrate: 187,05
Trihydrate: 232,10
Assay | Content not less than 98,0 % on the anhydrous basis
Description | White crystalline powder or lumps
Identification |
A.Positive tests for 1,2-dicarboxylic acid and for sodium | A. | Positive tests for 1,2-dicarboxylic acid and for sodium |
A. | Positive tests for 1,2-dicarboxylic acid and for sodium
B.Azo dye formation | B. | Azo dye formation | Positive
B. | Azo dye formation
C.Solubility | C. | Solubility | Freely soluble in water
C. | Solubility
Purity |
Loss on drying | Not more than 7,0 % (130oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130oC, 4h) for the trihydrate
Alkalinity | Not more than 0,2 % as Na2CO3
Fumaric acid | Not more than 1,0 %
Maleic acid | Not more than 0,05 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 350 (ii) SODIUM HYDROGEN MALATE
Synonyms | Monosodium salt of DL-malic acid
Definition |
Chemical name | Monosodium DL-malate, monosodium 2-DL-hydroxy succinate
Chemical formula | C4H5NaO5
Molecular weight | 156,07
Assay | Content not less than 99,0 % on the anhydrous basis
Description | White powder
Identification |
A.Positive tests for 1,2-dicarboxylic acid and for sodium | A. | Positive tests for 1,2-dicarboxylic acid and for sodium |
A. | Positive tests for 1,2-dicarboxylic acid and for sodium
B.Azo dye formation | B. | Azo dye formation | Positive
B. | Azo dye formation
Purity |
Loss on drying | Not more than 2,0 % (110oC, 3h)
Maleic acid | Not more than 0,05 %
Fumaric acid | Not more than 1,0 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 351 POTASSIUM MALATE
Synonyms | Potassium salt of malic acid
Definition |
Chemical name | Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid
Chemical formula | C4H4K2O5
Molecular weight | 210,27
Assay | Content not less than 59,5 %
Description | Colourless or almost colourless aqueous solution
Identification |
A.Positive tests for 1,2-dicarboxylic acid and for potassium | A. | Positive tests for 1,2-dicarboxylic acid and for potassium |
A. | Positive tests for 1,2-dicarboxylic acid and for potassium
B.Azo dye formation | B. | Azo dye formation | Positive
B. | Azo dye formation
Purity |
Alkalinity | Not more than 0,2 % as K2CO3
Fumaric acid | Not more than 1,0 %
Maleic acid | Not more than 0,05 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 352 (i) CALCIUM MALATE
Synonyms | Calcium salt of malic acid
Definition |
Chemical name | Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid
Chemical formula | C4H5CaO5
Molecular weight | 172,14
Assay | Content not less than 97,5 % on the anhydrous basis
Description | White powder
Identification |
A.Positive tests for malate, 1,2-dicarboxylic acid and for calcium | A. | Positive tests for malate, 1,2-dicarboxylic acid and for calcium |
A. | Positive tests for malate, 1,2-dicarboxylic acid and for calcium
B.Azo dye formation | B. | Azo dye formation | Positive
B. | Azo dye formation
C.Solubility | C. | Solubility | Slightly soluble in water
C. | Solubility
Purity |
Loss on drying | Not more than 2 % (100oC, 3h)
Alkalinity | Not more than 0,2 % as CaCO3
Maleic acid | Not more than 0,05 %
Fumaric acid | Not more than 1,0 %
Fluoride | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 352 (ii) CALCIUM HYDROGEN MALATE
Synonyms | Monocalcium salt of DL-malic acid
Definition |
Chemical name | Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
Chemical formula | (C4H5O5)2Ca
Assay | Content not less than 97,5 % on the anhydrous basis
Description | White powder
Identification |
A.Positive tests for 1,2-dicarboxylic acid and for calcium | A. | Positive tests for 1,2-dicarboxylic acid and for calcium |
A. | Positive tests for 1,2-dicarboxylic acid and for calcium
B.Azo dye formation | B. | Azo dye formation | Positive
B. | Azo dye formation
Purity |
Loss on drying | Not more than 2,0 % (110oC, 3h)
Maleic acid | Not more than 0,05 %
Fumaric acid | Not more than 1,0 %
Fluoride | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 353 METATARTARIC ACID
Synonyms | Ditartaric acid
Definition |
Chemical name | Metatartaric acid
Chemical formula | C4H6O6
Assay | Not less than 99,5 %
Description | Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel
Identification |
A. | Very soluble in water and ethanol
B. | Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150oC, an intense violet coloration appears
Purity |
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 354 CALCIUM TARTRATE
Synonyms | L-Calcium tartrate
Definition |
Chemical name | Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical formula | C4H4CaO6· 2H2O
Molecular weight | 224,18
Assay | Not less than 98,0 %
Description | Fine crystalline powder with a white or off-white colour
Identification |
A.Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids | A. | Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids |
A. | Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
B.Specific rotation [α]20D | B. | Specific rotation [α]20D | +7,0oto +7,4o(0,1 % in a 1N de HCl solution)
B. | Specific rotation [α]20D
C.pH of a 5 % slurry | C. | pH of a 5 % slurry | Between 6,0 and 9,0
C. | pH of a 5 % slurry
Purity |
Sulphates (as H2SO4) | Not more than 1 g/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 355 ADIPIC ACID
Definition |
Chemical name | Hexanedioic acid, 1,4-butanedicarboxylic acid
Einecs | 204-673-3
Chemical formula | C6H10O4
Molecular weight | 146,14
Assay | Content not less than 99,6 %
Description | White odourless crystals or crystalline powder
Identification |
A.Melting range | A. | Melting range | 151,5oC-154,0oC
A. | Melting range
B.Solubility | B. | Solubility | Slightly soluble in water. Freely soluble in ethanol
B. | Solubility
Purity |
Water | Not more than 0,2 % (Karl Fischer method)
Sulphated ash | Not more than 20 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 356 SODIUM ADIPATE
Definition |
Chemical name | Sodium adipate
Einecs | 231-293-5
Chemical formula | C6H8Na2O4
Molecular weight | 190,11
Assay | Content not less than 99,0 % (on anhydrous basis)
Description | White odourless crystals or crystalline powder
Identification |
A.Melting range | A. | Melting range | 151oC-152oC (for adipic acid)
A. | Melting range
B.Solubility | B. | Solubility | Approximately 50 g/100 ml water (20oC)
B. | Solubility
C.Positive test for sodium | C. | Positive test for sodium |
C. | Positive test for sodium
Purity |
Water | Not more than 3 % (Karl Fischer)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 357 POTASSIUM ADIPATE
Definition |
Chemical name | Potassium adipate
Einecs | 242-838-1
Chemical formula | C6H8K2O4
Molecular weight | 222,32
Assay | Content not less than 99,0 % (on anhydrous basis)
Description | White odourless crystals or crystalline powder
Identification |
A.Melting range | A. | Melting range | 151oC-152oC (for adipic acid)
A. | Melting range
B.Solubility | B. | Solubility | Approximately 60 g/100 ml water (20oC)
B. | Solubility
C.Positive test for potassium | C. | Positive test for potassium |
C. | Positive test for potassium
Purity |
Water | Not more than 3 % (Karl Fischer)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 363 SUCCINIC ACID
Definition |
Chemical name | Butanedioic acid
Einecs | 203-740-4
Chemical formula | C4H6O4
Molecular weight | 118,09
Assay | Content no less than 99,0 %
Description | Colourless or white, odourless crystals
Identification |
A.Melting range | A. | Melting range | Between 185,0oC and 190,0oC
A. | Melting range
Purity |
Residue on ignition | Not more than 0,025 % (800oC, 15 min)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 380 TRIAMMONIUM CITRATE
Synonyms | Tribasic ammonium citrate
Definition |
Chemical name | Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid
Einecs | 222-394-5
Chemical formula | C6H17N3O7
Molecular weight | 243,22
Assay | Content not less than 97,0 %
Description | White to off-white crystals or powder
Identification |
A.Positive tests for ammonium and for citrate | A. | Positive tests for ammonium and for citrate |
A. | Positive tests for ammonium and for citrate
B.Solubility | B. | Solubility | Freely soluble in water
B. | Solubility
Purity |
Oxalate | Not more than 0,04 % (as oxalic acid)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
Synonyms | Calcium disodium EDTA
Calcium disodium edetate
Definition |
Chemical name | N, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium
Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate
Einecs | 200-529-9
Chemical formula | C10H12O8CaN2Na2·2H2O
Molecular weight | 410,31
Assay | Content not less than 97 % on the anhydrous basis
Description | White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic
Identification |
A.Positive tests for sodium and for calcium | A. | Positive tests for sodium and for calcium |
A. | Positive tests for sodium and for calcium
B.Chelating activity to metal ions positive | B. | Chelating activity to metal ions positive |
B. | Chelating activity to metal ions positive
C.pH of a 1 % solution between 6,5 and 7,5 | C. | pH of a 1 % solution between 6,5 and 7,5 |
C. | pH of a 1 % solution between 6,5 and 7,5
Purity |
Water content | 5 to 13 % (Karl Fischer method)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 400 ALGINIC ACID
Definition | Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)
Einecs | 232-680-1
Chemical formula | (C6H8O6)n
Molecular weight | 10 000 -600 000 (typical average)
Assay | Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n(calculted on equivalent weight basis of 200)
Description | Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
Identification |
A.Solubility | A. | Solubility | Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
A. | Solubility
B.Calcium chloride precipitation test | B. | Calcium chloride precipitation test | To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum
B. | Calcium chloride precipitation test
C.Ammonium sulphate precipitation test | C. | Ammonium sulphate precipitation test | To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch
C. | Ammonium sulphate precipitation test
D.Colour reaction | D. | Colour reaction | Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple
D. | Colour reaction
Purity |
pH of a 3 % suspension | Between 2,0 and 3,5
Loss on drying | Not more than 15 % (105oC, 4 hours)
Sulphated ash | Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution) | Not more than 2 % on the anhydrous basis insoluble matter
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 500 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 401 SODIUM ALGINATE
Definition |
Chemical name | Sodium salt of alginic acid
Chemical formula | (C6H7NaO6)n
Molecular weight | 10 000 -600 000 (typical average)
Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)
Description | Nearly odourless, white to yellowish fibrous or granular powder
Identification |
A.Positive test for sodium and alginic acid | A. | Positive test for sodium and alginic acid |
A. | Positive test for sodium and alginic acid
Purity |
Loss on drying | Not more than 15 % (105oC, 4 hours)
Water-insoluble matter | Not more than 2 % on the anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 500 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 402 POTASSIUM ALGINATE
Definition |
Chemical name | Potassium salt of alginic acid
Chemical formula | (C6H7KO6)n
Molecular weight | 10 000 -600 000 (typical average)
Assay | Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)
Description | Nearly odourless, white to yellowish fibrous or granular powder
Identification |
A.Positive test for potassium and for alginic acid | A. | Positive test for potassium and for alginic acid |
A. | Positive test for potassium and for alginic acid
Purity |
Loss on drying | Not more than 15 % (105oC, 4 hours)
Water-insoluble matter | Not more than 2 % on the anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 500 colonies per gram
E.coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 403 AMMONIUM ALGINATE
Definition |
Chemical name | Ammonium salt of alginic acid
Chemical formula | (C6H11NO6)n
Molecular weight | 10 000 — 600 000 (typical average)
Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)
Description | White to yellowish fibrous or granular powder
Identification |
A.Positive test for ammonium and alginic acid | A. | Positive test for ammonium and alginic acid |
A. | Positive test for ammonium and alginic acid
Purity |
Loss on drying | Not more than 15 % (105oC, 4 hours)
Sulphated ash | Not more than 7 % on the dried basis
Water-insoluble matter | Not more than 2 % on the anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals | Not more than 20 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 500 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 404 CALCIUM ALGINATE
Synonyms | Calcium salt of alginate
Definition |
Chemical name | Calcium salt of alginic acid
Chemical formula | (C6H7Ca1/2O6)n
Molecular weight | 10 000 -600 000 (typical average)
Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)
Description | Nearly odourless, white to yellowish fibrous or granular powder
Identification |
A.Positive test for calcium and alginic acid | A. | Positive test for calcium and alginic acid |
A. | Positive test for calcium and alginic acid
Purity |
Loss on drying | Not more than 15,0 % (105oC, 4 hours)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 500 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 405 PROPANE-1,2-DIOL ALGINATE
Synonyms | Hydroxypropyl alginate
1,2-propanediol ester of alginic acid
Propylene glycol alginate
Definition |
Chemical name | Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule
Chemical formula | (C9H14O7)n(esterified)
Molecular weight | 10 000 -600 000 (typical average)
Assay | Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2of carbon dioxide
Description | Nearly odourless, white to yellowish brown fibrous or granular powder
Identification |
A.Positive test for 1,2-propanediol and alginic acid after hydrolysis | A. | Positive test for 1,2-propanediol and alginic acid after hydrolysis |
A. | Positive test for 1,2-propanediol and alginic acid after hydrolysis
Purity |
Loss on drying | Not more than 20 % (105oC, 4 hours)
Total propane-1,2-diol content | Not less than 15 % and not more than 45 %
Free propane-1,2-diol content | Not more than 15 %
Water-insoluble matter | Not more than 2 % on the anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 500 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 406 AGAR
Synonyms | Gelose
Japan agar
Bengal, Ceylon, Chinese or Japanese isinglass
Layor Carang
Definition |
Chemical name | Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the familiesGelidiaceaeandSphaerococcaceaeand related red algae of the classRhodophyceae
Einecs | 232-658-1
Assay | The threshold gel concentration should not be higher than 0,25 %
Description | Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
Identification |
A.Solubility | A. | Solubility | Insoluble in cold water; soluble in boiling water
A. | Solubility
Purity |
Loss on drying | Not more than 22 % (105oC, 5 hours)
Ash | Not more than 6,5 % on the anhydrous basis determined at 550oC
Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid) | Not more than 0,5 % determined at 550oC on the anhydrous basis
Insoluble matter (in hot water) | Not more than 1,0 %
Starch | Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Gelatin and other proteins | Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50oC. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
Water absorption | Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25oC for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 407 CARRAGEENAN
Synonyms | Products of commerce are sold under different names such as:
Irish moss gelose
Eucheuman (fromEucheumaspp.)
Iridophycan (fromIridaeaspp.)
Hypnean (fromHypneaspp.)
Furcellaran or Danish agar (fromFurcellaria fastigiata)
Carrageenan (fromChondrusandGigartinaspp.)
Definition | Carrageenan is obtained by aqueous extraction of natural strains of seaweeds ofGigartinaceae,Solieriaceae,HypneaceaeandFurcellariaceae, families of the classRhodophyceae(red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
Einecs | 232-524-2
Description | Yellowish to colourless, coarse to fine powder which is practically odourless
Identification |
A.Positive tests for galactose, for anhydrogalactose and for sulphate | A. | Positive tests for galactose, for anhydrogalactose and for sulphate |
A. | Positive tests for galactose, for anhydrogalactose and for sulphate
Purity |
Methanol, ethanol propane-2-ol content | Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75oC | Not less than 5 mPa.s
Loss on drying | Not more than 12 % (105oC, four hours)
Sulphate | Not less than 15 % and not more than 40 % on the dried basis (as SO4)
Ash | Not less than 15 % and not more than 40 % determined on the dried basis at 550oC
Acid-insoluble ash | Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matter | Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) | Not more than 5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 300 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 407a PROCESSED EUCHEUMA SEAWEED
Synonyms | PES (acronym for processed eucheuma seaweed)
Definition | Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweedsEucheuma cottoniiandEucheuma spinosum, of the classRhodophyceae(red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
Description | Tan to yellowish, coarse to fine powder which is practically odourless
Identification |
A.Positive tests for galactose, for anhydrogalactose and for sulphate | A. | Positive tests for galactose, for anhydrogalactose and for sulphate |
A. | Positive tests for galactose, for anhydrogalactose and for sulphate
B.Solubility | B. | Solubility | Forms cloudy viscous suspensions in water. Insoluble in ethanol
B. | Solubility
Purity |
Methanol, ethanol, propane-2-ol content | Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75oC | Not less than 5 mPa.s
Loss on drying | Not more than 12 % (105oC, four hours)
Sulphate | Not less than 15 % and not more than 40 % on the dried basis (as SO4)
Ash | Not less than 15 % and not more than 40 % determined on the dried basis at 550oC
Acid-insoluble ash | Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
Acid-insoluble matter | Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) | Not more than 5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and moulds | Not more than 300 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 410 LOCUST BEAN GUM
Synonyms | Carob bean gum
Algaroba gum
Definition | Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree,Cerationia siliqua(L.) Taub. (familyLeguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Molecular weight | 50 000 -3 000 000
Einecs | 232-541-5
Assay | Galactomannan content not less than 75 %
Description | White to yellowish-white, nearly odourless powder
Identification |
A.Positive tests for galactose mannose | A. | Positive tests for galactose mannose |
A. | Positive tests for galactose mannose
B.Microscopic examination | B. | Microscopic examination | Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
B. | Microscopic examination
C.Solubility | C. | Solubility | Soluble in hot water, insoluble in ethanol
C. | Solubility
Purity |
Loss on drying | Not more than 15 % (105oC, 5 hours)
Ash | Not more than 1,2 % determined at 800oC
Protein (N × 6,25 ) | Not more than 7 %
Acid-insoluble matter | Not more than 4 %
Starch | Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Ethanol and propane-2-ol | Not more than 1 %, single or in combinationE 412 GUAR GUM
Synonyms | Gum cyamopsis
Guar flour
Definition | Guar gum is the ground endosperm of the seeds of natural strains of the guar plant,Cyamopsis tetragonolobus(L.) Taub. (familyLeguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
Einecs | 232-536-0
Molecular weight | 50 000 -8 000 000
Assay | Galactomannan content not less than 75 %
Description | A white to yellowish-white, nearly odourless powder
Identification |
A.Positive tests for galactose and for mannose | A. | Positive tests for galactose and for mannose |
A. | Positive tests for galactose and for mannose
B.Solubility | B. | Solubility | Soluble in cold water
B. | Solubility
Purity |
Loss on drying | Not more than 15 % (105oC, 5 hours)
Ash | Not more than 1,5 % determined at 800oC
Acid-insoluble matter | Not more than 7 %
Protein (N × 6,25 ) | Not more than 10 %
Starch | Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 413 TRAGACANTH
Synonyms | Tragacanth gum
Tragant
Definition | Tragacanth is a dried exudation obtained from the stems and branches of natural strains ofAstragalus gummiferLabillardiere and other Asiatic species ofAstragalus(familyLeguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
Molecular weight | Approximately 800 000
Einecs | 232-252-5
Description | Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5 -2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
Identification |
A.Solubility | A. | Solubility | 1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
A. | Solubility
Purity |
Negative test for Karaya gum | Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
Loss on drying | Not more than 16 % (105oC, 5 hours)
Total ash | Not more than 4 %
Acid insoluble ash | Not more than 0,5 %
Acid insoluble matter | Not more than 2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Salmonellaspp. | Negative in 10 g
E. coli | Negative in 5 gE 414 ACACIA GUM
Synonyms | Gum arabic
Definition | Acacia gum is a dried exudation obtained from the stems and branches of natural strains ofAcacia senegal(L) Willdenow or closely related species of Acacia (familyLeguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
Molecular weight | Approximately 350 000
Einecs | 232-519-5
Description | Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.
Identification |
A.Solubility | A. | Solubility | 1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol
A. | Solubility
Purity |
Loss on drying | Not more than 17 % (105oC, 5 hours) for granular and not more than 10 % (105oC, 4 hours) for spray-dried material
Total ash | Not more than 4 %
Acid insoluble ash | Not more than 0,5 %
Acid insoluble matter | Not more than 1 %
Starch or dextrin | Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced
Tannin | To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Hydrolysis products | Mannose, xylose and galacturonic acid are absent (determined by chromatography)
Salmonellaspp. | Negative in 10 g
E. coli | Negative in 5 gE 415 XANTHAN GUM
Definition | Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains ofXanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
Molecular weight | Approximately 1 000 000
Einecs | 234-394-2
Assay | Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2corresponding to between 91 % and 108 % of xanthan gum
Description | Cream-coloured powder
Identification |
A.Solubility | A. | Solubility | Soluble in water. Insoluble in ethanol
A. | Solubility
Purity |
Loss on drying | Not more than 15 % (105oC, 21/2 hours)
Total ash | Not more than 16 % on the anhydrous basis determined at 650oC after drying at 105oC for four hours
Pyruvic acid | Not less than 1,5 %
Nitrogen | Not more than 1,5 %
Ethanol and propan-2-ol | Not more than 500 mg/kg singly or in combination
Lead | Not more than 2 mg/kg
Total plate count | Not more than 5 000 colonies per gram
Yeast and mould | Not more than 300 colonies per gram
E. coli | Absent in 5 g
Salmonellaspp. | Absent in 10 g
Xanthomonas campestris | Viable cells absent in 1 gE 416 KARAYA-GUM
Synonyms | Katilo
Kadaya
Gumsterculia
Sterculia
Karaya, gum karaya
Kullo
Kuterra
Definition | Karaya gum is a dried exudation from the stems and branches of natural strains of:Sterculia urensRoxburgh and other species ofSterculia(familySterculiaceae) or fromCochlospermum gossypiumA.P. De Candolle or other species ofCochlospermum(familyBixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid
Einecs | 232-539-4
Description | Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
Identification |
A.Solubility | A. | Solubility | Insoluble in ethanol
A. | Solubility
B.Swelling in ethanol solution | B. | Swelling in ethanol solution | Karaya gum swells in 60 % ethanol distinguishing it from other gums
B. | Swelling in ethanol solution
Purity |
Loss on drying | Not more than 20 % (105oC, 5 hours)
Total ash | Not more than 8 %
Acid insoluble ash | Not more than 1 %
Acid insoluble matter | Not more than 3 %
Volatile acid | Not less than 10 % (as acetic acid)
Starch | Not detectable
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Salmonellaspp. | Negative in 10 g
E. coli | Negative in 5 gE 417 TARA GUM
Definition | Tara gum is obtained by grinding the endosperm of the seeds of natural strains ofCaesalpinia spinosa(familyLeguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
Einecs | 254-409-6
Description | A white to white-yellow odourless powder
Identification |
A.Solubility | A. | Solubility | Soluble in water
A. | Solubility
Insoluble in ethanol
B.Gel formation | B. | Gel formation | To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
B. | Gel formation
Purity |
Loss on drying | Not more than 15 %
Ash | Not more than 1,5 %
Acid insoluble matter | Not more than 2 %
Protein | Not more than 3,5 % (factor N × 5,7 )
Starch | Not detectable
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 418 GELLAN GUM
Definition | Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains ofPseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt
Einecs | 275-117-5
Molecular weight | Approximately 500 000
Assay | Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2
Description | An off-white powder
Identification |
A.Solubility | A. | Solubility | Soluble in water, forming a viscous solution.
A. | Solubility
Insoluble in ethanol
Purity |
Loss on drying | Not more than 15 % after drying (105oC, 21/2 hours)
Nitrogen | Not more than 3 %
Propane-2-ol | Not more than 750 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total plate count | Not more than 10 000 colonies per gram
Yeast and mould | Not more than 400 colonies per gram
E. coli | Negative in 5 g
Salmonellaspp. | Negative in 10 gE 420(i) SORBITOLPurity criteria for this additive are the same as set out for this additive in Annex I to Commission Directive 2008/60/EC(7).
E 420(ii) SORBITOL SYRUPPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 421 MANNITOLPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 422 GLYCEROL
Synonyms | Glycerin
Glycerine
Definition |
Chemical names | 1,2,3-propanetriol
Glycerol
Trihydroxypropane
Einecs | 200-289-5
Chemical formula | C3H8O3
Molecular weight | 92,10
Assay | Content not less than 98 % of glycerol on the anhydrous basis
Description | Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable
Identification |
A.Acrolein formation on heating | A. | Acrolein formation on heating | Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved
A. | Acrolein formation on heating
B.Specific gravity (25/25oC) | B. | Specific gravity (25/25oC) | Not less than 1,257
B. | Specific gravity (25/25oC)
C.Refractive index [n]D20 | C. | Refractive index [n]D20 | Between 1,471 and 1,474
C. | Refractive index [n]D20
Purity |
Water | Not more than 5 % (Karl Fischer method)
Sulphated ash | Not more than 0,01 % determined at 800 ± 25oC
Butanetriols | Not more than 0,2 %
Acrolein, glucose and ammonium compounds | Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60oC for five minutes. It neither becomes yellow nor emits an odour of ammonia
Fatty acids and esters | Not more than 0,1 % calculated as butyric acid
Chlorinated compounds | Not more than 30 mg/kg (as chlorine)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 425(i) KONJAC GUM
Definition | Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plantAmorphophallus konjac.The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6 :1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units
Molecular weight | The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000
Assay | Not less than 75 % carbohydrate
Description | A white to cream to light tan powder
Identification |
A.Solubility | A. | Solubility | Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
A. | Solubility
B.Gel formation | B. | Gel formation | Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms
B. | Gel formation
C.Formation of heat-stable gel | C. | Formation of heat-stable gel | Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
C. | Formation of heat-stable gel
D.Viscosity (1 % solution) | D. | Viscosity (1 % solution) | Not less than 3 kgm-1s-1at 25oC
D. | Viscosity (1 % solution)
Purity |
Loss on drying | Not more than 12 % (105oC, 5 h)
Starch | Not more than 3 %
Protein | Not more than 3 % (N × 5,7 )
Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble material | Not more than 0,1 %
Total ash | Not more than 5,0 % (800oC, 3 to 4h)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 2 mg/kg
Salmonellaspp. | Absent in 12,5 g
E. coli | Absent in 5 gE 425(ii) KONJAC GLUCOMANNAN
Definition | Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plantAmorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6 :1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated
Molecular weight | 500 000 to 2 000 000
Assay | Total dietary fibre: not less than 95 % on a dry weight basis
Description | White to slightly brownish fine particle size, free flowing and odourless powder
Identification |
A.Solubility | A. | Solubility | Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0 . Solubility is increased by heat and mechanical agitation
A. | Solubility
B.Formation of heat-stable gel | B. | Formation of heat-stable gel | Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
B. | Formation of heat-stable gel
C.Viscosity (1 % solution) | C. | Viscosity (1 % solution) | Not less than 20 kgm-1s-1at 25oC
C. | Viscosity (1 % solution)
Purity |
Loss on drying | Not more than 8 % (105oC, 3h)
Starch | Not more than 1 %
Protein | Not more than 1,5 % (N × 5,7 )
Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble material | Not more than 0,5 %
Sulphite (as SO2) | Not more than 4 mg/kg
Chloride | Not more than 0,02 %
50 % Alcohol-soluble | Not more than 2,0 % material
Total ash | Not more than 2,0 % (800oC, 3 to 4h)
Lead | Not more than 1 mg/kg
Salmonellaspp. | Absent in 12,5 g
E. coli | Absent in 5 gE 426 SOYBEAN HEMICELLULOSE
Definition | Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction
Chemical names | Water soluble soybean polysaccharides
Water soluble soybean fibre
Assay | Not less than 74 % carbohydrate
Description | Free flowing spray-dried white powder
Identification |
A.Solubility pH of 1 % solution | A. | Solubility pH of 1 % solution | Soluble in hot and cold water without gel formation
A. | Solubility pH of 1 % solution
5,5 ±1,5
B.Viscosity of 10 % solution | B. | Viscosity of 10 % solution | Not more than 200 mPa.s
B. | Viscosity of 10 % solution
Purity |
Loss on drying | Not more than 7 % (105oC, 4h)
Protein | Not more than 14 %
Total ash | Not more than 9,5 % (600oC, 4h)
Arsenic | Not more than 2 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Standard plate count | Not more than 3 000 colonies per gram
Yeast and mould | Not more than 100 colonies per gram
E. coli | Negative in 10 gE 431 POLYOXYETHYLENE (40) STEARATE
Synonyms | Polyoxyl (40) stearate
polyoxyethylene (40) monostearate
Definition | A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
Assay | Content not less than 97,5 % on the anhydrous basis
Description | Cream-coloured flakes or waxy solid at 25oC with a faint odour
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
A. | Solubility
B.Congealing range | B. | Congealing range | 39oC-44oC
B. | Congealing range
C.Infrared absorption spectrum | C. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
C. | Infrared absorption spectrum
Purity |
Water | Not more than 3 % (Karl Fischer method)
Acid value | Not more than 1
Saponification value | Not less than 25 and not more than 35
Hydroxyl value | Not less than 27 and not more than 40
1,4-Dioxane | Not more than 5 mg/kg
Ethylene oxide | Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) | Not more than 0,25 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
Synonyms | Polysorbate 20
Polyoxyethylene (20) sorbitan monolaurate
Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay | Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis
Description | A lemon to amber-coloured oily liquid at 25oC with a faint characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
A. | Solubility
B.Infrared absorption spectrum | B. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. | Infrared absorption spectrum
Purity |
Water | Not more than 3 % (Karl Fischer method)
Acid value | Not more than 2
Saponification value | Not less than 40 and not more than 50
Hydroxyl value | Not less than 96 and not more than 108
1,4-dioxane | Not more than 5 mg/kg
Ethylene oxide | Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) | Not more than 0,25 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
Synonyms | Polysorbate 80
Polyoxyethylene (20) sorbitan monooleate
Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay | Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
Description | A lemon to amber-coloured oily liquid at 25oC with a faint characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
A. | Solubility
B.Infrared absorption spectrum | B. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. | Infrared absorption spectrum
Purity |
Water | Not more than 3 % (Karl Fischer method)
Acid value | Not more than 2
Saponification value | Not less than 45 and not more than 55
Hydroxyl value | Not less than 65 and not more than 80
1,4-dioxane | Not more than 5 mg/kg
Ethylene oxide | Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) | Not more than 0,25 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)
Synonyms | Polysorbate 40
Polyoxyethylene (20) sorbitan monopalmitate
Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay | Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
Description | A lemon to orange-coloured oily liquid or semi-gel at 25oC with a faint characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
A. | Solubility
B.Infrared absorption spectrum | B. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. | Infrared absorption spectrum
Purity |
Water | Not more than 3 % (Karl Fischer method)
Acid value | Not more than 2
Saponification value | Not less than 41 and not more than 52
Hydroxyl value | Not less than 90 and not more than 107
1,4-dioxane | Not more than 5 mg/kg
Ethylene oxide | Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) | Not more than 0,25 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)
Synonyms | Polysorbate 60
Polyoxyethylene (20) sorbitan monostearate
Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay | Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
Description | A lemon to orange-coloured oily liquid or semi-gel at 25oC with a faint characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
A. | Solubility
B.Infrared absorption spectrum | B. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
B. | Infrared absorption spectrum
Purity |
Water | Not more than 3 % (Karl Fischer method)
Acid value | Not more than 2
Saponification value | Not less than 45 and not more than 55
Hydroxyl value | Not less than 81 and not more than 96
1,4-dioxane | Not more than 5 mg/kg
Ethylene oxide | Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) | Not more than 0,25 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)
Synonyms | Polysorbate 65
Polyoxyethylene (20) sorbitan tristearate
Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay | Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
Description | A tan-coloured, waxy solid at 25oC with a faint characteristic odour
Identification |
A.Solubility | A. | Solubility | Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
A. | Solubility
B.Congealing range | B. | Congealing range | 29-33oC
B. | Congealing range
C.Infrared absorption spectrum | C. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
C. | Infrared absorption spectrum
Purity |
Water | Not more than 3 % (Karl Fischer method)
Acid value | Not more than 2
Saponification value | Not less than 88 and not more than 98
Hydroxyl value | Not less than 40 and not more than 60
1,4-dioxane | Not more than 5 mg/kg
Ethylene oxide | Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) | Not more than 0,25 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 440 (i) PECTIN
Definition | Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Einecs | 232-553-0
Assay | Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description | White, light yellow, light grey or light brown powder
Identification |
A.Solubility | A. | Solubility | Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
A. | Solubility
Purity |
Loss on drying | Not more than 12 % (105oC, 2 hours)
Acid insoluble ash | Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide | Not more than 50 mg/kg on the anhydrous basis
Nitrogen content | Not more than 1,0 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol | Not more than 1 %, singly or in combination, on the anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 440 (ii) AMIDATED PECTIN
Definition | Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Assay | Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description | White, light yellow, light greyish or light brownish powder
Identification |
A.Solubility | A. | Solubility | Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
A. | Solubility
Purity |
Loss on drying | Not more than 12 % (105oC, 2 hours)
Acid-insoluble ash | Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidation | Not more than 25 % of total carboxyl groups
Sulphur dioxide residue | Not more than 50 mg/kg on the anhydrous basis
Nitrogen content | Not more than 2,5 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol | Not more than 1 % single or in combination, on a volatile matter-free basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 442 AMMONIUM PHOSPHATIDES
Synonyms | Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides
Definition | A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
Assay | The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)
Description | Unctuous semi-solid
Identification |
A.Solubility | A. | Solubility | Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
A. | Solubility
B.Positive tests for glycerol, for fatty acid and for phosphate | B. | Positive tests for glycerol, for fatty acid and for phosphate |
B. | Positive tests for glycerol, for fatty acid and for phosphate
Purity |
Petroleum ether insoluble matter | Not more than 2,5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 444 SUCROSE ACETATE ISOBUTYRATE
Synonyms | SAIB
Definition | Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
Einecs | 204-771-6
Chemical name | Sucrose diacetate hexaisobutyrate
Chemical formulae | C40H62O19
Molecular weight | 832-856 (approximate), C40H62O19: 846,9
Assay | Content not less than 98,8 % and not more than 101,9 % of C40H62O19
Description | A pale straw-coloured liquid, clear and free of sediment and having a bland odour
Identification |
A.Solubility | A. | Solubility | Insoluble in water. Soluble in most organic solvents
A. | Solubility
B.Refractive index | B. | Refractive index | [n]40D: 1,4492 -1,4504
B. | Refractive index
C.Specific gravity | C. | Specific gravity | [d]25D: 1,141 -1,151
C. | Specific gravity
Purity |
Triacetin | Not more than 0,1 %
Acid value | Not more than 0,2
Saponification value | Not less than 524 and not more than 540
Arsenic | Not more than 3 mg/kg
Lead | Not more than 3 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 5 mg/kgE 445 GLYCEROL ESTERS OF WOOD ROSIN
Synonyms | Ester gum
Definition | A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
Description | Hard, yellow to pale amber-coloured solid
Identification |
A.Solubility | A. | Solubility | Insoluble in water, soluble in acetone
A. | Solubility
B.Infrared absorption spectrum | B. | Infrared absorption spectrum | Characteristic of the compound
B. | Infrared absorption spectrum
Purity |
Specific gravity of solution | [d]2025not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5 -176oC, d204: 0,84 )
Ring and ball softening range | Between 82oC and 90oC
Acid value | Not less than 3 and not more than 9
Hydroxyl value | Not less than 15 and not more than 45
Arsenic | Not more than 3 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Test for absence of tall oil rosin (sulphur test) | When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosinE 450 (i) DISODIUM DIPHOSPHATE
Synonyms | Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphate
Sodium acid pyrophosphate
Disodium pyrophosphate
Definition |
Chemical name | Disodium dihydrogen diphosphate
Einecs | 231-835-0
Chemical formula | Na2H2P2O7
Molecular weight | 221,94
Assay | Content not less than 95 % of disodium diphosphate
P2O5Content | Not less than 63,0 % and not more than 64,5 %
Description | White powder or grains
Identification |
A.Positive tests for sodium and for phosphate | A. | Positive tests for sodium and for phosphate |
A. | Positive tests for sodium and for phosphate
B.Solubility | B. | Solubility | Soluble in water
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 3,7 and 5,0
C. | pH of a 1 % solution
Purity |
Loss on drying | Not more than 0,5 % (105oC, four hours)
Water-insoluble matter | Not more than 1 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms | Acid trisodium pyrophosphate
Trisodium monohydrogen diphosphate
Definition |
Einecs | 238-735-6
Chemical formula | Monohydrate: Na3HP2O7· H2O
Anhydrous: Na3HP2O7
Molecular weight | Monohydrate: 261,95
Anhydrous: 243,93
Assay | Content not less than 95 % on the anhydrous basis
P2O5content | Not less than 57 % and not more than 59 %
Description | White powder or grains, occurs anhydrous or as a monohydrate
Identification |
A.Positive tests for sodium and for phosphate | A. | Positive tests for sodium and for phosphate |
A. | Positive tests for sodium and for phosphate
B.Solubility | B. | Solubility | Soluble in water
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 6,7 and 7,5
C. | pH of a 1 % solution
Purity |
Loss on ignition | Not more than 4,5 % on the anhydrous compound
Not more than 11,5 % on the monohydrous basis
Loss on drying | Not more than 0,5 % (105oC, four hours)
Water-insoluble matter | Not more than 0,2 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 450 (iii) TETRASODIUM DIPHOSPHATE
Synonyms | Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition |
Chemical name | Tetrasodium diphosphate
Einecs | 231-767-1
Chemical formula | Anhydrous: Na4P2O7
Decahydrate: Na4P2O7· 10H2O
Molecular weight | Anhydrous: 265,94
Decahydrate: 446,09
Assay | Content not less than 95 % of Na4P2O7on the ignited basis
P2O5content | Not less than 52,5 % and not more than 54,0 %
Description | Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air
Identification |
A.Positive tests for sodium and for phosphate | A. | Positive tests for sodium and for phosphate |
A. | Positive tests for sodium and for phosphate
B.Solubility | B. | Solubility | Soluble in water. Insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 9,8 and 10,8
C. | pH of a 1 % solution
Purity |
Loss on ignition | Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105oC for four hours, followed by ignition at 550oC for 30 minutes
Water-insoluble matter | Not more than 0,2 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms | Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition |
Chemical name | Tetrapotassium diphosphate
Einecs | 230-785-7
Chemical formula | K4P2O7
Molecular weight | 330,34 (anhydrous)
Assay | Content not less than 95 % on the ignited basis
P2O5content | Not less than 42,0 % and not more than 43,7 % on the anhydrous basis
Description | Colourless crystals or white, very hygroscopic powder
Identification |
A.Positive tests for potassium and for phosphate | A. | Positive tests for potassium and for phosphate |
A. | Positive tests for potassium and for phosphate
B.Solubility | B. | Solubility | Soluble in water, insoluble in ethanol
B. | Solubility
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 10,0 and 10,8
C. | pH of a 1 % solution
Purity |
Loss on ignition | Not more than 2 % after drying at 105oC for four hours and then ignition at 550oC for 30 minutes
Water-insoluble substances | Not more than 0,2 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 450 (vi) DICALCIUM DIPHOSPHATE
Synonyms | Calcium pyrophosphate
Definition |
Chemical name | Dicalcium diphosphate
Dicalcium pyrophosphate
Einecs | 232-221-5
Chemical formula | Ca2P2O7
Molecular weight | 254,12
Assay | Content not less than 96 %
P2O5content | Not less than 55 % and not more than 56 %
Description | A fine, white, odourless powder
Identification |
A.Positive tests for calcium and for phosphate | A. | Positive tests for calcium and for phosphate |
A. | Positive tests for calcium and for phosphate
B.Solubility | B. | Solubility | Insoluble in water. Soluble in dilute hydrochloric and nitric acids
B. | Solubility
C.pH of a 10 % suspension in water | C. | pH of a 10 % suspension in water | Between 5,5 and 7,0
C. | pH of a 10 % suspension in water
Purity |
Loss on ignition | Not more than 1,5 % at 800oC ± 25oC for 30 minutes
Fluoride | Not more than 50 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
Synonyms | Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition |
Chemical name | Calcium dihydrogen diphosphate
Einecs | 238-933-2
Chemical formula | CaH2P2O7
Molecular weight | 215,97
Assay | Content not less than 90 % on the anhydrous basis
P2O5content | Not less than 61 % and not more than 64 %
Description | White crystals or powder
Identification |
A.Positive tests for calcium and for phosphate | A. | Positive tests for calcium and for phosphate |
A. | Positive tests for calcium and for phosphate
Purity |
Acid-insoluble matter | Not more than 0,4 %
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 451 (i) PENTASODIUM TRIPHOSPHATE
Synonyms | Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition |
Chemical name | Pentasodium triphosphate
Einecs | 231-838-7
Chemical formula | Na5O10P3· nH2O (n = 0 or 6)
Molecular weight | 367,86
Assay | Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)
P2O5content | Not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)
Description | White, slightly hygroscopic granules or powder
Identification |
A.Solubility | A. | Solubility | Freely soluble in water. Insoluble in ethanol
A. | Solubility
B.Positive tests for sodium and for phosphate | B. | Positive tests for sodium and for phosphate |
B. | Positive tests for sodium and for phosphate
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 9,1 and 10,2
C. | pH of a 1 % solution
Purity |
Loss on drying | Anhydrous: Not more than 0,7 % (105oC, one hour)
Hexahydrate: Not more than 23,5 % (60oC, one hour, followed by drying at 105oC, four hours)
Water-insoluble substances | Not more than 0,1 %
Higher polyphosphates | Not more than 1 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
Synonyms | Pentapotassium tripolyphosphate
Potassium triphosphate
Potassium tripolyphosphate
Definition |
Chemical name | Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs | 237-574-9
Chemical formula | K5O10P3
Molecular weight | 448,42
Assay | Content not less than 85 % on the anhydrous basis
P2O5content | Not less than 46,5 % and not more than 48 %
Description | White, very hygroscopic powder or granules
Identification |
A.Solubility | A. | Solubility | Very soluble in water
A. | Solubility
B.Positive tests for potassium and for phosphate | B. | Positive tests for potassium and for phosphate |
B. | Positive tests for potassium and for phosphate
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 9,2 and 10,5
C. | pH of a 1 % solution
Purity |
Loss on ignition | Not more than 0,4 % (after drying at 105oC, four hours, followed by ignition at 550oC, 30 minutes)
Water-insoluble matter | Not more than 2 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 452 (i) SODIUM POLYPHOSPHATE1. SOLUBLE POLYPHOSPHATE
Synonyms | Sodium hexametaphosphate
Sodium tetrapolyphosphate
Graham’s salt
Sodium polyphosphates, glassy
Sodium polymetaphosphate
Sodium metaphosphate
Definition | Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)xwhere x ≥ 2, terminated by Na2PO4groups. These substances are usually identified by their Na2O/P2O5ratio or their P2O5content. The Na2O/P2O5ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham’s salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
Chemical name | Sodium polyphosphate
Einecs | 272-808-3
Chemical formula | Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight | (102)n
Assay P2O5content | Not less than 60 % and not more than 71 % on the ignited basis
Description | Colourless or white, transparent platelets, granules, or powders
Identification |
A.Solubility | A. | Solubility | Very soluble in water
A. | Solubility
B.Positive tests for sodium and for phosphate | B. | Positive tests for sodium and for phosphate |
B. | Positive tests for sodium and for phosphate
C.pH of a 1 % solution | C. | pH of a 1 % solution | Between 3,0 and 9,0
C. | pH of a 1 % solution
Purity |
Loss on ignition | Not more than 1 %
Water-insoluble matter | Not more than 0,1 %
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kg2. INSOLUBLE POLYPHOSPHATE
Synonyms | Insoluble sodium metaphosphate
Maddrell’s salt
Insoluble sodium polyphosphate, IMP
Definition | Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)xthat spiral in opposite directions about a common axis. The Na2O/P2O5ratio is about 1,0 . The pH of 1 in 3 suspension in water is about 6,5
Chemical name | Sodium polyphosphate
Einecs | 272-808-3
Chemical formula | Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight | (102)n
P2O5content | Not less than 68,7 % and not more than 70,0 %
Description | White crystalline powder
Identification |
A.Solubility | A. | Solubility | Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
A. | Solubility
B.Positive tests for sodium and for phosphate | B. | Positive tests for sodium and for phosphate |
B. | Positive tests for sodium and for phosphate
C.pH of 1 in 3 suspension in water | C. | pH of 1 in 3 suspension in water | About 6,5
C. | pH of 1 in 3 suspension in water
Purity |
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms | Potassium metaphosphate
Potassium polymetaphosphate
Kurrol salt
Definition |
Chemical name | Potassium polyphosphate
Einecs | 232-212-6
Chemical formula | (KPO3)n
Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight | (118)n
P2O5content | Not less than 53,5 % and not more than 61,5 % on the ignited basis
Description | Fine white powder or crystals or colourless glassy platelets
Identification |
A.Solubility | A. | Solubility | 1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
A. | Solubility
B.Positive tests for potassium and for phosphate | B. | Positive tests for potassium and for phosphate |
B. | Positive tests for potassium and for phosphate
C.pH of a 1 % suspension | C. | pH of a 1 % suspension | Not more than 7,8
C. | pH of a 1 % suspension
Purity |
Loss on ignition | Not more than 2 % (105oC, four hours followed by ignition at 550oC, 30 minutes)
Cyclic phosphate | Not more than 8 % on P2O5content
Fluoride | Not more than 10 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 452(iii) SODIUM CALCIUM POLYPHOSPHATE
Synonym | Sodium calcium polyphosphate, glassy
Definition |
Chemical name | Sodium calcium polyphosphate
Einecs | 233-782-9
Chemical formula | (NaPO3)nCaO where n is typically 5
Assay | Not less than 61 % and not more than 69 % as P2O5
Description | White glassy crystals, spheres
Identification |
A.pH of a 1 % m/m slurry | A. | pH of a 1 % m/m slurry | Approximately 5 to 7
A. | pH of a 1 % m/m slurry
B.CaO content | B. | CaO content | 7 %-15 % m/m
B. | CaO content
Purity |
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 4 mg/kg
Cadmium | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 452 (iv) CALCIUM POLYPHOSPHATE
Synonyms | Calcium metaphosphate
Calcium polymetaphosphate
Definition |
Chemical name | Calcium polyphosphate
Einecs | 236-769-6
Chemical formula | (CaP2O6)n
Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1)where ‘n’ is not less than 2
Molecular weight | (198)n
P2O5content | Not less than 71 % and not more than 73 % on the ignited basis
Description | Odourless, colourless crystals or white powder
Identification |
A.Solubility | A. | Solubility | Usually sparingly soluble in water. Soluble in acid medium
A. | Solubility
B.Positive tests for calcium and for phosphate | B. | Positive tests for calcium and for phosphate |
B. | Positive tests for calcium and for phosphate
C.CaO content | C. | CaO content | 27 to 29,5 %
C. | CaO content
Purity |
Loss on ignition | Not more than 2 % (105oC, four hours followed by ignition at 550oC, 30 minutes)
Cyclic phosphate | Not more than 8 % on P2O5content
Fluoride | Not more than 30 mg/kg (expressed as fluorine)
Arsenic | Not more than 3 mg/kg
Cadmium | Not more than 1 mg/kg
Lead | Not more than 4 mg/kg
Mercury | Not more than 1 mg/kgE 459 BETA-CYCLODEXTRIN
Definition | Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained fromBacillus circulans, Paenibacillus maceransor recombinantBacillus licheniformisstrain SJ1608 on partially hydrolysed starch
Chemical name | Cycloheptaamylose
Einecs | 231-493-2
Chemical formula | (C6H10O5)7
Molecular weight | 1 135
Assay | Content not less than 98,0 % of (C6H10O5)7on an anhydrous basis
Description | Virtually odourless white or almost white crystalline solid
Identification |
A.Solubility | A. | Solubility | Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
A. | Solubility
B.Specific rotation | B. | Specific rotation | [α]25D: + 160oto + 164o(1 % solution)
B. | Specific rotation
Purity |
Water | Not more than 14 % (Karl Fischer method)
Other cyclodextrins | Not more than 2 % on an anhydrous basis
Residual solvents (toluene and trichloroethylene) | Not more than 1 mg/kg for each solvent
Sulphated ash | Not more than 0,1 %
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kgE 460 (i) MICROCRISTALLINE CELLULOSE
Synonyms | Cellulose gel
Definition | Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
Chemical name | Cellulose
Einecs | 232-674-9
Chemical formula | (C6H10O5)n
Molecular weight | About 36 000
Assay | Not less than 97 % calculated as cellulose on the anhydrous basis
Description | A fine white or almost white odourless powder
Identification |
A.Solubility | A. | Solubility | Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
A. | Solubility
B.Colour reaction | B. | Colour reaction | To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced
B. | Colour reaction
C.To be identified by IR spectroscopy | C. | To be identified by IR spectroscopy |
C. | To be identified by IR spectroscopy
D.Suspension test | D. | Suspension test | Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
D. | Suspension test
Purity |
Loss on drying | Not more than 7 % (105oC, 3 hours)
Water-soluble matter | Not more than 0,24 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
pH of a 10 % suspension in water | The pH of the supernatant liquid is between 5,0 and 7,5
Starch | Not detectable
To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Particle size | Not less than 5μm (not more than 10 % of particles of less than 5μm)
Carboxyl groups | Not more than 1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 460 (ii) POWDERED CELLULOSE
Definition | Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials
Chemical name | Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs | 232-674-9
Chemical formula | (C6H10O5)n
Molecular weight | (162)n(n is predominantly 1 000 and greater)
Assay | Content not less than 92 %
Description | A white, odourless powder
Identification |
A.Solubility | A. | Solubility | Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
A. | Solubility
B.Suspension test | B. | Suspension test | Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settle and a supernatant liquid appears
B. | Suspension test
Purity |
Loss on drying | Not more than 7 % (105oC, 3 hours)
Water-soluble matter | Not more than 1,0 %
Sulphated ash | Not more than 0,3 % determined at 800 ± 25oC
pH of a 10 % suspension in water | The pH of the supernatant liquid is between 5,0 and 7,5
Starch | Not detectable
To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Particle size | Not less than 5μm (not more than 10 % of particles of less than 5μm)E 461 METHYL CELLULOSE
Synonyms | Cellulose methyl ether
Definition | Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups
Chemical name | Methyl ether of cellulose
Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3each may be one of the following:—H—CH3—or CH2CH3 | — | H | — | CH3 | — | or CH2CH3
— | H
— | CH3
— | or CH2CH3
Molecular weight | From about 20 000 to 380 000
Assay | Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)
Description | Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification |
A.Solubility | A. | Solubility | Swelling in water, producing a clear to opalescent, viscous, colloidal solution.
A. | Solubility
Insoluble in ethanol, ether and chloroform.
Soluble in glacial acetic acid
Purity |
Loss on drying | Not more than 10 % (105oC, 3 hours)
Sulphated ash | Not more than 1,5 % determined at 800 ± 25oC
pH of a 1 % colloidal solution | Not less than 5,0 and not more than 8,0
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 462 ETHYL CELLULOSE
Synonyms | Cellulose ethyl ether
Definition | Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
Chemical name | Ethyl ether of cellulose
Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2) where R1and R2may be any of the following:—H—CH2CH3 | — | H | — | CH2CH3
— | H
— | CH2CH3
Assay | Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)
Description | Slightly hygroscopic white to off-white, odourless and tasteless powder
Identification |
A.Solubility | A. | Solubility | Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate
A. | Solubility
B.Film forming test | B. | Film forming test | Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable
B. | Film forming test
Purity |
Loss on drying | Not more than 3 % (105oC, 2 hours)
Sulphated ash | Not more than 0,4 %
pH of a 1 % colloidal solution | Neutral to litmus
Arsenic | Not more than 3 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 463 HYDROXYPROPYL CELLULOSE
Synonyms | Cellulose hydroxypropyl ether
Definition | Hydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups
Chemical name | Hydroxypropyl ether of cellulose
Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3each may be one of the following:—H—CH2CHOHCH3—CH2CHO(CH2CHOHCH3)CH3—CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3 | — | H | — | CH2CHOHCH3 | — | CH2CHO(CH2CHOHCH3)CH3 | — | CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
— | H
— | CH2CHOHCH3
— | CH2CHO(CH2CHOHCH3)CH3
— | CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weight | From about 30 000 to 1 000 000
Assay | Content not less than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
Description | Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification |
A.Solubility | A. | Solubility | Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
A. | Solubility
B.Gas chromatography | B. | Gas chromatography | Determine the substituents by gas chromotography
B. | Gas chromatography
Purity |
Loss on drying | Not more than 10 % (105oC, 3 hours)
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
pH of a 1 % colloidal solution | Not less than 5,0 and not more than 8,0
Propylene chlorohydrins | Not more than 0,1 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 464 HYDROXYPROPYL METHYL CELLULOSE
Definition | Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
Chemical name | 2-Hydroxypropyl ether of methylcellulose
Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2R3each may be one of the following:—H—CH3—CH2CHOHCH3—CH2CHO (CH2CHOHCH3) CH3—CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3 | — | H | — | CH3 | — | CH2CHOHCH3 | — | CH2CHO (CH2CHOHCH3) CH3 | — | CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
— | H
— | CH3
— | CH2CHOHCH3
— | CH2CHO (CH2CHOHCH3) CH3
— | CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
Molecular weight | From about 13 000 to 200 000
Assay | Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis
Description | Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification |
A.Solubility | A. | Solubility | Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
A. | Solubility
B.Gas chromatography | B. | Gas chromatography | Determine the substituents by gas chromatography
B. | Gas chromatography
Purity |
Loss on drying | Not more than 10 % (105oC, 3 hours)
Sulphated ash | Not more than 1,5 % for products with viscosities of 50 mPa.s or above
Not more than 3 % for products with viscosities below 50 mPa.s
pH of a 1 % colloidal solution | Not less than 5,0 and not more than 8,0
Propylene chlorohydrins | Not more than 0,1 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 465 ETHYL METHYL CELLULOSE
Synonyms | Methylethylcellulose
Definition | Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups
Chemical name | Ethyl methyl ether of cellulose
Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2R3each may be one of the following:—H—CH3—CH2CH3 | — | H | — | CH3 | — | CH2CH3
— | H
— | CH3
— | CH2CH3
Molecular weight | From about 30 000 to 40 000
Assay | Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl
Description | Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification |
A.Solubility | A. | Solubility | Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
A. | Solubility
Purity |
Loss on drying | Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105oC to constant weight)
Sulphated ash | Not more than 0,6 %
pH of a 1 % colloidal solution | Not less than 5,0 and not more than 8,0
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kgE 466 SODIUM CARBOXY METHYL CELLULOSE
Synonyms | Carboxy methyl cellulose
CMC
NaCMC
Sodium CMC
Cellulose gum
Definition | Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material
Chemical name | Sodium salt of the carboxymethyl ether of cellulose
Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1, R2R3each may be one of the following:—H—CH2COONa—CH2COOH | — | H | — | CH2COONa | — | CH2COOH
— | H
— | CH2COONa
— | CH2COOH
Molecular weight | Higher than approximately 17 000 (degree of polymerisation approximately 100)
Assay | Content on the anhydrous basis not less than 99,5 %
Description | Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification |
A.Solubility | A. | Solubility | Yields a viscous colloidal solution with water. Insoluble in ethanol
A. | Solubility
B.Foam test | B. | Foam test | A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)
B. | Foam test
C.Precipitate formation | C. | Precipitate formation | To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
C. | Precipitate formation
D.Colour reaction | D. | Colour reaction | Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
D. | Colour reaction
Purity |
Degree of substitution | Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit
Loss on drying | Not more than 12 % (105oC to constant weight)
pH of a 1 % colloidal solution | Not less than 5,0 and not more than 8,5
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 20 mg/kg
Total glycolate | Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis
Sodium | Not more than 12,4 % on the anhydrous basisE 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE
Synonyms | Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum
Definition | Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
Chemical name | Sodium salt of the cross-linked carboxymethyl ether cellulose
Chemical formula | The polymers containing substituted anhydroglucose units with the general formula:
C6H7O2(OR1)(OR2)(OR3)
where R1, R2and R3may be any of the following:—H—CH2COONa—CH2COOH | — | H | — | CH2COONa | — | CH2COOH
— | H
— | CH2COONa
— | CH2COOH
Description | Slightly hygroscopic, white to off white, odourless powder
Identification |
A. | Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
B. | Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
C. | It gives the reaction of sodium
Purity |
Loss on drying | Not more than 6 % (105oC, 3h)
Water solubles | Not more than 10 %
Degree of substitution | Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
pH of 1 % | Not less than 5,0 and not more than 7,0
Sodium content | Not more than 12,4 % on anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Cadmium | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE
Synonyms | Sodium carboxymethyl cellulose, enzymatically hydrolysed
Definition | Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced byTrichoderma longibrachiatum(formerlyT. reesei)
Chemical name | Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed
Chemical formula | Sodium salts of polymers containing substituted anhydroglucose units with the general formula:
[C6H7O2(OH)x(OCH2COONa)y]n
where n is the degree of polymerisation
x = 1,50 to 2,80
y = 0,2 to 1,50
x + y = 3,0
(y = degree of substitution)
Formula weight | 178,14 where y = 0,20
282,18 where y = 1,50
Macromolecules: Not less than 800 (n about 4)
Assay | Not less than 99,5 %, including mono- and disaccharides, on the dried basis
Description | White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder
Identification |
A.Solubility | A. | Solubility | Soluble in water, insoluble in ethanol
A. | Solubility
B.Foam test | B. | Foam test | Vigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums
B. | Foam test
C.Precipitate formation | C. | Precipitate formation | To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
C. | Precipitate formation
D.Colour reaction | D. | Colour reaction | Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
D. | Colour reaction
E.Viscosity (60 % solids) | E. | Viscosity (60 % solids) | Not less than 2,500 kgm-1s-1at 25oC corresponding to an average molecule weight of 5 000 D
E. | Viscosity (60 % solids)
Purity |
Loss on drying | Not more than 12 % (105oC to constant weight)
Degree of substitution | Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis
pH of a 1 % colloidal solution | Not less than 6,0 and not more than 8,5
Sodium chloride and sodium glycolate | Not more than 0,5 % singly or in combination
Residual enzyme activity | Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose
Lead | Not more than 3 mg/kgE 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS
Definition | Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
Assay | Content on the anhydrous basis not less than 95 %
Description | White or creamy white light powders, flakes or semi-solids
Identification |
A.Solubility | A. | Solubility | Sodium and potassium salts: soluble in water and ethanol calcium salts:
A. | Solubility
insoluble in water, ethanol and ether
B.Positive tests for cations and for fatty acids | B. | Positive tests for cations and for fatty acids |
B. | Positive tests for cations and for fatty acids
Purity |
Sodium | Not less than 9 % and not more than 14 % expressed as Na2O
Potassium | Not less than 13 % and not more than 21,5 % expressed as K2O
Calcium | Not less than 8,5 % and not more than 13 % expressed as CaO
Unsaponifiable matter | Not more than 2 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Free alkali | Not more than 0,1 % expressed as NaOH
Matter insoluble in alcohol | Not more than 0,2 % (sodium and potassium salts only)E 470b MAGNESIUM SALTS OF FATTY ACIDS
Definition | Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
Assay | Content on the anhydrous basis not less than 95 %
Description | White or creamy-white light powders, flakes or semi-solids
Identification |
A.Solubility | A. | Solubility | Insoluble in water, partially soluble in ethanol and ether
A. | Solubility
B.Positive tests for magnesium and for fatty acids | B. | Positive tests for magnesium and for fatty acids |
B. | Positive tests for magnesium and for fatty acids
Purity |
Magnesium | Not less than 6,5 % and not more than 11 % expressed as MgO
Free alkali | Not more than 0,1 % expressed as MgO
Unsaponifiable matter | Not more than 2 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Glyceryl monostearate
Glyceryl monopalmitate
Glyceryl monooleate, etc.
Monostearin, monopalmitin, monoolein, etc.
GMS (for glyceryl monostearate)
Definition | Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
Assay | Content of mono- and diesters: not less than 70 %
Description | The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads
Identification |
A.Infrared spectrum | A. | Infrared spectrum | Characteristic of a partial fatty acid ester of a polyol
A. | Infrared spectrum
B.Positive tests for glycerol and for fatty acids | B. | Positive tests for glycerol and for fatty acids |
B. | Positive tests for glycerol and for fatty acids
C.Solubility | C. | Solubility | Insoluble in water, soluble in ethanol and toluene
C. | Solubility
Purity |
Water content | Not more than 2 % (Karl Fischer method)
Acid value | Not more than 6
Free glycerol | Not more than 7 %
Polyglycerols | Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Total glycerol | Not less than 16 % and not more than 33 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Acetic acid esters of mono- and diglycerides
Acetoglycerides
Acetylated mono- and diglycerides
Acetic and fatty acid esters of glycerol
Definition | Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides
Description | Clear, mobile liquids to solids, from white to pale yellow in colour
Identification |
A.Positive tests for glycerol, for fatty acids and for acetic acid | A. | Positive tests for glycerol, for fatty acids and for acetic acid |
A. | Positive tests for glycerol, for fatty acids and for acetic acid
B.Solubility | B. | Solubility | Insoluble in water. Soluble in ethanol
B. | Solubility
Purity |
Acids other than acetic and fatty acids | Not detectable
Free glycerol | Not more than 2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Total acetic acid | Not less than 9 % and not more than 32 %
Free fatty acids (and acetic acid) | Not more than 3 % estimated as oleic acid
Total glycerol | Not less than 14 % and not more than 31 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Lactic acid esters of mono- and diglycerides
Lactoglycerides
Mono- and diglycerides of fatty acids esterified with lactic acid
Definition | Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
Description | Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
Identification |
A.Positive tests for glycerol, for fatty acids and for lactic acid | A. | Positive tests for glycerol, for fatty acids and for lactic acid |
A. | Positive tests for glycerol, for fatty acids and for lactic acid
B.Solubility | B. | Solubility | Insoluble in cold water but dispersible in hot water
B. | Solubility
Purity |
Acids other than lactic and fatty acids | Not detectable
Free glycerol | Not more than 2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Total lactic acid | Not less than 13 % and not more than 45 %
Free fatty acids (and lactic acid) | Not more than 3 % estimated as oleic acid
Total glycerol | Not less than 13 % and not more than 30 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Citrem
Citric acid esters of mono- and diglycerides
Citroglycerides
Mono- and diglycerides of fatty acids esterified with citric acid
Definition | Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide
Description | Yellowish or light brown liquids to waxy solids or semi-solids
Identification |
A.Positive tests for glycerol, for fatty acids and for citric acid | A. | Positive tests for glycerol, for fatty acids and for citric acid |
A. | Positive tests for glycerol, for fatty acids and for citric acid
B.Solubility | B. | Solubility | Insoluble in cold water
B. | Solubility
Dispersible in hot water
Soluble in oils and fats
Insoluble in cold ethanol
Purity |
Acids other than citric and fatty acids | Not detectable
Free glycerol | Not more than 2 %
Total glycerol | Not less than 8 % and not more than 33 %
Total citric acid | Not less than 13 % and not more than 50 %
Sulphated ash (determined at 800 ± 25oC) | Non-neutralised products: not more than 0,5 %
Partially or wholly neutralised products: not more than 10 %
Lead | Not more than 2 mg/kg
Free fatty acids | Not more than 3 % estimated as oleic acid
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Tartaric acid esters of mono- and diglycerides
Mono- and diglycerides of fatty acids esterified with tartaric acid
Definition | Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
Description | Sticky viscous yellowish liquids to hard yellow waxes
Identification |
A.Positive tests for glycerol, for fatty acids and for tartaric acid | A. | Positive tests for glycerol, for fatty acids and for tartaric acid |
A. | Positive tests for glycerol, for fatty acids and for tartaric acid
Purity |
Acids other than tartaric and fatty acids | Not detectable
Free glycerol | Not more than 2 %
Total glycerol | Not less than 12 % and not more than 29 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Total tartaric acid | Not less than 15 % and not more than 50 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Diacetyltartaric acid esters of mono- and diglycerides
Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid
Diacetyltartaric and fatty acid esters of glycerol
Definition | Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
Description | Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
Identification |
A.Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid | A. | Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid |
A. | Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Purity |
Acids other than acetic, tartaric and fatty acids | Not detectable
Free glycerol | Not more than 2 %
Total glycerol | Not less than 11 % and not more than 28 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Total tartaric acid | Not less than 10 % and not more than 40 %
Total acetic acid | Not less than 8 % and not more than 32 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid
Definition | Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
Description | Sticky liquids to solids, from white to pale-yellow in colour
Identification |
A.Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid | A. | Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid |
A. | Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Purity |
Acids other than acetic, tartaric and fatty acids | Not detectable
Free glycerol | Not more than 2 %
Total glycerol | Not less than 12 % and not more than 27 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Total acetic acid | Not less than 10 % and not more than 20 %
Total tartaric acid | Not less than 20 % and not more than 40 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 473 SUCROSE ESTERS OF FATTY ACIDS
Synonyms | Sucroesters
Sugar esters
Definition | Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation
Assay | Content not less than 80 %
Description | Stiff gels, soft solids or white to slightly greyish-white powders
Identification |
A.Positive tests for sugar for fatty acids | A. | Positive tests for sugar for fatty acids |
A. | Positive tests for sugar for fatty acids
B.Solubility | B. | Solubility | Sparingly soluble in water
B. | Solubility
Soluble in ethanol
Purity |
Sulphated ash | Not more than 2 % determined at 800 ± 25oC
Free sugar | Not more than 5 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Methanol | Not more than 10 mg/kg
Dimethylsulphoxide | Not more than 2 mg/kg
Dimethylformamide | Not more than 1 mg/kg
2-methyl-1-propanol | Not more than 10 mg/kg
Ethylacetate | | Not more than 350 mg/kg, singly or in combination
Propane-2-ol
Prolyleneglycol
Methyl ethyl ketone | Not more than 10 mg/kg
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 474 SUCROGLYCERIDES
Synonyms | Sugar glycerides
Definition | Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol
Assay | Content not less than 40 % and not more than 60 % of sucrose fatty acid esters
Description | Soft solid masses, stiff gels or white to off-white powders
Identification |
A.Positive tests for sugar and for fatty acids | A. | Positive tests for sugar and for fatty acids |
A. | Positive tests for sugar and for fatty acids
B.Solubility | B. | Solubility | Insoluble in cold water
B. | Solubility
Soluble in ethanol
Purity |
Sulphated ash | Not more than 2 % determined at 800 ± 25oC
Free sugar | Not more than 5 %
Free fatty acids | Not more than 3 % estimated as oleic acid
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Methanol | Not more than 10 mg/kg
Dimethylformamide | Not more than 1 mg/kg
2-methyl-1-propanol | | Not more than 10 mg/kg, single or in combination
Cyclohexane
Ethylacetate | | Not more than 350 mg/kg, single or in combination
Propane-2-ol
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS
Synonyms | Polyglycerol fatty acid esters
Polyglycerin esters of fatty acid esters
Definition | Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Assay | Content of total fatty acid ester not less than 90 %
Description | Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids
Identification |
A.Positive tests for glycerol, for polyglycerols and for fatty acids | A. | Positive tests for glycerol, for polyglycerols and for fatty acids |
A. | Positive tests for glycerol, for polyglycerols and for fatty acids
B.Solubility | B. | Solubility | The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils
B. | Solubility
Purity |
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Acids other than fatty acids | Not detectable
Free fatty acids | Not more than 6 % estimated as oleic acid
Total glycerol and polyglycerol | Not less than 18 % and not more than 60 %
Free glycerol and polyglycerol | Not more than 7 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 476 POLYGLYCEROL POLYRICINOLEATE
Synonyms | Glycerol esters of condensed castor oil fatty acids
Polyglycerol esters of polycondensed fatty acids from castor oil
Polyglycerol esters of interesterified ricinoleic acid
PGPR
Definition | Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids
Description | Clear, highly viscous liquid
Identification |
A.Solubility | A. | Solubility | Insoluble in water and in ethanol.
A. | Solubility
Soluble in ether, hydrocarbons and halogenated hydrocarbons
B.Positive tests for glycerol, polyglycerol and for ricinoleic acid | B. | Positive tests for glycerol, polyglycerol and for ricinoleic acid |
B. | Positive tests for glycerol, polyglycerol and for ricinoleic acid
C.Refractive index [n]65 | C. | Refractive index [n]65 | Between 1,4630 and 1,4665
C. | Refractive index [n]65
Purity |
Polyglycerols | The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Hydroxyl value | Not less than 80 and not more than 100
Acid value | Not more than 6
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS
Synonyms | Propylene glycol esters of fatty acids
Definition | Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent
Assay | Content of total fatty acid ester not less than 85 %
Description | Clear liquids or waxy white flakes, beads or solids having a bland odour
Identification |
A.Positive tests for propylene glycol and for fatty acids | A. | Positive tests for propylene glycol and for fatty acids |
A. | Positive tests for propylene glycol and for fatty acids
Purity |
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Acids other than fatty acids | Not detectable
Free fatty acids | Not more than 6 % estimated as oleic acid
Total propane-1,2-diol | Not less than 11 % and not more than 31 %
Free propane-1,2-diol | Not more than 5 %
Dimer and trimer of propylene glycol | Not more than 0,5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Note:Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). | Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms | TOSOM
Definition | Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans
Description | Pale yellow to light brown a waxy or solid consistency
Identification |
A.Solubility | A. | Solubility | Insoluble in water. Soluble in hot oil or fat
A. | Solubility
Purity |
Melting range | 55-65oC
Free fatty acids | Not more than 1,5 % estimated as oleic acid
Free glycerol | Not more than 2 %
Total fatty acids | 83-90 %
Total glycerol | 16-22 %
Fatty acid methyl esters, not forming adduct with urea | Not more than 9 % of total fatty acid methyl esters
Fatty acids, insoluble in petroleum ether | Not more than 2 % of total fatty acids
Peroxide value | Not more than 3
Epoxides | Not more than 0,03 % oxirane oxygen
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 481 SODIUM STEAROYL-2-LACTYLATE
Synonyms | Sodium stearoyl lactylate
Sodium stearoyl lactate
Definition | A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Chemical names | Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs | 246-929-7
Chemical formula (major components) | C21H39O4Na
C19H35O4Na
Description | White or slightly yellowish powder or brittle solid with a characteristic odour
Identification |
A.Positive tests for sodium, for fatty acids and for lactic acid | A. | Positive tests for sodium, for fatty acids and for lactic acid |
A. | Positive tests for sodium, for fatty acids and for lactic acid
B.Solubility | B. | Solubility | Insoluble in water. Soluble in ethanol
B. | Solubility
Purity |
Sodium | Not less than 2,5 % and not more than 5 %
Ester value | Not less than 90 and not more than 190
Acid value | Not less than 60 and not more than 130
Total lactic acid | Not less than 15 % and not more than 40 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 482 CALCIUM STEAROYL-2-LACTYLATE
Synonyms | Calcium stearoyl lactate
Definition | A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
Chemical name | Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs | 227-335-7
Chemical formula | C42H78O8Ca
C38H70O8Ca
Description | White or slightly yellowish powder or brittle solid with a characteristic odour
Identification |
A.Positive tests for calcium, for fatty acids and for lactid acid | A. | Positive tests for calcium, for fatty acids and for lactid acid |
A. | Positive tests for calcium, for fatty acids and for lactid acid
B.Solubility | B. | Solubility | Slightly soluble in hot water
B. | Solubility
Purity |
Calcium | Not less than 1 % and not more than 5,2 %
Ester value | Not less than 125 and not more than 190
Total lactic acid | Not less than 15 % and not more than 40 %
Acid value | Not less than 50 and not more than 130
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 483 STEARYL TARTRATE
Synonyms | Stearyl palmityl tartrate
Definition | Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
Chemical name | Distearyl tartrate
Dipalmityl tartrate
Chemical formula | C38H74O6to C40H78O6
Molecular weight | 627 to 655
Assay | Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180
Description | Cream-coloured unctuous solid (at 25oC)
Identification |
A.Positive tests for tartare | A. | Positive tests for tartare |
A. | Positive tests for tartare
B.Melting range | B. | Melting range | Between 67oC and 77oC. After saponification the saturated long chain fatty alcohols have a melting range of 49oC to 55oC
B. | Melting range
Purity |
Hydroxyl value | Not less than 200 and not more than 220
Acid value | Not more than 5,6
Total tartaric acid content | Not less than 18 % and not more than 35 %
Sulphated ash | Not more than 0,5 % determined at 800 ± 25oC
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Unsaponifiable matter | Not less than 77 % and not more than 83 %
Iodine value | Not more than 4 (Wijs method)E 491 SORBITAN MONOSTEARATE
Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs | 215-664-9
Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description | Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50oC in mineral oil and ethyl acetate
A. | Solubility
B.Congealing range | B. | Congealing range | 50-52oC
B. | Congealing range
C.Infrared absorption spectrum | C. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyol
C. | Infrared absorption spectrum
Purity |
Water | Not more than 2 % (Karl Fischer method)
Sulphated ash | Not more than 0,5 %
Acid value | Not more than 10
Saponification value | Not less than 147 and not more than 157
Hydroxyl value | Not less than 235 and not more than 260
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 492 SORBITAN TRISTEARATE
Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs | 247-891-4
Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description | Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour
Identification |
A.Solubility | A. | Solubility | Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol
A. | Solubility
B.Congealing range | B. | Congealing range | 47-50oC
B. | Congealing range
C.Infrared absorption spectrum | C. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyol
C. | Infrared absorption spectrum
Purity |
Water | Not more than 2 % (Karl Fischer method)
Sulphated ash | Not more than 0,5 %
Acid value | Not more than 15
Saponification value | Not less than 176 and not more than 188
Hydroxyl value | Not less than 66 and not more than 80
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 493 SORBITAN MONOLAURATE
Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
Einecs | 215-663-3
Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description | Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour
Identification |
A.Solubility | A. | Solubility | Dispersible in hot and cold water
A. | Solubility
B.Infrared absorption spectrum | B. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyol
B. | Infrared absorption spectrum
Purity |
Water | Not more than 2 % (Karl Fischer method)
Sulphated ash | Not more than 0,5 %
Acid value | Not more than 7
Saponification value | Not less than 155 and not more than 170
Hydroxyl value | Not less than 330 and not more than 358
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 494 SORBITAN MONOOLEATE
Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
Einecs | 215-665-4
Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters
Description | Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water
A. | Solubility
B.Iodine value | B. | Iodine value | The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100
B. | Iodine value
Purity |
Water | Not more than 2 % (Karl Fischer method)
Sulphated ash | Not more than 0,5 %
Acid value | Not more than 8
Saponification value | Not less than 145 and not more than 160
Hydroxyl value | Not less than 193 and not more than 210
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 495 SORBITAN MONOPALMITATE
Synonyms | Sorbitan palmitate
Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid
Einecs | 247-568-8
Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description | Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification |
A.Solubility | A. | Solubility | Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water
A. | Solubility
B.Congealing range | B. | Congealing range | 45-47oC
B. | Congealing range
C.Infrared absorption spectrum | C. | Infrared absorption spectrum | Characteristic of a partial fatty acid ester of polyol
C. | Infrared absorption spectrum
Purity |
Water | Not more than 2 % (Karl Fischer method)
Sulphate ash | Not more than 0,5 %
Acid value | Not more than 7,5
Saponification value | Not less than 140 and not more than 150
Hydroxyl value | Not less than 270 and not more than 305
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 500(i) SODIUM CARBONATE
Synonyms | Soda ash
Definition |
Chemical name | Sodium carbonate
Einecs | 207-838-8
Chemical formula | Na2CO3· nH2O (n = 0, 1 or 10)
Molecular weight | 106,00 (anhydrous)
Assay | Content not less than 99 % of Na2CO3on the anhydrous basis
Description | Colourless crystals or white, granular or crystalline powder
The anhydrous form is hygroscopic, the decahydrate efflorescent
Identification |
A.Positive tests for sodium and for carbonate | A. | Positive tests for sodium and for carbonate |
A. | Positive tests for sodium and for carbonate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
Purity |
Loss on drying | Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70oC raising gradually to 300oC, to constant weight)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 500(ii) SODIUM HYDROGEN CARBONATE
Synonyms | Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking soda
Definition |
Chemical name | Sodium hydrogen carbonate
Einecs | 205-633-8
Chemical formula | NaHCO3
Molecular weight | 84,01
Assay | Content not less than 99 % on the anhydrous basis
Description | Colourless or white crystalline masses or crystalline powder
Identification |
A.Positive tests for sodium and for carbonate | A. | Positive tests for sodium and for carbonate |
A. | Positive tests for sodium and for carbonate
B.pH of a 1 % solution | B. | pH of a 1 % solution | Between 8,0 and 8,6
B. | pH of a 1 % solution
C.Solubility | C. | Solubility | Soluble in water. Insoluble in ethanol
C. | Solubility
Purity |
Loss on drying | Not more than 0,25 % (over silica gel, 4h)
Ammonium salts | No odour of ammonia detectable after heating
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 500(iii) SODIUM SESQUICARBONATE
Definition |
Chemical name | Sodium monohydrogen dicarbonate
Einecs | 208-580-9
Chemical formula | Na2(CO)3· NaHCO3· 2H2O
Molecular weight | 226,03
Assay | Content between 35,0 % and 38,6 % of NaHCO3and between 46,4 % and 50,0 % of Na2CO3
Description | White flakes, crystals or crystalline powder
Identification |
A.Positive tests for sodium and for carbonate | A. | Positive tests for sodium and for carbonate |
A. | Positive tests for sodium and for carbonate
B.Solubility | B. | Solubility | Freely soluble in water
B. | Solubility
Purity |
Sodium chloride | Not more than 0,5 %
Iron | Not more than 20 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 501(i) POTASSIUM CARBONATE
Definition |
Chemical name | Potassium carbonate
Einecs | 209-529-3
Chemical formula | K2CO3· nH2O (n = 0 or 1,5 )
Molecular weight | 138,21 (anhydrous)
Assay | Content not less than 99,0 % on the anhydrous basis
Description | White, very deliquescent powder.
The hydrate occurs as small, white, translucent crystals or granules
Identification |
A.Positive tests for potassium and for carbonate | A. | Positive tests for potassium and for carbonate |
A. | Positive tests for potassium and for carbonate
B.Solubility | B. | Solubility | Very soluble in water. Insoluble in ethanol
B. | Solubility
Purity |
Loss on drying | Not more than 5 % (anhydrous) or 18 % (hydrate) (180oC, 4h)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 501(ii) POTASSIUM HYDROGEN CARBONATE
Synonyms | Potassium bicarbonate, acid potassium carbonate
Definition |
Chemical name | Potassium hydrogen carbonate
Einecs | 206-059-0
Chemical formula | KHCO3
Molecular weight | 100,11
Assay | Content not less than 99,0 % and not more than 101,0 % KHCO3on the anhydrous basis
Description | Colourless crystals or white powder or granules
Identification |
A.Positive tests for potassium and for carbonate | A. | Positive tests for potassium and for carbonate |
A. | Positive tests for potassium and for carbonate
B.Solubility | B. | Solubility | Freely soluble in water. Insoluble in ethanol
B. | Solubility
Purity |
Loss on drying | Not more than 0,25 % (over silica gel, 4h)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 503(i) AMMONIUM CARBONATE
Definition | Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
Chemical name | Ammonium carbonate
Einecs | 233-786-0
Chemical formula | CH6N2O2, CH8N2O3and CH5NO3
Molecular weight | Ammonium carbamate 78,06 ; ammonium carbonate 98,73 ; ammonium hydrogen carbonate 79,06
Assay | Content not less than 30,0 % and not more than 34,0 % of NH3
Description | White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide
Identification |
A.Positive tests for ammonium and for carbonate | A. | Positive tests for ammonium and for carbonate |
A. | Positive tests for ammonium and for carbonate
B.pH of a 5 % solution | B. | pH of a 5 % solution | about 8,6
B. | pH of a 5 % solution
C.Solubility | C. | Solubility | Soluble in water
C. | Solubility
Purity |
Non-volatile matter | Not more than 500 mg/kg
Chlorides | Not more than 30 mg/kg
Sulphate | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 503(ii) AMMONIUM HYDROGEN CARBONATE
Synonyms | Ammonium bicarbonate
Definition |
Chemical name | Ammonium hydrogen carbonate
Einecs | 213-911-5
Chemical formula | CH5NO3
Molecular weight | 79,06
Assay | Content not less than 99,0 %
Description | White crystals or crystalline powder
Identification |
A.Positive tests for ammonium and for carbonate | A. | Positive tests for ammonium and for carbonate |
A. | Positive tests for ammonium and for carbonate
B.pH of a 5 % solution | B. | pH of a 5 % solution | about 8,0
B. | pH of a 5 % solution
C.Solubility | C. | Solubility | Freely soluble in water. Insoluble in ethanol
C. | Solubility
Purity |
Non-volatile matter | Not more than 500 mg/kg
Chlorides | Not more than 30 mg/kg
Sulphate | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 504(ii) MAGNESIUM HYDROXIDE CARBONATE
Synonyms | Magnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxide
Definition |
Chemical name | Magnesium carbonate hydroxide hydrated
Einecs | 235-192-7
Chemical formula | 4MgCO3Mg(OH)25H2O
Molecular weight | 485
Assay | Mg content not less than 40,0 % and not more than 45,0 % calculated as MgO
Description | Light, white friable mass or bulky white powder
Identification |
A.Positive tests for magnesium and for carbonate | A. | Positive tests for magnesium and for carbonate |
A. | Positive tests for magnesium and for carbonate
B.Solubility | B. | Solubility | Practically insoluble in water. Insoluble in ethanol
B. | Solubility
Purity |
Acid insoluble matter | Not more than 0,05 %
Water soluble matter | Not more than 1,0 %
Calcium | Not more than 1,0 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kgE 507 HYDROCHLORIC ACID
Synonyms | Hydrogen chloride, muriatic acid
Definition |
Chemical name | Hydrochloric acid
Einecs | 231-595-7
Chemical formula | HCl
Molecular weight | 36,46
Assay | Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HCl
Description | Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour
Identification |
A.Positive tests for acid and for chloride | A. | Positive tests for acid and for chloride |
A. | Positive tests for acid and for chloride
B.Solubility | B. | Solubility | Soluble in water and in ethanol
B. | Solubility
Purity |
Total organic compounds | Total organic compounds (non-fluorine containing): not more than 5 mg/kg
Benzene: not more than 0,05 mg/kg
Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter | Not more than 0,5 %
Reducing substances | Not more than 70 mg/kg (as SO2)
Oxidising substances | Not more than 30 mg/kg (as Cl2)
Sulphate | Not more than 0,5 %
Iron | Not more than 5 mg/kg
Arsenic | Not more than 1 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 508 POTASSIUM CHLORIDE
Synonyms | Sylvine
Sylvite
Definition |
Chemical name | Potassium chloride
Einecs | 231-211-8
Chemical formulae | KCl
Molecular weight | 74,56
Assay | Content not less than 99 % on the dried basis
Description | Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless
Identification |
A.Solubility | A. | Solubility | Freely soluble in water. Insoluble in ethanol
A. | Solubility
B.Positive tests for potassium and for chloride | B. | Positive tests for potassium and for chloride |
B. | Positive tests for potassium and for chloride
Purity |
Loss on drying | Not more than 1 % (105oC, 2 hours)
Sodium | Negative test
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kgE 509 CALCIUM CHLORIDE
Definition |
Chemical name | Calcium chloride
Einecs | 233-140-8
Chemical formula | CaCl2· nH2O (n = 0,2 or 6)
Molecular weight | 110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)
Assay | Content not less than 93,0 % on the anhydrous basis
Description | White, odourless, hygroscopic powder or deliquescent crystals
Identification |
A.Positive tests for calcium and for chloride | A. | Positive tests for calcium and for chloride |
A. | Positive tests for calcium and for chloride
B.Solubility | B. | Solubility | Anhydrous calcium chloride: freely soluble in water and ethanol
B. | Solubility
Dihydrate: freely soluble in water, soluble in ethanol
Hexahydrate: very soluble in water and ethanol
Purity |
Magnesium and alkali salts | Not more than 5 % on the anhydrous basis
Fluoride | Not more than 40 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kgE 511 MAGNESIUM CHLORIDE
Definition |
Chemical name | Magnesium chloride
Einecs | 232-094-6
Chemical formula | MgCl2· 6H2O
Molecular weight | 203,30
Assay | Content not less than 99,0 %
Description | Colourless, odourless, very deliquescent flakes or crystals
Identification |
A.Positive tests for magnesium and for chloride | A. | Positive tests for magnesium and for chloride |
A. | Positive tests for magnesium and for chloride
B.Solubility | B. | Solubility | Very soluble in water, freely soluble in ethanol
B. | Solubility
Purity |
Ammonium | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kgE 512 STANNOUS CHLORIDE
Synonyms | Tin chloride, tin dichloride
Definition |
Chemical name | Stannous chloride dihydrate
Einecs | 231-868-0
Chemical formula | SnCl2· 2H2O
Molecular weight | 225,63
Assay | Content not less than 98,0 %
Description | Colourless or white crystals
May have a slight odour of hydrochloric acid
Identification |
A.Positive tests for tin (II) and for chloride | A. | Positive tests for tin (II) and for chloride |
A. | Positive tests for tin (II) and for chloride
B.Solubility | B. | Solubility | Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water
B. | Solubility
Ethanol: soluble
Purity |
Sulphate | Not more than 30 mg/kg
Arsenic | Not more than 2 mg/kg
Mercury | Not more than 1 mg/kg
Lead | Not more than 5 mg/kgE 513 SULPHURIC ACID
Synonyms | Oil of vitriol, dihydrogen sulphate
Definition |
Chemical name | Sulphuric acid
Einecs | 231-639-5
Chemical formula | H2SO4
Molecular weight | 98,07
Assay | Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %
Description | Clear, colourless or slightly brown, very corrosive oily liquid
Identification |
A.Positive tests for acid and for sulphate | A. | Positive tests for acid and for sulphate |
A. | Positive tests for acid and for sulphate
B.Solubility | B. | Solubility | Miscible with water, with generation of much heat, also with ethanol
B. | Solubility
Purity |
Ash | Not more than 0,02 %
Reducing matter | Not more than 40 mg/kg (as SO2)
Nitrate | Not more than 10 mg/kg (on H2SO4basis)
Chloride | Not more than 50 mg/kg
Iron | Not more than 20 mg/kg
Selenium | Not more than 20 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 514(i) SODIUM SULPHATE
Definition |
Chemical name | Sodium sulphate
Chemical formula | Na2SO4· nH2O (n = 0 or 10)
Molecular weight | 142,04 (anhydrous)
322,04 (decahydrate)
Assay | Content not less than 99,0 % on the anhydrous basis
Description | Colourless crystals or a fine, white, crystalline powder
The decahydrate is efflorescent
Identification |
A.Positive tests for sodium and for sulphate | A. | Positive tests for sodium and for sulphate |
A. | Positive tests for sodium and for sulphate
B.Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper | B. | Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper |
B. | Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
Purity |
Loss on drying | Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °C
Selenium | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 514(ii) SODIUM HYDROGEN SULPHATE
Synonyms | Acid sodium sulphate, sodium bisulphate, nitre cake
Definition |
Chemical name | Sodium hydrogen sulphate
Chemical formula | NaHSO4
Molecular weight | 120,06
Assay | Content not less than 95,2 %
Description | White, odourless crystals or granules
Identification |
A.Positive tests for sodium and for sulphate | A. | Positive tests for sodium and for sulphate |
A. | Positive tests for sodium and for sulphate
B.Solutions are strongly acidic | B. | Solutions are strongly acidic |
B. | Solutions are strongly acidic
Purity |
Loss on drying | Not more than 0,8 %
Water insoluble | Not more than 0,05 %
Selenium | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 515(i) POTASSIUM SULPHATE
Definition |
Chemical name | Potassium sulphate
Chemical formula | K2SO4
Molecular weight | 174,25
Assay | Content not less than 99,0 %
Description | Colourless or white crystals or crystalline powder
Identification |
A.Positive tests for potassium and for sulphate | A. | Positive tests for potassium and for sulphate |
A. | Positive tests for potassium and for sulphate
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 5,5 and 8,5
B. | pH of a 5 % solution
C.Solubility | C. | Solubility | Freely soluble in water, insoluble in ethanol
C. | Solubility
Purity |
Selenium | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 515(ii) POTASSIUM HYDROGEN SULPHATE
Definition |
Synonyms | Potassium bisulphate, potassium acid sulphate
Chemical name | Potassium hydrogen sulphate
Chemical formula | KHSO4
Molecular weight | 136,17
Assay | Content not less than 99 %
Melting point | 197oC
Description | White deliquescent crystals, pieces or granules
Identification |
A.Positive test for potassium | A. | Positive test for potassium |
A. | Positive test for potassium
B.Solubility | B. | Solubility | Freely soluble in water, insoluble in ethanol
B. | Solubility
Purity |
Selenium | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 516 CALCIUM SULPHATE
Synonyms | Gypsum, selenite, anhydrite
Definition |
Chemical name | Calcium sulphate
Einecs | 231-900-3
Chemical formula | CaSO4· nH2O (n = 0 or 2)
Molecular weight | 136,14 (anhydrous), 172,18 (dihydrate)
Assay | Content not less than 99,0 % on the anhydrous basis
Description | Fine, white to slightly yellowish-white odourless powder
Identification |
A.Positive tests for calcium and for sulphate | A. | Positive tests for calcium and for sulphate |
A. | Positive tests for calcium and for sulphate
B.Solubility | B. | Solubility | Slightly soluble in water, insoluble in ethanol
B. | Solubility
Purity |
Loss on drying | Anhydrous: not more than 1,5 % (250oC, constant weight)
Dihydrate: not more than 23 % (ibid.)
Fluoride | Not more than 30 mg/kg
Selenium | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 517 AMMONIUM SULPHATE
Definition |
Chemical name | Ammonium sulphate
Einecs | 231-984-1
Chemical formula | (NH4)2SO4
Molecular weight | 132,14
Assay | Content not less than 99,0 % and not more than 100,5 %
Description | White powder, shining plates or crystalline fragments
Identification |
A.Positive tests for ammonium and for sulphate | A. | Positive tests for ammonium and for sulphate |
A. | Positive tests for ammonium and for sulphate
B.Solubility | B. | Solubility | Freely soluble in water, insoluble in ethanol
B. | Solubility
Purity |
Loss on ignition | Not more than 0,25 %
Selenium | Not more than 30 mg/kg
Lead | Not more than 5 mg/kgE 520 ALUMINIUM SULPHATE
Synonyms | Alum
Definition |
Chemical name | Aluminium sulphate
Einecs | 233-135-0
Chemical formula | Al2(SO4)3
Molecular weight | 342,13
Assay | Content not less than 99,5 % on the ignited basis
Description | White powder, shining plates or crystalline fragments
Identification |
A.Positive tests for aluminium and for sulphateB.pH of a 5 % solution 2,9 or above | A. | Positive tests for aluminium and for sulphate | B. | pH of a 5 % solution 2,9 or above |
A. | Positive tests for aluminium and for sulphate
B. | pH of a 5 % solution 2,9 or above
C.Solubility | C. | Solubility | Freely soluble in water, insoluble in ethanol
C. | Solubility
Purity |
Loss on ignition | Not more than 5 % (500oC, 3h)
Alkalies and alkaline earths | Not more than 0,4 %
Selenium | Not more than 30 mg/kg
Fluoride | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kgE 521 ALUMINIUM SODIUM SULPHATE
Synonyms | Soda alum, sodium alum
Definition |
Chemical name | Aluminium sodium sulphate
Einecs | 233-277-3
Chemical formula | AlNa(SO4)2· nH2O (n = 0 or 12)
Molecular weight | 242,09 (anhydrous)
Assay | Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)
Description | Transparent crystals or white crystalline powder
Identification |
A.Positive tests for aluminium, for sodium and for sulphate | A. | Positive tests for aluminium, for sodium and for sulphate |
A. | Positive tests for aluminium, for sodium and for sulphate
B.Solubility | B. | Solubility | Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol
B. | Solubility
Purity |
Loss on drying | Anhydrous form: not more than 10,0 % (220oC, 16h)
Dodecahydrate: not more than 47,2 % (50oC-55oC, 1h then 200oC, 16h)
Ammonium salts | No odour of ammonia detectable after heating
Selenium | Not more than 30 mg/kg
Fluoride | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 522 ALUMINIUM POTASSIUM SULPHATE
Synonyms | Potassium alum, potash alum
Definition |
Chemical name | Aluminium potassium sulphate dodecahydrate
Einecs | 233-141-3
Chemical formula | AlK(SO4)2· 12 H2O
Molecular weight | 474,38
Assay | Content not less than 99,5 %
Description | Large, transparent crystals or white crystalline powder
Identification |
A.Positive tests for aluminium, for potassium and for sulphate | A. | Positive tests for aluminium, for potassium and for sulphate |
A. | Positive tests for aluminium, for potassium and for sulphate
B.pH of a 10 % solution between 3,0 and 4,0 | B. | pH of a 10 % solution between 3,0 and 4,0 |
B. | pH of a 10 % solution between 3,0 and 4,0
C.Solubility | C. | Solubility | Freely soluble in water, insoluble in ethanol
C. | Solubility
Purity |
Ammonium salts | No odour of ammonia detectable after heating
Selenium | Not more than 30 mg/kg
Fluoride | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 523 ALUMINIUM AMMONIUM SULPHATE
Synonyms | Ammonium alum
Definition |
Chemical name | Aluminium ammonium sulphate
Einecs | 232-055-3
Chemical formula | AlNH4(SO4)2· 12 H2O
Molecular weight | 453,32
Assay | Content not less than 99,5 %
Description | Large, colourless crystals or white powder
Identification |
A.Positive tests for aluminium, for ammonium and for sulphate | A. | Positive tests for aluminium, for ammonium and for sulphate |
A. | Positive tests for aluminium, for ammonium and for sulphate
B.Solubility | B. | Solubility | Freely soluble in water, soluble in ethanol
B. | Solubility
Purity |
Alkali metals and alkaline earths | Not more than 0,5 %
Selenium | Not more than 30 mg/kg
Fluoride | Not more than 30 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 524 SODIUM HYDROXIDE
Synonyms | Caustic soda, lye
Definition |
Chemical name | Sodium hydroxide
Einecs | 215-185-5
Chemical formula | NaOH
Molecular weight | 40,0
Assay | Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
Description | White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
Identification |
A.Positive tests for sodium | A. | Positive tests for sodium |
A. | Positive tests for sodium
B.A 1 % solution is strongly alkaline | B. | A 1 % solution is strongly alkaline |
B. | A 1 % solution is strongly alkaline
C.Solubility | C. | Solubility | Very soluble in water. Freely soluble in ethanol
C. | Solubility
Purity |
Water insoluble and organic matter | A 5 % solution is completely clear and colourless to slightly coloured
Carbonate | Not more than 0,5 % (as Na2CO3)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 0,5 mg/kg
Mercury | Not more than 1 mg/kgE 525 POTASSIUM HYDROXIDE
Synonyms | Caustic potash
Definition |
Chemical name | Potassium hydroxide
Einecs | 215-181-3
Chemical formula | KOH
Molecular weight | 56,11
Assay | Content not less than 85,0 % of alkali calculated as KOH
Description | White or nearly white pellets, flakes, sticks, fused masses or other forms
Identification |
A.Positive tests for potassium | A. | Positive tests for potassium |
A. | Positive tests for potassium
B.A 1 % solution is strongly alkaline | B. | A 1 % solution is strongly alkaline |
B. | A 1 % solution is strongly alkaline
C.Solubility | C. | Solubility | Very soluble in water. Freely soluble in ethanol
C. | Solubility
Purity |
Water insoluble matter | A 5 % solution is completely clear and colourless
Carbonate | Not more than 3,5 % (as K2CO3)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kgE 526 CALCIUM HYDROXIDE
Synonyms | Slaked lime, hydrated lime
Definition |
Chemical name | Calcium hydroxide
Einecs | 215-137-3
Chemical formula | Ca(OH)2
Molecular weight | 74,09
Assay | Content not less than 92,0 %
Description | White powder
Identification |
A.Positive tests for alkali and for calcium | A. | Positive tests for alkali and for calcium |
A. | Positive tests for alkali and for calcium
B.Solubility | B. | Solubility | Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
B. | Solubility
Purity |
Acid insoluble ash | Not more than 1,0 %
Magnesium and alkali salts | Not more than 1,0 %
Barium | Not more than 300 mg/kg
Fluoride | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kgE 527 AMMONIUM HYDROXIDE
Synonyms | Aqua ammonia, strong ammonia solution
Definition |
Chemical name | Ammonium hydroxide
Chemical formula | NH4OH
Molecular weight | 35,05
Assay | Content not less than 27 % of NH3
Description | Clear, colourless solution, having an exceedingly pungent, characteristic odour
Identification |
A.Positive tests for ammonia | A. | Positive tests for ammonia |
A. | Positive tests for ammonia
Purity |
Non-volatile matter | Not more than 0,02 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kgE 528 MAGNESIUM HYDROXIDE
Definition |
Chemical name | Magnesium hydroxide
Einecs | 215-170-3
Chemical formula | Mg(OH)2
Molecular weight | 58,32
Assay | Content not less than 95,0 % on the anhydrous basis
Description | Odourless, white bulky powder
Identification |
A.Positive test for magnesium and for alkali | A. | Positive test for magnesium and for alkali |
A. | Positive test for magnesium and for alkali
B.Solubility | B. | Solubility | Practically insoluble in water and in ethanol
B. | Solubility
Purity |
Loss on drying | Not more than 2,0 % (105oC, 2h)
Loss on ignition | Not more than 33 % (800oC to constant weight)
Calcium oxide | Not more than 1,5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kgE 529 CALCIUM OXIDE
Synonyms | Burnt lime
Definition |
Chemical name | Calcium oxide
Einecs | 215-138-9
Chemical formula | CaO
Molecular weight | 56,08
Assay | Content not less than 95,0 % on the ignited basis
Description | Odourless, hard, white or greyish white masses of granules, or white to greyish powder
Identification |
A.Positive test for alkali and for calcium | A. | Positive test for alkali and for calcium |
A. | Positive test for alkali and for calcium
B.Heat is generated on moistening the sample with water | B. | Heat is generated on moistening the sample with water |
B. | Heat is generated on moistening the sample with water
C.Solubility | C. | Solubility | Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
C. | Solubility
Purity |
Loss on ignition | Not more than 10,0 % (ca 800oC to constant weight)
Acid insoluble matter | Not more than 1,0 %
Barium | Not more than 300 mg/kg
Magnesium and alkali salts | Not more than 1,5 %
Fluoride | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kgE 530 MAGNESIUM OXIDE
Definition |
Chemical name | Magnesium oxide
Einecs | 215-171-9
Chemical formula | MgO
Molecular weight | 40,31
Assay | Content not less than 98,0 % on the ignited basis
Description | A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml
Identification |
A.Positive test for alkali and for magnesium | A. | Positive test for alkali and for magnesium |
A. | Positive test for alkali and for magnesium
B.Solubility | B. | Solubility | Practically insoluble in water. Insoluble in ethanol
B. | Solubility
Purity |
Loss on ignition | Not more than 5,0 % (ca 800oC to constant weight)
Calcium oxide | Not more than 1,5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kgE 535 SODIUM FERROCYANIDE
Synonyms | Yellow prussiate of soda, sodium hexacyanoferrate
Definition |
Chemical name | Sodium ferrocyanide
Einecs | 237-081-9
Chemical formula | Na4Fe(CN)6· 10 H2O
Molecular weight | 484,1
Assay | Content not less than 99,0 %
Description | Yellow crystals or crystalline powder
Identification |
A.Positive test for sodium and for ferrocyanide | A. | Positive test for sodium and for ferrocyanide |
A. | Positive test for sodium and for ferrocyanide
Purity |
Free moisture | Not more than 1,0 %
Water insoluble matter | Not more than 0,03 %
Chloride | Not more than 0,2 %
Sulphate | Not more than 0,1 %
Free cyanide | Not detectable
Ferricyanide | Not detectable
Lead | Not more than 5 mg/kgE 536 POTASSIUM FERROCYANIDE
Synonyms | Yellow prussiate of potash, potassium hexacyanoferrate
Definition |
Chemical name | Potassium ferrocyanide
Einecs | 237-722-2
Chemical formula | K4Fe(CN)6· 3 H2O
Molecular weight | 422,4
Assay | Content not less than 99,0 %
Description | Lemon yellow crystals
Identification |
A.Positive test for potassium and for ferrocyanide | A. | Positive test for potassium and for ferrocyanide |
A. | Positive test for potassium and for ferrocyanide
Purity |
Free moisture | Not more than 1,0 %
Water insoluble matter | Not more than 0,03 %
Chloride | Not more than 0,2 %
Sulphate | Not more than 0,1 %
Free cyanide | Not detectable
Ferricyanide | Not detectable
Lead | Not more than 5 mg/kgE 538 CALCIUM FERROCYANIDE
Synonyms | Yellow prussiate of lime, calcium hexacyanoferrate
Definition |
Chemical name | Calcium ferrocyanide
Einecs | 215-476-7
Chemical formula | Ca2Fe(CN)6· 12H2O
Molecular weight | 508,3
Assay | Content not less than 99,0 %
Description | Yellow crystals or crystalline powder
Identification |
A.Positive test for calcium and for ferrocyanide | A. | Positive test for calcium and for ferrocyanide |
A. | Positive test for calcium and for ferrocyanide
Purity |
Free moisture | Not more than 1,0 %
Water insoluble matter | Not more than 0,03 %
Chloride | Not more than 0,2 %
Sulphate | Not more than 0,1 %
Free cyanide | Not detectable
Ferricyanide | Not detectable
Lead | Not more than 5 mg/kgE 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC
Synonyms | SALP
Definition |
Chemical name | Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or
Trisodium dialuminium pentadecahydrogen octaphosphate (B)
Einecs | 232-090-4
Chemical formula | NaAl3H14(PO4)8· 4H2O (A)
Na3Al2H15(PO4)8(B)
Molecular weight | 949,88 (A)
897,82 (B)
Assay | Content not less than 95,0 % (both forms)
Description | White odourless powder
Identification |
A.Positive test for sodium, for aluminium and for phosphate | A. | Positive test for sodium, for aluminium and for phosphate |
A. | Positive test for sodium, for aluminium and for phosphate
B.pH | B. | pH | Acid to litmus
B. | pH
C.Solubility | C. | Solubility | Insoluble in water. Soluble in hydrochloric acid
C. | Solubility
Purity |
Loss on ignition | 19,5 %-21,0 % (A) } (750oC-800oC, 2h)
15 %-16 % (B) } (750oC-800oC, 2h)
Fluoride | Not more than 25 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 4 mg/kg
Cadmium | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 551 SILICON DIOXIDE
Synonyms | Silica, silicium dioxide
Definition | Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
Chemical name | Silicon dioxide
Einecs | 231-545-4
Chemical formula | (SiO2)n
Molecular weight | 60,08 (SiO2)
Assay | Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)
Description | White, fluffy powder or granules
Hygroscopic
Identification |
A.Positive test for silica | A. | Positive test for silica |
A. | Positive test for silica
Purity |
Loss on drying | Not more than 2,5 % (fumed silica, 105oC, 2h)
Not more than 8,0 % (precipitated silica and silica gel, 105oC, 2h)
Not more than 70 % (hydrous silica, 105oC, 2h)
Loss on ignition | Not more than 2,5 % after drying (1 000oC, fumed silica)
Not more than 8,5 % after drying (1 000oC, hydrated forms)
Soluble ionisable salts | Not more than 5,0 % (as Na2SO4)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 552 CALCIUM SILICATE
Definition | Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2
Chemical name | Calcium silicate
Einecs | 215-710-8
Assay | Content on the anhydrous basis:—as SiO2not less than 50 % and not more than 95 %—as CaO not less than 3 % and not more than 35 % | — | as SiO2not less than 50 % and not more than 95 % | — | as CaO not less than 3 % and not more than 35 %
— | as SiO2not less than 50 % and not more than 95 %
— | as CaO not less than 3 % and not more than 35 %
Description | White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids
Identification |
A.Positive test for silicate and for calcium | A. | Positive test for silicate and for calcium |
A. | Positive test for silicate and for calcium
B.Forms a gel with mineral acids | B. | Forms a gel with mineral acids |
B. | Forms a gel with mineral acids
Purity |
Loss on drying | Not more than 10 % (105oC, 2h)
Loss on ignition | Not less than 5 % and not more than 14 % (1 000oC, constant weight)
Sodium | Not more than 3 %
Fluoride | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 553a(i) MAGNESIUM SILICATE
Definition | Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
Assay | Content not less than 15 % of MgO and not less than 67 % of SiO2on the ignited basis
Description | Very fine, white, odourless powder, free from grittiness
Identification |
A.Positive test for magnesium and for silicate | A. | Positive test for magnesium and for silicate |
A. | Positive test for magnesium and for silicate
B.pH of a 10 % slurry | B. | pH of a 10 % slurry | Between 7,0 and 10,8
B. | pH of a 10 % slurry
Purity |
Loss on drying | Not more than 15 % (105oC, 2h)
Loss on ignition | Not more than 15 % after drying (1 000oC, 20 min)
Water soluble salts | Not more than 3 %
Free alkali | Not more than 1 % (as NaOH)
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 553a(ii) MAGNESIUM TRISILICATE
Definition |
Chemical name | Magnesium trisilicate
Chemical formula | Mg2Si3O8· xH2O (approximate composition)
Einecs | 239-076-7
Assay | Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2both on the ignited basis
Description | Fine, white powder, free from grittiness
Identification |
A.Positive test for magnesium and for silicate | A. | Positive test for magnesium and for silicate |
A. | Positive test for magnesium and for silicate
B.pH of a 5 % slurry | B. | pH of a 5 % slurry | Between 6,3 and 9,5
B. | pH of a 5 % slurry
Purity |
Loss on ignition | Not less than 17 % and not more than 34 % (1 000oC)
Water soluble salts | Not more than 2 %
Free alkali | Not more than 1 % (as NaOH)
Fluoride | Not more than 10 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 553b TALC
Synonyms | Talcum
Definition | Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite
Chemical name | Magnesium hydrogen metasilicate
Einecs | 238-877-9
Chemical formula | Mg3(Si4O10)(OH)2
Molecular weight | 379,22
Description | Light, homogeneous, white or almost white powder, greasy to the touch
Identification |
A.IR absorption | A. | IR absorption | Characteristic peaks at 3 677 , 1 018 and 669 cm-1
A. | IR absorption
B.X-ray diffraction | B. | X-ray diffraction | Peaks at 9,34 /4,66/3,12 Å
B. | X-ray diffraction
C.Solubility | C. | Solubility | Insoluble in water and ethanol
C. | Solubility
Purity |
Loss on drying | Not more than 0,5 % (105oC, 1h)
Acid-soluble matter | Not more than 6 %
Water-soluble matter | Not more than 0,2 %
Acid-soluble iron | Not detectable
Arsenic | Not more than 10 mg/kg
Lead | Not more than 5 mg/kgE 554 SODIUM ALUMINIUM SILICATE
Synonyms | Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate
Definition |
Chemical name | Sodium aluminium silicate
Assay | Content on the anhydrous basis:—as SiO2not less than 66,0 % and not more than 88,0 %—as Al2O3not less than 5,0 % and not more than 15,0 % | — | as SiO2not less than 66,0 % and not more than 88,0 % | — | as Al2O3not less than 5,0 % and not more than 15,0 %
— | as SiO2not less than 66,0 % and not more than 88,0 %
— | as Al2O3not less than 5,0 % and not more than 15,0 %
Description | Fine white amorphous powder or beads
Identification |
A.Positive tests for sodium, for aluminium and for silicate | A. | Positive tests for sodium, for aluminium and for silicate |
A. | Positive tests for sodium, for aluminium and for silicate
B.pH of a 5 % slurry | B. | pH of a 5 % slurry | Between 6,5 and 11,5
B. | pH of a 5 % slurry
Purity |
Loss on drying | Not more than 8,0 % (105oC, 2h)
Loss on ignition | Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000oC, constant weight)
Sodium | Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 555 POTASSIUM ALUMINIUM SILICATE
Synonyms | Mica
Definition | Natural mica consists of mainly potassium aluminium silicate (muscovite)
Einecs | 310-127-6
Chemical name | Potassium aluminium silicate
Chemical formulae | KAl2[AlSi3O10](OH)2
Molecular weight | 398
Assay | Content not less than 98 %
Description | Light grey to white crystalline platelets or powder
Identification |
A.Solubility | A. | Solubility | Insoluble in water, diluted acids and alkali and organic solvents
A. | Solubility
Purity |
Loss on drying | Not more than 0,5 % (105oC, 2h)
Antimony | Not more than 20 mg/kg
Zinc | Not more than 25 mg/kg
Barium | Not more than 25 mg/kg
Chromium | Not more than 100 mg/kg
Copper | Not more than 25 mg/kg
Nickel | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 2 mg/kg
Lead | Not more than 10 mg/kgE 556 CALCIUM ALUMINIUM SILICATE
Synonyms | Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate
Definition |
Chemical name | Calcium aluminium silicate
Assay | Content on the anhydrous basis:—as SiO2not less than 44,0 % and not more than 50,0 %—as Al2O3not less than 3,0 % and not more than 5,0 %—as CaO not less than 32,0 % and not more than 38,0 % | — | as SiO2not less than 44,0 % and not more than 50,0 % | — | as Al2O3not less than 3,0 % and not more than 5,0 % | — | as CaO not less than 32,0 % and not more than 38,0 %
— | as SiO2not less than 44,0 % and not more than 50,0 %
— | as Al2O3not less than 3,0 % and not more than 5,0 %
— | as CaO not less than 32,0 % and not more than 38,0 %
Description | Fine white, free-flowing powder
Identification |
A.Positive tests for calcium, for aluminium and for silicate | A. | Positive tests for calcium, for aluminium and for silicate |
A. | Positive tests for calcium, for aluminium and for silicate
Purity |
Loss on drying | Not more than 10,0 % (105oC, 2h)
Loss on ignition | Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000oC, constant weight)
Fluoride | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 10 mg/kg
Mercury | Not more than 1 mg/kgE 558 BENTONITE
Definition | Bentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite
Einecs | 215-108-5
Chemical formula | (Al, Mg)8(Si4O10)4(OH)8· 12H2O
Molecular weight | 819
Assay | Montmorillonite content not less than 80 %
Description | Very fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)
Identification |
A.Methylene blue test | A. | Methylene blue test |
A. | Methylene blue test
B.X-Ray diffraction | B. | X-Ray diffraction | Characteristic peaks at 12,5 /15 A
B. | X-Ray diffraction
C.IR absorption | C. | IR absorption | Peaks at 428/470/530/1 110 -1 020 /3 750 — 3 400 cm-1
C. | IR absorption
Purity |
Loss on drying | Not more than 15,0 % (105oC, 2h)
Arsenic | Not more than 2 mg/kg
Lead | Not more than 20 mg/kgE 559 ALUMINIUM SILICATE (KAOLIN)
Synonyms | Kaolin, light or heavy
Definition | Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption
Einecs | 215-286-4 (kaolinite)
Chemical formula | Al2Si2O5(OH)4(kaolinite)
Molecular weight | 264
Assay | Content not less than 90 % (sum of silica and alumina, after ignition)
Silica (SiO2) | Between 45 % and 55 %
Alumina (Al2O3) | Between 30 % and 39 %
Description | Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes
Identification |
A.Positive tests for alumina and for silicate | A. | Positive tests for alumina and for silicate |
A. | Positive tests for alumina and for silicate
B.X-ray diffraction: | B. | X-ray diffraction: | Characteristic peaks at 7,18 /3,58/2,38/1,78 Å
B. | X-ray diffraction:
C.IR absorption: | C. | IR absorption: | Peaks at 3 700 and 3 620 cm-1
C. | IR absorption:
Purity |
Loss on ignition | Between 10 and 14 % (1 000oC, constant weight)
Water soluble matter | Not more than 0,3 %
Acid soluble matter | Not more than 2 %
Iron | Not more than 5 %
Potassium oxide (K2O) | Not more than 5 %
Carbon | Not more than 0,5 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 570 FATTY ACIDS
Definition | Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
Chemical name | octanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1)
Assay | Not less than 98 % by chromatography
Description | A colourless liquid or white solid obtained from oils and fats
Identification |
A.Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight | A. | Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight |
A. | Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight
Purity |
Residue on ignition | Not more than 0,1 %
Unsaponifiable matter | Not more than 1,5 %
Water | Not more than 0,2 % (Karl Fischer method)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 1 mg/kg
Mercury | Not more than 1 mg/kgE 574 GLUCONIC ACID
Synonyms | D-gluconic acid, dextronic acid
Definition | Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone
Chemical name | Gluconic acid
Chemical formula | C6H12O7(gluconic acid)
Molecular weight | 196,2
Assay | Content not less than 50,0 % (as gluconic acid)
Description | Colourless to light yellow, clear syrupy liquid
Identification |
A.Formation of phenylhydrazine derivative positive | A. | Formation of phenylhydrazine derivative positive | Compound formed melts between 196oC and 202oC with decomposition
A. | Formation of phenylhydrazine derivative positive
Purity |
Residue on ignition | Not more than 1,0 %
Reducing matter | Not more than 0,75 % (as D-glucose)
Chloride | Not more than 350 mg/kg
Sulphate | Not more than 240 mg/kg
Sulphite | Not more than 20 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 575 GLUCONO-DELTA-LACTONE
Synonyms | Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone
Definition | Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones
Chemical name | D-Glucono-1,5 -lactone
Einecs | 202-016-5
Chemical formula | C6H10O6
Molecular weight | 178,14
Assay | Content not less than 99,0 % on the anhydrous basis
Description | Fine, white, nearly odourless, crystalline powder
Identification |
A.Formation of phenylhydrazine derivative of gluconic acid positive | A. | Formation of phenylhydrazine derivative of gluconic acid positive | Compound formed melts between 196oC and 202oC with decomposition
A. | Formation of phenylhydrazine derivative of gluconic acid positive
B.Solubility | B. | Solubility | Freely soluble in water. Sparingly soluble in ethanol
B. | Solubility
C.Melting point | C. | Melting point | 152oC ± 2oC
C. | Melting point
Purity |
Water | Not more than 1,0 % (Karl Fischer method)
Reducing substances | Not more than 0,75 % (as D-glucose)
Lead | Not more than 2 mg/kgE 576 SODIUM GLUCONATE
Synonyms | Sodium salt of D-gluconic acid
Definition |
Chemical name | Sodium D-gluconate
Einecs | 208-407-7
Chemical formula | C6H11NaO7(anhydrous)
Molecular weight | 218,14
Assay | Content not less than 98,0 %
Description | White to tan, granular to fine, crystalline powder
Identification |
A.Positive test for sodium and for gluconate | A. | Positive test for sodium and for gluconate |
A. | Positive test for sodium and for gluconate
B.Solubility | B. | Solubility | Very soluble in water. Sparingly soluble in ethanol
B. | Solubility
C.pH of a 10 % solution | C. | pH of a 10 % solution | Between 6,5 and 7,5
C. | pH of a 10 % solution
Purity |
Reducing matter | Not more than 1,0 % (as D-glucose)
Lead | Not more than 2 mg/kgE 577 POTASSIUM GLUCONATE
Synonyms | Potassium salt of D-gluconic acid
Definition |
Chemical name | Potassium D-gluconate
Einecs | 206-074-2
Chemical formula | C6H11KO7(anhydrous)
C6H11KO7· H2O (monohydrate)
Molecular weight | 234,25 (anhydrous)
252,26 (monohydrate)
Assay | Content not less than 97,0 % and not more than 103,0 % on dried basis
Description | Odourless, free flowing white to yellowish white, crystalline powder or granules
Identification |
A.Positive test for potassium and for gluconate | A. | Positive test for potassium and for gluconate |
A. | Positive test for potassium and for gluconate
B.pH of a 10 % solution | B. | pH of a 10 % solution | Between 7,0 and 8,3
B. | pH of a 10 % solution
Purity |
Loss on drying | Anhydrous: not more than 3,0 % (105oC, 4h, vacuum)Monohydrate: not less than 6 % and not more than 7,5 % (105oC, 4h, vacuum)
Reducing substances | Not more than 1,0 % (as D-glucose)
Lead | Not more than 2 mg/kgE 578 CALCIUM GLUCONATE
Synonyms | Calcium salt of D-gluconic acid
Definition |
Chemical name | Calcium di-D-gluconate
Einecs | 206-075-8
Chemical formula | C12H22CaO14(anhydrous)
C12H22CaO14· H2O (monohydrate)
Molecular weight | 430,38 (anhydrous form)
448,39 (monohydrate)
Assay | Content not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basis
Description | Odourless, white crystalline granules or powder, stable in air
Identification |
A.Positive test for calcium and for gluconate | A. | Positive test for calcium and for gluconate |
A. | Positive test for calcium and for gluconate
B.Solubility | B. | Solubility | Soluble in water, insoluble in ethanol
B. | Solubility
C.pH of a 5 % solution | C. | pH of a 5 % solution | Between 6,0 and 8,0
C. | pH of a 5 % solution
Purity |
Loss on drying | Not more than 3,0 % (105oC, 16h) (anhydrous)
Not more than 2,0 % (105oC, 16h) (monohydrate)
Reducing substances | Not more than 1,0 % (as D-glucose)
Lead | Not more than 2 mg/kgE 579 FERROUS GLUCONATE
Definition |
Chemical name | Ferrous di-D-gluconate dihydrate
Iron(II) di-gluconate dihydrate
Einecs | 206-076-3
Chemical formulae | C12H22FeO14·2H2O
Molecular weight | 482,17
Assay | Content not less than 95 % on the dried basis
Description | Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar
Identification |
A.Solubility | A. | Solubility | Soluble with slight heating in water. Practically insoluble in ethanol
A. | Solubility
B.Positive test for ferrous ion | B. | Positive test for ferrous ion |
B. | Positive test for ferrous ion
C.Formation of phenylhy-drazine derivative of gluconic acid positive | C. | Formation of phenylhy-drazine derivative of gluconic acid positive |
C. | Formation of phenylhy-drazine derivative of gluconic acid positive
D.pH of a 10 % solution | D. | pH of a 10 % solution | Between 4 and 5,5
D. | pH of a 10 % solution
Purity |
Loss on drying | Not more than 10 % (105oC, 16 hours)
Oxalic acid | Not detectable
Iron (Fe III) | Not more than 2 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kg
Reducing substances | Not more than 0,5 % expressed as glucoseE 585 FERROUS LACTATE
Synonyms | Iron(II) lactate
Iron(II) 2-hydroxy propanoate
Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Definition |
Chemical name | Ferrous 2-hydroxy propanoate
Einecs | 227-608-0
Chemical formulae | C6H10FeO6·xH2O (x = 2 or 3)
Molecular weight | 270,02 (dihydrate)
288,03 (trihydrate)
Assay | Content not less than 96 % on the dried basis
Description | Greenish-white crystals or light green powder having a characteristic smell
Identification |
A.Solubility | A. | Solubility | Soluble in water. Practically insoluble in ethanol
A. | Solubility
B.Positive test for ferrous ion and for lactate | B. | Positive test for ferrous ion and for lactate |
B. | Positive test for ferrous ion and for lactate
C.pH of a 2 % solution | C. | pH of a 2 % solution | Between 4 and 6
C. | pH of a 2 % solution
Purity |
Loss on drying | Not more than 18 % (100oC, under vacuum, approximately 700 mm Hg)
Iron (Fe III) | Not more than 0,6 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Cadmium | Not more than 1 mg/kgE 586 4-HEXYLRESORCINOL
Synonyms | 4-Hexyl-1,3-benzenediol
Hexylresorcinol
Definition |
Chemical name | 4-Hexylresorcinol
Einecs | 205-257-4
Chemical formula | C12H18O2
Molecular weight | 197,24
Assay | Not less than 98 % on the dried basis
Description | White powder
Identification |
A.Solubility | A. | Solubility | Freely soluble in ether and acetone; very slightly soluble in water
A. | Solubility
B.Nitric acid test | B. | Nitric acid test | To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears
B. | Nitric acid test
C.Bromine test | C. | Bromine test | To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution
C. | Bromine test
D.Melting range | D. | Melting range | 62 to 67oC
D. | Melting range
Purity |
Acidity | Not more than 0,05 %
Sulphated ash | Not more than 0,1 %
Resorcinol and other phenols | Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced
Nickel | Not more than 2 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 3 mg/kgE 620 GLUTAMIC ACID
Synonyms | L-Glutamic acid, L-α-aminoglutaric acid
Definition |
Chemical name | L-Glutamic acid, L-2-amino-pentanedioic acid
Einecs | 200-293-7
Chemical formula | C5H9NO4
Molecular weight | 147,13
Assay | Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Description | White crystals or crystalline powder
Identification |
A.Positive test for glutamic acid by thin layer chromatography | A. | Positive test for glutamic acid by thin layer chromatography |
A. | Positive test for glutamic acid by thin layer chromatography
B.Specific rotation [α]D20 | B. | Specific rotation [α]D20 | Between +31,5oand +32,2o
B. | Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
C.pH of a saturated solution | C. | pH of a saturated solution | Between 3,0 and 3,5
C. | pH of a saturated solution
Purity |
Loss on drying | Not more than 0,2 % (80oC, 3h)
Sulphated ash | Not more than 0,2 %
Chloride | Not more than 0,2 %
Pyrrolidone carboxylic acid | Not more than 0,2 %
Lead | Not more than 2 mg/kgE 621 MONOSODIUM GLUTAMATE
Synonyms | Sodium glutamate, MSG
Definition |
Chemical name | Monosodium L-glutamate monohydrate
Einecs | 205-538-1
Chemical formula | C5H8NaNO4· H2O
Molecular weight | 187,13
Assay | Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Description | White, practically odourless crystals or crystalline powder
Identification |
A.Positive test for sodium | A. | Positive test for sodium |
A. | Positive test for sodium
B.Positive test for glutamic acid by thin-layer chromatography | B. | Positive test for glutamic acid by thin-layer chromatography |
B. | Positive test for glutamic acid by thin-layer chromatography
C.Specific rotation [α]D20 | C. | Specific rotation [α]D20 | Between +24,8oand +25,3o
C. | Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 5 % solution | D. | pH of a 5 % solution | Between 6,7 and 7,2
D. | pH of a 5 % solution
Purity |
Loss on drying | Not more than 0,5 % (98oC, 5h)
Chloride | Not more than 0,2 %
Pyrrolidone carboxylic acid | Not more than 0,2 %
Lead | Not more than 2 mg/kgE 622 MONOPOTASSIUM GLUTAMATE
Synonyms | Potassium glutamate, MPG
Definition |
Chemical name | Monopotassium L-glutamate monohydrate
Einecs | 243-094-0
Chemical formula | C5H8KNO4· H2O
Molecular weight | 203,24
Assay | Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Description | White, practically odourless crystals or crystalline powder
Identification |
A.Positive test for potassium | A. | Positive test for potassium |
A. | Positive test for potassium
B.Positive test for glutamic acid by thin-layer chromatog-raphy | B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
B. | Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 | C. | Specific rotation [α]D20 | Between +22,5oand +24,0o
C. | Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 2 % solution | D. | pH of a 2 % solution | Between 6,7 and 7,3
D. | pH of a 2 % solution
Purity |
Loss on drying | Not more than 0,2 % (80oC, 5h)
Chloride | Not more than 0,2 %
Pyrrolidone carboxylic acid | Not more than 0,2 %
Lead | Not more than 2 mg/kgE 623 CALCIUM DIGLUTAMATE
Synonyms | Calcium glutamate
Definition |
Chemical name | Monocalcium di-L-glutamate
Einecs | 242-905-5
Chemical formula | C10H16CaN2O8· x H2O (x = 0, 1, 2 or 4)
Molecular weight | 332,32 (anhydrous)
Assay | Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis
Description | White, practically odourless crystals or crystalline powder
Identification |
A.Positive test for calcium | A. | Positive test for calcium |
A. | Positive test for calcium
B.Positive test for glutamic acid by thin-layer chromatog-raphy | B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
B. | Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 | C. | Specific rotation [α]D20 | Between +27,4 and +29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
C. | Specific rotation [α]D20
Purity |
Water | Not more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)
Chloride | Not more than 0,2 %
Pyrrolidone carboxylic acid | Not more than 0,2 %
Lead | Not more than 2 mg/kgE 624 MONOAMMONIUM GLUTAMATE
Synonyms | Ammonium glutamate
Definition |
Chemical name | Monoammonium L-glutamate monohydrate
Einecs | 231-447-1
Chemical formula | C5H12N2O4· H2O
Molecular weight | 182,18
Assay | Content not less than 99,0 % and not more 101,0 % on the anhydrous basis
Description | White, practically odourless crystals or crystalline powder
Identification |
A.Positive test for ammonium | A. | Positive test for ammonium |
A. | Positive test for ammonium
B.Positive test for glutamic acid by thin-layer chromatog-raphy | B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
B. | Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 | C. | Specific rotation [α]D20 | Between +25,4oand +26,4o
C. | Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 5 % solution | D. | pH of a 5 % solution | Between 6,0 and 7,0
D. | pH of a 5 % solution
Purity |
Loss on drying | Not more than 0,5 % (50oC, 4h)
Sulphated ash | Not more than 0,1 %
Pyrrolidone carboxylic acid | Not more than 0,2 %
Lead | Not more than 2 mg/kgE 625 MAGNESIUM DIGLUTAMATE
Synonyms | Magnesium glutamate
Definition |
Chemical name | Monomagnesium di-L-glutamate tetrahydrate
Einecs | 242-413-0
Chemical formula | C10H16MgN2O8· 4H2O
Molecular weight | 388,62
Assay | Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis
Description | Odourless, white or off-white crystals or powder
Identification |
A.Positive test for magnesium | A. | Positive test for magnesium |
A. | Positive test for magnesium
B.Positive test for glutamic acid by thin-layer chromatog-raphy | B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
B. | Positive test for glutamic acid by thin-layer chromatog-raphy
C.Specific rotation [α]D20 | C. | Specific rotation [α]D20 | Between +23,8oand +24,4o
C. | Specific rotation [α]D20
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.pH of a 10 % solution | D. | pH of a 10 % solution | Between 6,4 and 7,5
D. | pH of a 10 % solution
Purity |
Water | Not more than 24 % (Karl Fischer)
Chloride | Not more than 0,2 %
Pyrrolidone carboxylic acid | Not more than 0,2 %
Lead | Not more than 2 mg/kgE 626 GUANYLIC ACID
Synonyms | Guanylic acid
Definition |
Chemical name | Guanosine-5′-monophosphoric acid
Einecs | 201-598-8
Chemical formula | C10H14N5O8P
Molecular weight | 363,22
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or white crystalline powder
Identification |
A.Positive test for ribose and for organic phosphate | A. | Positive test for ribose and for organic phosphate |
A. | Positive test for ribose and for organic phosphate
B.pH of a 0,25 % solution | B. | pH of a 0,25 % solution | Between 1,5 and 2,5
B. | pH of a 0,25 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. | Spectrometry:
Purity |
Loss on drying | Not more than 1,5 % (120oC, 4h)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 627 DISODIUM GUANYLATE
Synonyms | Sodium guanylate, sodium 5′-guanylate
Definition |
Chemical name | Disodium guanosine-5′-monophosphate
Einecs | 221-849-5
Chemical formula | C10H12N5Na2O8P· x H2O (x = ca. 7)
Molecular weight | 407,19 (anhydrous)
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or white crystalline powder
Identification |
A.Positive test for ribose, for organic phosphate, and for sodium | A. | Positive test for ribose, for organic phosphate, and for sodium |
A. | Positive test for ribose, for organic phosphate, and for sodium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 7,0 and 8,5
B. | pH of a 5 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. | Spectrometry:
Purity |
Loss on drying | Not more than 25 % (120oC, 4h)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 628 DIPOTASSIUM GUANYLATE
Synonyms | Potassium guanylate, potassium 5′-guanylate
Definition |
Chemical name | Dipotassium guanosine-5′-monophosphate
Einecs | 226-914-1
Chemical formula | C10H12K2N5O8P
Molecular weight | 439,40
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or white crystalline powder
Identification |
A.Positive test for ribose, for organic phosphate, and for potassium | A. | Positive test for ribose, for organic phosphate, and for potassium |
A. | Positive test for ribose, for organic phosphate, and for potassium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 7,0 and 8,5
B. | pH of a 5 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. | Spectrometry:
Purity |
Loss on drying | Not more than 5 % (120oC, 4h)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 629 CALCIUM GUANYLATE
Synonyms | Calcium 5′-guanylate
Definition |
Chemical name | Calcium guanosine-5′-monophosphate
Chemical formula | C10H12CaN5O8P· nH2O
Molecular weight | 401,20 (anhydrous)
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, white or off-white crystals or powder
Identification |
A.Positive test for ribose, for organic phosphate, and for calcium | A. | Positive test for ribose, for organic phosphate, and for calcium |
A. | Positive test for ribose, for organic phosphate, and for calcium
B.pH of a 0,05 % solution | B. | pH of a 0,05 % solution | Between 7,0 and 8,0
B. | pH of a 0,05 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 256 nm
C. | Spectrometry:
Purity |
Loss on drying | Not more than 23,0 % (120oC, 4h)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 630 INOSINIC ACID
Synonyms | 5′-Inosinic acid
Definition |
Chemical name | Inosine-5′-monophosphoric acid
Einecs | 205-045-1
Chemical formula | C10H13N4O8P
Molecular weight | 348,21
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or powder
Identification |
A.Positive test for ribose, and for organic phosphate | A. | Positive test for ribose, and for organic phosphate |
A. | Positive test for ribose, and for organic phosphate
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 1,0 and 2,0
B. | pH of a 5 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. | Spectrometry:
Purity |
Loss on drying | Not more than 3,0 % (120oC, 4h)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 631 DISODIUM INOSINATE
Synonyms | Sodium inosinate, sodium 5′-inosinate
Definition |
Chemical name | Disodium inosine-5′-monophosphate
Einecs | 225-146-4
Chemical formula | C10H11N4Na2O8P· H2O
Molecular weight | 392,17 (anhydrous)
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or powder
Identification |
A.Positive test for ribose, and for organic phosphate and for sodium | A. | Positive test for ribose, and for organic phosphate and for sodium |
A. | Positive test for ribose, and for organic phosphate and for sodium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 7,0 and 8,5
B. | pH of a 5 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. | Spectrometry:
Purity |
Water | Not more than 28,5 % (Karl Fischer)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 632 DIPOTASSIUM INOSINATE
Synonyms | Potassium inosinate, potassium 5′-inosinate
Definition |
Chemical name | Dipotassium inosine-5′-monophosphate
Einecs | 243-652-3
Chemical formula | C10H11K2N4O8P
Molecular weight | 424,39
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or powder
Identification |
A.Positive test for ribose, and for organic phosphate and for potassium | A. | Positive test for ribose, and for organic phosphate and for potassium |
A. | Positive test for ribose, and for organic phosphate and for potassium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 7,0 and 8,5
B. | pH of a 5 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. | Spectrometry:
Purity |
Water | Not more than 10,0 % (Karl Fischer)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 633 CALCIUM INOSINATE
Synonyms | Calcium 5′-inosinate
Definition |
Chemical name | Calcium inosine-5′-monophosphate
Chemical formula | C10H11CaN4O8P· nH2O
Molecular weight | 386,19 (anhydrous)
Assay | Content not less than 97,0 % on the anhydrous basis
Description | Odourless, colourless or white crystals or powder
Identification |
A.Positive test for ribose, and for organic phosphate and for calcium | A. | Positive test for ribose, and for organic phosphate and for calcium |
A. | Positive test for ribose, and for organic phosphate and for calcium
B.pH of a 0,05 % solution | B. | pH of a 0,05 % solution | Between 7,0 and 8,0
B. | pH of a 0,05 % solution
C.Spectrometry: | C. | Spectrometry: | maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm
C. | Spectrometry:
Purity |
Water | Not more than 23,0 % (Karl Fischer)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 634 CALCIUM 5′-RIBONUCLEOTIDE
Definition |
Chemical name | Calcium 5′-ribonucleotide is essentially a mixture of calcium inosine-5′-monophosphate and calcium guanosine-5′-monophosphate
Chemical formula | C10H11N4CaO8P· nH2O y
C10H12N5CaO8P· nH2O
Assay | Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis
Description | Odourless, white or nearly white crystals or powder
Identification |
A.Positive test for ribose, and for organic phosphate and for calcium | A. | Positive test for ribose, and for organic phosphate and for calcium |
A. | Positive test for ribose, and for organic phosphate and for calcium
B.pH of a 0,05 % solution | B. | pH of a 0,05 % solution | Between 7,0 and 8,0
B. | pH of a 0,05 % solution
Purity |
Water | Not more than 23,0 % (Karl Fischer)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 635 DISODIUM 5′-RIBONUCLEOTIDE
Synonyms | Sodium 5′-ribonucleotide
Definition |
Chemical name | Disodium 5′-ribonucleotide is essentially a mixture of disodium inosine-5′-monophosphate and disodium guanosine-5′-monophosphate
Chemical formula | C10H11N4Na2O8P · nH2O and
C10H12N5Na2O8P· nH2O
Assay | Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis
Description | Odourless, white or nearly white crystals or powder
Identification |
A.Positive test for ribose, and for organic phosphate and for sodium | A. | Positive test for ribose, and for organic phosphate and for sodium |
A. | Positive test for ribose, and for organic phosphate and for sodium
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 7,0 and 8,5
B. | pH of a 5 % solution
Purity |
Water | Not more than 26,0 % (Karl Fischer)
Other nucleotides | Not detectable by thin-layer chromatography
Lead | Not more than 2 mg/kgE 640 GLYCINE AND ITS SODIUM SALT
Synonyms(gly) | Aminoacetic acid, glycocoll
(Na salt) | Sodium glycinate
Definition |
Chemical name (gly) | Aminoacetic acid
(Na salt) | Sodium glycinate
Chemical formula (gly) | C2H5NO2
(Na salt) | C2H5NO2Na
Einecs (gly) | 200-272-2
(Na salt) | 227-842-3
Molecular weight (gly) | 75,07
(Na salt) | 98
Assay | Content not less than 98,5 % on the anhydrous basis
Description | White crystals or crystalline powder
Identification |
A.Positive test for amino acid (gly and Na salt) | A. | Positive test for amino acid (gly and Na salt) |
A. | Positive test for amino acid (gly and Na salt)
B.Positive test for sodium (Na salt) | B. | Positive test for sodium (Na salt) |
B. | Positive test for sodium (Na salt)
Purity |
Loss on drying (gly) | Not more than 0,2 % (105oC, 3h)
(Na salt) | Not more than 0,2 % (105oC, 3h)
Residue on ignition (gly) | Not more than 0,1 %
(Na salt) | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 650 ZINC ACETATE
Synonyms | Acetic acid, zinc salt, dihydrate
Definition |
Chemical name | Zinc acetate dihydrate
Chemical formula | C4H6O4Zn· 2H2O
Molecular weight | 219,51
Assay | Content not less than 98 % and not more than 102 % of C4H6O4Zn · 2H2O
Description | Colourless crystals or fine, off-white powder
Identification |
A.Positive tests for acetate and for zinc | A. | Positive tests for acetate and for zinc |
A. | Positive tests for acetate and for zinc
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 6,0 and 8,0
B. | pH of a 5 % solution
Purity |
Insoluble matter | Not more than 0,005 %
Chlorides | Not more than 50 mg/kg
Sulphates | Not more than 100 mg/kg
Alkalines and alkaline earths | Not more than 0,2 %
Organic volatile impurities | Passes test
Iron | Not more than 50 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 20 mg/kg
Cadmium | Not more than 5 mg/kgE 900 DIMETHYL POLYSILOXANE
Synonyms | Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone
Definition | Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3SiO
Chemical name | Siloxanes and silicones, di-methyl
Chemical formula | (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3
Assay | Content of total silicon not less than 37,3 % and not more than 38,5 %
Description | Clear, colourless, viscous liquid
Identification |
A.Specific gravity (25o/25oC) | A. | Specific gravity (25o/25oC) | Between 0,964 and 0,977
A. | Specific gravity (25o/25oC)
B.Refractive index [n]D25 | B. | Refractive index [n]D25 | Between 1,400 and 1,405
B. | Refractive index [n]D25
C.Infrared spectrum characteristic of the compound | C. | Infrared spectrum characteristic of the compound |
C. | Infrared spectrum characteristic of the compound
Purity |
Loss on drying | Not more than 0,5 % (150oC, 4h)
Viscosity | Not less than 1,00 · 10-4m2s-1at 25oC
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 901 BEESWAX
Synonyms | White wax, yellow wax
Definition | Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee,Apis melliferaL., with hot water and removing foreign matter
White beeswax is obtained by bleaching yellow beeswax
Einecs | 232-383-7 (beeswax)
Description | Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour
Identification |
A.Melting range | A. | Melting range | Between 62oC and 65oC
A. | Melting range
B.Specific gravity | B. | Specific gravity | About 0,96
B. | Specific gravity
C.Solubility | C. | Solubility | Insoluble in water
C. | Solubility
Sparingly soluble in alcohol
Very soluble in chloroform and ether
Purity |
Acid value | Not less than 17 and not more than 24
Saponification value | 87-104
Peroxide value | Not more than 5
Glycerol and other polyols | Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes | Absent
Fats, Japan wax, rosin and soaps | Absent
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 902 CANDELILLA WAX
Definition | Candelilla wax is a purified wax obtained from the leaves of the candelilla plant,Euphorbia antisyphilitica
Einecs | 232-347-0
Description | Hard, yellowish brown, opaque to translucent wax
Identification |
A.Specific gravity | A. | Specific gravity | About 0,983
A. | Specific gravity
B.Melting range | B. | Melting range | Between 68,5oC and 72,5oC
B. | Melting range
C.Solubility | C. | Solubility | Insoluble in water
C. | Solubility
Soluble in chloroform and toluene
Purity |
Acid value | Not less than 12 and not more than 22
Saponification value | Not less than 43 and not more than 65
Glycerol and other polyols | Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes | Absent
Fats, Japan wax, rosin and soaps | Absent
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 903 CARNAUBA WAX
Definition | Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm,Copernicia cerifera
Einecs | 232-399-4
Description | Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
Identification |
A.Specific gravity | A. | Specific gravity | About 0,997
A. | Specific gravity
B.Melting range | B. | Melting range | Between 82oC and 86oC
B. | Melting range
C.Solubility | C. | Solubility | Insoluble in water
C. | Solubility
Partly soluble in boiling ethanol
Soluble in chloroform and diethyl ether
Purity |
Sulphated ash | Not more than 0,25 %
Acid value | Not less than 2 and not more than 7
Ester value | Not less than 71 and not more than 88
Unsaponifiable matter | Not less than 50 % and not more than 55 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 904 SHELLAC
Synonyms | Bleached shellac, white shellac
Definition | Shellac is the purified and bleached lac, the resinous secretion of the insectLaccifer (Tachardia) laccaKerr (Fam.Coccidae)
Einecs | 232-549-9
Description | Bleached shellac — off-white, amorphous, granular resin
Wax-free bleached shellac — light yellow, amorphous, granular resin
Identification |
A.Solubility | A. | Solubility | Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
A. | Solubility
B.Acid value | B. | Acid value | Between 60 and 89
B. | Acid value
Purity |
Loss on drying | Not more than 6,0 % (40oC, over silica gel, 15h)
Rosin | Absent
Wax | Bleached shellac: not more than 5,5 %
Wax-free bleached shellac: not more than 0,2 %
Lead | Not more than 2 mg/kgE 905 MICROCRYSTALLINE WAX
Synonyms | Petroleum wax
Definition | Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum
Description | White to amber, odourless wax
Identification |
A.Solubility | A. | Solubility | Insoluble in water, very slightly soluble in ethanol
A. | Solubility
B.Refractive Index | B. | Refractive Index | nD1001,434 -1,448
B. | Refractive Index
Purity |
Molecular weight | Average not less than 500
Viscosity at 100oC | Not less than 1,1 · 10-5m2s-1
Residue on ignition | Not more than 0,1 %
Carbon number at 5 % distillation point | Not more than 5 % of molecules with carbon number less than 25
Colour | Passes test
Sulphur | Not more than 0,4 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 3 mg/kg
Polycyclic aromatic compounds | The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:
| nm | Maximum absorbance per cm path length
| 280-289 | 0,15
| 290-299 | 0,12
| 300-359 | 0,08
| 360-400 | 0,02E 907 HYDROGENATED POLY-1-DECENE
Synonyms | Hydrogenated polydec-1-ene
Hydrogenated poly-alpha-olefin
Definition |
Chemical formula | C10nH20n+2where n = 3-6
Molecular weight | 560 (average)
Assay | Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:
C30: 13-37 %
C40: 35-70 %
C50: 9-25 %
C60: 1-7 %
Description |
Identification |
A.Solubility | A. | Solubility | Insoluble in water; slightly soluble in ethanol; soluble in toluene
A. | Solubility
B.Burning | B. | Burning | Burns with a bright flame and a paraffin-like characteristic smell
B. | Burning
Purity |
Viscosity | Between 5,7 × 10-6and 6,1 × 10-6m2s-1at 100oC
Compounds with carbon number less than 30 | Not more than 1,5 %
Readily carbonisable substances | After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour
Nickel | Not more than 1 mg/kg
Lead | Not more than 1 mg/kgE 912 MONTAN ACID ESTERS
Definition | Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
Chemical name | Montan acid esters
Description | Almost white to yellowish flakes, powder, granules or pellets
Identification |
A.Density (20oC) | A. | Density (20oC) | Between 0,98 and 1,05
A. | Density (20oC)
B.Drop point | B. | Drop point | Greater than 77oC
B. | Drop point
Purity |
Acid value | Not more than 40
Glycerol | Not more than 1 % (by gas chromatography)
Other polyols | Not more than 1 % (by gas chromatography)
Other wax types | Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
Arsenic | Not more than 2 mg/kg
Chromium | Not more than 3 mg/kg
Lead | Not more than 2 mg/kgE 914 OXIDISED POLYETHYLENE WAX
Definition | Polar reaction products from mild oxidation of polyethylene
Chemical name | Oxidised polyethylene
Description | Almost white flakes, powder, granules or pellets
Identification |
A.Density (20oC) | A. | Density (20oC) | Between 0,92 and 1,05
A. | Density (20oC)
B.Drop point | B. | Drop point | Greater than 95oC
B. | Drop point
Purity |
Acid value | Not more than 70
Viscosity at 120oC | Not less than 8,1 · 10-5m2s-1
Other wax types | Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
Oxygen | Not more than 9,5 %
Chromium | Not more than 5 mg/kg
Lead | Not more than 2 mg/kgE 920 L-CYSTEINE
Definition | L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance
Einecs | 200-157-7 (anhydrous)
Chemical formula | C3H7NO2S· HCl· n H20 (where n = 0 or 1)
Molecular weight | 157,62 (anhydrous)
Assay | Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis
Description | White powder or colourless crystals
Identification |
A.Solubility | A. | Solubility | Freely soluble in water and in ethanol
A. | Solubility
B.Melting range | B. | Melting range | Anhydrous form melts at about 175oC
B. | Melting range
C.Specific rotation | C. | Specific rotation | [α]20D: between +5,0oand +8,0oor
C. | Specific rotation
[α]25D: between +4,9oand 7,9o
Purity |
Loss on drying | Between 8,0 % and 12,0 %
Not more than 2,0 % (anhydrous form)
Residue on ignition | Not more than 0,1 %
Ammonium-ion | Not more than 200 mg/kg
Arsenic | Not more than 1,5 mg/kg
Lead | Not more than 5 mg/kgE 927b CARBAMIDE
Synonyms | Urea
Definition |
Einecs | 200-315-5
Chemical formula | CH4N2O
Molecular weight | 60,06
Assay | Content not less than 99,0 % on the anhydrous basis
Description | Colourless to white, prismatic, crystalline powder or small, white pellets
Identification |
A.Solubility | A. | Solubility | Very soluble in water
A. | Solubility
Soluble in ethanol
B.Precipitation with nitric acid | B. | Precipitation with nitric acid | To pass the test a white, crystalline precipitate is formed
B. | Precipitation with nitric acid
C.Colour reaction | C. | Colour reaction | To pass the test a reddish-violet colour is produced
C. | Colour reaction
D.Melting range | D. | Melting range | 132oC to 135oC
D. | Melting range
Purity |
Loss on drying | Not more than 1,0 % (105oC, 1h)
Sulphated ash | Not more than 0,1 %
Ethanol-insoluble matter | Not more than 0,04 %
Alkalinity | Passes test
Ammonium-ion | Not more than 500 mg/kg
Biuret | Not more than 0,1 %
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kgE 938 ARGON
Definition |
Chemical name | Argon
Einecs | 231-147-0
Chemical formula | Ar
Molecular weight | 40
Assay | Not less than 99 %
Description | Colourless, odourless, non-flammable gas
Purity |
Water | Not more than 0,05 %
Methane and other hydrocarbons calculated as methane | Not more than 100 μl/lE 939 HELIUM
Definition |
Chemical name | Helium
Einecs | 231-168-5
Chemical formula | He
Molecular weight | 4
Assay | Not less than 99 %
Description | Colourless, odourless, non-flammable gas
Purity |
Water | Not more than 0,05 %
Methane and other hydrocarbons calculated as methane | Not more than 100 μl/lE 941 NITROGEN
Definition |
Chemical name | Nitrogen
Einecs | 231-783-9
Chemical formula | N2
Molecular weight | 28
Assay | Not less than 99 %
Description | Colourless, odourless, non-flammable gas
Purity |
Water | Not more than 0,05 %
Carbon monoxide | Not more than 10 μl/l
Methane and other hydrocarbons calculated as methane | Not more than 100 μl/l
Nitrogen dioxide and nitrogen oxide | Not more than 10 μl/l
Oxygen | Not more than 1 %E 942 NITROUS OXIDE
Definition |
Chemical name | Nitrous oxide
Einecs | 233-032-0
Chemical formula | N2O
Molecular weight | 44
Assay | Not less than 99 %
Description | Colourless, non-flammable gas, sweetish odour
Purity |
Water | Not more than 0,05 %
Carbon monoxide | Not more than 30 μl/l
Nitrogen dioxide and nitrogen oxide | Not more than 10 μl/lE 943a BUTANE
Synonyms | n-Butane
Definition |
Chemical name | Butane
Chemical formula | CH3CH2CH2CH3
Molecular weight | 58,12
Assay | Content not less than 96 %
Description | Colourless gas or liquid with mild, characteristic odour
Identification |
A.Vapour pressure | A. | Vapour pressure | 108,935 kPa at 20oC
A. | Vapour pressure
Purity |
Methane | Not more than 0,15 % v/v
Ethane | Not more than 0,5 % v/v
Propane | Not more than 1,5 % v/v
Isobutane | Not more than 3,0 % v/v
1,3-butadiene | Not more than 0,1 % v/v
Moisture | Not more than 0,005 %E 943b ISOBUTANE
Synonyms | 2-methyl propane
Definition |
Chemical name | 2-methyl propane
Chemical formula | (CH3)2CH CH3
Molecular weight | 58,12
Assay | Content not less than 94 %
Description | Colourless gas or liquid with mild, characteristic odour
Identification |
A.Vapour pressure | A. | Vapour pressure | 205,465 kPa at 20oC
A. | Vapour pressure
Purity |
Methane | Not more than 0,15 % v/v
Ethane | Not more than 0,5 % v/v
Propane | Not more than 2,0 % v/v
n-Butane | Not more than 4,0 % v/v
1,3 -butadiene | Not more than 0,1 % v/v
Moisture | Not more than 0,005 %E 944 PROPANE
Definition |
Chemical name | Propane
Chemical formula | CH3CH2CH3
Molecular weight | 44,09
Assay | Content not less than 95 %
Description | Colourless gas or liquid with mild, characteristic odour
Identification |
A.Vapour pressure | A. | Vapour pressure | 732,910 kPa at 20oC
A. | Vapour pressure
Purity |
Methane | Not more than 0,15 % v/v
Ethane | Not more than 1,5 % v/v
Isobutane | Not more than 2,0 % v/v
n-Butane | Not more than 1,0 % v/v
1,3-butadiene | Not more than 0,1 % v/v
Moisture | Not more than 0,005 %E 948 OXYGEN
Definition |
Chemical name | Oxygen
Einecs | 231-956-9
Chemical formula | O2
Molecular weight | 32
Assay | Not less than 99 %
Description | Colourless, odourless, non-flammable gas
Purity |
Water | Not more than 0,05 %
Methane and other hydrocarbons calculated as methane | Not more than 100 μl/lE 949 HYDROGEN
Definition |
Chemical name | Hydrogen
Einecs | 215-605-7
Chemical formula | H2
Molecular weight | 2
Assay | Content not less than 99,9 %
Description | Colourless, odourless, highly flammable gas
Purity |
Water | Not more than 0,005 % v/v
Oxygen | Not more than 0,001 % v/v
Nitrogen | Not more than 0,75 % v/vE 950 ACESULFAME KPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 951 ASPARTAMEPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 953 ISOMALTPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 957 THAUMATINPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 959 NEOHESPERIDINE DIHYDROCHALCONEPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 965(i) MALTITOLPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 965(ii) MALTITOL SYRUPPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 966 LACTITOLPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 967 XYLITOLPurity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 999 QUILLAIA EXTRACT
Synonyms | Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract
Definition | Quillaia extract is obtained by aqueous extraction ofQuillaia saponariaMolina, or otherQuillaiaspecies, trees of the familyRosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components
Description | Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
Identification |
A.pH of a 2,5 % solution | A. | pH of a 2,5 % solution | Between 4,5 and 5,5
A. | pH of a 2,5 % solution
Purity |
Water | Not more than 6,0 % (Karl Fischer method) (powder form only)
Arsenic | Not more than 2 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kgE 1103 INVERTASE
Definition | Invertase is produced fromSaccharomyces cerevisiae
Systematic name | β-D-Fructofuranoside fructohydrolase
Enzyme Commission No | EC 3.2.1.26
Einecs | 232-615-7
Purity |
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
Cadmium | Not more than 0,5 mg/kg
Total bacterial count | Not more than 50 000 /g
Salmonellaspp. | Absent by test in 25 g
Coliforms | Not more than 30/g
E. coli | Absent by test in 25 gE 1105 LYSOZYME
Synonyms | Lysozyme hydrochloride
Muramidase
Definition | Lysozyme is a linear polypeptide obtained from hens’ egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride
Chemical name | Enzyme Commission (EC) No: 3.2.1.17
Einecs | 232-620-4
Molecular weight | About 14 000
Assay | Content not less than 950 mg/g on the anhydrous basis
Description | White, odourless powder having a slightly sweet taste
Identification |
A.Isoelectric point 10,7 | A. | Isoelectric point 10,7 |
A. | Isoelectric point 10,7
B.pH of a 2 % aqueous solution between 3,0 and 3,6 | B. | pH of a 2 % aqueous solution between 3,0 and 3,6 |
B. | pH of a 2 % aqueous solution between 3,0 and 3,6
C.Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm | C. | Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm |
C. | Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Purity |
Water content | Not more than 6,0 % (Karl Fischer method) (powder form only)
Residue on ignition | Not more than 1,5 %
Nitrogen | Not less than 16,8 % and not more than 17,8 %
Arsenic | Not more than 1 mg/kg
Lead | Not more than 5 mg/kg
Mercury | Not more than 1 mg/kg
Heavy metals (as Pb) | Not more than 10 mg/kg
Microbiological criteria |
Total bacterial count | Not more than 5 × 104col/g
Salmonellae | Absent in 25 g
Staphylococcus aureus | Absent in 1 g
Escherichia coli | Absent in 1 gE 1200 POLYDEXTROSE
Synonyms | Modified polydextroses
Definition | Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose
Assay | Content not less than 90 % of polymer on the ash free and anhydrous basis
Description | White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution
Identification |
A.Positive tests for sugar and for reducing sugar | A. | Positive tests for sugar and for reducing sugar |
A. | Positive tests for sugar and for reducing sugar
B.pH of a 10 % solution | B. | pH of a 10 % solution | Between 2,5 and 7,0 for polydextrose
B. | pH of a 10 % solution
Between 5,0 and 6,0 for polydextrose-N
Purity |
Water | Not more than 4,0 % (Karl Fischer method)
Sulphated ash | Not more than 0,3 % (polydextrose)
Not more than 2,0 % (polydextrose N)
Nickel | Not more than 2 mg/kg for hydrogenated polydextroses
1,6-Anhydro-D-glucose | Not more than 4,0 % on the ash-free and the dried basis
Glucose and sorbitol | Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately
Molecular weight limit | Negative test for polymers of molecular weight greater than 22 000
5-Hydroxy-methylfurfural | Not more than 0,1 % (polydextrose)
Not more than 0,05 % (polydextrose-N)
Lead | Not more than 0,5 mg/kgE 1201 POLYVINYLPYRROLIDONE
Synonyms | Povidone
PVP
Soluble polyvinylpyrrolidone
Definition |
Chemical name | Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula | (C6H9NO)n
Molecular weight | Not less than 25 000
Assay | Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis
Description | White or nearly white powder
Identification |
A.Solubility | A. | Solubility | Soluble in water and in ethanol. Insoluble in ether
A. | Solubility
B.pH of a 5 % solution | B. | pH of a 5 % solution | Between 3,0 and 7,0
B. | pH of a 5 % solution
Purity |
Water | Not more than 5 % (Karl Fischer)
Total ash | Not more than 0,1 %
Aldehyde | Not more than 500 mg/kg (as acetaldehyde)
Free-N-vinylpyrrolidone | Not more than 10 mg/kg
Hydrazine | Not more than 1 mg/kg
Lead | Not more than 5 mg/kgE 1202 POLYVINYLPOLYPYRROLIDONE
Synonyms | Crospovidone
Cross linked polyvidone
Insoluble polyvinylpyrrolidone
Definition | Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N’-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination
Chemical name | Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula | (C6H9NO)n
Assay | Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis
Description | A white hygroscopic powder with a faint, non-objectionable odour
Identification |
A.Solubility | A. | Solubility | Insoluble in water, ethanol and ether
A. | Solubility
B.pH of a 1 % suspension in water | B. | pH of a 1 % suspension in water | Between 5,0 and 8,0
B. | pH of a 1 % suspension in water
Purity |
Water | Not more than 6 % (Karl Fischer)
Sulphated ash | Not more than 0,4 %
Water-soluble matter | Not more than 1 %
Free-N-vinylpyrrolidone | Not more than 10 mg/kg
Free-N, N’-divinyl-imidazolidone | Not more than 2 mg/kg
Lead | Not more than 5 mg/kgE 1204 PULLULAN
Definition | Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain ofAureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography
Einecs | 232-945-1
Chemical formula | (C6H10O5)x
Assay | Not less than 90 % of glucan on the dried basis
Description | White to off-white odourless powder
Identification |
A.Solubility | A. | Solubility | Soluble in water, practically insoluble in ethanol
A. | Solubility
B.pH of 10 % solution | B. | pH of 10 % solution | 5,0 to 7,0
B. | pH of 10 % solution
C.Precipitation with polyethylene glycol 600 | C. | Precipitation with polyethylene glycol 600 | Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed
C. | Precipitation with polyethylene glycol 600
D.Depoly-merisation with pullulanase | D. | Depoly-merisation with pullulanase | Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
D. | Depoly-merisation with pullulanase
Purity |
Loss on drying | Not more than 6 % (90oC, pressure not more than 50 mm Hg, 6 h)
Mono-, di- and oligosaccharides | Not more than 10 % expressed as glucose
Viscosity | 100 to 180 mm2/s (10 % w/w aqueous solution at 30oC)
Lead | Not more than 1 mg/kg
Yeast and moulds | Not more than 100 colonies per gram
Coliforms | Absent in 25 g
Salmonella | Absent in 25 gE 1404 OXIDISED STARCH
Definition | Oxidised starch is starch treated with sodium hypochlorite
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl groups | Not more than 1,1 %
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1410 MONOSTARCH PHOSPHATE
Definition | Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate | Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1412 DISTARCH PHOSPHATE
Definition | Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate | Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1413 PHOSPHATED DISTARCH PHOSPHATE
Definition | Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate | Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1414 ACETYLATED DISTARCH PHOSPHATE
Definition | Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups | Not more than 2,5 %
Residual phosphate | Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 % (as P) for other starches
Vinyl acetate | Not more than 0,1 mg/kg
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1420 ACETYLATED STARCH
Synonyms | Starch acetate
Definition | Acetylated starch is starch esterified with acetic anhydride or vinyl acetate
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups | Not more than 2,5 %
Vinyl acetate | Not more than 0,1 mg/kg
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1422 ACETYLATED DISTARCH ADIPATE
Definition | Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups | Not more than 2,5 %
Adipate groups | Not more than 0,135 %
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1440 HYDROXYPROPYL STARCH
Definition | Hydroxypropyl starch is starch etherified with propylene oxide
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups | Not more than 7,0 %
Propylene chlorohydrin | Not more than 1 mg/kg
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
Definition | Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups | Not more than 7,0 %
Residual phosphate | Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin | Not more than 1 mg/kg
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1450 STARCH SODIUM OCTENYL SUCCINATE
Synonyms | SSOS
Definition | Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Octenylsuccinyl groups | Not more than 3 %
Octenylsuccinic acid residue | Not more than 0,3 %
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1451 ACETYLATED OXIDISED STARCH
Definition | Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl groups | Not more than 1,3 %
Acetyl groups | Not more than 2,5 %
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kgE 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
Synonyms | SAOS
Definition | Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate
Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification |
A.If not pregelatinised: by microscopic observation | A. | If not pregelatinised: by microscopic observation |
A. | If not pregelatinised: by microscopic observation
B.Iodine staining positive (dark blue to light red colour) | B. | Iodine staining positive (dark blue to light red colour) |
B. | Iodine staining positive (dark blue to light red colour)
Purity(all values expressed on an anhydrous basis except for loss on drying) |
Loss on drying | Not more than 21,0 %
Octenylsuccinyl groups | Not more than 3 %
Octenylsuccinic acid residue | Not more than 0,3 %
Sulphur dioxide | Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for the other modified starches, unless otherwise specified
Arsenic | Not more than 1 mg/kg
Lead | Not more than 2 mg/kg
Mercury | Not more than 0,1 mg/kg
Aluminium | Not more than 0,3 %E 1505 TRIETHYL CITRATE
Synonyms | Ethyl citrate
Definition |
Chemical name | Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
Einecs | 201-070-7
Chemical formula | C12H20O7
Molecular weight | 276,29
Assay | Content not less than 99,0 %
Description | Odourless, practically colourless, oily liquid
Identification |
A.Specific gravity | A. | Specific gravity | d2525: 1,135 -1,139
A. | Specific gravity
B.Refractive index | B. | Refractive index | [n]D20: 1,439 -1,441
B. | Refractive index
Purity |
Water | Not more than 0,25 % (Karl Fischer method)
Acidity | Not more than 0,02 % (as citric acid)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kgE 1517 GLYCERYL DIACETATE
Synonyms | Diacetin
Definition | Glyceryl diacetate consist predominantly of a mixture of the 1,2 – and 1,3 -diacetates of glycerol, with minor amounts of the mono- and tri-esters
Chemical names | Glyceryl diacetate
1, 2, 3-propanetriol diacetate
Chemical formula | C7H12O5
Molecular weight | 176,17
Assay | Not less than 94,0 %
Description | Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour
Identification |
A.Solubility | A. | Solubility | Soluble in water. Miscible with ethanol
A. | Solubility
B.Positive tests for glycerol and acetate | B. | Positive tests for glycerol and acetate |
B. | Positive tests for glycerol and acetate
C.Specific gravity | C. | Specific gravity | d2020: 1,175 -1,195
C. | Specific gravity
D.Boiling range | D. | Boiling range | Between 259 and 261oC
D. | Boiling range
Purity |
Total ash | Not more than 0,02 %
Acidity | Not more than 0,4 % (as ascetic acid)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kgE 1518 GLYCERYL TRIACETATE
Synonyms | Triacetin
Definition |
Chemical name | Glyceryl triacetate
Einecs | 203-051-9
Chemical formula | C9H14O6
Molecular weight | 218,21
Assay | Content not less than 98,0 %
Description | Colourless, somewhat oily liquid having a slightly fatty odour
Identification |
A.Positive tests for acetate and for glycerol | A. | Positive tests for acetate and for glycerol |
A. | Positive tests for acetate and for glycerol
B.Refractive index | B. | Refractive index | Between 1,429 and 1,431 at 25oC
B. | Refractive index
C.Specific gravity (25oC/25oC) | C. | Specific gravity (25oC/25oC) | Between 1,154 and 1,158
C. | Specific gravity (25oC/25oC)
D.Boiling range | D. | Boiling range | Between 258 and 270oC
D. | Boiling range
Purity |
Water | Not more than 0,2 % (Karl Fischer method)
Sulphated ash | Not more than 0,02 % (as citric acid)
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kgE 1519 BENZYL ALCOHOL
Synonyms | Phenylcarbinol
Phenylmethyl alcohol
Benzenemethanol
Alpha-hydroxytoluene
Definition |
Chemical names | Benzyl alcohol
Phenylmethanol
Chemical formula | C7H8O
Molecular weight | 108,14
Assay | Not less than 98,0 %
Description | Colourless, clear liquid with a faint, aromatic odour
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethanol and ether
A. | Solubility
B.Refractive index | B. | Refractive index | [n]D20: 1,538 -1,541
B. | Refractive index
C.Specific gravity | C. | Specific gravity | d2525: 1,042 -1,047
C. | Specific gravity
D.Positive test for peroxides | D. | Positive test for peroxides |
D. | Positive test for peroxides
Purity |
Distillation range | Not less than 95 % v/v distils between 202 and 208oC
Acid value | Not more than 0,5
Aldehydes | Not more than 0,2 % v/v (as bezaldehyde)
Lead | Not more than 5 mg/kgE 1520 PROPANE-1,2-DIOL
Synonyms | Propylene glycol
Definition |
Chemical names | 1,2-dihydroxypropane
Einecs | 200-338-0
Chemical formula | C3H8O2
Molecular weight | 76,10
Assay | Content not less than 99,5 % on the anhydrous basis
Description | Clear, colourless, hygroscopic, viscous liquid
Identification |
A.Solubility | A. | Solubility | Soluble in water, ethanol and acetone
A. | Solubility
B.Specific gravity | B. | Specific gravity | d2020: 1,035 -1,040
B. | Specific gravity
C.Refractive index | C. | Refractive index | [n]20D: 1,431 -1,433
C. | Refractive index
Purity |
Distillation range | 99 % v/v distils between 185oC-189oC
Sulphated ash | Not more than 0,07 %
Water | Not more than 1,0 % (Karl Fischer method)
Lead | Not more than 5 mg/kgPOLYETHYLENE GLYCOL 6000
Synonyms | PEG 6000
Macrogol 6000
Definition | Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000
Chemical formula | (C2H4O)nH2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000 , about 140)
Molecular weight | 5 600 -7 000
Assay | Not less than 90,0 % and not more than 110,0 %
Description | A white or almost white solid with a waxy or paraffin-like appearance
Identification |
A.Solubility | A. | Solubility | Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils
A. | Solubility
B.Melting range | B. | Melting range | Between 55oC and 61oC
B. | Melting range
Purity |
Viscosity | Between 0,220 and 0,275 kgm-1s-1at 20oC
Hydroxyl value | Between 16 and 22
Sulphated ash | Not more than 0,2 %
Ethylene oxide | Not more than 0,2 mg/kg
Arsenic | Not more than 3 mg/kg
Lead | Not more than 5 mg/kg
(1)
OJ L 226, 22.9.1995, p. 1.
(*1) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.
(2) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml.
(3) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.
(4) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml.
(5) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
(6) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
(7)
OJ L 158, 18.6.2008, p. 17.

PART A

ANNEX IIRepealed Directive with list of its successive amendments
(referred to in Article 2)

Commission Directive 96/77/ECCommission Directive 98/86/ECCommission Directive 2000/63/ECCommission Directive 2001/30/ECCommission Directive 2002/82/ECCommission Directive 2003/95/ECCommission Directive 2004/45/ECCommission Directive 2006/129/EC | | Commission Directive 98/86/EC | | Commission Directive 2000/63/EC | | Commission Directive 2001/30/EC | | Commission Directive 2002/82/EC | | Commission Directive 2003/95/EC | | Commission Directive 2004/45/EC | | Commission Directive 2006/129/EC | (OJ L 339, 30.12.1996, p. 1)(OJ L 334, 9.12.1998, p. 1)(OJ L 277, 30.10.2000, p. 1)(OJ L 146, 31.5.2001, p. 1)(OJ L 292, 28.10.2002, p. 1)(OJ L 283, 31.10.2003, p. 71)(OJ L 113, 20.4.2004, p. 19)(OJ L 346, 9.12.2006, p. 15) | | (OJ L 334, 9.12.1998, p. 1) | | (OJ L 277, 30.10.2000, p. 1) | | (OJ L 146, 31.5.2001, p. 1) | | (OJ L 292, 28.10.2002, p. 1) | | (OJ L 283, 31.10.2003, p. 71) | | (OJ L 113, 20.4.2004, p. 19) | | (OJ L 346, 9.12.2006, p. 15)
| Commission Directive 98/86/EC
| Commission Directive 2000/63/EC
| Commission Directive 2001/30/EC
| Commission Directive 2002/82/EC
| Commission Directive 2003/95/EC
| Commission Directive 2004/45/EC
| Commission Directive 2006/129/EC
| (OJ L 334, 9.12.1998, p. 1)
| (OJ L 277, 30.10.2000, p. 1)
| (OJ L 146, 31.5.2001, p. 1)
| (OJ L 292, 28.10.2002, p. 1)
| (OJ L 283, 31.10.2003, p. 71)
| (OJ L 113, 20.4.2004, p. 19)
| (OJ L 346, 9.12.2006, p. 15)PART BList of time-limits for transposition into national law
(referred to in Article 2)

Directive | Time-limit for transposition
96/77/EC | 1 July 1997(1)
98/86/EC | 1 July 1999(2)
2000/63/EC | 31 March 2001(3)
2001/30/EC | 1 June 2002(4)
2002/82/EC | 31 August 2003
2003/95/EC | 1 November 2004(5)
2004/45/EC | 1 April 2005(6)
2006/129/EC | 15 February 2008
(1) According to Article 3(2) of Directive 96/77/EC, products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.
(2) According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted.
(3) According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply with this Directive may be marketed until stocks are exhausted.
(4) According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted.
(5) According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted.
(6) According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted.

ANNEX IIICorrelation table
Directive 96/77/EC | This Directive
Article 1 | Article 1
Article 2 | —
Article 3 | —
— | Article 2
Article 4 | Article 3
Article 5 | Article 4
Annex | Annex I
— | Annex II
— | Annex III