Pending: 32008L0071

January 16, 2026
8.8.2008 EN Official Journal of the European Union L 213/31
(1) Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) Pursuant to Article 3(1)(c) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(4), animals for intra-Community trade must be identified in accordance with the requirements of Community rules and be registered in such a way that the original or transit holding, centre or organisation can be traced. Before 1 January 1993, those identification and registration systems had to be extended to the movements of animals within the territory of each Member State.
(3) Article 14 of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries(5)states that the identification and registration provided for in Article 3(1)(c) of Directive 90/425/EEC of such animals must, except in the case of animals for slaughter and registered equidae, be carried out after the said checks have been made.
(4) It is necessary to ensure the rapid and efficient exchange of information between Member States for the correct application of this Directive. Community provisions have been laid down by Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters(6)and by Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters(7).
(5) Keepers of animals should maintain up-to-date records of the animals on their holdings. Persons involved in the commerce of animals should keep records of their dealings. The competent authority should have access to these records on request.
(6) In order to permit movements of animals to be traced rapidly and accurately, animals should be able to be identified. A decision should be taken at a later date to determine the nature of the mark and, pending such decision, the national systems of identification should be maintained for movements restricted to the national market.
(7) Provision should be made for the possibility of waiving the requirements for marks in the case of animals moving directly from a farm to a slaughterhouse. However, these animals should in any case be identified so that their farm of origin can be traced.
(8) Provision should be made for the possibility of waiving the obligation to register the keepers of animals kept for personal purposes and, in order to take into account certain particular cases, the procedures for keeping registers.
(9) In the case of animals in which the mark has become illegible or been lost, a new mark enabling a link with the previous mark to be established should be applied.
(10) This Directive should not affect specific requirements set out in Commission Decision 89/153/EEC of 13 February 1989 concerning the correlation of samples taken for residue examination with animals and their farms of origin(8)or any relevant applicatory rules established in accordance with Directive 91/496/EEC.
(11) Provision should be made for a management committee procedure for the adoption of any necessary implementing rules for this Directive.
(12) 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 Directive set out in Annex I, Part B,
(a) ‘animal’ means any animal of theSuidaefamily, excluding feral pigs as defined in Article 2(b) of Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(9);
(b) ‘holding’ means any establishment, construction or, in the case of an open-air farm, any place in which animals are held, kept or handled;
(c) ‘keeper’ means any natural or legal person responsible, even on a temporary basis, for animals;
(d) ‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence for the purposes of implementing this Directive;
(e) ‘trade’ means trade as defined in point (3) of Article 2 of Directive 90/425/EEC.
(a) the competent authority has an up-to-date list of all the holdings which keep animals covered by this Directive and are situated on its territory, specifying the keepers of the animals; such holdings must remain on that list until three consecutive years have elapsed with no animals on the holding. That list must also include the mark or marks which permit the identification of the holding in accordance with the first subparagraph of Article 5(2) and Article 8;
(b) the Commission and the competent authority can have access to all information obtained under this Directive.
(a) any keeper supplies the competent authority, upon request, with all information concerning the origin, identification and, where appropriate, the destination of animals which he has owned, kept, transported, marketed or slaughtered;
(b) any keeper of animals to be moved to or from a market or collection centre provides a document, containing details of the animals in question, to the operator, on the market or in the collection centre, who is a keeper of the animals, on a temporary basis.That operator may use the documents obtained in accordance with the first subparagraph to carry out the obligations laid down in the third subparagraph of paragraph 1;
(c) the registers and information are available on the holding and to the competent authority, upon request, for a minimum period to be determined by the competent authority but which may not be less than three years.
(a) identification marks must be applied before animals leave the holding of birth;
(b) no mark may be removed or replaced without the permission of the competent authority.Where a mark has become illegible or has been lost, a new mark shall be applied in accordance with this Article;
(c) the keeper shall record any new mark in the register referred to in Article 4 in order to establish a link with the previous mark applied to the animal.
Council Directive 92/102/EEC(OJ L 355, 5.12.1992, p. 32)
Point V.E.I.4.6. of Annex I to the 1994 Act of Accession(OJ C 241, 29.8.1994, p. 21)
Council Regulation (EC) No 21/2004(OJ L 5, 9.1.2004, p. 8) only Article 15
Directive Time limit for transposition(1)
92/102/EEC 31.12.1993(2)31.12.1995(3)
Directive 92/102/EEC This Directive
Articles 1, 2 and 3 Articles 1, 2 and 3
Article 4(1)(a) Article 4(1)
Article 4(2) —
Article 4(3) Article 4(2)
Article 5(1), points (a), (b) and (c) Article 5(1), points (a), (b) and (c)
Article 5(1)(d) —
Article 5(3) Article 5(2)
Articles 6 to 9 Articles 6 to 9
Article 10 —
Article 11(1) —
Article 11(2) Article 10
Article 11(3) —
— Article 11
— Article 12
Article 12 Article 13
— Annex I
— Annex II
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament(1),
(1) Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) Pursuant to Article 3(1)(c) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(4), animals for intra-Community trade must be identified in accordance with the requirements of Community rules and be registered in such a way that the original or transit holding, centre or organisation can be traced. Before 1 January 1993, those identification and registration systems had to be extended to the movements of animals within the territory of each Member State.
(3) Article 14 of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries(5)states that the identification and registration provided for in Article 3(1)(c) of Directive 90/425/EEC of such animals must, except in the case of animals for slaughter and registered equidae, be carried out after the said checks have been made.
(4) It is necessary to ensure the rapid and efficient exchange of information between Member States for the correct application of this Directive. Community provisions have been laid down by Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters(6)and by Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters(7).
(5) Keepers of animals should maintain up-to-date records of the animals on their holdings. Persons involved in the commerce of animals should keep records of their dealings. The competent authority should have access to these records on request.
(6) In order to permit movements of animals to be traced rapidly and accurately, animals should be able to be identified. A decision should be taken at a later date to determine the nature of the mark and, pending such decision, the national systems of identification should be maintained for movements restricted to the national market.
(7) Provision should be made for the possibility of waiving the requirements for marks in the case of animals moving directly from a farm to a slaughterhouse. However, these animals should in any case be identified so that their farm of origin can be traced.
(8) Provision should be made for the possibility of waiving the obligation to register the keepers of animals kept for personal purposes and, in order to take into account certain particular cases, the procedures for keeping registers.
(9) In the case of animals in which the mark has become illegible or been lost, a new mark enabling a link with the previous mark to be established should be applied.
(10) This Directive should not affect specific requirements set out in Commission Decision 89/153/EEC of 13 February 1989 concerning the correlation of samples taken for residue examination with animals and their farms of origin(8)or any relevant applicatory rules established in accordance with Directive 91/496/EEC.
(11) Provision should be made for a management committee procedure for the adoption of any necessary implementing rules for this Directive.
(12) 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 Directive set out in Annex I, Part B,
HAS ADOPTED THIS DIRECTIVE:

Article 1
This Directive sets out the minimum requirements for the identification and registration of pigs, without prejudice to more detailed Community rules which may be established for disease eradication or control purposes.
It shall apply without prejudice to Decision 89/153/EEC and to implementing rules laid down in accordance with Directive 91/496/EEC.

Article 2
For the purposes of this Directive, the following definitions shall apply:
(a)
‘animal’ means any animal of theSuidaefamily, excluding feral pigs as defined in Article 2(b) of Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(9);
(b)
‘holding’ means any establishment, construction or, in the case of an open-air farm, any place in which animals are held, kept or handled;
(c)
‘keeper’ means any natural or legal person responsible, even on a temporary basis, for animals;
(d)
‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence for the purposes of implementing this Directive;
(e)
‘trade’ means trade as defined in point (3) of Article 2 of Directive 90/425/EEC.

Article 3
1. Member States shall ensure that:
(a)
the competent authority has an up-to-date list of all the holdings which keep animals covered by this Directive and are situated on its territory, specifying the keepers of the animals; such holdings must remain on that list until three consecutive years have elapsed with no animals on the holding. That list must also include the mark or marks which permit the identification of the holding in accordance with the first subparagraph of Article 5(2) and Article 8;
(b)
the Commission and the competent authority can have access to all information obtained under this Directive.
2. Member States may be authorised in accordance with the procedure referred to in Article 18 of Directive 90/425/EEC to exclude from the list in paragraph 1(a) of this Article natural persons who keep one single animal which is intended for their own use or consumption, or to take account of particular circumstances, provided that this animal is subjected to the controls laid down in this Directive before any movement.

Article 4
1. Member States shall ensure that any keeper contained in the list provided for in Article 3(1)(a) keeps a register stating the number of animals present on the holding.
That register shall include an up-to-date record of movements (numbers of animals concerned by each entering and leaving operation) at least on the basis of aggregate movements, stating as appropriate their origin or destination, and the date of such movements.
The identification mark applied in conformity with Articles 5 and 8 shall be stated in all cases.
In the case of pure-bred and hybrid pigs, which are entered in a herd-book in accordance with Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species(10), an alternative registration system based on individual identification allowing the animals to be identified may be recognised in accordance with the procedure referred to in Article 18 of Directive 90/425/EEC if it offers guarantees equivalent to a register.
2. Member States shall also ensure that:
(a)
any keeper supplies the competent authority, upon request, with all information concerning the origin, identification and, where appropriate, the destination of animals which he has owned, kept, transported, marketed or slaughtered;
(b)
any keeper of animals to be moved to or from a market or collection centre provides a document, containing details of the animals in question, to the operator, on the market or in the collection centre, who is a keeper of the animals, on a temporary basis.
That operator may use the documents obtained in accordance with the first subparagraph to carry out the obligations laid down in the third subparagraph of paragraph 1;
(c)
the registers and information are available on the holding and to the competent authority, upon request, for a minimum period to be determined by the competent authority but which may not be less than three years.

Article 5
1. Member States shall ensure that the following general principles are respected:
(a)
identification marks must be applied before animals leave the holding of birth;
(b)
no mark may be removed or replaced without the permission of the competent authority.
Where a mark has become illegible or has been lost, a new mark shall be applied in accordance with this Article;
(c)
the keeper shall record any new mark in the register referred to in Article 4 in order to establish a link with the previous mark applied to the animal.
2. Animals must be marked as soon as possible, and in any case before they leave the holding, with an eartag or tattoo making it possible to determine the holding from which they came and enabling reference to be made to any accompanying document which must mention such eartag or tattoo and to the list referred to in Article 3(1)(a).
Member States may, by derogation from the second subparagraph of Article 3(1)(c) of Directive 90/425/EEC, apply their national systems for all movements of animals in their territories. Such systems must enable the holding from which they came and the holding on which they were born to be identified. Member States shall notify the Commission of the systems which they intend to introduce for this purpose. In accordance with the procedure referred to in Article 18 of Directive 90/425/EEC, a Member State may be asked to make amendments to its system where it does not fulfil that requirement.
Animals bearing a temporary mark identifying a consignment must be accompanied throughout their movement by a document which enables the origin, ownership, place of departure and destination to be determined.

Article 6
1. Where the competent authority of the Member State of destination decides not to keep the identification mark allocated to the animal in the holding of origin all charges incurred as a result of replacing the mark shall be borne by that authority. Where the mark has been so replaced, a link shall be established between the identification allocated by the competent authority of the Member State of dispatch and the new identification allocated by the competent authority of the Member State of destination; that link shall be recorded in the register provided for in Article 4.
The option in the first subparagraph may not be invoked in the case of animals intended for slaughter which are imported under Article 8 without bearing a new mark in accordance with Article 5.
2. Where the animals have been traded, the competent authority of the Member State of destination may, for the purposes of Article 5 of Directive 90/425/EEC, have recourse to Article 4 of Directive 89/608/EEC in order to obtain the information relating to the animals, their herd of origin and any movement to which they have been subject.

Article 7
Member States shall ensure that any information relating to movements of animals not accompanied by a certificate or a document required by veterinary or zootechnical legislation remains available to the competent authority, upon request, for a minimum period to be set by the latter.

Article 8
Any animal imported from a third country which has passed the checks laid down by Directive 91/496/EEC and which remains within Community territory shall, within thirty days of undergoing those checks, and, in any event, before their movement, be identified by a mark complying with Article 5 of this Directive unless the holding of destination is a slaughterhouse situated on the territory of the competent authority responsible for veterinary checks and the animal is actually slaughtered within that 30-day period.
A link shall be established between the identification established by the third country and the identification allocated to it by the Member State of destination. That link shall be recorded in the register provided for in Article 4.

Article 9
Member States shall adopt necessary administrative and/or penal measures to punish any infringement of Community veterinary legislation, where it is established that the marking or identification or the keeping of registers provided for in Article 4 has not been carried out in conformity with the requirements of this Directive.

Article 10
Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.

Article 11
Directive 92/102/EEC, as amended by the acts listed in Annex I, 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 Directive set out in Annex I, 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 set out in Annex II.

Article 12
This Directive shall enter into force on the 20th day following that of its publication in theOfficial Journal of the European Union.

Article 13
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 37 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament(1),
(1) Council Directive 92/102/EEC of 27 November 1992 on the identification and registration of animals(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) Pursuant to Article 3(1)(c) of Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market(4), animals for intra-Community trade must be identified in accordance with the requirements of Community rules and be registered in such a way that the original or transit holding, centre or organisation can be traced. Before 1 January 1993, those identification and registration systems had to be extended to the movements of animals within the territory of each Member State.
(3) Article 14 of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries(5)states that the identification and registration provided for in Article 3(1)(c) of Directive 90/425/EEC of such animals must, except in the case of animals for slaughter and registered equidae, be carried out after the said checks have been made.
(4) It is necessary to ensure the rapid and efficient exchange of information between Member States for the correct application of this Directive. Community provisions have been laid down by Council Regulation (EC) No 515/97 of 13 March 1997 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of the law on customs and agricultural matters(6)and by Council Directive 89/608/EEC of 21 November 1989 on mutual assistance between the administrative authorities of the Member States and cooperation between the latter and the Commission to ensure the correct application of legislation on veterinary and zootechnical matters(7).
(5) Keepers of animals should maintain up-to-date records of the animals on their holdings. Persons involved in the commerce of animals should keep records of their dealings. The competent authority should have access to these records on request.
(6) In order to permit movements of animals to be traced rapidly and accurately, animals should be able to be identified. A decision should be taken at a later date to determine the nature of the mark and, pending such decision, the national systems of identification should be maintained for movements restricted to the national market.
(7) Provision should be made for the possibility of waiving the requirements for marks in the case of animals moving directly from a farm to a slaughterhouse. However, these animals should in any case be identified so that their farm of origin can be traced.
(8) Provision should be made for the possibility of waiving the obligation to register the keepers of animals kept for personal purposes and, in order to take into account certain particular cases, the procedures for keeping registers.
(9) In the case of animals in which the mark has become illegible or been lost, a new mark enabling a link with the previous mark to be established should be applied.
(10) This Directive should not affect specific requirements set out in Commission Decision 89/153/EEC of 13 February 1989 concerning the correlation of samples taken for residue examination with animals and their farms of origin(8)or any relevant applicatory rules established in accordance with Directive 91/496/EEC.
(11) Provision should be made for a management committee procedure for the adoption of any necessary implementing rules for this Directive.
(12) 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 Directive set out in Annex I, Part B,
HAS ADOPTED THIS DIRECTIVE:
This Directive sets out the minimum requirements for the identification and registration of pigs, without prejudice to more detailed Community rules which may be established for disease eradication or control purposes.
It shall apply without prejudice to Decision 89/153/EEC and to implementing rules laid down in accordance with Directive 91/496/EEC.
For the purposes of this Directive, the following definitions shall apply:
(a)
‘animal’ means any animal of theSuidaefamily, excluding feral pigs as defined in Article 2(b) of Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(9);
(b)
‘holding’ means any establishment, construction or, in the case of an open-air farm, any place in which animals are held, kept or handled;
(c)
‘keeper’ means any natural or legal person responsible, even on a temporary basis, for animals;
(d)
‘competent authority’ means the central authority of a Member State competent to carry out veterinary checks or any authority to which it has delegated that competence for the purposes of implementing this Directive;
(e)
‘trade’ means trade as defined in point (3) of Article 2 of Directive 90/425/EEC.
1. Member States shall ensure that:
(a)
the competent authority has an up-to-date list of all the holdings which keep animals covered by this Directive and are situated on its territory, specifying the keepers of the animals; such holdings must remain on that list until three consecutive years have elapsed with no animals on the holding. That list must also include the mark or marks which permit the identification of the holding in accordance with the first subparagraph of Article 5(2) and Article 8;
(b)
the Commission and the competent authority can have access to all information obtained under this Directive.
2. Member States may be authorised in accordance with the procedure referred to in Article 18 of Directive 90/425/EEC to exclude from the list in paragraph 1(a) of this Article natural persons who keep one single animal which is intended for their own use or consumption, or to take account of particular circumstances, provided that this animal is subjected to the controls laid down in this Directive before any movement.
1. Member States shall ensure that any keeper contained in the list provided for in Article 3(1)(a) keeps a register stating the number of animals present on the holding.
That register shall include an up-to-date record of movements (numbers of animals concerned by each entering and leaving operation) at least on the basis of aggregate movements, stating as appropriate their origin or destination, and the date of such movements.
The identification mark applied in conformity with Articles 5 and 8 shall be stated in all cases.
In the case of pure-bred and hybrid pigs, which are entered in a herd-book in accordance with Council Directive 88/661/EEC of 19 December 1988 on the zootechnical standards applicable to breeding animals of the porcine species(10), an alternative registration system based on individual identification allowing the animals to be identified may be recognised in accordance with the procedure referred to in Article 18 of Directive 90/425/EEC if it offers guarantees equivalent to a register.
2. Member States shall also ensure that:
(a)
any keeper supplies the competent authority, upon request, with all information concerning the origin, identification and, where appropriate, the destination of animals which he has owned, kept, transported, marketed or slaughtered;
(b)
any keeper of animals to be moved to or from a market or collection centre provides a document, containing details of the animals in question, to the operator, on the market or in the collection centre, who is a keeper of the animals, on a temporary basis.
That operator may use the documents obtained in accordance with the first subparagraph to carry out the obligations laid down in the third subparagraph of paragraph 1;
(c)
the registers and information are available on the holding and to the competent authority, upon request, for a minimum period to be determined by the competent authority but which may not be less than three years.
1. Member States shall ensure that the following general principles are respected:
(a)
identification marks must be applied before animals leave the holding of birth;
(b)
no mark may be removed or replaced without the permission of the competent authority.
Where a mark has become illegible or has been lost, a new mark shall be applied in accordance with this Article;
(c)
the keeper shall record any new mark in the register referred to in Article 4 in order to establish a link with the previous mark applied to the animal.
2. Animals must be marked as soon as possible, and in any case before they leave the holding, with an eartag or tattoo making it possible to determine the holding from which they came and enabling reference to be made to any accompanying document which must mention such eartag or tattoo and to the list referred to in Article 3(1)(a).
Member States may, by derogation from the second subparagraph of Article 3(1)(c) of Directive 90/425/EEC, apply their national systems for all movements of animals in their territories. Such systems must enable the holding from which they came and the holding on which they were born to be identified. Member States shall notify the Commission of the systems which they intend to introduce for this purpose. In accordance with the procedure referred to in Article 18 of Directive 90/425/EEC, a Member State may be asked to make amendments to its system where it does not fulfil that requirement.
Animals bearing a temporary mark identifying a consignment must be accompanied throughout their movement by a document which enables the origin, ownership, place of departure and destination to be determined.
1. Where the competent authority of the Member State of destination decides not to keep the identification mark allocated to the animal in the holding of origin all charges incurred as a result of replacing the mark shall be borne by that authority. Where the mark has been so replaced, a link shall be established between the identification allocated by the competent authority of the Member State of dispatch and the new identification allocated by the competent authority of the Member State of destination; that link shall be recorded in the register provided for in Article 4.
The option in the first subparagraph may not be invoked in the case of animals intended for slaughter which are imported under Article 8 without bearing a new mark in accordance with Article 5.
2. Where the animals have been traded, the competent authority of the Member State of destination may, for the purposes of Article 5 of Directive 90/425/EEC, have recourse to Article 4 of Directive 89/608/EEC in order to obtain the information relating to the animals, their herd of origin and any movement to which they have been subject.
Member States shall ensure that any information relating to movements of animals not accompanied by a certificate or a document required by veterinary or zootechnical legislation remains available to the competent authority, upon request, for a minimum period to be set by the latter.
Any animal imported from a third country which has passed the checks laid down by Directive 91/496/EEC and which remains within Community territory shall, within thirty days of undergoing those checks, and, in any event, before their movement, be identified by a mark complying with Article 5 of this Directive unless the holding of destination is a slaughterhouse situated on the territory of the competent authority responsible for veterinary checks and the animal is actually slaughtered within that 30-day period.
A link shall be established between the identification established by the third country and the identification allocated to it by the Member State of destination. That link shall be recorded in the register provided for in Article 4.
Member States shall adopt necessary administrative and/or penal measures to punish any infringement of Community veterinary legislation, where it is established that the marking or identification or the keeping of registers provided for in Article 4 has not been carried out in conformity with the requirements of this Directive.
Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.
Directive 92/102/EEC, as amended by the acts listed in Annex I, 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 Directive set out in Annex I, 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 set out in Annex II.
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.

PART A

ANNEX IRepealed Directive with list of its successive amendments(referred to in Article 11)
Council Directive 92/102/EEC(OJ L 355, 5.12.1992, p. 32) |
Point V.E.I.4.6. of Annex I to the 1994 Act of Accession(OJ C 241, 29.8.1994, p. 21) |
Council Regulation (EC) No 21/2004(OJ L 5, 9.1.2004, p. 8) | only Article 15PART BList of time limits for transposition into national law(referred to in Article 11)
Directive | Time limit for transposition(1)
92/102/EEC | 31.12.1993(2)31.12.1995(3)
(1) The setting of the deadline for transposition into national law at 1 January 1994 shall be without prejudice to the abolition of veterinary checks at frontiers provided for in Directive 90/425/EEC (see Article 11(3) of Directive 92/102/EEC).
(2) For the requirements regarding porcine animals (see the first indent of Article 11(1) of Directive 92/102/EEC).
(3) For Finland, as concerns the requirements for bovine animals, swine, sheep and goats (see the second indent of Article 11(1) of Directive 92/102/EEC).
ANNEX IICORRELATION TABLE
Directive 92/102/EEC | This Directive
Articles 1, 2 and 3 | Articles 1, 2 and 3
Article 4(1)(a) | Article 4(1)
Article 4(2) | —
Article 4(3) | Article 4(2)
Article 5(1), points (a), (b) and (c) | Article 5(1), points (a), (b) and (c)
Article 5(1)(d) | —
Article 5(3) | Article 5(2)
Articles 6 to 9 | Articles 6 to 9
Article 10 | —
Article 11(1) | —
Article 11(2) | Article 10
Article 11(3) | —
— | Article 11
— | Article 12
Article 12 | Article 13
— | Annex I
— | Annex II

Pending: 32008L0060

January 16, 2026
18.6.2008 EN Official Journal of the European Union L 158/17
(1) Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs(2)has been substantially amended several times(3). In the interest of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs(4).
(3) It is necessary to take into account the specifications and analytical techniques for sweeteners 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 line 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,
E 420 (i) —SORBITOL
Synonyms D-glucitol, D-sorbitol
Definition
Chemical name D-glucitol
Einecs 200-061-5
Chemical formula C6H14O6
Relative molecular mass 182,17
Assay Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis.Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer
Description White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste
Identification
A.Solubility A. Solubility Very soluble in water, slightly soluble in ethanol
A. Solubility
B.Melting range B. Melting range 88 to 102 °C
B. Melting range
C.Sorbitol monobenzylidene derivative C. Sorbitol monobenzylidene derivative To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
C. Sorbitol monobenzylidene derivative
Purity
Water content Not more than 1 % (Karl Fischer method)
Sulphated ash Not more than 0,1 % expressed on dry weight basis
Reducing sugars Not more than 0,3 % expressed as glucose on dry weight basis
Total sugars Not more than 1 % expressed as glucose on dry weight basis
Chlorides Not more than 50 mg/kg expressed on dry weight basis
Sulphates Not more than 100 mg/kg expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
E 420 (ii) —SORBITOL SYRUP
Synonyms D-glucitol syrup
Definition
Chemical name Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols wheren≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer
Einecs 270-337-8
Assay Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis
Description Clear colourless and sweet-tasting aqueous solution
Identification
A.Solubility A. Solubility Miscible with water, with glycerol, and with propane-1,2-diol
A. Solubility
B.Melting range B. Melting range To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
B. Melting range
Purity
Water content Not more than 31 % (Karl Fischer method)
Sulphated ash Not more than 0,1 % expressed on dry weight basis
Reducing sugars Not more than 0,3 % expressed as glucose on dry weight basis
Chlorides Not more than 50 mg/kg expressed on dry weight basis
Sulphates Not more than 100 mg/kg expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
E 421 —MANNITOL
(I)MANNITOL
Synonyms D-mannitol
Definition Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose
Chemical name D-mannitol
Einecs 200-711-8
Chemical formula C6H14O6
Molecular weight 182,2
Assay Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
Description White, odourless, crystalline powder
Identification
A.Solubility A. Solubility Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
A. Solubility
B.Melting range B. Melting range Between 164 and 169 °C
B. Melting range
C.Thin layer chromatography C. Thin layer chromatography Passes test
C. Thin layer chromatography
D.Specific rotation D. Specific rotation [α]20D: + 23 ° to + 25 ° (borate solution)
D. Specific rotation
E.pH E. pH Between 5 and 8Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
E. pH
Purity
Loss on drying Not more than 0,3 % (105 °C, four hours)
Reducing sugars Not more than 0,3 % (as glucose)
Total sugars Not more than 1 % (as glucose)
Sulphated ash Not more than 0,1 %
Chlorides Not more than 70 mg/kg
Sulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg
(II)MANNITOL MANUFACTURED BY FERMENTATION
Synonyms D-mannitol
Definition Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeastZygosaccharomyces rouxii
Chemical name D-mannitol
Einecs 200-711-8
Chemical formula C6H14O6
Molecular weight 182,2
Assay Not less than 99 % on the dried basis
Description White, odourless crystalline powder
Identification
A.Solubility A. Solubility Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
A. Solubility
B.Melting range B. Melting range Between 164 and 169 °C
B. Melting range
C.Thin layer chromatography C. Thin layer chromatography Passes test
C. Thin layer chromatography
D.Specific rotation D. Specific rotation [α]20D: + 23 ° to + 25 ° (borate solution)
D. Specific rotation
E.pH E. pH Between 5 and 8Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
E. pH
Purity
Arabitol Not more than 0,3 %
Loss on drying Not more than 0,3 % (105 °C, four hours)
Reducing sugars Not more than 0,3 % (as glucose)
Total sugars Not more than 1 % (as glucose)
Sulphated ash Not more than 0,1 %
Chlorides Not more than 70 mg/kg
Sulphate Not more than 100 mg/kg
Lead Not more than 1 mg/kg
Aerobic mesophilic bacteria Not more than 103/g
Coliforms Absent in 10 g
Salmonella Absent in 10 g
E. Coli Absent in 10 g
Staphylococcus aureus Absent in 10 g
Pseudomonas aeruginosa Absent in 10 g
Moulds Not more than 100/g
Yeasts Not more than 100/g
E 950 —ACESULFAME K
Synonyms Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxide
Definition
Chemical name 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt
Einecs 259-715-3
Chemical formula C4H4KNO4S
Molecular weight 201,24
Assay Content not less than 99 % of C4H4KNO4S on the anhydrous basis
Description Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose
Identification
A.Solubility A. Solubility Very soluble in water, very slightly soluble in ethanol
A. Solubility
B.Ultraviolet absorption B. Ultraviolet absorption Maximum 227 ± 2 nm for a solution of 10 mg in 1 000  ml of water
B. Ultraviolet absorption
C.Positive test for potassium C. Positive test for potassium Passes test (test the residue obtained by igniting 2 g of the sample)
C. Positive test for potassium
D.Precipitation test D. Precipitation test Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced
D. Precipitation test
Purity
Loss on drying Not more than 1 % (105 °C, two hours)
Organic impurities Passes test for 20 mg/kg of UV active components
Fluoride Not more than 3 mg/kg
Lead Not more than 1 mg/kg
E 951 —ASPARTAME
Synonyms Aspartyl phenylalanine methyl ester
Definition
Chemical name N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester
Einecs 245-261-3
Chemical formula C14H18N2O5
Relative molecular mass 294,31
Assay Not less than 98 % and not more than 102 % of C14H18N2O5on the anhydrous basis
Description White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose
Identification
Solubility Slightly soluble in water and in ethanol
Purity
Loss on drying Not more than 4,5 % (105 °C, four hours)
Sulphated ash Not more than 0,2 % expressed on dry weight basis
pH Between 4,5 and 6,0 (1 in 125 solution)
Transmittance The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022
Specific rotation [α]D20: + 14,5 to + 16,5 °Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
5-Benzyl-3,6-dioxo-2-piperazineacetic acid Not more than 1,5 % expressed on dry weight basis
E 952 —CYCLAMIC ACID AND ITS Na AND Ca SALTS
(I)CYCLAMIC ACID
Synonyms Cyclohexylsulphamic acid, cyclamate
Definition
Chemical name Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid
Einecs 202-898-1
Chemical formula C6H13NO3S
Relative molecular mass 179,24
Assay Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis
Description A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose
Identification
A.Solubility A. Solubility Soluble in water and in ethanol
A. Solubility
B.Precipitation test B. Precipitation test Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
B. Precipitation test
Purity
Loss on drying Not more than 1 % (105 °C, one hour)
Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis
Aniline Not more than 1 mg/kg expressed on dry weight basis
(II)SODIUM CYCLAMATE
Synonyms Cyclamate, sodium salt of cyclamic acid
Definition
Chemical name Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate
Einecs 205-348-9
Chemical formula C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O
Relative molecular mass 201,22 calculated on the anhydrous form237,22 calculated on the hydrated form
Assay Not less than 98 % and not more than 102 % on the dried basisDihydrate form: not less than 84 % on the dried basis
Description White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
Solubility Soluble in water, practically insoluble in ethanol
Purity
Loss on drying Not more than 1 % (105 °C, one hour)Not more than 15,2 % (105 °C, two hours) for the dihydrate form
Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis
Aniline Not more than 1 mg/kg expressed on dry weight basis
(III)CALCIUM CYCLAMATE
Synonyms Cyclamate, calcium salt of cyclamic acid
Definition
Chemical name Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate
Einecs 205-349-4
Chemical formula C12H24CaN2O6S2·2H2O
Relative molecular mass 432,57
Assay Not less than 98 % and not more than 101 % on the dried basis
Description White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
Solubility Soluble in water, sparingly soluble in ethanol
Purity
Loss on drying Not more than 1 % (105 °C, one hour)Not more than 8,5 % (140 °C, four hours) for the dihydrate form
Selenium Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine Not more than 1 mg/kg expressed on dry weight basis
Aniline Not more than 1 mg/kg expressed on dry weight basis
E 953 —ISOMALT
Synonyms Hydrogenated isomaltulose, hydrogenated palatinose.
Definition
Chemical name Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) 6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
Chemical formula 6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O111-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O
Relative molecular mass 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,321-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32
Assay Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.
Description Odourless, white, slightly hygroscopic, crystalline mass.
Identification
A.Solubility A. Solubility Soluble in water, very slightly soluble in ethanol.
A. Solubility
B.Thin layer chromatography B. Thin layer chromatography Examine by thin layer chromatography using a plate coated with an approximately 0,2 mm layer of chromatographic silica gel. The principal spots in the chromatogram are those of 1,1-GPM and 1,6-GPS.
B. Thin layer chromatography
Purity
Water content Not more than 7 % (Karl Fischer Method)
Sulphated ash Not more than 0,05 % expressed on dry weight basis
D-Mannitol Not more than 3 %
D-Sorbitol Not more than 6 %
Reducing sugars Not more than 0,3 % expressed as glucose on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals (as Pb) Not more than 10 mg/kg expressed on dry weight basis.
E 954 —SACCHARIN AND ITS Na, K AND Ca SALTS
(I)SACCHARIN
Definition
Chemical name 3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide
Einecs 201-321-0
Chemical formula C7H5NO3S
Relative molecular mass 183,18
Assay Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis
Description White crystals or a white crystalline powder, odourless or with a faint, aromatic odour, having a sweet taste even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
Purity
Loss on drying Not more than 1 % (105 °C, two hours)
Melting range 226 to 230 °C
Sulphated ash Not more than 0,2 % expressed on dry weight basis
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances Absent
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Selenium Not more than 30 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
(II)SODIUM SACCHARIN
Synonyms Saccharin, sodium salt of saccharin
Definition
Chemical name Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
Einecs 204-886-1
Chemical formula C7H4NNaO3S·2H2O
Relative molecular mass 241,19
Assay Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis
Description White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on drying Not more than 15 % (120 °C, four hours)
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances Absent
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Selenium Not more than 30 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
(III)CALCIUM SACCHARIN
Synonyms Saccharin, calcium salt of saccharin
Definition
Chemical name Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
Einecs 229-349-9
Chemical formula C14H8CaN2O6S2·3H2O
Relative molecular mass 467,48
Assay Not less than 95 % of C14H8CaN2O6S2on the anhydrous basis
Description White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility Freely soluble in water, soluble in ethanol
Purity
Loss on drying Not more than 13,5 % (120 °C, four hours)
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances Absent
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Selenium Not more than 30 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
(IV)POTASSIUM SACCHARIN
Synonyms Saccharin, potassium salt of saccharin
Definition
Chemical name Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate
Einecs
Chemical formula C7H4KNO3S·H2O
Relative molecular mass 239,77
Assay Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis
Description White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on drying Not more than 8 % (120 °C, four hours)
Benzoic and salicylic acid To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances Absent
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Selenium Not more than 30 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
E 955 —SUCRALOSE
Synonyms 4,1′,6′-Trichlorogalactosucrose
Definition
Chemical name 1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside
Einecs 259-952-2
Chemical formula C12H19Cl3O8
Molecular weight 397,64
Assay Content not less than 98 % and not more than 102 % C12H19Cl3O8calculated on an anhydrous basis.
Description White to off-white, practically odourless, crystalline powder.
Identification
A.Solubility A. Solubility Freely soluble in water, methanol and ethanolSlightly soluble in ethyl acetate
A. Solubility
B.Infrared absorption B. Infrared absorption The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.
B. Infrared absorption
C.Thin layer chromatography C. Thin layer chromatography The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.
C. Thin layer chromatography
D.Specific rotation D. Specific rotation [α]20D+ 84,0 ° to + 87,5 ° calculated on the anhydrous basis(10 % w/v solution)
D. Specific rotation
Purity
Water Not more than 2,0 % (Karl Fischer method)
Sulphated ash Not more than 0,7 %
Other chlorinated disaccharides Not more than 0,5 %
Chlorinated monosaccharides Not more than 0,1 %
Triphenylphosphine oxide Not more than 150 mg/kg
Methanol Not more than 0,1 %
Lead Not more than 1 mg/kg
E 957 —THAUMATIN
Synonyms
Definition
Chemical name Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of the natural strain ofThaumatococcus daniellii(Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material
Einecs 258-822-2
Chemical formula Polypeptide of 207 amino acids
Relative molecular mass Thaumatin I 22209Thaumatin II 22293
Assay Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8)
Description Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose
Identification
Solubility Very soluble in water, insoluble in acetone
Purity
Loss on drying Not more than 9 % (105 °C to constant weight)
Carbohydrates Not more than 3 % expressed on dry weight basis
Sulphated ash Not more than 2 % expressed on dry weight basis
Aluminium Not more than 100 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead 3 mg/kg expressed on dry weight basis
Microbiological criteria Total aerobic microbial count: Max 1 000 /gE. Coli:absent in 1 g
E 959 —NEOHESPERIDINE DIHYDROCHALCONE
Synonyms Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC
Definition
Chemical name 2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin
Einecs 243-978-6
Chemical formula C28H36O15
Relative molecular mass 612,6
Assay Content not less than 96 % on the dried basis
Description Off-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose
Identification
A.Solubility A. Solubility Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
A. Solubility
B.Ultraviolet absorption maximum B. Ultraviolet absorption maximum 282 to 283 nm for a solution of 2 mg in 100 ml methanol
B. Ultraviolet absorption maximum
C.Neu's test C. Neu's test Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
C. Neu's test
Purity
Loss on drying Not more than 11 % (105 °C, three hours)
Sulphated ash Not more than 0,2 % expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 2 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
E 962 —SALT OF ASPARTAME-ACESULFAME
Synonyms Aspartame-acesulfame, Aspartame-acesulfame salt
Definition The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
Chemical name 6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid
Chemical formula C18H23O9N3S
Molecular weight 457,46
Assay 63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)
Description A white, odourless, crystalline powder.
Identification
A.Solubility A. Solubility Sparingly soluble water; slightly soluble in ethanol
A. Solubility
B.Transmittance B. Transmittance The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.
B. Transmittance
C.Specific rotation C. Specific rotation [α]20D+ 14,5 ° to + 16,5 °Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
C. Specific rotation
Purity
Loss on drying Not more than 0,5 % (105 °C, four hours)
5-Benzyl-3,6-dioxo-2-piper-azineacetic acid Not more than 0,5 %
Lead Not more than 1 mg/kg
E 965 (i) —MALTITOL
Synonyms D-Maltitol, hydrogenated maltose
Definition
Chemical name (α)-D-Glucopyranosyl-1,4-D-glucitol
Einecs 209-567-0
Chemical formula C12H24O11
Relative molecular mass 344,31
Assay Content not less than 98 % D-maltitol C12H24O11on the anhydrous basis
Description Sweet tasting, white crystalline powder
Identification
A.Solubility A. Solubility Very soluble in water, slightly soluble in ethanol
A. Solubility
B.Melting range B. Melting range 148 to 151 °C
B. Melting range
C.Specific rotation C. Specific rotation [α]D20= + 105,5 ° to + 108,5 ° (5 % w/v solution)
C. Specific rotation
Purity
Water content Not more than 1 % (Karl Fischer method)
Sulphated ash Not more than 0,1 % expressed on dry weight basis
Reducing sugars Not more than 0,1 % expressed as glucose on dry weight basis
Chlorides Not more than 50 mg/kg expressed on dry weight basis
Sulphates Not more than 100 mg/kg expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
E 965 (ii) —MALTITOL SYRUP
Synonyms Hydrogenated high-maltose-glucose syrup, hydrogenated glucose syrup
Definition A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
Assay Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis
Description Colourless and odourless, clear viscous liquids or white crystalline masses
Identification
A.Solubility A. Solubility Very soluble in water, slightly soluble in ethanol
A. Solubility
B.Thin layer chromatography B. Thin layer chromatography Passes test
B. Thin layer chromatography
Purity
Water Not more than 31 % (Karl Fischer)
Reducing sugars Not more than 0,3 % (as glucose)
Sulphated ash Not more than 0,1 %
Chlorides Not more than 50 mg/kg
Sulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg
E 966 —LACTITOL
Synonyms Lactit, lactositol, lactobiosit
Definition
Chemical name 4-O-β-D-Galactopyranosyl-D-glucitol
Einecs 209-566-5
Chemical formula C12H24O11
Relative molecular mass 344,32
Assay Not less than 95 % on the dry weight basis
Description Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms
Identification
A.Solubility A. Solubility Very soluble in water
A. Solubility
B.Specific rotation B. Specific rotation [α]D20= + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution)
B. Specific rotation
Purity
Water content Crystalline products; not more than 10,5 % (Karl Fischer method)
Other polyols Not more than 2,5 % on the anhydrous basis
Reducing sugars Not more than 0,2 % expressed as glucose on dry weight basis
Chlorides Not more than 100 mg/kg expressed on dry weight basis
Sulphates Not more than 200 mg/kg expressed on dry weight basis
Sulphated ash Not more than 0,1 % expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
E 967 —XYLITOL
Synonyms Xylitol
Definition
Chemical name D-xylitol
Einecs 201-788-0
Chemical formula C5H12O5
Relative molecular mass 152,15
Assay Not less than 98,5 % as xylitol on the anhydrous basis
Description White, crystalline powder, practically odourless with a very sweet taste
Identification
A.Solubility A. Solubility Very soluble in water, sparingly soluble in ethanol
A. Solubility
B.Melting range B. Melting range 92 to 96 °C
B. Melting range
C.pH C. pH 5 to 7 (10 % w/v aqueous solution)
C. pH
Purity
Loss on drying Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours
Sulphated ash Not more than 0,1 % expressed on dry weight basis
Reducing sugars Not more than 0,2 % expressed as glucose on dry weight basis
Other polyhydric alcohols Not more than 1 % expressed on dry weight basis
Nickel Not more than 2 mg/kg expressed on dry weight basis
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 1 mg/kg expressed on dry weight basis
Heavy metals Not more than 10 mg/kg expressed as Pb on dry weight basis
Chlorides Not more than 100 mg/kg expressed on dry weight basis
Sulphates Not more than 200 mg/kg expressed on dry weight basis
E 968 —ERYTHRITOL
Synonyms Meso-erythritol, tetrahydroxybutane, erythrite
Definition Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such asMoniliella pollinisorTrichosporonoides megachilensis, followed by purification and drying
Chemical name 1,2,3,4-Butanetetrol
Einecs 205-737-3
Chemical formula C4H10O4
Molecular weight 122,12
Assay Not less than 99 % after drying
Description White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.
Identification
A.Solubility A. Solubility Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.
A. Solubility
B.Melting range B. Melting range 119-123 °C
B. Melting range
Purity
Loss on drying Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)
Sulphated ash Not more than 0,1 %
Reducing substances Not more than 0,3 % expressed as D-glucose
Ribitol and glycerol Not more than 0,1 %
Lead Not more than 0,5 mg/kg
A. Solubility
B. Melting range
C. Sorbitol monobenzylidene derivative
A. Solubility
B. Melting range
A. Solubility
B. Melting range
C. Thin layer chromatography
D. Specific rotation
E. pH
A. Solubility
B. Melting range
C. Thin layer chromatography
D. Specific rotation
E. pH
A. Solubility
B. Ultraviolet absorption
C. Positive test for potassium
D. Precipitation test
A. Solubility
B. Precipitation test
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
A. Solubility
B. Thin layer chromatography
A. Solubility
B. Infrared absorption
C. Thin layer chromatography
D. Specific rotation
A. Solubility
B. Ultraviolet absorption maximum
C. Neu's test
A. Solubility
B. Transmittance
C. Specific rotation
A. Solubility
B. Melting range
C. Specific rotation
A. Solubility
B. Thin layer chromatography
A. Solubility
B. Specific rotation
A. Solubility
B. Melting range
C. pH
A. Solubility
B. Melting range
Commission Directive 95/31/EC (OJ L 178, 28.7.1995, p. 1)
Commission Directive 98/66/EC (OJ L 257, 19.9.1998, p. 35)
Commission Directive 2000/51/EC (OJ L 198, 4.8.2000, p. 41)
Commission Directive 2001/52/EC (OJ L 190, 12.7.2001, p. 18)
Commission Directive 2004/46/EC (OJ L 114, 21.4.2004, p. 15)
Commission Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6)
Directive Time-limit for transposition
95/31/EC 1 July 1996(1)
98/66/EC 1 July 1999
2000/51/EC 30 June 2001
2001/52/EC 30 June 2002
2004/46/EC 1 April 2005
2006/128/EC 15 February 2008
Directive 95/31/EC This Directive
Article 1(1) Article 1
Article 1(2) —
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 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs(2)has been substantially amended several times(3). In the interest of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs(4).
(3) It is necessary to take into account the specifications and analytical techniques for sweeteners 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 line 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 sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.

Article 2
Directive 95/31/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 twentieth 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 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs(2)has been substantially amended several times(3). In the interest of clarity and rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs(4).
(3) It is necessary to take into account the specifications and analytical techniques for sweeteners 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 line 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 sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.
Directive 95/31/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 twentieth day following that of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX I
E 420 (i) —SORBITOL
Synonyms | D-glucitol, D-sorbitol
Definition
Chemical name | D-glucitol
Einecs | 200-061-5
Chemical formula | C6H14O6
Relative molecular mass | 182,17
Assay | Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis.Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer
Description | White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste
Identification
A.Solubility | A. | Solubility | Very soluble in water, slightly soluble in ethanol
A. | Solubility
B.Melting range | B. | Melting range | 88 to 102 °C
B. | Melting range
C.Sorbitol monobenzylidene derivative | C. | Sorbitol monobenzylidene derivative | To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
C. | Sorbitol monobenzylidene derivative
Purity
Water content | Not more than 1 % (Karl Fischer method)
Sulphated ash | Not more than 0,1 % expressed on dry weight basis
Reducing sugars | Not more than 0,3 % expressed as glucose on dry weight basis
Total sugars | Not more than 1 % expressed as glucose on dry weight basis
Chlorides | Not more than 50 mg/kg expressed on dry weight basis
Sulphates | Not more than 100 mg/kg expressed on dry weight basis
Nickel | Not more than 2 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
E 420 (ii) —SORBITOL SYRUP
Synonyms | D-glucitol syrup
Definition
Chemical name | Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols wheren≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer
Einecs | 270-337-8
Assay | Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis
Description | Clear colourless and sweet-tasting aqueous solution
Identification
A.Solubility | A. | Solubility | Miscible with water, with glycerol, and with propane-1,2-diol
A. | Solubility
B.Melting range | B. | Melting range | To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
B. | Melting range
Purity
Water content | Not more than 31 % (Karl Fischer method)
Sulphated ash | Not more than 0,1 % expressed on dry weight basis
Reducing sugars | Not more than 0,3 % expressed as glucose on dry weight basis
Chlorides | Not more than 50 mg/kg expressed on dry weight basis
Sulphates | Not more than 100 mg/kg expressed on dry weight basis
Nickel | Not more than 2 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
E 421 —MANNITOL
(I)MANNITOL
Synonyms | D-mannitol
Definition | Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose
Chemical name | D-mannitol
Einecs | 200-711-8
Chemical formula | C6H14O6
Molecular weight | 182,2
Assay | Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
Description | White, odourless, crystalline powder
Identification
A.Solubility | A. | Solubility | Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
A. | Solubility
B.Melting range | B. | Melting range | Between 164 and 169 °C
B. | Melting range
C.Thin layer chromatography | C. | Thin layer chromatography | Passes test
C. | Thin layer chromatography
D.Specific rotation | D. | Specific rotation | [α]20D: + 23 ° to + 25 ° (borate solution)
D. | Specific rotation
E.pH | E. | pH | Between 5 and 8Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
E. | pH
Purity
Loss on drying | Not more than 0,3 % (105 °C, four hours)
Reducing sugars | Not more than 0,3 % (as glucose)
Total sugars | Not more than 1 % (as glucose)
Sulphated ash | Not more than 0,1 %
Chlorides | Not more than 70 mg/kg
Sulphate | Not more than 100 mg/kg
Nickel | Not more than 2 mg/kg
Lead | Not more than 1 mg/kg
(II)MANNITOL MANUFACTURED BY FERMENTATION
Synonyms | D-mannitol
Definition | Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeastZygosaccharomyces rouxii
Chemical name | D-mannitol
Einecs | 200-711-8
Chemical formula | C6H14O6
Molecular weight | 182,2
Assay | Not less than 99 % on the dried basis
Description | White, odourless crystalline powder
Identification
A.Solubility | A. | Solubility | Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
A. | Solubility
B.Melting range | B. | Melting range | Between 164 and 169 °C
B. | Melting range
C.Thin layer chromatography | C. | Thin layer chromatography | Passes test
C. | Thin layer chromatography
D.Specific rotation | D. | Specific rotation | [α]20D: + 23 ° to + 25 ° (borate solution)
D. | Specific rotation
E.pH | E. | pH | Between 5 and 8Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
E. | pH
Purity
Arabitol | Not more than 0,3 %
Loss on drying | Not more than 0,3 % (105 °C, four hours)
Reducing sugars | Not more than 0,3 % (as glucose)
Total sugars | Not more than 1 % (as glucose)
Sulphated ash | Not more than 0,1 %
Chlorides | Not more than 70 mg/kg
Sulphate | Not more than 100 mg/kg
Lead | Not more than 1 mg/kg
Aerobic mesophilic bacteria | Not more than 103/g
Coliforms | Absent in 10 g
Salmonella | Absent in 10 g
E. Coli | Absent in 10 g
Staphylococcus aureus | Absent in 10 g
Pseudomonas aeruginosa | Absent in 10 g
Moulds | Not more than 100/g
Yeasts | Not more than 100/g
E 950 —ACESULFAME K
Synonyms | Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxide
Definition
Chemical name | 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt
Einecs | 259-715-3
Chemical formula | C4H4KNO4S
Molecular weight | 201,24
Assay | Content not less than 99 % of C4H4KNO4S on the anhydrous basis
Description | Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose
Identification
A.Solubility | A. | Solubility | Very soluble in water, very slightly soluble in ethanol
A. | Solubility
B.Ultraviolet absorption | B. | Ultraviolet absorption | Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water
B. | Ultraviolet absorption
C.Positive test for potassium | C. | Positive test for potassium | Passes test (test the residue obtained by igniting 2 g of the sample)
C. | Positive test for potassium
D.Precipitation test | D. | Precipitation test | Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced
D. | Precipitation test
Purity
Loss on drying | Not more than 1 % (105 °C, two hours)
Organic impurities | Passes test for 20 mg/kg of UV active components
Fluoride | Not more than 3 mg/kg
Lead | Not more than 1 mg/kg
E 951 —ASPARTAME
Synonyms | Aspartyl phenylalanine methyl ester
Definition
Chemical name | N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester
Einecs | 245-261-3
Chemical formula | C14H18N2O5
Relative molecular mass | 294,31
Assay | Not less than 98 % and not more than 102 % of C14H18N2O5on the anhydrous basis
Description | White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose
Identification
Solubility | Slightly soluble in water and in ethanol
Purity
Loss on drying | Not more than 4,5 % (105 °C, four hours)
Sulphated ash | Not more than 0,2 % expressed on dry weight basis
pH | Between 4,5 and 6,0 (1 in 125 solution)
Transmittance | The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022
Specific rotation | [α]D20: + 14,5 to + 16,5 °Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
5-Benzyl-3,6-dioxo-2-piperazineacetic acid | Not more than 1,5 % expressed on dry weight basis
E 952 —CYCLAMIC ACID AND ITS Na AND Ca SALTS
(I)CYCLAMIC ACID
Synonyms | Cyclohexylsulphamic acid, cyclamate
Definition
Chemical name | Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid
Einecs | 202-898-1
Chemical formula | C6H13NO3S
Relative molecular mass | 179,24
Assay | Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis
Description | A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose
Identification
A.Solubility | A. | Solubility | Soluble in water and in ethanol
A. | Solubility
B.Precipitation test | B. | Precipitation test | Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
B. | Precipitation test
Purity
Loss on drying | Not more than 1 % (105 °C, one hour)
Selenium | Not more than 30 mg/kg expressed as selenium on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Cyclohexylamine | Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine | Not more than 1 mg/kg expressed on dry weight basis
Aniline | Not more than 1 mg/kg expressed on dry weight basis
(II)SODIUM CYCLAMATE
Synonyms | Cyclamate, sodium salt of cyclamic acid
Definition
Chemical name | Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate
Einecs | 205-348-9
Chemical formula | C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O
Relative molecular mass | 201,22 calculated on the anhydrous form237,22 calculated on the hydrated form
Assay | Not less than 98 % and not more than 102 % on the dried basisDihydrate form: not less than 84 % on the dried basis
Description | White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
Solubility | Soluble in water, practically insoluble in ethanol
Purity
Loss on drying | Not more than 1 % (105 °C, one hour)Not more than 15,2 % (105 °C, two hours) for the dihydrate form
Selenium | Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine | Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine | Not more than 1 mg/kg expressed on dry weight basis
Aniline | Not more than 1 mg/kg expressed on dry weight basis
(III)CALCIUM CYCLAMATE
Synonyms | Cyclamate, calcium salt of cyclamic acid
Definition
Chemical name | Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate
Einecs | 205-349-4
Chemical formula | C12H24CaN2O6S2·2H2O
Relative molecular mass | 432,57
Assay | Not less than 98 % and not more than 101 % on the dried basis
Description | White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
Identification
Solubility | Soluble in water, sparingly soluble in ethanol
Purity
Loss on drying | Not more than 1 % (105 °C, one hour)Not more than 8,5 % (140 °C, four hours) for the dihydrate form
Selenium | Not more than 30 mg/kg expressed as selenium on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
Cyclohexylamine | Not more than 10 mg/kg expressed on dry weight basis
Dicyclohexylamine | Not more than 1 mg/kg expressed on dry weight basis
Aniline | Not more than 1 mg/kg expressed on dry weight basis
E 953 —ISOMALT
Synonyms | Hydrogenated isomaltulose, hydrogenated palatinose.
Definition
Chemical name | Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) | | 6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and | | 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
| 6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
| 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
Chemical formula | 6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O111-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O
Relative molecular mass | 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,321-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32
Assay | Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.
Description | Odourless, white, slightly hygroscopic, crystalline mass.
Identification
A.Solubility | A. | Solubility | Soluble in water, very slightly soluble in ethanol.
A. | Solubility
B.Thin layer chromatography | B. | Thin layer chromatography | Examine by thin layer chromatography using a plate coated with an approximately 0,2 mm layer of chromatographic silica gel. The principal spots in the chromatogram are those of 1,1-GPM and 1,6-GPS.
B. | Thin layer chromatography
Purity
Water content | Not more than 7 % (Karl Fischer Method)
Sulphated ash | Not more than 0,05 % expressed on dry weight basis
D-Mannitol | Not more than 3 %
D-Sorbitol | Not more than 6 %
Reducing sugars | Not more than 0,3 % expressed as glucose on dry weight basis
Nickel | Not more than 2 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals (as Pb) | Not more than 10 mg/kg expressed on dry weight basis.
E 954 —SACCHARIN AND ITS Na, K AND Ca SALTS
(I)SACCHARIN
Definition
Chemical name | 3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide
Einecs | 201-321-0
Chemical formula | C7H5NO3S
Relative molecular mass | 183,18
Assay | Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis
Description | White crystals or a white crystalline powder, odourless or with a faint, aromatic odour, having a sweet taste even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility | Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
Purity
Loss on drying | Not more than 1 % (105 °C, two hours)
Melting range | 226 to 230 °C
Sulphated ash | Not more than 0,2 % expressed on dry weight basis
Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide | Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances | Absent
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Selenium | Not more than 30 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
(II)SODIUM SACCHARIN
Synonyms | Saccharin, sodium salt of saccharin
Definition
Chemical name | Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
Einecs | 204-886-1
Chemical formula | C7H4NNaO3S·2H2O
Relative molecular mass | 241,19
Assay | Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis
Description | White crystals or a white crystalline efflorescent powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility | Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on drying | Not more than 15 % (120 °C, four hours)
Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide | Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances | Absent
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Selenium | Not more than 30 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
(III)CALCIUM SACCHARIN
Synonyms | Saccharin, calcium salt of saccharin
Definition
Chemical name | Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
Einecs | 229-349-9
Chemical formula | C14H8CaN2O6S2·3H2O
Relative molecular mass | 467,48
Assay | Not less than 95 % of C14H8CaN2O6S2on the anhydrous basis
Description | White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility | Freely soluble in water, soluble in ethanol
Purity
Loss on drying | Not more than 13,5 % (120 °C, four hours)
Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide | Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances | Absent
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Selenium | Not more than 30 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
(IV)POTASSIUM SACCHARIN
Synonyms | Saccharin, potassium salt of saccharin
Definition
Chemical name | Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate
Einecs |
Chemical formula | C7H4KNO3S·H2O
Relative molecular mass | 239,77
Assay | Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis
Description | White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility | Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on drying | Not more than 8 % (120 °C, four hours)
Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
o-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
p-Toluenesulphonamide | Not more than 10 mg/kg expressed on dry weight basis
Benzoic acid p-sulphonamide | Not more than 25 mg/kg expressed on dry weight basis
Readily carbonisable substances | Absent
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Selenium | Not more than 30 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
E 955 —SUCRALOSE
Synonyms | 4,1′,6′-Trichlorogalactosucrose
Definition
Chemical name | 1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside
Einecs | 259-952-2
Chemical formula | C12H19Cl3O8
Molecular weight | 397,64
Assay | Content not less than 98 % and not more than 102 % C12H19Cl3O8calculated on an anhydrous basis.
Description | White to off-white, practically odourless, crystalline powder.
Identification
A.Solubility | A. | Solubility | Freely soluble in water, methanol and ethanolSlightly soluble in ethyl acetate
A. | Solubility
B.Infrared absorption | B. | Infrared absorption | The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.
B. | Infrared absorption
C.Thin layer chromatography | C. | Thin layer chromatography | The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.
C. | Thin layer chromatography
D.Specific rotation | D. | Specific rotation | [α]20D+ 84,0 ° to + 87,5 ° calculated on the anhydrous basis(10 % w/v solution)
D. | Specific rotation
Purity
Water | Not more than 2,0 % (Karl Fischer method)
Sulphated ash | Not more than 0,7 %
Other chlorinated disaccharides | Not more than 0,5 %
Chlorinated monosaccharides | Not more than 0,1 %
Triphenylphosphine oxide | Not more than 150 mg/kg
Methanol | Not more than 0,1 %
Lead | Not more than 1 mg/kg
E 957 —THAUMATIN
Synonyms |
Definition
Chemical name | Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of the natural strain ofThaumatococcus daniellii(Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material
Einecs | 258-822-2
Chemical formula | Polypeptide of 207 amino acids
Relative molecular mass | Thaumatin I 22209Thaumatin II 22293
Assay | Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8)
Description | Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose
Identification
Solubility | Very soluble in water, insoluble in acetone
Purity
Loss on drying | Not more than 9 % (105 °C to constant weight)
Carbohydrates | Not more than 3 % expressed on dry weight basis
Sulphated ash | Not more than 2 % expressed on dry weight basis
Aluminium | Not more than 100 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | 3 mg/kg expressed on dry weight basis
Microbiological criteria | Total aerobic microbial count: Max 1 000 /gE. Coli:absent in 1 g
E 959 —NEOHESPERIDINE DIHYDROCHALCONE
Synonyms | Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC
Definition
Chemical name | 2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin
Einecs | 243-978-6
Chemical formula | C28H36O15
Relative molecular mass | 612,6
Assay | Content not less than 96 % on the dried basis
Description | Off-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose
Identification
A.Solubility | A. | Solubility | Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
A. | Solubility
B.Ultraviolet absorption maximum | B. | Ultraviolet absorption maximum | 282 to 283 nm for a solution of 2 mg in 100 ml methanol
B. | Ultraviolet absorption maximum
C.Neu’s test | C. | Neu’s test | Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
C. | Neu’s test
Purity
Loss on drying | Not more than 11 % (105 °C, three hours)
Sulphated ash | Not more than 0,2 % expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 2 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
E 962 —SALT OF ASPARTAME-ACESULFAME
Synonyms | Aspartame-acesulfame, Aspartame-acesulfame salt
Definition | The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
Chemical name | 6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid
Chemical formula | C18H23O9N3S
Molecular weight | 457,46
Assay | 63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)
Description | A white, odourless, crystalline powder.
Identification
A.Solubility | A. | Solubility | Sparingly soluble water; slightly soluble in ethanol
A. | Solubility
B.Transmittance | B. | Transmittance | The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.
B. | Transmittance
C.Specific rotation | C. | Specific rotation | [α]20D+ 14,5 ° to + 16,5 °Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
C. | Specific rotation
Purity
Loss on drying | Not more than 0,5 % (105 °C, four hours)
5-Benzyl-3,6-dioxo-2-piper-azineacetic acid | Not more than 0,5 %
Lead | Not more than 1 mg/kg
E 965 (i) —MALTITOL
Synonyms | D-Maltitol, hydrogenated maltose
Definition
Chemical name | (α)-D-Glucopyranosyl-1,4-D-glucitol
Einecs | 209-567-0
Chemical formula | C12H24O11
Relative molecular mass | 344,31
Assay | Content not less than 98 % D-maltitol C12H24O11on the anhydrous basis
Description | Sweet tasting, white crystalline powder
Identification
A.Solubility | A. | Solubility | Very soluble in water, slightly soluble in ethanol
A. | Solubility
B.Melting range | B. | Melting range | 148 to 151 °C
B. | Melting range
C.Specific rotation | C. | Specific rotation | [α]D20= + 105,5 ° to + 108,5 ° (5 % w/v solution)
C. | Specific rotation
Purity
Water content | Not more than 1 % (Karl Fischer method)
Sulphated ash | Not more than 0,1 % expressed on dry weight basis
Reducing sugars | Not more than 0,1 % expressed as glucose on dry weight basis
Chlorides | Not more than 50 mg/kg expressed on dry weight basis
Sulphates | Not more than 100 mg/kg expressed on dry weight basis
Nickel | Not more than 2 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
E 965 (ii) —MALTITOL SYRUP
Synonyms | Hydrogenated high-maltose-glucose syrup, hydrogenated glucose syrup
Definition | A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
Assay | Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis
Description | Colourless and odourless, clear viscous liquids or white crystalline masses
Identification
A.Solubility | A. | Solubility | Very soluble in water, slightly soluble in ethanol
A. | Solubility
B.Thin layer chromatography | B. | Thin layer chromatography | Passes test
B. | Thin layer chromatography
Purity
Water | Not more than 31 % (Karl Fischer)
Reducing sugars | Not more than 0,3 % (as glucose)
Sulphated ash | Not more than 0,1 %
Chlorides | Not more than 50 mg/kg
Sulphate | Not more than 100 mg/kg
Nickel | Not more than 2 mg/kg
Lead | Not more than 1 mg/kg
E 966 —LACTITOL
Synonyms | Lactit, lactositol, lactobiosit
Definition
Chemical name | 4-O-β-D-Galactopyranosyl-D-glucitol
Einecs | 209-566-5
Chemical formula | C12H24O11
Relative molecular mass | 344,32
Assay | Not less than 95 % on the dry weight basis
Description | Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms
Identification
A.Solubility | A. | Solubility | Very soluble in water
A. | Solubility
B.Specific rotation | B. | Specific rotation | [α]D20= + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution)
B. | Specific rotation
Purity
Water content | Crystalline products; not more than 10,5 % (Karl Fischer method)
Other polyols | Not more than 2,5 % on the anhydrous basis
Reducing sugars | Not more than 0,2 % expressed as glucose on dry weight basis
Chlorides | Not more than 100 mg/kg expressed on dry weight basis
Sulphates | Not more than 200 mg/kg expressed on dry weight basis
Sulphated ash | Not more than 0,1 % expressed on dry weight basis
Nickel | Not more than 2 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
E 967 —XYLITOL
Synonyms | Xylitol
Definition
Chemical name | D-xylitol
Einecs | 201-788-0
Chemical formula | C5H12O5
Relative molecular mass | 152,15
Assay | Not less than 98,5 % as xylitol on the anhydrous basis
Description | White, crystalline powder, practically odourless with a very sweet taste
Identification
A.Solubility | A. | Solubility | Very soluble in water, sparingly soluble in ethanol
A. | Solubility
B.Melting range | B. | Melting range | 92 to 96 °C
B. | Melting range
C.pH | C. | pH | 5 to 7 (10 % w/v aqueous solution)
C. | pH
Purity
Loss on drying | Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours
Sulphated ash | Not more than 0,1 % expressed on dry weight basis
Reducing sugars | Not more than 0,2 % expressed as glucose on dry weight basis
Other polyhydric alcohols | Not more than 1 % expressed on dry weight basis
Nickel | Not more than 2 mg/kg expressed on dry weight basis
Arsenic | Not more than 3 mg/kg expressed on dry weight basis
Lead | Not more than 1 mg/kg expressed on dry weight basis
Heavy metals | Not more than 10 mg/kg expressed as Pb on dry weight basis
Chlorides | Not more than 100 mg/kg expressed on dry weight basis
Sulphates | Not more than 200 mg/kg expressed on dry weight basis
E 968 —ERYTHRITOL
Synonyms | Meso-erythritol, tetrahydroxybutane, erythrite
Definition | Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such asMoniliella pollinisorTrichosporonoides megachilensis, followed by purification and drying
Chemical name | 1,2,3,4-Butanetetrol
Einecs | 205-737-3
Chemical formula | C4H10O4
Molecular weight | 122,12
Assay | Not less than 99 % after drying
Description | White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.
Identification
A.Solubility | A. | Solubility | Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.
A. | Solubility
B.Melting range | B. | Melting range | 119-123 °C
B. | Melting range
Purity
Loss on drying | Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)
Sulphated ash | Not more than 0,1 %
Reducing substances | Not more than 0,3 % expressed as D-glucose
Ribitol and glycerol | Not more than 0,1 %
Lead | Not more than 0,5 mg/kg

PART A

ANNEX IIRepealed Directive with list of its successive amendments(referred to in Article 2)
Commission Directive 95/31/EC | (OJ L 178, 28.7.1995, p. 1)
Commission Directive 98/66/EC | (OJ L 257, 19.9.1998, p. 35)
Commission Directive 2000/51/EC | (OJ L 198, 4.8.2000, p. 41)
Commission Directive 2001/52/EC | (OJ L 190, 12.7.2001, p. 18)
Commission Directive 2004/46/EC | (OJ L 114, 21.4.2004, p. 15)
Commission Directive 2006/128/EC | (OJ L 346, 9.12.2006, p. 6)PART BList of time-limits for transposition into national law(referred to in Article 2)
Directive | Time-limit for transposition
95/31/EC | 1 July 1996(1)
98/66/EC | 1 July 1999
2000/51/EC | 30 June 2001
2001/52/EC | 30 June 2002
2004/46/EC | 1 April 2005
2006/128/EC | 15 February 2008
(1) According to Article 2(2) of Directive 95/31/EC, products put on the market or labelled before 1 July 1996 which do not comply with this Directive may be marketed until stocks are exhausted.
ANNEX IIICorrelation table
Directive 95/31/EC | This Directive
Article 1(1) | Article 1
Article 1(2) | —
Article 2 | —
— | Article 2
Article 3 | Article 3
Article 4 | Article 4
Annex | Annex I
— | Annex II
— | Annex III

Pending: 32008L0051

January 16, 2026
8.7.2008 EN Official Journal of the European Union L 179/5
(1) Directive 91/477/EEC(3)established an accompanying measure for the internal market. It creates a balance between on the one hand the undertaking to ensure a certain freedom of movement for some firearms within the Community, and on the other the need to control this freedom using security guarantees suited to this type of product.
(2) In accordance with Council Decision 2001/748/EC of 16 October 2001 concerning the signing on behalf of the European Community of the United Nations Protocol on the illicit manufacturing of and trafficking in firearms, their parts, components and ammunition, annexed to the Convention against transnational organised crime(4), the Commission signed that Protocol (hereinafter referred to as the Protocol) on behalf of the Community on 16 January 2002.
(3) The accession of the Community to the Protocol requires amendments to certain provisions of Directive 91/477/EEC. Indeed, it is important to ensure the coherent, effective and rapid application of the international commitments affecting that Directive. Furthermore, it is necessary to take the opportunity of this revision in order to improve that Directive by addressing certain issues, in particular those that were identified in the report of the Commission to the European Parliament and the Council of 15 December 2000 on the implementation of Directive 91/477/EEC.
(4) Police intelligence evidence shows an increase in the use of converted weapons within the Community. It is therefore essential to ensure that such convertible weapons are brought within the definition of a firearm for the purposes of Directive 91/477/EEC.
(5) Firearms, their parts and ammunition, when imported from third countries, are subject to Community legislation and, accordingly, to the requirements of Directive 91/477/EEC.
(6) The notions of illicit manufacturing and trafficking of firearms, their parts and ammunition, as well as the notion of tracing, should therefore be defined for the purposes of Directive 91/477/EEC.
(7) Furthermore, the Protocol establishes an obligation to mark weapons at the time of manufacture and at the time of transfer from government stocks to permanent civilian use, whereas Directive 91/477/EEC refers only indirectly to the marking obligation. In order to facilitate the tracing of weapons, it is necessary to use alphanumeric codes and to include in the marking the year of manufacture of the weapon (if not part of the serial number). The Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms should, to the greatest extent possible, be used as a reference for the marking system in the Community as a whole.
(8) Moreover, while the Protocol provides that the period during which registers containing information on weapons are to be kept must be increased to at least 10 years, it is necessary, in view of the dangerous nature and durability of weapons, to extend this period up to a minimum of 20 years in order to allow the proper tracing of firearms. It is also necessary that Member States keep a computerised data-filing system, either a centralised system or a decentralised system which guarantees access to authorised authorities to the data-filing systems in which the necessary information regarding each firearm is recorded. Access by police, judicial and other authorised authorities to the information contained in the computerised data-filing system must be subject to compliance with Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms.
(9) In addition, the brokering activities referred to in Article 15 of the Protocol should be defined for the purposes of Directive 91/477/EEC.
(10) In some serious cases, compliance with Articles 5 and 6 of the Protocol requires the application of criminal sanctions and the confiscation of the weapons.
(11) With regard to the deactivation of firearms, point (a) of Part III of Annex I to Directive 91/477/EEC simply refers to national legislation. The Protocol sets out more explicit general principles for the deactivation of weapons. Annex I to Directive 91/477/EEC should therefore be amended.
(12) Due to the special nature of the activity of dealers, it is necessary that Member States exercise a strict control over this activity, in particular by verifying the professional integrity and abilities of dealers.
(13) The acquisition of firearms by private individuals by means of distance communications, for example via the Internet should, where authorised, be subject to the rules laid down in Directive 91/477/EEC and, as a general rule, the acquisition of firearms by persons convicted by a final court judgment of certain serious criminal offences should be prohibited.
(14) The European firearms pass functions in a satisfactory way on the whole and should be regarded as the main document needed by hunters and marksmen for the possession of a firearm during a journey to another Member State. Member States should not make the acceptance of the European firearms pass conditional upon the payment of any fee or charge.
(15) In order to facilitate the tracing of firearms and efficiently to combat the illicit trafficking and manufacturing of firearms, their parts and ammunition, it is necessary to improve the exchange of information between Member States.
(16) The processing of information is subject to compliance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(5)and does not prejudice the level of protection of individuals with regard to the processing of personal data under Community and national law, and in particular does not alter the obligations and rights set out in Directive 95/46/EC.
(17) The measures necessary for the implementation of Directive 91/477/EEC 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(6).
(18) Several Member States have simplified the way they classify firearms by switching from four categories to the following two: prohibited firearms and firearms subject to authorisation. Member States should fall into line with this simplified classification, although Member States which divide firearms into a further set of categories may, in accordance with the principle of subsidiarity, maintain their existing classification systems.
(19) Authorisations for the acquisition and possession of firearms should, as far as possible, involve a single administrative procedure.
(20) Article 2(2) of Directive 91/477/EEC among other things excludes from the scope of application of that Directive the acquisition or possession of weapons and ammunition in accordance with national law by collectors and bodies concerned with the cultural and historical aspects of weapons and recognised as such by the Member State in whose territory they are established.
(21) In accordance with point 34 of the Interinstitutional Agreement on better law-making(7), Member States should draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and make them public.
(22) Directive 91/477/EEC should therefore be amended accordingly,
1. Article 1 shall be amended as follows:(a)paragraph 1 shall be replaced by the following:‘1.   For the purposes of this Directive, “firearm” shall mean any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded for one of the reasons listed in Part III of Annex I. Firearms are classified in part II of Annex I.For the purposes of this Directive, an object shall be considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:—it has the appearance of a firearm, and—as a result of its construction or the material from which it is made, it can be so converted.’;(b)the following paragraphs shall be inserted:‘1a.   For the purposes of this Directive, “part” shall mean any element or replacement element specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm.1b.   For the purposes of this Directive, “essential component” shall mean the breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.1c.   For the purposes of this Directive, “ammunition” shall mean the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State.1d.   For the purposes of this Directive, “tracing” shall mean the systematic tracking of firearms and, where possible, their parts and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking.1e.   For the purposes of this Directive, “broker” shall mean any natural or legal person, other than a dealer, whose trade or business consists wholly or partly in the buying, selling or arranging the transfer of weapons.’;(c)paragraph 2 shall be replaced by the following:‘2.   For the purposes of this Directive, “dealer” shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms, parts and ammunition.’;(d)the following paragraphs shall be inserted:‘2a.   For the purposes of this Directive, “illicit manufacturing” shall mean the manufacturing or assembly of firearms, their parts and ammunition:(i)from any essential component of such firearms illicitly trafficked;(ii)without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or(iii)without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).2b.   For the purposes of this Directive, “illicit trafficking” shall mean the acquisition, sale, delivery, movement or transfer of firearms, their parts or ammunition from or across the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with the terms of this Directive or if the assembled firearms are not marked in accordance with Article 4(1).’;(e)paragraph 4 shall be replaced by the following:‘4.   A “European firearms pass” shall be issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It must always be in the possession of the person using the firearm and any change in the possession or characteristics of the firearm, as well as the loss or theft thereof, shall be indicated on the pass.’; (a) paragraph 1 shall be replaced by the following:‘1.   For the purposes of this Directive, “firearm” shall mean any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded for one of the reasons listed in Part III of Annex I. Firearms are classified in part II of Annex I.For the purposes of this Directive, an object shall be considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:—it has the appearance of a firearm, and—as a result of its construction or the material from which it is made, it can be so converted.’; — it has the appearance of a firearm, and — as a result of its construction or the material from which it is made, it can be so converted.’; (b) the following paragraphs shall be inserted:‘1a.   For the purposes of this Directive, “part” shall mean any element or replacement element specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm.1b.   For the purposes of this Directive, “essential component” shall mean the breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.1c.   For the purposes of this Directive, “ammunition” shall mean the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State.1d.   For the purposes of this Directive, “tracing” shall mean the systematic tracking of firearms and, where possible, their parts and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking.1e.   For the purposes of this Directive, “broker” shall mean any natural or legal person, other than a dealer, whose trade or business consists wholly or partly in the buying, selling or arranging the transfer of weapons.’; (c) paragraph 2 shall be replaced by the following:‘2.   For the purposes of this Directive, “dealer” shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms, parts and ammunition.’; (d) the following paragraphs shall be inserted:‘2a.   For the purposes of this Directive, “illicit manufacturing” shall mean the manufacturing or assembly of firearms, their parts and ammunition:(i)from any essential component of such firearms illicitly trafficked;(ii)without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or(iii)without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).2b.   For the purposes of this Directive, “illicit trafficking” shall mean the acquisition, sale, delivery, movement or transfer of firearms, their parts or ammunition from or across the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with the terms of this Directive or if the assembled firearms are not marked in accordance with Article 4(1).’; (i) from any essential component of such firearms illicitly trafficked; (ii) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or (iii) without marking the assembled firearms at the time of manufacture in accordance with Article 4(1). (e) paragraph 4 shall be replaced by the following:‘4.   A “European firearms pass” shall be issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It must always be in the possession of the person using the firearm and any change in the possession or characteristics of the firearm, as well as the loss or theft thereof, shall be indicated on the pass.’;
(a) paragraph 1 shall be replaced by the following:‘1.   For the purposes of this Directive, “firearm” shall mean any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded for one of the reasons listed in Part III of Annex I. Firearms are classified in part II of Annex I.For the purposes of this Directive, an object shall be considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:—it has the appearance of a firearm, and—as a result of its construction or the material from which it is made, it can be so converted.’; — it has the appearance of a firearm, and — as a result of its construction or the material from which it is made, it can be so converted.’;
— it has the appearance of a firearm, and
— as a result of its construction or the material from which it is made, it can be so converted.’;
(b) the following paragraphs shall be inserted:‘1a.   For the purposes of this Directive, “part” shall mean any element or replacement element specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm.1b.   For the purposes of this Directive, “essential component” shall mean the breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.1c.   For the purposes of this Directive, “ammunition” shall mean the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State.1d.   For the purposes of this Directive, “tracing” shall mean the systematic tracking of firearms and, where possible, their parts and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking.1e.   For the purposes of this Directive, “broker” shall mean any natural or legal person, other than a dealer, whose trade or business consists wholly or partly in the buying, selling or arranging the transfer of weapons.’;
(c) paragraph 2 shall be replaced by the following:‘2.   For the purposes of this Directive, “dealer” shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms, parts and ammunition.’;
(d) the following paragraphs shall be inserted:‘2a.   For the purposes of this Directive, “illicit manufacturing” shall mean the manufacturing or assembly of firearms, their parts and ammunition:(i)from any essential component of such firearms illicitly trafficked;(ii)without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or(iii)without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).2b.   For the purposes of this Directive, “illicit trafficking” shall mean the acquisition, sale, delivery, movement or transfer of firearms, their parts or ammunition from or across the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with the terms of this Directive or if the assembled firearms are not marked in accordance with Article 4(1).’; (i) from any essential component of such firearms illicitly trafficked; (ii) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or (iii) without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
(i) from any essential component of such firearms illicitly trafficked;
(ii) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or
(iii) without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
(e) paragraph 4 shall be replaced by the following:‘4.   A “European firearms pass” shall be issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It must always be in the possession of the person using the firearm and any change in the possession or characteristics of the firearm, as well as the loss or theft thereof, shall be indicated on the pass.’;
(a) paragraph 1 shall be replaced by the following:‘1.   For the purposes of this Directive, “firearm” shall mean any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded for one of the reasons listed in Part III of Annex I. Firearms are classified in part II of Annex I.For the purposes of this Directive, an object shall be considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:—it has the appearance of a firearm, and—as a result of its construction or the material from which it is made, it can be so converted.’; — it has the appearance of a firearm, and — as a result of its construction or the material from which it is made, it can be so converted.’;
— it has the appearance of a firearm, and
— as a result of its construction or the material from which it is made, it can be so converted.’;
— it has the appearance of a firearm, and
— as a result of its construction or the material from which it is made, it can be so converted.’;
(b) the following paragraphs shall be inserted:‘1a.   For the purposes of this Directive, “part” shall mean any element or replacement element specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm.1b.   For the purposes of this Directive, “essential component” shall mean the breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.1c.   For the purposes of this Directive, “ammunition” shall mean the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State.1d.   For the purposes of this Directive, “tracing” shall mean the systematic tracking of firearms and, where possible, their parts and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking.1e.   For the purposes of this Directive, “broker” shall mean any natural or legal person, other than a dealer, whose trade or business consists wholly or partly in the buying, selling or arranging the transfer of weapons.’;
(c) paragraph 2 shall be replaced by the following:‘2.   For the purposes of this Directive, “dealer” shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms, parts and ammunition.’;
(d) the following paragraphs shall be inserted:‘2a.   For the purposes of this Directive, “illicit manufacturing” shall mean the manufacturing or assembly of firearms, their parts and ammunition:(i)from any essential component of such firearms illicitly trafficked;(ii)without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or(iii)without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).2b.   For the purposes of this Directive, “illicit trafficking” shall mean the acquisition, sale, delivery, movement or transfer of firearms, their parts or ammunition from or across the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with the terms of this Directive or if the assembled firearms are not marked in accordance with Article 4(1).’; (i) from any essential component of such firearms illicitly trafficked; (ii) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or (iii) without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
(i) from any essential component of such firearms illicitly trafficked;
(ii) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or
(iii) without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
(i) from any essential component of such firearms illicitly trafficked;
(ii) without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or
(iii) without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
(e) paragraph 4 shall be replaced by the following:‘4.   A “European firearms pass” shall be issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It must always be in the possession of the person using the firearm and any change in the possession or characteristics of the firearm, as well as the loss or theft thereof, shall be indicated on the pass.’;
2. Article 4 shall be replaced by the following:‘Article 41.   Member States shall ensure either that any firearm or part placed on the market has been marked and registered in compliance with this Directive, or that it has been deactivated.2.   For the purpose of identifying and tracing each assembled firearm, Member States shall, at the time of manufacture of each firearm, either:(a)require a unique marking, including the name of the manufacturer, the country or place of manufacture, the serial number and the year of manufacture (if not part of the serial number). This shall be without prejudice to the affixing of the manufacturer’s trademark. For these purposes, the Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms; or(b)maintain any alternative unique user-friendly marking with a number or alphanumeric code, permitting ready identification by all States of the country of manufacture.The marking shall be affixed to an essential component of the firearm, the destruction of which would render the firearm unusable.Member States shall ensure that each elementary package of complete ammunition is marked so as to provide the name of the manufacturer, the identification batch (lot) number, the calibre and the type of ammunition. For these purposes Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms.Furthermore, Member States shall ensure, at the time of transfer of a firearm from government stocks to permanent civilian use, the appropriate unique marking permitting identification by States of the transferring country.3.   Member States shall make the pursuit of the activity of dealer within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer. In the case of a legal person, the check shall be on the person who directs the undertaking.4.   Member States shall, by 31 December 2014, ensure the establishment and maintenance of a computerised data-filing system, either a centralised system or a decentralised system which guarantees to authorised authorities access to the data-filing systems in which each firearm subject to this Directive shall be recorded. This filing system shall record and maintain for not less than 20 years each firearm’s type, make, model, calibre and serial number, as well as the names and addresses of the supplier and the person acquiring or possessing the firearm.Throughout their period of activity, dealers shall be required to maintain a register in which all firearms subject to this Directive and which are received or disposed of by them shall be recorded, together with such particulars as enable the firearm to be identified and traced, in particular the type, make, model, calibre and serial number thereof and the names and addresses of the persons supplying and acquiring it. Upon the cessation of his activities, the dealer shall deliver the register to the national authority responsible for the filing system provided for in subparagraph 1.5.   Member States shall ensure that all firearms may be linked to their owner at any moment. However, as regards firearms classified in category D, Member States shall, as from 28 July 2010, put into place appropriate tracing measures, including, as from 31 December 2014, measures enabling linking at any moment to the owner of firearms placed on the market after 28 July 2010.’; (a) require a unique marking, including the name of the manufacturer, the country or place of manufacture, the serial number and the year of manufacture (if not part of the serial number). This shall be without prejudice to the affixing of the manufacturer’s trademark. For these purposes, the Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms; or (b) maintain any alternative unique user-friendly marking with a number or alphanumeric code, permitting ready identification by all States of the country of manufacture.
(a) require a unique marking, including the name of the manufacturer, the country or place of manufacture, the serial number and the year of manufacture (if not part of the serial number). This shall be without prejudice to the affixing of the manufacturer’s trademark. For these purposes, the Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms; or
(b) maintain any alternative unique user-friendly marking with a number or alphanumeric code, permitting ready identification by all States of the country of manufacture.
(a) require a unique marking, including the name of the manufacturer, the country or place of manufacture, the serial number and the year of manufacture (if not part of the serial number). This shall be without prejudice to the affixing of the manufacturer’s trademark. For these purposes, the Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms; or
(b) maintain any alternative unique user-friendly marking with a number or alphanumeric code, permitting ready identification by all States of the country of manufacture.
3. the following articles shall be inserted:‘Article 4aWithout prejudice to Article 3, Member States shall allow the acquisition and possession of firearms only by persons who have been granted a licence or, with respect to categories C or D, who are specifically permitted to acquire and possess such firearms in accordance with national law.Article 4bMember States shall consider establishing a system for the regulation of the activities of brokers. Such a system might include one or more measures such as:(a)requiring the registration of brokers operating within their territory;(b)requiring the licensing or authorisation of the activity of brokering.’; (a) requiring the registration of brokers operating within their territory; (b) requiring the licensing or authorisation of the activity of brokering.’;
(a) requiring the registration of brokers operating within their territory;
(b) requiring the licensing or authorisation of the activity of brokering.’;
(a) requiring the registration of brokers operating within their territory;
(b) requiring the licensing or authorisation of the activity of brokering.’;
4. Article 5 shall be replaced by the following:‘Article 5Without prejudice to Article 3, Member States shall permit the acquisition and possession of firearms only by persons who have good cause and who:(a)are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons of less than 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licenced or otherwise approved training centre;(b)are not likely to be a danger to themselves, to public order or to public safety. Having been convicted of a violent intentional crime shall be considered as indicative of such danger.Member States may withdraw authorisation for possession of a firearm if any of the conditions on the basis of which it was granted are no longer satisfied.Member States may not prohibit persons resident within their territory from possessing a weapon acquired in another Member State unless they prohibit the acquisition of the same weapon within their own territory.’; (a) are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons of less than 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licenced or otherwise approved training centre; (b) are not likely to be a danger to themselves, to public order or to public safety. Having been convicted of a violent intentional crime shall be considered as indicative of such danger.
(a) are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons of less than 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licenced or otherwise approved training centre;
(b) are not likely to be a danger to themselves, to public order or to public safety. Having been convicted of a violent intentional crime shall be considered as indicative of such danger.
(a) are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons of less than 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licenced or otherwise approved training centre;
(b) are not likely to be a danger to themselves, to public order or to public safety. Having been convicted of a violent intentional crime shall be considered as indicative of such danger.
5. in Article 6, the following paragraph shall be added:‘Member States shall ensure that, except with respect to dealers, the acquisition of firearms and their parts and ammunition by means of distance communication, as defined in Article 2 of 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(*1), shall, where authorised, be strictly controlled.(*1)OJ L 144, 4.6.1997, p. 19. Directive as last amended by Directive 2005/29/EC (OJ L 149, 11.6.2005, p. 22).’;"
6. in Article 7, the following paragraphs shall be added:‘4.   Member States may consider granting persons who satisfy the conditions for the granting of an authorisation for a firearm a multiannual licence for the acquisition and possession of all firearms subject to authorisation, without prejudice to:(a)the obligation to notify the competent authorities of transfers;(b)the periodic verification that those persons continue to satisfy the conditions; and(c)the maximum limits for possession laid down in national law.5.   Member States shall adopt rules to ensure that persons holding authorisations for firearms of category B in force under national law as at 28 July 2008 do not need to apply for a licence or permit regarding firearms they hold in categories C or D due to the entry into force of Directive 2008/51/EC of the European Parliament and of the Council of 21 May 2008(*2). However, any subsequent transfer of firearms of categories C or D shall be subject to the transferee obtaining or having a licence or being specifically permitted to possess those firearms in accordance with national law.(*2)OJ L 179, 8.7.2008, p. 5.’;" (a) the obligation to notify the competent authorities of transfers; (b) the periodic verification that those persons continue to satisfy the conditions; and (c) the maximum limits for possession laid down in national law.
(a) the obligation to notify the competent authorities of transfers;
(b) the periodic verification that those persons continue to satisfy the conditions; and
(c) the maximum limits for possession laid down in national law.
(a) the obligation to notify the competent authorities of transfers;
(b) the periodic verification that those persons continue to satisfy the conditions; and
(c) the maximum limits for possession laid down in national law.
7. in Article 11(3), the second subparagraph shall be replaced by the following:‘Prior to the date of transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2. Those authorities shall carry out inspections, where appropriate on the spot, to verify the correspondence between the information communicated by the dealer and the actual characteristics of the transfer. The information shall be communicated by the dealer within a period allowing sufficient time.’;
8. in Article 12(2), the first subparagraph shall be replaced by the following:‘Notwithstanding paragraph 1, hunters, in respect of categories C and D, and marksmen, in respect of categories B, C and D, may, without prior authorisation, be in possession of one or more firearms during a journey through two or more Member States with a view to engaging in their activities, provided that they are in possession of a European firearms pass listing such firearm or firearms and provided that they are able to substantiate the reasons for their journey, in particular by producing an invitation or other proof of their hunting or target shooting activities in the Member State of destination.Member States may not make acceptance of a European firearms pass conditional upon the payment of any fee or charge.’;
9. Article 13(3) shall be replaced by the following:‘3.   For the purposes of the efficient application of this Directive, Member States shall exchange information on a regular basis. To this end, the Commission shall set up, by 28 July 2009, a contact group for the exchange of information for the purposes of applying this Article. Member States shall inform each other and the Commission of the national authorities responsible for transmitting and receiving information and for complying with the obligations set out in Article 11(4).’;
10. the following article shall be inserted:‘Article 13a1.   The Commission shall be assisted by a committee.2.   Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(*3)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 three months.(*3)OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).’;"
11. Article 16 shall be replaced by the following:‘Article 16Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.’;
12. Article 17 shall be replaced by the following:‘Article 17The Commission shall, by 28 July 2015, submit a report to the European Parliament and the Council on the situation resulting from the application of this Directive, accompanied, if appropriate, by proposals.The Commission shall, by 28 July 2012, carry out research and submit a report to the European Parliament and the Council on the possible advantages and disadvantages of a reduction to two categories of firearms (prohibited or authorised) with a view to the better functioning of the internal market for the products in question by means of possible simplification.The Commission shall, by 28 July 2010, submit a report to the European Parliament and the Council presenting the conclusions of a study of the issue of the placing on the market of replica firearms in order to determine whether the inclusion of such products within the scope of this Directive is possible and desirable.’;
13. Annex I shall be amended as follows:(a)in Part I, the first indent shall be replaced by the following:‘—any firearm as defined in Article 1 of the Directive,’;(b)Part III shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;(ii)the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’. (a) in Part I, the first indent shall be replaced by the following:‘—any firearm as defined in Article 1 of the Directive,’; ‘— any firearm as defined in Article 1 of the Directive,’; (b) Part III shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;(ii)the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’. (i) point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; ‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; (ii) the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.
(a) in Part I, the first indent shall be replaced by the following:‘—any firearm as defined in Article 1 of the Directive,’; ‘— any firearm as defined in Article 1 of the Directive,’;
‘— any firearm as defined in Article 1 of the Directive,’;
(b) Part III shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;(ii)the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’. (i) point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; ‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; (ii) the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.
(i) point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; ‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
(ii) the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.
(a) in Part I, the first indent shall be replaced by the following:‘—any firearm as defined in Article 1 of the Directive,’; ‘— any firearm as defined in Article 1 of the Directive,’;
‘— any firearm as defined in Article 1 of the Directive,’;
‘— any firearm as defined in Article 1 of the Directive,’;
(b) Part III shall be amended as follows:(i)point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;(ii)the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’. (i) point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; ‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; (ii) the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.
(i) point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; ‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
(ii) the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.
(i) point (a) shall be replaced by the following:‘(a)have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’; ‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
‘(a) have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
(ii) the following paragraph shall be inserted after the first paragraph:‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95(1) 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 91/477/EEC(3)established an accompanying measure for the internal market. It creates a balance between on the one hand the undertaking to ensure a certain freedom of movement for some firearms within the Community, and on the other the need to control this freedom using security guarantees suited to this type of product.
(2) In accordance with Council Decision 2001/748/EC of 16 October 2001 concerning the signing on behalf of the European Community of the United Nations Protocol on the illicit manufacturing of and trafficking in firearms, their parts, components and ammunition, annexed to the Convention against transnational organised crime(4), the Commission signed that Protocol (hereinafter referred to as the Protocol) on behalf of the Community on 16 January 2002.
(3) The accession of the Community to the Protocol requires amendments to certain provisions of Directive 91/477/EEC. Indeed, it is important to ensure the coherent, effective and rapid application of the international commitments affecting that Directive. Furthermore, it is necessary to take the opportunity of this revision in order to improve that Directive by addressing certain issues, in particular those that were identified in the report of the Commission to the European Parliament and the Council of 15 December 2000 on the implementation of Directive 91/477/EEC.
(4) Police intelligence evidence shows an increase in the use of converted weapons within the Community. It is therefore essential to ensure that such convertible weapons are brought within the definition of a firearm for the purposes of Directive 91/477/EEC.
(5) Firearms, their parts and ammunition, when imported from third countries, are subject to Community legislation and, accordingly, to the requirements of Directive 91/477/EEC.
(6) The notions of illicit manufacturing and trafficking of firearms, their parts and ammunition, as well as the notion of tracing, should therefore be defined for the purposes of Directive 91/477/EEC.
(7) Furthermore, the Protocol establishes an obligation to mark weapons at the time of manufacture and at the time of transfer from government stocks to permanent civilian use, whereas Directive 91/477/EEC refers only indirectly to the marking obligation. In order to facilitate the tracing of weapons, it is necessary to use alphanumeric codes and to include in the marking the year of manufacture of the weapon (if not part of the serial number). The Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms should, to the greatest extent possible, be used as a reference for the marking system in the Community as a whole.
(8) Moreover, while the Protocol provides that the period during which registers containing information on weapons are to be kept must be increased to at least 10 years, it is necessary, in view of the dangerous nature and durability of weapons, to extend this period up to a minimum of 20 years in order to allow the proper tracing of firearms. It is also necessary that Member States keep a computerised data-filing system, either a centralised system or a decentralised system which guarantees access to authorised authorities to the data-filing systems in which the necessary information regarding each firearm is recorded. Access by police, judicial and other authorised authorities to the information contained in the computerised data-filing system must be subject to compliance with Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms.
(9) In addition, the brokering activities referred to in Article 15 of the Protocol should be defined for the purposes of Directive 91/477/EEC.
(10) In some serious cases, compliance with Articles 5 and 6 of the Protocol requires the application of criminal sanctions and the confiscation of the weapons.
(11) With regard to the deactivation of firearms, point (a) of Part III of Annex I to Directive 91/477/EEC simply refers to national legislation. The Protocol sets out more explicit general principles for the deactivation of weapons. Annex I to Directive 91/477/EEC should therefore be amended.
(12) Due to the special nature of the activity of dealers, it is necessary that Member States exercise a strict control over this activity, in particular by verifying the professional integrity and abilities of dealers.
(13) The acquisition of firearms by private individuals by means of distance communications, for example via the Internet should, where authorised, be subject to the rules laid down in Directive 91/477/EEC and, as a general rule, the acquisition of firearms by persons convicted by a final court judgment of certain serious criminal offences should be prohibited.
(14) The European firearms pass functions in a satisfactory way on the whole and should be regarded as the main document needed by hunters and marksmen for the possession of a firearm during a journey to another Member State. Member States should not make the acceptance of the European firearms pass conditional upon the payment of any fee or charge.
(15) In order to facilitate the tracing of firearms and efficiently to combat the illicit trafficking and manufacturing of firearms, their parts and ammunition, it is necessary to improve the exchange of information between Member States.
(16) The processing of information is subject to compliance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(5)and does not prejudice the level of protection of individuals with regard to the processing of personal data under Community and national law, and in particular does not alter the obligations and rights set out in Directive 95/46/EC.
(17) The measures necessary for the implementation of Directive 91/477/EEC 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(6).
(18) Several Member States have simplified the way they classify firearms by switching from four categories to the following two: prohibited firearms and firearms subject to authorisation. Member States should fall into line with this simplified classification, although Member States which divide firearms into a further set of categories may, in accordance with the principle of subsidiarity, maintain their existing classification systems.
(19) Authorisations for the acquisition and possession of firearms should, as far as possible, involve a single administrative procedure.
(20) Article 2(2) of Directive 91/477/EEC among other things excludes from the scope of application of that Directive the acquisition or possession of weapons and ammunition in accordance with national law by collectors and bodies concerned with the cultural and historical aspects of weapons and recognised as such by the Member State in whose territory they are established.
(21) In accordance with point 34 of the Interinstitutional Agreement on better law-making(7), Member States should draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and make them public.
(22) Directive 91/477/EEC should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Amendments to Directive 91/477/EEC
Article 1
Directive 91/477/EEC is hereby amended as follows:
1.
Article 1 shall be amended as follows:
(a)
paragraph 1 shall be replaced by the following:
‘1. For the purposes of this Directive, “firearm” shall mean any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded for one of the reasons listed in Part III of Annex I. Firearms are classified in part II of Annex I.
For the purposes of this Directive, an object shall be considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:
—
it has the appearance of a firearm, and
—
as a result of its construction or the material from which it is made, it can be so converted.’;
(b)
the following paragraphs shall be inserted:
‘1a. For the purposes of this Directive, “part” shall mean any element or replacement element specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm.
1b. For the purposes of this Directive, “essential component” shall mean the breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.
1c. For the purposes of this Directive, “ammunition” shall mean the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State.
1d. For the purposes of this Directive, “tracing” shall mean the systematic tracking of firearms and, where possible, their parts and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking.
1e. For the purposes of this Directive, “broker” shall mean any natural or legal person, other than a dealer, whose trade or business consists wholly or partly in the buying, selling or arranging the transfer of weapons.’;
(c)
paragraph 2 shall be replaced by the following:
‘2. For the purposes of this Directive, “dealer” shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms, parts and ammunition.’;
(d)
the following paragraphs shall be inserted:
‘2a. For the purposes of this Directive, “illicit manufacturing” shall mean the manufacturing or assembly of firearms, their parts and ammunition:
(i)
from any essential component of such firearms illicitly trafficked;
(ii)
without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or
(iii)
without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
2b. For the purposes of this Directive, “illicit trafficking” shall mean the acquisition, sale, delivery, movement or transfer of firearms, their parts or ammunition from or across the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with the terms of this Directive or if the assembled firearms are not marked in accordance with Article 4(1).’;
(e)
paragraph 4 shall be replaced by the following:
‘4. A “European firearms pass” shall be issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It must always be in the possession of the person using the firearm and any change in the possession or characteristics of the firearm, as well as the loss or theft thereof, shall be indicated on the pass.’;
2.
Article 4 shall be replaced by the following:
1. Member States shall ensure either that any firearm or part placed on the market has been marked and registered in compliance with this Directive, or that it has been deactivated.
2. For the purpose of identifying and tracing each assembled firearm, Member States shall, at the time of manufacture of each firearm, either:
(a)
require a unique marking, including the name of the manufacturer, the country or place of manufacture, the serial number and the year of manufacture (if not part of the serial number). This shall be without prejudice to the affixing of the manufacturer’s trademark. For these purposes, the Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms; or
(b)
maintain any alternative unique user-friendly marking with a number or alphanumeric code, permitting ready identification by all States of the country of manufacture.
The marking shall be affixed to an essential component of the firearm, the destruction of which would render the firearm unusable.
Member States shall ensure that each elementary package of complete ammunition is marked so as to provide the name of the manufacturer, the identification batch (lot) number, the calibre and the type of ammunition. For these purposes Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms.
Furthermore, Member States shall ensure, at the time of transfer of a firearm from government stocks to permanent civilian use, the appropriate unique marking permitting identification by States of the transferring country.
3. Member States shall make the pursuit of the activity of dealer within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer. In the case of a legal person, the check shall be on the person who directs the undertaking.
4. Member States shall, by 31 December 2014, ensure the establishment and maintenance of a computerised data-filing system, either a centralised system or a decentralised system which guarantees to authorised authorities access to the data-filing systems in which each firearm subject to this Directive shall be recorded. This filing system shall record and maintain for not less than 20 years each firearm’s type, make, model, calibre and serial number, as well as the names and addresses of the supplier and the person acquiring or possessing the firearm.
Throughout their period of activity, dealers shall be required to maintain a register in which all firearms subject to this Directive and which are received or disposed of by them shall be recorded, together with such particulars as enable the firearm to be identified and traced, in particular the type, make, model, calibre and serial number thereof and the names and addresses of the persons supplying and acquiring it. Upon the cessation of his activities, the dealer shall deliver the register to the national authority responsible for the filing system provided for in subparagraph 1.
5. Member States shall ensure that all firearms may be linked to their owner at any moment. However, as regards firearms classified in category D, Member States shall, as from 28 July 2010, put into place appropriate tracing measures, including, as from 31 December 2014, measures enabling linking at any moment to the owner of firearms placed on the market after 28 July 2010.’;
3.
the following articles shall be inserted:
Without prejudice to Article 3, Member States shall allow the acquisition and possession of firearms only by persons who have been granted a licence or, with respect to categories C or D, who are specifically permitted to acquire and possess such firearms in accordance with national law.
Member States shall consider establishing a system for the regulation of the activities of brokers. Such a system might include one or more measures such as:
(a)
requiring the registration of brokers operating within their territory;
(b)
requiring the licensing or authorisation of the activity of brokering.’;
4.
Article 5 shall be replaced by the following:
Without prejudice to Article 3, Member States shall permit the acquisition and possession of firearms only by persons who have good cause and who:
(a)
are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons of less than 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licenced or otherwise approved training centre;
(b)
are not likely to be a danger to themselves, to public order or to public safety. Having been convicted of a violent intentional crime shall be considered as indicative of such danger.
Member States may withdraw authorisation for possession of a firearm if any of the conditions on the basis of which it was granted are no longer satisfied.
Member States may not prohibit persons resident within their territory from possessing a weapon acquired in another Member State unless they prohibit the acquisition of the same weapon within their own territory.’;
5.
in Article 6, the following paragraph shall be added:
‘Member States shall ensure that, except with respect to dealers, the acquisition of firearms and their parts and ammunition by means of distance communication, as defined in Article 2 of 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(*1), shall, where authorised, be strictly controlled.
6.
in Article 7, the following paragraphs shall be added:
‘4. Member States may consider granting persons who satisfy the conditions for the granting of an authorisation for a firearm a multiannual licence for the acquisition and possession of all firearms subject to authorisation, without prejudice to:
(a)
the obligation to notify the competent authorities of transfers;
(b)
the periodic verification that those persons continue to satisfy the conditions; and
(c)
the maximum limits for possession laid down in national law.
5. Member States shall adopt rules to ensure that persons holding authorisations for firearms of category B in force under national law as at 28 July 2008 do not need to apply for a licence or permit regarding firearms they hold in categories C or D due to the entry into force of Directive 2008/51/EC of the European Parliament and of the Council of 21 May 2008(*2). However, any subsequent transfer of firearms of categories C or D shall be subject to the transferee obtaining or having a licence or being specifically permitted to possess those firearms in accordance with national law.
7.
in Article 11(3), the second subparagraph shall be replaced by the following:
‘Prior to the date of transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2. Those authorities shall carry out inspections, where appropriate on the spot, to verify the correspondence between the information communicated by the dealer and the actual characteristics of the transfer. The information shall be communicated by the dealer within a period allowing sufficient time.’;
8.
in Article 12(2), the first subparagraph shall be replaced by the following:
‘Notwithstanding paragraph 1, hunters, in respect of categories C and D, and marksmen, in respect of categories B, C and D, may, without prior authorisation, be in possession of one or more firearms during a journey through two or more Member States with a view to engaging in their activities, provided that they are in possession of a European firearms pass listing such firearm or firearms and provided that they are able to substantiate the reasons for their journey, in particular by producing an invitation or other proof of their hunting or target shooting activities in the Member State of destination.
Member States may not make acceptance of a European firearms pass conditional upon the payment of any fee or charge.’;
9.
Article 13(3) shall be replaced by the following:
‘3. For the purposes of the efficient application of this Directive, Member States shall exchange information on a regular basis. To this end, the Commission shall set up, by 28 July 2009, a contact group for the exchange of information for the purposes of applying this Article. Member States shall inform each other and the Commission of the national authorities responsible for transmitting and receiving information and for complying with the obligations set out in Article 11(4).’;
10.
the following article shall be inserted:
1. The Commission shall be assisted by a committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(*3)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 three months.
11.
Article 16 shall be replaced by the following:
Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.’;
12.
Article 17 shall be replaced by the following:
The Commission shall, by 28 July 2015, submit a report to the European Parliament and the Council on the situation resulting from the application of this Directive, accompanied, if appropriate, by proposals.
The Commission shall, by 28 July 2012, carry out research and submit a report to the European Parliament and the Council on the possible advantages and disadvantages of a reduction to two categories of firearms (prohibited or authorised) with a view to the better functioning of the internal market for the products in question by means of possible simplification.
The Commission shall, by 28 July 2010, submit a report to the European Parliament and the Council presenting the conclusions of a study of the issue of the placing on the market of replica firearms in order to determine whether the inclusion of such products within the scope of this Directive is possible and desirable.’;
13.
Annex I shall be amended as follows:
(a)
in Part I, the first indent shall be replaced by the following:
‘—
any firearm as defined in Article 1 of the Directive,’;
(b)
Part III shall be amended as follows:
(i)
point (a) shall be replaced by the following:
‘(a)
have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
(ii)
the following paragraph shall be inserted after the first paragraph:
‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.

Transposition
Article 2
1. Member States shall, by 28 July 2010, bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures.
When Member States adopt those measures, 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 references are 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.

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

Addressees
Article 4
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(1) 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 91/477/EEC(3)established an accompanying measure for the internal market. It creates a balance between on the one hand the undertaking to ensure a certain freedom of movement for some firearms within the Community, and on the other the need to control this freedom using security guarantees suited to this type of product.
(2) In accordance with Council Decision 2001/748/EC of 16 October 2001 concerning the signing on behalf of the European Community of the United Nations Protocol on the illicit manufacturing of and trafficking in firearms, their parts, components and ammunition, annexed to the Convention against transnational organised crime(4), the Commission signed that Protocol (hereinafter referred to as the Protocol) on behalf of the Community on 16 January 2002.
(3) The accession of the Community to the Protocol requires amendments to certain provisions of Directive 91/477/EEC. Indeed, it is important to ensure the coherent, effective and rapid application of the international commitments affecting that Directive. Furthermore, it is necessary to take the opportunity of this revision in order to improve that Directive by addressing certain issues, in particular those that were identified in the report of the Commission to the European Parliament and the Council of 15 December 2000 on the implementation of Directive 91/477/EEC.
(4) Police intelligence evidence shows an increase in the use of converted weapons within the Community. It is therefore essential to ensure that such convertible weapons are brought within the definition of a firearm for the purposes of Directive 91/477/EEC.
(5) Firearms, their parts and ammunition, when imported from third countries, are subject to Community legislation and, accordingly, to the requirements of Directive 91/477/EEC.
(6) The notions of illicit manufacturing and trafficking of firearms, their parts and ammunition, as well as the notion of tracing, should therefore be defined for the purposes of Directive 91/477/EEC.
(7) Furthermore, the Protocol establishes an obligation to mark weapons at the time of manufacture and at the time of transfer from government stocks to permanent civilian use, whereas Directive 91/477/EEC refers only indirectly to the marking obligation. In order to facilitate the tracing of weapons, it is necessary to use alphanumeric codes and to include in the marking the year of manufacture of the weapon (if not part of the serial number). The Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms should, to the greatest extent possible, be used as a reference for the marking system in the Community as a whole.
(8) Moreover, while the Protocol provides that the period during which registers containing information on weapons are to be kept must be increased to at least 10 years, it is necessary, in view of the dangerous nature and durability of weapons, to extend this period up to a minimum of 20 years in order to allow the proper tracing of firearms. It is also necessary that Member States keep a computerised data-filing system, either a centralised system or a decentralised system which guarantees access to authorised authorities to the data-filing systems in which the necessary information regarding each firearm is recorded. Access by police, judicial and other authorised authorities to the information contained in the computerised data-filing system must be subject to compliance with Article 8 of the European Convention for the Protection of Human Rights and Fundamental Freedoms.
(9) In addition, the brokering activities referred to in Article 15 of the Protocol should be defined for the purposes of Directive 91/477/EEC.
(10) In some serious cases, compliance with Articles 5 and 6 of the Protocol requires the application of criminal sanctions and the confiscation of the weapons.
(11) With regard to the deactivation of firearms, point (a) of Part III of Annex I to Directive 91/477/EEC simply refers to national legislation. The Protocol sets out more explicit general principles for the deactivation of weapons. Annex I to Directive 91/477/EEC should therefore be amended.
(12) Due to the special nature of the activity of dealers, it is necessary that Member States exercise a strict control over this activity, in particular by verifying the professional integrity and abilities of dealers.
(13) The acquisition of firearms by private individuals by means of distance communications, for example via the Internet should, where authorised, be subject to the rules laid down in Directive 91/477/EEC and, as a general rule, the acquisition of firearms by persons convicted by a final court judgment of certain serious criminal offences should be prohibited.
(14) The European firearms pass functions in a satisfactory way on the whole and should be regarded as the main document needed by hunters and marksmen for the possession of a firearm during a journey to another Member State. Member States should not make the acceptance of the European firearms pass conditional upon the payment of any fee or charge.
(15) In order to facilitate the tracing of firearms and efficiently to combat the illicit trafficking and manufacturing of firearms, their parts and ammunition, it is necessary to improve the exchange of information between Member States.
(16) The processing of information is subject to compliance with Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data(5)and does not prejudice the level of protection of individuals with regard to the processing of personal data under Community and national law, and in particular does not alter the obligations and rights set out in Directive 95/46/EC.
(17) The measures necessary for the implementation of Directive 91/477/EEC 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(6).
(18) Several Member States have simplified the way they classify firearms by switching from four categories to the following two: prohibited firearms and firearms subject to authorisation. Member States should fall into line with this simplified classification, although Member States which divide firearms into a further set of categories may, in accordance with the principle of subsidiarity, maintain their existing classification systems.
(19) Authorisations for the acquisition and possession of firearms should, as far as possible, involve a single administrative procedure.
(20) Article 2(2) of Directive 91/477/EEC among other things excludes from the scope of application of that Directive the acquisition or possession of weapons and ammunition in accordance with national law by collectors and bodies concerned with the cultural and historical aspects of weapons and recognised as such by the Member State in whose territory they are established.
(21) In accordance with point 34 of the Interinstitutional Agreement on better law-making(7), Member States should draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and make them public.
(22) Directive 91/477/EEC should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Amendments to Directive 91/477/EEC

Directive 91/477/EEC is hereby amended as follows:
1.
Article 1 shall be amended as follows:
(a)
paragraph 1 shall be replaced by the following:
‘1. For the purposes of this Directive, “firearm” shall mean any portable barrelled weapon that expels, is designed to expel or may be converted to expel a shot, bullet or projectile by the action of a combustible propellant, unless it is excluded for one of the reasons listed in Part III of Annex I. Firearms are classified in part II of Annex I.
For the purposes of this Directive, an object shall be considered as capable of being converted to expel a shot, bullet or projectile by the action of a combustible propellant if:
—
it has the appearance of a firearm, and
—
as a result of its construction or the material from which it is made, it can be so converted.’;
(b)
the following paragraphs shall be inserted:
‘1a. For the purposes of this Directive, “part” shall mean any element or replacement element specifically designed for a firearm and essential to its operation, including a barrel, frame or receiver, slide or cylinder, bolt or breech block, and any device designed or adapted to diminish the sound caused by firing a firearm.
1b. For the purposes of this Directive, “essential component” shall mean the breach-closing mechanism, the chamber and the barrel of a firearm which, being separate objects, are included in the category of the firearms on which they are or are intended to be mounted.
1c. For the purposes of this Directive, “ammunition” shall mean the complete round or the components thereof, including cartridge cases, primers, propellant powder, bullets or projectiles, that are used in a firearm, provided that those components are themselves subject to authorisation in the relevant Member State.
1d. For the purposes of this Directive, “tracing” shall mean the systematic tracking of firearms and, where possible, their parts and ammunition from manufacturer to purchaser for the purpose of assisting the competent authorities of Member States in detecting, investigating and analysing illicit manufacturing and illicit trafficking.
1e. For the purposes of this Directive, “broker” shall mean any natural or legal person, other than a dealer, whose trade or business consists wholly or partly in the buying, selling or arranging the transfer of weapons.’;
(c)
paragraph 2 shall be replaced by the following:
‘2. For the purposes of this Directive, “dealer” shall mean any natural or legal person whose trade or business consists wholly or partly in the manufacture, trade, exchange, hiring out, repair or conversion of firearms, parts and ammunition.’;
(d)
the following paragraphs shall be inserted:
‘2a. For the purposes of this Directive, “illicit manufacturing” shall mean the manufacturing or assembly of firearms, their parts and ammunition:
(i)
from any essential component of such firearms illicitly trafficked;
(ii)
without an authorisation issued in accordance with Article 4 by a competent authority of the Member State where the manufacture or assembly takes place; or
(iii)
without marking the assembled firearms at the time of manufacture in accordance with Article 4(1).
2b. For the purposes of this Directive, “illicit trafficking” shall mean the acquisition, sale, delivery, movement or transfer of firearms, their parts or ammunition from or across the territory of one Member State to that of another Member State if any one of the Member States concerned does not authorise it in accordance with the terms of this Directive or if the assembled firearms are not marked in accordance with Article 4(1).’;
(e)
paragraph 4 shall be replaced by the following:
‘4. A “European firearms pass” shall be issued on request by the authorities of a Member State to a person lawfully entering into possession of and using a firearm. It shall be valid for a maximum period of five years, which may be extended, and shall contain the information set out in Annex II. It shall be non-transferable and shall record the firearm or firearms possessed and used by the holder of the pass. It must always be in the possession of the person using the firearm and any change in the possession or characteristics of the firearm, as well as the loss or theft thereof, shall be indicated on the pass.’;
2.
Article 4 shall be replaced by the following:
1. Member States shall ensure either that any firearm or part placed on the market has been marked and registered in compliance with this Directive, or that it has been deactivated.
2. For the purpose of identifying and tracing each assembled firearm, Member States shall, at the time of manufacture of each firearm, either:
(a)
require a unique marking, including the name of the manufacturer, the country or place of manufacture, the serial number and the year of manufacture (if not part of the serial number). This shall be without prejudice to the affixing of the manufacturer’s trademark. For these purposes, the Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms; or
(b)
maintain any alternative unique user-friendly marking with a number or alphanumeric code, permitting ready identification by all States of the country of manufacture.
The marking shall be affixed to an essential component of the firearm, the destruction of which would render the firearm unusable.
Member States shall ensure that each elementary package of complete ammunition is marked so as to provide the name of the manufacturer, the identification batch (lot) number, the calibre and the type of ammunition. For these purposes Member States may choose to apply the provisions of the Convention of 1 July 1969 on Reciprocal Recognition of Proofmarks on Small Arms.
Furthermore, Member States shall ensure, at the time of transfer of a firearm from government stocks to permanent civilian use, the appropriate unique marking permitting identification by States of the transferring country.
3. Member States shall make the pursuit of the activity of dealer within their territory conditional upon authorisation on the basis of at least a check of the private and professional integrity and of the abilities of the dealer. In the case of a legal person, the check shall be on the person who directs the undertaking.
4. Member States shall, by 31 December 2014, ensure the establishment and maintenance of a computerised data-filing system, either a centralised system or a decentralised system which guarantees to authorised authorities access to the data-filing systems in which each firearm subject to this Directive shall be recorded. This filing system shall record and maintain for not less than 20 years each firearm’s type, make, model, calibre and serial number, as well as the names and addresses of the supplier and the person acquiring or possessing the firearm.
Throughout their period of activity, dealers shall be required to maintain a register in which all firearms subject to this Directive and which are received or disposed of by them shall be recorded, together with such particulars as enable the firearm to be identified and traced, in particular the type, make, model, calibre and serial number thereof and the names and addresses of the persons supplying and acquiring it. Upon the cessation of his activities, the dealer shall deliver the register to the national authority responsible for the filing system provided for in subparagraph 1.
5. Member States shall ensure that all firearms may be linked to their owner at any moment. However, as regards firearms classified in category D, Member States shall, as from 28 July 2010, put into place appropriate tracing measures, including, as from 31 December 2014, measures enabling linking at any moment to the owner of firearms placed on the market after 28 July 2010.’;
3.
the following articles shall be inserted:
Without prejudice to Article 3, Member States shall allow the acquisition and possession of firearms only by persons who have been granted a licence or, with respect to categories C or D, who are specifically permitted to acquire and possess such firearms in accordance with national law.
Member States shall consider establishing a system for the regulation of the activities of brokers. Such a system might include one or more measures such as:
(a)
requiring the registration of brokers operating within their territory;
(b)
requiring the licensing or authorisation of the activity of brokering.’;
4.
Article 5 shall be replaced by the following:
Without prejudice to Article 3, Member States shall permit the acquisition and possession of firearms only by persons who have good cause and who:
(a)
are at least 18 years of age, except in relation to the acquisition, other than through purchase, and possession of firearms for hunting and target shooting, provided that in that case persons of less than 18 years of age have parental permission, or are under parental guidance or the guidance of an adult with a valid firearms or hunting licence, or are within a licenced or otherwise approved training centre;
(b)
are not likely to be a danger to themselves, to public order or to public safety. Having been convicted of a violent intentional crime shall be considered as indicative of such danger.
Member States may withdraw authorisation for possession of a firearm if any of the conditions on the basis of which it was granted are no longer satisfied.
Member States may not prohibit persons resident within their territory from possessing a weapon acquired in another Member State unless they prohibit the acquisition of the same weapon within their own territory.’;
5.
in Article 6, the following paragraph shall be added:
‘Member States shall ensure that, except with respect to dealers, the acquisition of firearms and their parts and ammunition by means of distance communication, as defined in Article 2 of 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(*1), shall, where authorised, be strictly controlled.
6.
in Article 7, the following paragraphs shall be added:
‘4. Member States may consider granting persons who satisfy the conditions for the granting of an authorisation for a firearm a multiannual licence for the acquisition and possession of all firearms subject to authorisation, without prejudice to:
(a)
the obligation to notify the competent authorities of transfers;
(b)
the periodic verification that those persons continue to satisfy the conditions; and
(c)
the maximum limits for possession laid down in national law.
5. Member States shall adopt rules to ensure that persons holding authorisations for firearms of category B in force under national law as at 28 July 2008 do not need to apply for a licence or permit regarding firearms they hold in categories C or D due to the entry into force of Directive 2008/51/EC of the European Parliament and of the Council of 21 May 2008(*2). However, any subsequent transfer of firearms of categories C or D shall be subject to the transferee obtaining or having a licence or being specifically permitted to possess those firearms in accordance with national law.
7.
in Article 11(3), the second subparagraph shall be replaced by the following:
‘Prior to the date of transfer, the dealer shall communicate to the authorities of the Member State from which the transfer is to be effected all the particulars listed in the first subparagraph of paragraph 2. Those authorities shall carry out inspections, where appropriate on the spot, to verify the correspondence between the information communicated by the dealer and the actual characteristics of the transfer. The information shall be communicated by the dealer within a period allowing sufficient time.’;
8.
in Article 12(2), the first subparagraph shall be replaced by the following:
‘Notwithstanding paragraph 1, hunters, in respect of categories C and D, and marksmen, in respect of categories B, C and D, may, without prior authorisation, be in possession of one or more firearms during a journey through two or more Member States with a view to engaging in their activities, provided that they are in possession of a European firearms pass listing such firearm or firearms and provided that they are able to substantiate the reasons for their journey, in particular by producing an invitation or other proof of their hunting or target shooting activities in the Member State of destination.
Member States may not make acceptance of a European firearms pass conditional upon the payment of any fee or charge.’;
9.
Article 13(3) shall be replaced by the following:
‘3. For the purposes of the efficient application of this Directive, Member States shall exchange information on a regular basis. To this end, the Commission shall set up, by 28 July 2009, a contact group for the exchange of information for the purposes of applying this Article. Member States shall inform each other and the Commission of the national authorities responsible for transmitting and receiving information and for complying with the obligations set out in Article 11(4).’;
10.
the following article shall be inserted:
1. The Commission shall be assisted by a committee.
2. Where reference is made to this paragraph, Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(*3)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 three months.
11.
Article 16 shall be replaced by the following:
Member States shall lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive.’;
12.
Article 17 shall be replaced by the following:
The Commission shall, by 28 July 2015, submit a report to the European Parliament and the Council on the situation resulting from the application of this Directive, accompanied, if appropriate, by proposals.
The Commission shall, by 28 July 2012, carry out research and submit a report to the European Parliament and the Council on the possible advantages and disadvantages of a reduction to two categories of firearms (prohibited or authorised) with a view to the better functioning of the internal market for the products in question by means of possible simplification.
The Commission shall, by 28 July 2010, submit a report to the European Parliament and the Council presenting the conclusions of a study of the issue of the placing on the market of replica firearms in order to determine whether the inclusion of such products within the scope of this Directive is possible and desirable.’;
13.
Annex I shall be amended as follows:
(a)
in Part I, the first indent shall be replaced by the following:
‘—
any firearm as defined in Article 1 of the Directive,’;
(b)
Part III shall be amended as follows:
(i)
point (a) shall be replaced by the following:
‘(a)
have been rendered permanently unfit for use by deactivation, ensuring that all essential parts of the firearm have been rendered permanently inoperable and incapable of removal, replacement or a modification that would permit the firearm to be reactivated in any way’;
(ii)
the following paragraph shall be inserted after the first paragraph:
‘Member States shall make arrangements for the deactivation measures referred to in point (a) to be verified by a competent authority in order to ensure that the modifications made to a firearm render it irreversibly inoperable. Member States shall, in the context of this verification, provide for the issuance of a certificate or record attesting to the deactivation of the firearm or the apposition of a clearly visible mark to that effect on the firearm. The Commission shall, acting in accordance with the procedure referred to in Article 13a(2) of the Directive, issue common guidelines on deactivation standards and techniques to ensure that deactivated firearms are rendered irreversibly inoperable.’.

Transposition

1. Member States shall, by 28 July 2010, bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those measures.
When Member States adopt those measures, 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 references are 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.

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.

Pending: 32008L0042

January 16, 2026
4.4.2008 EN Official Journal of the European Union L 93/13
(1) On the basis of the IFRA (International Fragrance Association) Code of Practice, the Scientific Committee on Consumer Products (SCCP)(2), identified substances used as fragrance compounds in cosmetic products for which some restrictions should be provided.
(2) Considering that whatever the function of these substances in cosmetic products is, it is the exposure to these substances which should be considered. Therefore, the restrictions should not be limited to the use of the identified substances as fragrance compounds in cosmetic products.
(3) However, sensitisation would not exist when the substance is used in oral products. Therefore, in order to ensure consistency, as some of these substances are authorised as flavouring substances by Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996(3), these restrictions should not apply to substances listed under this register.
(4) In the light of the opinions of the SCCP, it is necessary to amend the restrictions related to the identified substances which are already listed in Annex III to Directive 76/768/EEC under entries 45, 72, 73, 88 and 89. Furthermore, it is appropriate to include in that Annex those identified substances which are not yet listed with their respective restrictions, as well as, for consistency, substances belonging to the same family identified in Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products(4).
(5) Benzyl alcohol being listed twice in Annex III part 1, under reference numbers 45 and 68, the content of entry 68 as well as the new restrictions should be included in entry 45.
(6) Following clarification by the SCCP regarding Peru balsam, entry 1136 of Annex II should be amended.
(7) Directive 76/768/EEC should therefore be amended accordingly.
(8) In order to ensure a smooth progression from the existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.
(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,
(1) In Annex II, reference number 1136 is replaced by the following: ‘Exudation ofMyroxylon pereirae(Royle) Klotzch (Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient’.
(2) Part 1 of Annex III is amended as follows:(a)reference number 68 is deleted;(b)reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)(c)The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002  %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1  %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4  %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6  %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02  %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02  %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02  %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02  %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02  %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02  %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02  %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02  %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02  %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002  %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1  %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1  %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5  %1723-methylnon-2-enenitrileCAS No 53153-66-50,2  %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3  %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01  %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5  %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06  %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002  %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2  %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6  %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6  %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6  %184Opopanax chironium resinCAS No 93384-32-80,6  % (a) reference number 68 is deleted; (b) reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘45 Benzyl alcohol(*1)CAS No 100-51-6 (a)Solvent(b)fragrance/aromatic compositions/their raw materials (a) Solvent (b) fragrance/aromatic compositions/their raw materials (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products 72 HydroxycitronellalCAS No 107-75-5 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products (b)Other products (b) Other products (b)1,0 % (b) 1,0 % 73 IsoeugenolCAS No 97-54-1 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products (b)Other products (b) Other products (b)0,02 % (b) 0,02 % 88 d-LimoneneCAS No 5989-27-5 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) — 0,001 % in leave-on products — 0,01 % in rinse-off products 89 Methyl 2-octynoateCAS No 111-12-6 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products Methyl heptine carbonate (b)Other products (b) Other products (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (c) The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002  %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1  %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4  %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6  %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02  %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02  %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02  %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02  %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02  %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02  %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02  %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02  %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02  %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002  %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1  %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1  %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5  %1723-methylnon-2-enenitrileCAS No 53153-66-50,2  %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3  %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01  %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5  %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06  %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002  %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2  %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6  %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6  %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6  %184Opopanax chironium resinCAS No 93384-32-80,6  % Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘103 Abies alba cone oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3) 104 Abies alba needle oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3) 105 Abies pectinata needle oil and extractCAS No 92128-34-2 Peroxide value less than 10 mmoles/L(*3) 106 Abies sibirica needle oil and extractCAS No 91697-89-1 Peroxide value less than 10 mmoles/L(*3) 107 Abies balsamea needle oil and extractCAS No 85085-34-3 Peroxide value less than 10 mmoles/L(*3) 108 Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 Peroxide value less than 10 mmoles/L(*3) 109 Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 Peroxide value less than 10 mmoles/L(*3) 110 Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 Peroxide value less than 10 mmoles/L(*3) 111 Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 Peroxide value less than 10 mmoles/L(*3) 112 Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 Peroxide value less than 10 mmoles/L(*3) 113 Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 Peroxide value less than 10 mmoles/L(*3) 114 Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 Peroxide value less than 10 mmoles/L(*3) 115 Pinus species leaf and twig oil and extractCAS No 94266-48-5 Peroxide value less than 10 mmoles/L(*3) 116 Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 Peroxide value less than 10 mmoles/L(*3) 117 Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 Peroxide value less than 10 mmoles/L(*3) 118 Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 Peroxide value less than 10 mmoles/L(*3) 119 Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3) 120 Thuja Occidentalis Stem OilCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3) 121 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) Peroxide value less than 10 mmoles/L(*3) 122 Cedrus atlantica wood oil and extractCAS No 92201-55-3 Peroxide value less than 10 mmoles/L(*3) 123 Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 Peroxide value less than 10 mmoles/L(*3) 124 Turpentine gum (Pinusspp.)CAS No 9005-90-7 Peroxide value less than 10 mmoles/L(*3) 125 Turpentine oil and rectified oilCAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3) 126 Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3) 127 Terpene alcohols acetatesCAS No 69103-01-1 Peroxide value less than 10 mmoles/L(*3) 128 Terpene hydrocarbonsCAS No 68956-56-9 Peroxide value less than 10 mmoles/L(*3) 129 Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 Peroxide value less than 10 mmoles/L(*3) 130 Terpene terpenoids sinpineCAS No 68917-63-5 Peroxide value less than 10 mmoles/L(*3) 131 α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene Peroxide value less than 10 mmoles/L(*3) 132 γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene Peroxide value less than 10 mmoles/L(*3) 133 TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene Peroxide value less than 10 mmoles/L(*3) 134 Acetyl hexamethyl indanCAS No 15323-35-0 (a)Leave-on products (a) Leave-on products (a)2 % (a) 2 % 1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone (b)Rinse-off products (b) Rinse-off products 135 Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate Level of free allyl alcohol in the ester should be less than 0,1 % 136 Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate Level of free allyl alcohol in the ester should be less than 0,1 % 137 Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate Level of free allyl alcohol in the ester should be less than 0,1 % 138 Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate Level of free allyl alcohol in the ester should be less than 0,1 % 139 Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate Level of free allyl alcohol in the ester should be less than 0,1 % 140 Allyl caproateCAS No 123-68-2Allyl hexanoate Level of free allyl alcohol in the ester should be less than 0,1 % 141 Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate Level of free allyl alcohol in the ester should be less than 0,1 % 142 Allyl octanoateCAS No 4230-97-12-Allyl caprylate Level of free allyl alcohol in the ester should be less than 0,1 % 143 Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate Level of free allyl alcohol in the ester should be less than 0,1 % 144 Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate Level of free allyl alcohol in the ester should be less than 0,1 % 145 Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 Level of free allyl alcohol in the ester should be less than 0,1 % 146 Allyl cyclohexyloxyacetateCAS No 68901-15-5 Level of free allyl alcohol in the ester should be less than 0,1 % 147 Allyl isoamyloxyacetateCAS No 67634-00-8 Level of free allyl alcohol in the ester should be less than 0,1 % 148 Allyl 2-methylbutoxyacetateCAS No 67634-01-9 Level of free allyl alcohol in the ester should be less than 0,1 % 149 Allyl nonanoateCAS No 7493-72-3 Level of free allyl alcohol in the ester should be less than 0,1 % 150 Allyl propionateCAS No 2408-20-0 Level of free allyl alcohol in the ester should be less than 0,1 % 151 Allyl trimethylhexanoateCAS No 68132-80-9 Level of free allyl alcohol in the ester should be less than 0,1 % 152 Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) 0,002  % This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate) 153 AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one 0,1  % 154 Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) 0,4  % 155 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde 0,6  % 156 Cuminum cyminum fruit oil and extractCAS No 84775-51-9 (a)Leave-on products(b)Rinse-off products (a) Leave-on products (b) Rinse-off products (a)0,4 % of Cumin oil (a) 0,4 % of Cumin oil 157 cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 158 trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 159 trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) 0,02  % 160 Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 161 Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 162 cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 163 trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 164 Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (b)0,02  % (b) 0,02  % 165 trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 166 trans-2-hexenalCAS No 6728-26-3 (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002  % (b) 0,002  % 167 l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene Peroxide value less than 20 mmoles/L(*3) 168 dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) Peroxide value less than 20 mmoles/L(*3) 169 PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,1  % (b) 0,1  % 170 IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate 0,1  % 171 Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde 0,5  % 172 3-methylnon-2-enenitrileCAS No 53153-66-5 0,2  % 173 Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) 174 Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,3  % (b) 0,3  % 175 PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,01  % (b) 0,01  % 176 IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol 0,5  % 177 2-Hexylidene cyclopentanoneCAS No 17373-89-6 (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,06  % (b) 0,06  % 178 Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002  % (b) 0,002  % 179 p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde 0,2  % 180 Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) 0,6  % 181 Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) 0,6  % 182 Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) All cosmetic products, with the exception of oral products (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % (a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % (b) rinse-off products: 0,2 % 183 Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 0,6  % 184 Opopanax chironium resinCAS No 93384-32-8 0,6  %
(a) reference number 68 is deleted;
(b) reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘45 Benzyl alcohol(*1)CAS No 100-51-6 (a)Solvent(b)fragrance/aromatic compositions/their raw materials (a) Solvent (b) fragrance/aromatic compositions/their raw materials (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products 72 HydroxycitronellalCAS No 107-75-5 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products (b)Other products (b) Other products (b)1,0 % (b) 1,0 % 73 IsoeugenolCAS No 97-54-1 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products (b)Other products (b) Other products (b)0,02 % (b) 0,02 % 88 d-LimoneneCAS No 5989-27-5 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) — 0,001 % in leave-on products — 0,01 % in rinse-off products 89 Methyl 2-octynoateCAS No 111-12-6 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products Methyl heptine carbonate (b)Other products (b) Other products (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘45 Benzyl alcohol(*1)CAS No 100-51-6 (a)Solvent(b)fragrance/aromatic compositions/their raw materials (a) Solvent (b) fragrance/aromatic compositions/their raw materials (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Solvent
(b) fragrance/aromatic compositions/their raw materials
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
72 HydroxycitronellalCAS No 107-75-5 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b)Other products (b) Other products (b)1,0 % (b) 1,0 %
(b) Other products
(b) 1,0 %
73 IsoeugenolCAS No 97-54-1 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b)Other products (b) Other products (b)0,02 % (b) 0,02 %
(b) Other products
(b) 0,02 %
88 d-LimoneneCAS No 5989-27-5 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) — 0,001 % in leave-on products — 0,01 % in rinse-off products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
89 Methyl 2-octynoateCAS No 111-12-6 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
Methyl heptine carbonate (b)Other products (b) Other products (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) Other products
(b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(c) The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002  %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1  %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4  %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6  %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02  %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02  %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02  %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02  %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02  %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02  %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02  %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02  %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02  %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002  %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1  %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1  %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5  %1723-methylnon-2-enenitrileCAS No 53153-66-50,2  %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3  %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01  %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5  %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06  %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002  %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2  %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6  %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6  %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6  %184Opopanax chironium resinCAS No 93384-32-80,6  % Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘103 Abies alba cone oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3) 104 Abies alba needle oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3) 105 Abies pectinata needle oil and extractCAS No 92128-34-2 Peroxide value less than 10 mmoles/L(*3) 106 Abies sibirica needle oil and extractCAS No 91697-89-1 Peroxide value less than 10 mmoles/L(*3) 107 Abies balsamea needle oil and extractCAS No 85085-34-3 Peroxide value less than 10 mmoles/L(*3) 108 Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 Peroxide value less than 10 mmoles/L(*3) 109 Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 Peroxide value less than 10 mmoles/L(*3) 110 Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 Peroxide value less than 10 mmoles/L(*3) 111 Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 Peroxide value less than 10 mmoles/L(*3) 112 Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 Peroxide value less than 10 mmoles/L(*3) 113 Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 Peroxide value less than 10 mmoles/L(*3) 114 Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 Peroxide value less than 10 mmoles/L(*3) 115 Pinus species leaf and twig oil and extractCAS No 94266-48-5 Peroxide value less than 10 mmoles/L(*3) 116 Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 Peroxide value less than 10 mmoles/L(*3) 117 Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 Peroxide value less than 10 mmoles/L(*3) 118 Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 Peroxide value less than 10 mmoles/L(*3) 119 Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3) 120 Thuja Occidentalis Stem OilCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3) 121 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) Peroxide value less than 10 mmoles/L(*3) 122 Cedrus atlantica wood oil and extractCAS No 92201-55-3 Peroxide value less than 10 mmoles/L(*3) 123 Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 Peroxide value less than 10 mmoles/L(*3) 124 Turpentine gum (Pinusspp.)CAS No 9005-90-7 Peroxide value less than 10 mmoles/L(*3) 125 Turpentine oil and rectified oilCAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3) 126 Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3) 127 Terpene alcohols acetatesCAS No 69103-01-1 Peroxide value less than 10 mmoles/L(*3) 128 Terpene hydrocarbonsCAS No 68956-56-9 Peroxide value less than 10 mmoles/L(*3) 129 Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 Peroxide value less than 10 mmoles/L(*3) 130 Terpene terpenoids sinpineCAS No 68917-63-5 Peroxide value less than 10 mmoles/L(*3) 131 α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene Peroxide value less than 10 mmoles/L(*3) 132 γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene Peroxide value less than 10 mmoles/L(*3) 133 TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene Peroxide value less than 10 mmoles/L(*3) 134 Acetyl hexamethyl indanCAS No 15323-35-0 (a)Leave-on products (a) Leave-on products (a)2 % (a) 2 % 1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone (b)Rinse-off products (b) Rinse-off products 135 Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate Level of free allyl alcohol in the ester should be less than 0,1 % 136 Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate Level of free allyl alcohol in the ester should be less than 0,1 % 137 Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate Level of free allyl alcohol in the ester should be less than 0,1 % 138 Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate Level of free allyl alcohol in the ester should be less than 0,1 % 139 Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate Level of free allyl alcohol in the ester should be less than 0,1 % 140 Allyl caproateCAS No 123-68-2Allyl hexanoate Level of free allyl alcohol in the ester should be less than 0,1 % 141 Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate Level of free allyl alcohol in the ester should be less than 0,1 % 142 Allyl octanoateCAS No 4230-97-12-Allyl caprylate Level of free allyl alcohol in the ester should be less than 0,1 % 143 Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate Level of free allyl alcohol in the ester should be less than 0,1 % 144 Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate Level of free allyl alcohol in the ester should be less than 0,1 % 145 Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 Level of free allyl alcohol in the ester should be less than 0,1 % 146 Allyl cyclohexyloxyacetateCAS No 68901-15-5 Level of free allyl alcohol in the ester should be less than 0,1 % 147 Allyl isoamyloxyacetateCAS No 67634-00-8 Level of free allyl alcohol in the ester should be less than 0,1 % 148 Allyl 2-methylbutoxyacetateCAS No 67634-01-9 Level of free allyl alcohol in the ester should be less than 0,1 % 149 Allyl nonanoateCAS No 7493-72-3 Level of free allyl alcohol in the ester should be less than 0,1 % 150 Allyl propionateCAS No 2408-20-0 Level of free allyl alcohol in the ester should be less than 0,1 % 151 Allyl trimethylhexanoateCAS No 68132-80-9 Level of free allyl alcohol in the ester should be less than 0,1 % 152 Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) 0,002  % This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate) 153 AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one 0,1  % 154 Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) 0,4  % 155 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde 0,6  % 156 Cuminum cyminum fruit oil and extractCAS No 84775-51-9 (a)Leave-on products(b)Rinse-off products (a) Leave-on products (b) Rinse-off products (a)0,4 % of Cumin oil (a) 0,4 % of Cumin oil 157 cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 158 trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 159 trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) 0,02  % 160 Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 161 Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 162 cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 163 trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 164 Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (b)0,02  % (b) 0,02  % 165 trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 166 trans-2-hexenalCAS No 6728-26-3 (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002  % (b) 0,002  % 167 l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene Peroxide value less than 20 mmoles/L(*3) 168 dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) Peroxide value less than 20 mmoles/L(*3) 169 PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,1  % (b) 0,1  % 170 IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate 0,1  % 171 Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde 0,5  % 172 3-methylnon-2-enenitrileCAS No 53153-66-5 0,2  % 173 Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) 174 Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,3  % (b) 0,3  % 175 PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,01  % (b) 0,01  % 176 IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol 0,5  % 177 2-Hexylidene cyclopentanoneCAS No 17373-89-6 (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,06  % (b) 0,06  % 178 Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002  % (b) 0,002  % 179 p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde 0,2  % 180 Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) 0,6  % 181 Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) 0,6  % 182 Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) All cosmetic products, with the exception of oral products (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % (a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % (b) rinse-off products: 0,2 % 183 Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 0,6  % 184 Opopanax chironium resinCAS No 93384-32-8 0,6  %
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘103 Abies alba cone oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3)
104 Abies alba needle oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3)
105 Abies pectinata needle oil and extractCAS No 92128-34-2 Peroxide value less than 10 mmoles/L(*3)
106 Abies sibirica needle oil and extractCAS No 91697-89-1 Peroxide value less than 10 mmoles/L(*3)
107 Abies balsamea needle oil and extractCAS No 85085-34-3 Peroxide value less than 10 mmoles/L(*3)
108 Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 Peroxide value less than 10 mmoles/L(*3)
109 Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 Peroxide value less than 10 mmoles/L(*3)
110 Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 Peroxide value less than 10 mmoles/L(*3)
111 Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 Peroxide value less than 10 mmoles/L(*3)
112 Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 Peroxide value less than 10 mmoles/L(*3)
113 Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 Peroxide value less than 10 mmoles/L(*3)
114 Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 Peroxide value less than 10 mmoles/L(*3)
115 Pinus species leaf and twig oil and extractCAS No 94266-48-5 Peroxide value less than 10 mmoles/L(*3)
116 Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 Peroxide value less than 10 mmoles/L(*3)
117 Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 Peroxide value less than 10 mmoles/L(*3)
118 Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 Peroxide value less than 10 mmoles/L(*3)
119 Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3)
120 Thuja Occidentalis Stem OilCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3)
121 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) Peroxide value less than 10 mmoles/L(*3)
122 Cedrus atlantica wood oil and extractCAS No 92201-55-3 Peroxide value less than 10 mmoles/L(*3)
123 Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 Peroxide value less than 10 mmoles/L(*3)
124 Turpentine gum (Pinusspp.)CAS No 9005-90-7 Peroxide value less than 10 mmoles/L(*3)
125 Turpentine oil and rectified oilCAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3)
126 Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3)
127 Terpene alcohols acetatesCAS No 69103-01-1 Peroxide value less than 10 mmoles/L(*3)
128 Terpene hydrocarbonsCAS No 68956-56-9 Peroxide value less than 10 mmoles/L(*3)
129 Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 Peroxide value less than 10 mmoles/L(*3)
130 Terpene terpenoids sinpineCAS No 68917-63-5 Peroxide value less than 10 mmoles/L(*3)
131 α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene Peroxide value less than 10 mmoles/L(*3)
132 γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene Peroxide value less than 10 mmoles/L(*3)
133 TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene Peroxide value less than 10 mmoles/L(*3)
134 Acetyl hexamethyl indanCAS No 15323-35-0 (a)Leave-on products (a) Leave-on products (a)2 % (a) 2 %
(a) Leave-on products
(a) 2 %
1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone (b)Rinse-off products (b) Rinse-off products
(b) Rinse-off products
135 Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate Level of free allyl alcohol in the ester should be less than 0,1 %
136 Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate Level of free allyl alcohol in the ester should be less than 0,1 %
137 Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate Level of free allyl alcohol in the ester should be less than 0,1 %
138 Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate Level of free allyl alcohol in the ester should be less than 0,1 %
139 Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate Level of free allyl alcohol in the ester should be less than 0,1 %
140 Allyl caproateCAS No 123-68-2Allyl hexanoate Level of free allyl alcohol in the ester should be less than 0,1 %
141 Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate Level of free allyl alcohol in the ester should be less than 0,1 %
142 Allyl octanoateCAS No 4230-97-12-Allyl caprylate Level of free allyl alcohol in the ester should be less than 0,1 %
143 Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate Level of free allyl alcohol in the ester should be less than 0,1 %
144 Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate Level of free allyl alcohol in the ester should be less than 0,1 %
145 Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 Level of free allyl alcohol in the ester should be less than 0,1 %
146 Allyl cyclohexyloxyacetateCAS No 68901-15-5 Level of free allyl alcohol in the ester should be less than 0,1 %
147 Allyl isoamyloxyacetateCAS No 67634-00-8 Level of free allyl alcohol in the ester should be less than 0,1 %
148 Allyl 2-methylbutoxyacetateCAS No 67634-01-9 Level of free allyl alcohol in the ester should be less than 0,1 %
149 Allyl nonanoateCAS No 7493-72-3 Level of free allyl alcohol in the ester should be less than 0,1 %
150 Allyl propionateCAS No 2408-20-0 Level of free allyl alcohol in the ester should be less than 0,1 %
151 Allyl trimethylhexanoateCAS No 68132-80-9 Level of free allyl alcohol in the ester should be less than 0,1 %
152 Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) 0,002  % This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)
153 AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one 0,1  %
154 Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) 0,4  %
155 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde 0,6  %
156 Cuminum cyminum fruit oil and extractCAS No 84775-51-9 (a)Leave-on products(b)Rinse-off products (a) Leave-on products (b) Rinse-off products (a)0,4 % of Cumin oil (a) 0,4 % of Cumin oil
(a) Leave-on products
(b) Rinse-off products
(a) 0,4 % of Cumin oil
157 cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
158 trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
159 trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) 0,02  %
160 Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
161 Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
162 cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
163 trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
164 Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (b)0,02  % (b) 0,02  %
(b) 0,02  %
165 trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
166 trans-2-hexenalCAS No 6728-26-3 (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002  % (b) 0,002  %
(b) Other products
(b) 0,002  %
167 l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene Peroxide value less than 20 mmoles/L(*3)
168 dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) Peroxide value less than 20 mmoles/L(*3)
169 PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,1  % (b) 0,1  %
(b) Other products
(b) 0,1  %
170 IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate 0,1  %
171 Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde 0,5  %
172 3-methylnon-2-enenitrileCAS No 53153-66-5 0,2  %
173 Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) Other products
(b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
174 Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,3  % (b) 0,3  %
(b) Other products
(b) 0,3  %
175 PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,01  % (b) 0,01  %
(b) Other products
(b) 0,01  %
176 IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol 0,5  %
177 2-Hexylidene cyclopentanoneCAS No 17373-89-6 (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,06  % (b) 0,06  %
(b) Other products
(b) 0,06  %
178 Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002  % (b) 0,002  %
(b) Other products
(b) 0,002  %
179 p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde 0,2  %
180 Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) 0,6  %
181 Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) 0,6  %
182 Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) All cosmetic products, with the exception of oral products (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % (a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % (b) rinse-off products: 0,2 %
(a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %
(b) rinse-off products: 0,2 %
183 Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 0,6  %
184 Opopanax chironium resinCAS No 93384-32-8 0,6  %
(a) reference number 68 is deleted;
(b) reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘45 Benzyl alcohol(*1)CAS No 100-51-6 (a)Solvent(b)fragrance/aromatic compositions/their raw materials (a) Solvent (b) fragrance/aromatic compositions/their raw materials (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products 72 HydroxycitronellalCAS No 107-75-5 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products (b)Other products (b) Other products (b)1,0 % (b) 1,0 % 73 IsoeugenolCAS No 97-54-1 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products (b)Other products (b) Other products (b)0,02 % (b) 0,02 % 88 d-LimoneneCAS No 5989-27-5 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) — 0,001 % in leave-on products — 0,01 % in rinse-off products 89 Methyl 2-octynoateCAS No 111-12-6 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products Methyl heptine carbonate (b)Other products (b) Other products (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘45 Benzyl alcohol(*1)CAS No 100-51-6 (a)Solvent(b)fragrance/aromatic compositions/their raw materials (a) Solvent (b) fragrance/aromatic compositions/their raw materials (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Solvent
(b) fragrance/aromatic compositions/their raw materials
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
72 HydroxycitronellalCAS No 107-75-5 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b)Other products (b) Other products (b)1,0 % (b) 1,0 %
(b) Other products
(b) 1,0 %
73 IsoeugenolCAS No 97-54-1 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b)Other products (b) Other products (b)0,02 % (b) 0,02 %
(b) Other products
(b) 0,02 %
88 d-LimoneneCAS No 5989-27-5 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) — 0,001 % in leave-on products — 0,01 % in rinse-off products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
89 Methyl 2-octynoateCAS No 111-12-6 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
Methyl heptine carbonate (b)Other products (b) Other products (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) Other products
(b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘45 Benzyl alcohol(*1)CAS No 100-51-6 (a)Solvent(b)fragrance/aromatic compositions/their raw materials (a) Solvent (b) fragrance/aromatic compositions/their raw materials (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Solvent
(b) fragrance/aromatic compositions/their raw materials
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
72 HydroxycitronellalCAS No 107-75-5 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b)Other products (b) Other products (b)1,0 % (b) 1,0 %
(b) Other products
(b) 1,0 %
73 IsoeugenolCAS No 97-54-1 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b)Other products (b) Other products (b)0,02 % (b) 0,02 %
(b) Other products
(b) 0,02 %
88 d-LimoneneCAS No 5989-27-5 The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) — 0,001 % in leave-on products — 0,01 % in rinse-off products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
89 Methyl 2-octynoateCAS No 111-12-6 (a)Oral products (a) Oral products (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products — 0,001 % in leave-on products — 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
Methyl heptine carbonate (b)Other products (b) Other products (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) Other products
(b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(a) Solvent
(b) fragrance/aromatic compositions/their raw materials
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b) Other products
(b) 1,0 %
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b) Other products
(b) 0,02 %
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(a) Oral products
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
(b) Other products
(b) 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(c) The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002  %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1  %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4  %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6  %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02  %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02  %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02  %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02  %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02  %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02  %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02  %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02  %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02  %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002  %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1  %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1  %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5  %1723-methylnon-2-enenitrileCAS No 53153-66-50,2  %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3  %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01  %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5  %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06  %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002  %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2  %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6  %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6  %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6  %184Opopanax chironium resinCAS No 93384-32-80,6  % Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements a b c d e f ‘103 Abies alba cone oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3) 104 Abies alba needle oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3) 105 Abies pectinata needle oil and extractCAS No 92128-34-2 Peroxide value less than 10 mmoles/L(*3) 106 Abies sibirica needle oil and extractCAS No 91697-89-1 Peroxide value less than 10 mmoles/L(*3) 107 Abies balsamea needle oil and extractCAS No 85085-34-3 Peroxide value less than 10 mmoles/L(*3) 108 Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 Peroxide value less than 10 mmoles/L(*3) 109 Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 Peroxide value less than 10 mmoles/L(*3) 110 Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 Peroxide value less than 10 mmoles/L(*3) 111 Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 Peroxide value less than 10 mmoles/L(*3) 112 Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 Peroxide value less than 10 mmoles/L(*3) 113 Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 Peroxide value less than 10 mmoles/L(*3) 114 Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 Peroxide value less than 10 mmoles/L(*3) 115 Pinus species leaf and twig oil and extractCAS No 94266-48-5 Peroxide value less than 10 mmoles/L(*3) 116 Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 Peroxide value less than 10 mmoles/L(*3) 117 Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 Peroxide value less than 10 mmoles/L(*3) 118 Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 Peroxide value less than 10 mmoles/L(*3) 119 Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3) 120 Thuja Occidentalis Stem OilCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3) 121 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) Peroxide value less than 10 mmoles/L(*3) 122 Cedrus atlantica wood oil and extractCAS No 92201-55-3 Peroxide value less than 10 mmoles/L(*3) 123 Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 Peroxide value less than 10 mmoles/L(*3) 124 Turpentine gum (Pinusspp.)CAS No 9005-90-7 Peroxide value less than 10 mmoles/L(*3) 125 Turpentine oil and rectified oilCAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3) 126 Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3) 127 Terpene alcohols acetatesCAS No 69103-01-1 Peroxide value less than 10 mmoles/L(*3) 128 Terpene hydrocarbonsCAS No 68956-56-9 Peroxide value less than 10 mmoles/L(*3) 129 Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 Peroxide value less than 10 mmoles/L(*3) 130 Terpene terpenoids sinpineCAS No 68917-63-5 Peroxide value less than 10 mmoles/L(*3) 131 α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene Peroxide value less than 10 mmoles/L(*3) 132 γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene Peroxide value less than 10 mmoles/L(*3) 133 TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene Peroxide value less than 10 mmoles/L(*3) 134 Acetyl hexamethyl indanCAS No 15323-35-0 (a)Leave-on products (a) Leave-on products (a)2 % (a) 2 % 1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone (b)Rinse-off products (b) Rinse-off products 135 Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate Level of free allyl alcohol in the ester should be less than 0,1 % 136 Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate Level of free allyl alcohol in the ester should be less than 0,1 % 137 Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate Level of free allyl alcohol in the ester should be less than 0,1 % 138 Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate Level of free allyl alcohol in the ester should be less than 0,1 % 139 Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate Level of free allyl alcohol in the ester should be less than 0,1 % 140 Allyl caproateCAS No 123-68-2Allyl hexanoate Level of free allyl alcohol in the ester should be less than 0,1 % 141 Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate Level of free allyl alcohol in the ester should be less than 0,1 % 142 Allyl octanoateCAS No 4230-97-12-Allyl caprylate Level of free allyl alcohol in the ester should be less than 0,1 % 143 Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate Level of free allyl alcohol in the ester should be less than 0,1 % 144 Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate Level of free allyl alcohol in the ester should be less than 0,1 % 145 Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 Level of free allyl alcohol in the ester should be less than 0,1 % 146 Allyl cyclohexyloxyacetateCAS No 68901-15-5 Level of free allyl alcohol in the ester should be less than 0,1 % 147 Allyl isoamyloxyacetateCAS No 67634-00-8 Level of free allyl alcohol in the ester should be less than 0,1 % 148 Allyl 2-methylbutoxyacetateCAS No 67634-01-9 Level of free allyl alcohol in the ester should be less than 0,1 % 149 Allyl nonanoateCAS No 7493-72-3 Level of free allyl alcohol in the ester should be less than 0,1 % 150 Allyl propionateCAS No 2408-20-0 Level of free allyl alcohol in the ester should be less than 0,1 % 151 Allyl trimethylhexanoateCAS No 68132-80-9 Level of free allyl alcohol in the ester should be less than 0,1 % 152 Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) 0,002  % This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate) 153 AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one 0,1  % 154 Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) 0,4  % 155 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde 0,6  % 156 Cuminum cyminum fruit oil and extractCAS No 84775-51-9 (a)Leave-on products(b)Rinse-off products (a) Leave-on products (b) Rinse-off products (a)0,4 % of Cumin oil (a) 0,4 % of Cumin oil 157 cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 158 trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 159 trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) 0,02  % 160 Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 161 Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 162 cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 163 trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 164 Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (b)0,02  % (b) 0,02  % 165 trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,02  % (b) 0,02  % 166 trans-2-hexenalCAS No 6728-26-3 (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002  % (b) 0,002  % 167 l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene Peroxide value less than 20 mmoles/L(*3) 168 dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) Peroxide value less than 20 mmoles/L(*3) 169 PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,1  % (b) 0,1  % 170 IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate 0,1  % 171 Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde 0,5  % 172 3-methylnon-2-enenitrileCAS No 53153-66-5 0,2  % 173 Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) 174 Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,3  % (b) 0,3  % 175 PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,01  % (b) 0,01  % 176 IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol 0,5  % 177 2-Hexylidene cyclopentanoneCAS No 17373-89-6 (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,06  % (b) 0,06  % 178 Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one (a)Oral products (a) Oral products (b)Other products (b) Other products (b)0,002  % (b) 0,002  % 179 p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde 0,2  % 180 Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) 0,6  % 181 Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) 0,6  % 182 Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) All cosmetic products, with the exception of oral products (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % (a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % (b) rinse-off products: 0,2 % 183 Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 0,6  % 184 Opopanax chironium resinCAS No 93384-32-8 0,6  %
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘103 Abies alba cone oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3)
104 Abies alba needle oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3)
105 Abies pectinata needle oil and extractCAS No 92128-34-2 Peroxide value less than 10 mmoles/L(*3)
106 Abies sibirica needle oil and extractCAS No 91697-89-1 Peroxide value less than 10 mmoles/L(*3)
107 Abies balsamea needle oil and extractCAS No 85085-34-3 Peroxide value less than 10 mmoles/L(*3)
108 Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 Peroxide value less than 10 mmoles/L(*3)
109 Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 Peroxide value less than 10 mmoles/L(*3)
110 Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 Peroxide value less than 10 mmoles/L(*3)
111 Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 Peroxide value less than 10 mmoles/L(*3)
112 Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 Peroxide value less than 10 mmoles/L(*3)
113 Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 Peroxide value less than 10 mmoles/L(*3)
114 Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 Peroxide value less than 10 mmoles/L(*3)
115 Pinus species leaf and twig oil and extractCAS No 94266-48-5 Peroxide value less than 10 mmoles/L(*3)
116 Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 Peroxide value less than 10 mmoles/L(*3)
117 Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 Peroxide value less than 10 mmoles/L(*3)
118 Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 Peroxide value less than 10 mmoles/L(*3)
119 Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3)
120 Thuja Occidentalis Stem OilCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3)
121 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) Peroxide value less than 10 mmoles/L(*3)
122 Cedrus atlantica wood oil and extractCAS No 92201-55-3 Peroxide value less than 10 mmoles/L(*3)
123 Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 Peroxide value less than 10 mmoles/L(*3)
124 Turpentine gum (Pinusspp.)CAS No 9005-90-7 Peroxide value less than 10 mmoles/L(*3)
125 Turpentine oil and rectified oilCAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3)
126 Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3)
127 Terpene alcohols acetatesCAS No 69103-01-1 Peroxide value less than 10 mmoles/L(*3)
128 Terpene hydrocarbonsCAS No 68956-56-9 Peroxide value less than 10 mmoles/L(*3)
129 Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 Peroxide value less than 10 mmoles/L(*3)
130 Terpene terpenoids sinpineCAS No 68917-63-5 Peroxide value less than 10 mmoles/L(*3)
131 α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene Peroxide value less than 10 mmoles/L(*3)
132 γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene Peroxide value less than 10 mmoles/L(*3)
133 TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene Peroxide value less than 10 mmoles/L(*3)
134 Acetyl hexamethyl indanCAS No 15323-35-0 (a)Leave-on products (a) Leave-on products (a)2 % (a) 2 %
(a) Leave-on products
(a) 2 %
1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone (b)Rinse-off products (b) Rinse-off products
(b) Rinse-off products
135 Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate Level of free allyl alcohol in the ester should be less than 0,1 %
136 Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate Level of free allyl alcohol in the ester should be less than 0,1 %
137 Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate Level of free allyl alcohol in the ester should be less than 0,1 %
138 Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate Level of free allyl alcohol in the ester should be less than 0,1 %
139 Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate Level of free allyl alcohol in the ester should be less than 0,1 %
140 Allyl caproateCAS No 123-68-2Allyl hexanoate Level of free allyl alcohol in the ester should be less than 0,1 %
141 Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate Level of free allyl alcohol in the ester should be less than 0,1 %
142 Allyl octanoateCAS No 4230-97-12-Allyl caprylate Level of free allyl alcohol in the ester should be less than 0,1 %
143 Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate Level of free allyl alcohol in the ester should be less than 0,1 %
144 Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate Level of free allyl alcohol in the ester should be less than 0,1 %
145 Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 Level of free allyl alcohol in the ester should be less than 0,1 %
146 Allyl cyclohexyloxyacetateCAS No 68901-15-5 Level of free allyl alcohol in the ester should be less than 0,1 %
147 Allyl isoamyloxyacetateCAS No 67634-00-8 Level of free allyl alcohol in the ester should be less than 0,1 %
148 Allyl 2-methylbutoxyacetateCAS No 67634-01-9 Level of free allyl alcohol in the ester should be less than 0,1 %
149 Allyl nonanoateCAS No 7493-72-3 Level of free allyl alcohol in the ester should be less than 0,1 %
150 Allyl propionateCAS No 2408-20-0 Level of free allyl alcohol in the ester should be less than 0,1 %
151 Allyl trimethylhexanoateCAS No 68132-80-9 Level of free allyl alcohol in the ester should be less than 0,1 %
152 Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) 0,002  % This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)
153 AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one 0,1  %
154 Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) 0,4  %
155 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde 0,6  %
156 Cuminum cyminum fruit oil and extractCAS No 84775-51-9 (a)Leave-on products(b)Rinse-off products (a) Leave-on products (b) Rinse-off products (a)0,4 % of Cumin oil (a) 0,4 % of Cumin oil
(a) Leave-on products
(b) Rinse-off products
(a) 0,4 % of Cumin oil
157 cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
158 trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
159 trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) 0,02  %
160 Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
161 Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
162 cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
163 trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
164 Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (b)0,02  % (b) 0,02  %
(b) 0,02  %
165 trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
166 trans-2-hexenalCAS No 6728-26-3 (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002  % (b) 0,002  %
(b) Other products
(b) 0,002  %
167 l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene Peroxide value less than 20 mmoles/L(*3)
168 dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) Peroxide value less than 20 mmoles/L(*3)
169 PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,1  % (b) 0,1  %
(b) Other products
(b) 0,1  %
170 IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate 0,1  %
171 Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde 0,5  %
172 3-methylnon-2-enenitrileCAS No 53153-66-5 0,2  %
173 Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) Other products
(b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
174 Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,3  % (b) 0,3  %
(b) Other products
(b) 0,3  %
175 PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,01  % (b) 0,01  %
(b) Other products
(b) 0,01  %
176 IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol 0,5  %
177 2-Hexylidene cyclopentanoneCAS No 17373-89-6 (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,06  % (b) 0,06  %
(b) Other products
(b) 0,06  %
178 Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002  % (b) 0,002  %
(b) Other products
(b) 0,002  %
179 p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde 0,2  %
180 Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) 0,6  %
181 Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) 0,6  %
182 Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) All cosmetic products, with the exception of oral products (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % (a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % (b) rinse-off products: 0,2 %
(a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %
(b) rinse-off products: 0,2 %
183 Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 0,6  %
184 Opopanax chironium resinCAS No 93384-32-8 0,6  %
Reference number Substance Restrictions Conditions of use and warnings which must be printed on the label
Field of application and/or use Maximum authorised concentration in the finished cosmetic product Other limitations and requirements
a b c d e f
‘103 Abies alba cone oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3)
104 Abies alba needle oil and extractCAS No 90028-76-5 Peroxide value less than 10 mmoles/L(*3)
105 Abies pectinata needle oil and extractCAS No 92128-34-2 Peroxide value less than 10 mmoles/L(*3)
106 Abies sibirica needle oil and extractCAS No 91697-89-1 Peroxide value less than 10 mmoles/L(*3)
107 Abies balsamea needle oil and extractCAS No 85085-34-3 Peroxide value less than 10 mmoles/L(*3)
108 Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 Peroxide value less than 10 mmoles/L(*3)
109 Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 Peroxide value less than 10 mmoles/L(*3)
110 Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 Peroxide value less than 10 mmoles/L(*3)
111 Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 Peroxide value less than 10 mmoles/L(*3)
112 Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 Peroxide value less than 10 mmoles/L(*3)
113 Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 Peroxide value less than 10 mmoles/L(*3)
114 Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 Peroxide value less than 10 mmoles/L(*3)
115 Pinus species leaf and twig oil and extractCAS No 94266-48-5 Peroxide value less than 10 mmoles/L(*3)
116 Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 Peroxide value less than 10 mmoles/L(*3)
117 Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 Peroxide value less than 10 mmoles/L(*3)
118 Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 Peroxide value less than 10 mmoles/L(*3)
119 Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3)
120 Thuja Occidentalis Stem OilCAS No 90131-58-1 Peroxide value less than 10 mmoles/L(*3)
121 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) Peroxide value less than 10 mmoles/L(*3)
122 Cedrus atlantica wood oil and extractCAS No 92201-55-3 Peroxide value less than 10 mmoles/L(*3)
123 Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 Peroxide value less than 10 mmoles/L(*3)
124 Turpentine gum (Pinusspp.)CAS No 9005-90-7 Peroxide value less than 10 mmoles/L(*3)
125 Turpentine oil and rectified oilCAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3)
126 Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 Peroxide value less than 10 mmoles/L(*3)
127 Terpene alcohols acetatesCAS No 69103-01-1 Peroxide value less than 10 mmoles/L(*3)
128 Terpene hydrocarbonsCAS No 68956-56-9 Peroxide value less than 10 mmoles/L(*3)
129 Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 Peroxide value less than 10 mmoles/L(*3)
130 Terpene terpenoids sinpineCAS No 68917-63-5 Peroxide value less than 10 mmoles/L(*3)
131 α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene Peroxide value less than 10 mmoles/L(*3)
132 γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene Peroxide value less than 10 mmoles/L(*3)
133 TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene Peroxide value less than 10 mmoles/L(*3)
134 Acetyl hexamethyl indanCAS No 15323-35-0 (a)Leave-on products (a) Leave-on products (a)2 % (a) 2 %
(a) Leave-on products
(a) 2 %
1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone (b)Rinse-off products (b) Rinse-off products
(b) Rinse-off products
135 Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate Level of free allyl alcohol in the ester should be less than 0,1 %
136 Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate Level of free allyl alcohol in the ester should be less than 0,1 %
137 Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate Level of free allyl alcohol in the ester should be less than 0,1 %
138 Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate Level of free allyl alcohol in the ester should be less than 0,1 %
139 Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate Level of free allyl alcohol in the ester should be less than 0,1 %
140 Allyl caproateCAS No 123-68-2Allyl hexanoate Level of free allyl alcohol in the ester should be less than 0,1 %
141 Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate Level of free allyl alcohol in the ester should be less than 0,1 %
142 Allyl octanoateCAS No 4230-97-12-Allyl caprylate Level of free allyl alcohol in the ester should be less than 0,1 %
143 Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate Level of free allyl alcohol in the ester should be less than 0,1 %
144 Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate Level of free allyl alcohol in the ester should be less than 0,1 %
145 Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 Level of free allyl alcohol in the ester should be less than 0,1 %
146 Allyl cyclohexyloxyacetateCAS No 68901-15-5 Level of free allyl alcohol in the ester should be less than 0,1 %
147 Allyl isoamyloxyacetateCAS No 67634-00-8 Level of free allyl alcohol in the ester should be less than 0,1 %
148 Allyl 2-methylbutoxyacetateCAS No 67634-01-9 Level of free allyl alcohol in the ester should be less than 0,1 %
149 Allyl nonanoateCAS No 7493-72-3 Level of free allyl alcohol in the ester should be less than 0,1 %
150 Allyl propionateCAS No 2408-20-0 Level of free allyl alcohol in the ester should be less than 0,1 %
151 Allyl trimethylhexanoateCAS No 68132-80-9 Level of free allyl alcohol in the ester should be less than 0,1 %
152 Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) 0,002  % This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)
153 AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one 0,1  %
154 Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) 0,4  %
155 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde 0,6  %
156 Cuminum cyminum fruit oil and extractCAS No 84775-51-9 (a)Leave-on products(b)Rinse-off products (a) Leave-on products (b) Rinse-off products (a)0,4 % of Cumin oil (a) 0,4 % of Cumin oil
(a) Leave-on products
(b) Rinse-off products
(a) 0,4 % of Cumin oil
157 cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
158 trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
159 trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) 0,02  %
160 Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
161 Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
162 cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
163 trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
164 Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one (b)0,02  % (b) 0,02  %
(b) 0,02  %
165 trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,02  % (b) 0,02  %
(b) Other products
(b) 0,02  %
166 trans-2-hexenalCAS No 6728-26-3 (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002  % (b) 0,002  %
(b) Other products
(b) 0,002  %
167 l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene Peroxide value less than 20 mmoles/L(*3)
168 dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) Peroxide value less than 20 mmoles/L(*3)
169 PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,1  % (b) 0,1  %
(b) Other products
(b) 0,1  %
170 IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate 0,1  %
171 Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde 0,5  %
172 3-methylnon-2-enenitrileCAS No 53153-66-5 0,2  %
173 Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) (b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) Other products
(b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
174 Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,3  % (b) 0,3  %
(b) Other products
(b) 0,3  %
175 PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,01  % (b) 0,01  %
(b) Other products
(b) 0,01  %
176 IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol 0,5  %
177 2-Hexylidene cyclopentanoneCAS No 17373-89-6 (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,06  % (b) 0,06  %
(b) Other products
(b) 0,06  %
178 Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one (a)Oral products (a) Oral products
(a) Oral products
(b)Other products (b) Other products (b)0,002  % (b) 0,002  %
(b) Other products
(b) 0,002  %
179 p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde 0,2  %
180 Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) 0,6  %
181 Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) 0,6  %
182 Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) All cosmetic products, with the exception of oral products (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % (a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % (b) rinse-off products: 0,2 %
(a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %
(b) rinse-off products: 0,2 %
183 Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 0,6  %
184 Opopanax chironium resinCAS No 93384-32-8 0,6  %
(a) Leave-on products
(a) 2 %
(b) Rinse-off products
(a) Leave-on products
(b) Rinse-off products
(a) 0,4 % of Cumin oil
(a) Oral products
(b) Other products
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,02  %
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,02  %
(a) Oral products
(b) Other products
(b) 0,002  %
(a) Oral products
(b) Other products
(b) 0,1  %
(a) Oral products
(b) Other products
(b) 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(a) Oral products
(b) Other products
(b) 0,3  %
(a) Oral products
(b) Other products
(b) 0,01  %
(a) Oral products
(b) Other products
(b) 0,06  %
(a) Oral products
(b) Other products
(b) 0,002  %
(a) leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %
(b) rinse-off products: 0,2 %
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,
(1) On the basis of the IFRA (International Fragrance Association) Code of Practice, the Scientific Committee on Consumer Products (SCCP)(2), identified substances used as fragrance compounds in cosmetic products for which some restrictions should be provided.
(2) Considering that whatever the function of these substances in cosmetic products is, it is the exposure to these substances which should be considered. Therefore, the restrictions should not be limited to the use of the identified substances as fragrance compounds in cosmetic products.
(3) However, sensitisation would not exist when the substance is used in oral products. Therefore, in order to ensure consistency, as some of these substances are authorised as flavouring substances by Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996(3), these restrictions should not apply to substances listed under this register.
(4) In the light of the opinions of the SCCP, it is necessary to amend the restrictions related to the identified substances which are already listed in Annex III to Directive 76/768/EEC under entries 45, 72, 73, 88 and 89. Furthermore, it is appropriate to include in that Annex those identified substances which are not yet listed with their respective restrictions, as well as, for consistency, substances belonging to the same family identified in Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products(4).
(5) Benzyl alcohol being listed twice in Annex III part 1, under reference numbers 45 and 68, the content of entry 68 as well as the new restrictions should be included in entry 45.
(6) Following clarification by the SCCP regarding Peru balsam, entry 1136 of Annex II should be amended.
(7) Directive 76/768/EEC should therefore be amended accordingly.
(8) In order to ensure a smooth progression from the existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.
(9) 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 of Directive 76/768/EEC are amended in accordance with the Annex to this Directive.

Article 2
Member States shall take all necessary measures to ensure that products which fail to comply with this Directive are not sold or disposed of to the final consumer after 4 October 2009.

Article 3
1. Member States shall adopt and publish, by 4 October 2008 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 4 April 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 4
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

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 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,
(1) On the basis of the IFRA (International Fragrance Association) Code of Practice, the Scientific Committee on Consumer Products (SCCP)(2), identified substances used as fragrance compounds in cosmetic products for which some restrictions should be provided.
(2) Considering that whatever the function of these substances in cosmetic products is, it is the exposure to these substances which should be considered. Therefore, the restrictions should not be limited to the use of the identified substances as fragrance compounds in cosmetic products.
(3) However, sensitisation would not exist when the substance is used in oral products. Therefore, in order to ensure consistency, as some of these substances are authorised as flavouring substances by Commission Decision 1999/217/EC of 23 February 1999 adopting a register of flavouring substances used in or on foodstuffs drawn up in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council of 28 October 1996(3), these restrictions should not apply to substances listed under this register.
(4) In the light of the opinions of the SCCP, it is necessary to amend the restrictions related to the identified substances which are already listed in Annex III to Directive 76/768/EEC under entries 45, 72, 73, 88 and 89. Furthermore, it is appropriate to include in that Annex those identified substances which are not yet listed with their respective restrictions, as well as, for consistency, substances belonging to the same family identified in Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products(4).
(5) Benzyl alcohol being listed twice in Annex III part 1, under reference numbers 45 and 68, the content of entry 68 as well as the new restrictions should be included in entry 45.
(6) Following clarification by the SCCP regarding Peru balsam, entry 1136 of Annex II should be amended.
(7) Directive 76/768/EEC should therefore be amended accordingly.
(8) In order to ensure a smooth progression from the existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.
(9) 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 of Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
Member States shall take all necessary measures to ensure that products which fail to comply with this Directive are not sold or disposed of to the final consumer after 4 October 2009.
1. Member States shall adopt and publish, by 4 October 2008 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 4 April 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 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, reference number 1136 is replaced by the following: ‘Exudation ofMyroxylon pereirae(Royle) Klotzch (Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient’.
(2) | Part 1 of Annex III is amended as follows:(a)reference number 68 is deleted;(b)reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)(c)The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002 %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1 %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4 %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6 %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02 %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02 %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02 %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02 %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02 %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02 %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02 %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02 %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02 %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002 %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1 %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1 %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5 %1723-methylnon-2-enenitrileCAS No 53153-66-50,2 %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3 %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01 %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5 %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06 %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002 %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2 %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6 %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6 %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6 %184Opopanax chironium resinCAS No 93384-32-80,6 % | (a) | reference number 68 is deleted; | (b) | reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘45 | Benzyl alcohol(*1)CAS No 100-51-6 | (a)Solvent(b)fragrance/aromatic compositions/their raw materials | (a) | Solvent | (b) | fragrance/aromatic compositions/their raw materials | | (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | 72 | HydroxycitronellalCAS No 107-75-5 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | (b)Other products | (b) | Other products | (b)1,0 % | (b) | 1,0 % | 73 | IsoeugenolCAS No 97-54-1 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 88 | d-LimoneneCAS No 5989-27-5 | | | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | 89 | Methyl 2-octynoateCAS No 111-12-6 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | Methyl heptine carbonate | (b)Other products | (b) | Other products | (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (b) | 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (c) | The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002 %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1 %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4 %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6 %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02 %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02 %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02 %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02 %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02 %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02 %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02 %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02 %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02 %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002 %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1 %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1 %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5 %1723-methylnon-2-enenitrileCAS No 53153-66-50,2 %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3 %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01 %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5 %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06 %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002 %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2 %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6 %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6 %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6 %184Opopanax chironium resinCAS No 93384-32-80,6 % | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘103 | Abies alba cone oil and extractCAS No 90028-76-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 104 | Abies alba needle oil and extractCAS No 90028-76-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 105 | Abies pectinata needle oil and extractCAS No 92128-34-2 | | | Peroxide value less than 10 mmoles/L(*3) | | 106 | Abies sibirica needle oil and extractCAS No 91697-89-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 107 | Abies balsamea needle oil and extractCAS No 85085-34-3 | | | Peroxide value less than 10 mmoles/L(*3) | | 108 | Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 | | | Peroxide value less than 10 mmoles/L(*3) | | 109 | Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 | | | Peroxide value less than 10 mmoles/L(*3) | | 110 | Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 111 | Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 | | | Peroxide value less than 10 mmoles/L(*3) | | 112 | Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 | | | Peroxide value less than 10 mmoles/L(*3) | | 113 | Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 | | | Peroxide value less than 10 mmoles/L(*3) | | 114 | Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 | | | Peroxide value less than 10 mmoles/L(*3) | | 115 | Pinus species leaf and twig oil and extractCAS No 94266-48-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 116 | Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 117 | Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 | | | Peroxide value less than 10 mmoles/L(*3) | | 118 | Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 | | | Peroxide value less than 10 mmoles/L(*3) | | 119 | Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 120 | Thuja Occidentalis Stem OilCAS No 90131-58-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 121 | 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) | | | Peroxide value less than 10 mmoles/L(*3) | | 122 | Cedrus atlantica wood oil and extractCAS No 92201-55-3 | | | Peroxide value less than 10 mmoles/L(*3) | | 123 | Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 124 | Turpentine gum (Pinusspp.)CAS No 9005-90-7 | | | Peroxide value less than 10 mmoles/L(*3) | | 125 | Turpentine oil and rectified oilCAS No 8006-64-2 | | | Peroxide value less than 10 mmoles/L(*3) | | 126 | Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 | | | Peroxide value less than 10 mmoles/L(*3) | | 127 | Terpene alcohols acetatesCAS No 69103-01-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 128 | Terpene hydrocarbonsCAS No 68956-56-9 | | | Peroxide value less than 10 mmoles/L(*3) | | 129 | Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 | | | Peroxide value less than 10 mmoles/L(*3) | | 130 | Terpene terpenoids sinpineCAS No 68917-63-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 131 | α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene | | | Peroxide value less than 10 mmoles/L(*3) | | 132 | γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene | | | Peroxide value less than 10 mmoles/L(*3) | | 133 | TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene | | | Peroxide value less than 10 mmoles/L(*3) | | 134 | Acetyl hexamethyl indanCAS No 15323-35-0 | (a)Leave-on products | (a) | Leave-on products | (a)2 % | (a) | 2 % | | | 1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone | (b)Rinse-off products | (b) | Rinse-off products | 135 | Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 136 | Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 137 | Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 138 | Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 139 | Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 140 | Allyl caproateCAS No 123-68-2Allyl hexanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 141 | Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 142 | Allyl octanoateCAS No 4230-97-12-Allyl caprylate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 143 | Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 144 | Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 145 | Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 146 | Allyl cyclohexyloxyacetateCAS No 68901-15-5 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 147 | Allyl isoamyloxyacetateCAS No 67634-00-8 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 148 | Allyl 2-methylbutoxyacetateCAS No 67634-01-9 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 149 | Allyl nonanoateCAS No 7493-72-3 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 150 | Allyl propionateCAS No 2408-20-0 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 151 | Allyl trimethylhexanoateCAS No 68132-80-9 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 152 | Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) | | 0,002 % | This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate) | | 153 | AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one | | 0,1 % | | | 154 | Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) | | 0,4 % | | | 155 | 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde | | 0,6 % | | | 156 | Cuminum cyminum fruit oil and extractCAS No 84775-51-9 | (a)Leave-on products(b)Rinse-off products | (a) | Leave-on products | (b) | Rinse-off products | (a)0,4 % of Cumin oil | (a) | 0,4 % of Cumin oil | | | 157 | cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 158 | trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 159 | trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) | | 0,02 % | | | 160 | Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 161 | Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 162 | cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 163 | trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 164 | Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one | | (b)0,02 % | (b) | 0,02 % | | | 165 | trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 166 | trans-2-hexenalCAS No 6728-26-3 | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,002 % | (b) | 0,002 % | 167 | l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene | | | Peroxide value less than 20 mmoles/L(*3) | | 168 | dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) | | | Peroxide value less than 20 mmoles/L(*3) | | 169 | PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,1 % | (b) | 0,1 % | 170 | IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate | | 0,1 % | | | 171 | Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde | | 0,5 % | | | 172 | 3-methylnon-2-enenitrileCAS No 53153-66-5 | | 0,2 % | | | 173 | Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (b) | 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | 174 | Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,3 % | (b) | 0,3 % | 175 | PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,01 % | (b) | 0,01 % | 176 | IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol | | 0,5 % | | | 177 | 2-Hexylidene cyclopentanoneCAS No 17373-89-6 | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,06 % | (b) | 0,06 % | 178 | Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,002 % | (b) | 0,002 % | 179 | p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde | | 0,2 % | | | 180 | Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) | | 0,6 % | | | 181 | Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) | | 0,6 % | | | 182 | Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) | All cosmetic products, with the exception of oral products | (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % | (a) | leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % | (b) | rinse-off products: 0,2 % | | | 183 | Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 | | 0,6 % | | | 184 | Opopanax chironium resinCAS No 93384-32-8 | | 0,6 % | |
(a) | reference number 68 is deleted;
(b) | reference numbers 45, 72, 73, 88 and 89 are replaced by the following:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘45Benzyl alcohol(*1)CAS No 100-51-6(a)Solvent(b)fragrance/aromatic compositions/their raw materials(b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products72HydroxycitronellalCAS No 107-75-5(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)1,0 %73IsoeugenolCAS No 97-54-1(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products(b)Other products(b)0,02 %88d-LimoneneCAS No 5989-27-5The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2)89Methyl 2-octynoateCAS No 111-12-6(a)Oral products(a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsMethyl heptine carbonate(b)Other products(b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘45 | Benzyl alcohol(*1)CAS No 100-51-6 | (a)Solvent(b)fragrance/aromatic compositions/their raw materials | (a) | Solvent | (b) | fragrance/aromatic compositions/their raw materials | | (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | 72 | HydroxycitronellalCAS No 107-75-5 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | (b)Other products | (b) | Other products | (b)1,0 % | (b) | 1,0 % | 73 | IsoeugenolCAS No 97-54-1 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 88 | d-LimoneneCAS No 5989-27-5 | | | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | 89 | Methyl 2-octynoateCAS No 111-12-6 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products | | Methyl heptine carbonate | (b)Other products | (b) | Other products | (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (b) | 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label
Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements
a | b | c | d | e | f
‘45 | Benzyl alcohol(*1)CAS No 100-51-6 | (a)Solvent(b)fragrance/aromatic compositions/their raw materials | (a) | Solvent | (b) | fragrance/aromatic compositions/their raw materials | | (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products |
(a) | Solvent
(b) | fragrance/aromatic compositions/their raw materials
— | 0,001 % in leave-on products
— | 0,01 % in rinse-off products
72 | HydroxycitronellalCAS No 107-75-5 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products |
(a) | Oral products
— | 0,001 % in leave-on products
— | 0,01 % in rinse-off products
(b)Other products | (b) | Other products | (b)1,0 % | (b) | 1,0 %
(b) | Other products
(b) | 1,0 %
73 | IsoeugenolCAS No 97-54-1 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products |
(a) | Oral products
— | 0,001 % in leave-on products
— | 0,01 % in rinse-off products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
88 | d-LimoneneCAS No 5989-27-5 | | | The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off productsPeroxide value less than 20 mmoles/L(*2) | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products |
— | 0,001 % in leave-on products
— | 0,01 % in rinse-off products
89 | Methyl 2-octynoateCAS No 111-12-6 | (a)Oral products | (a) | Oral products | | (a) (b)The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds:—0,001 % in leave-on products—0,01 % in rinse-off products | — | 0,001 % in leave-on products | — | 0,01 % in rinse-off products |
(a) | Oral products
— | 0,001 % in leave-on products
— | 0,01 % in rinse-off products
Methyl heptine carbonate | (b)Other products | (b) | Other products | (b)0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (b) | 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) | Other products
(b) | 0,01 % when used aloneWhen present in combination with methyl octine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(c) | The following reference numbers 103 to 184 are added:Reference numberSubstanceRestrictionsConditions of use and warnings which must be printed on the labelField of application and/or useMaximum authorised concentration in the finished cosmetic productOther limitations and requirementsabcdef‘103Abies alba cone oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)104Abies alba needle oil and extractCAS No 90028-76-5Peroxide value less than 10 mmoles/L(*3)105Abies pectinata needle oil and extractCAS No 92128-34-2Peroxide value less than 10 mmoles/L(*3)106Abies sibirica needle oil and extractCAS No 91697-89-1Peroxide value less than 10 mmoles/L(*3)107Abies balsamea needle oil and extractCAS No 85085-34-3Peroxide value less than 10 mmoles/L(*3)108Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8Peroxide value less than 10 mmoles/L(*3)109Pinus mugo leaf and twig oil and extractCAS No 90082-72-7Peroxide value less than 10 mmoles/L(*3)110Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1Peroxide value less than 10 mmoles/L(*3)111Pinus nigra leaf and twig oil and extractCAS No 90082-74-9Peroxide value less than 10 mmoles/L(*3)112Pinus palustris leaf and twig oil and extractCAS No 97435-14-8Peroxide value less than 10 mmoles/L(*3)113Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0Peroxide value less than 10 mmoles/L(*3)114Pinus pumila leaf and twig oil and extractCAS No 97676-05-6Peroxide value less than 10 mmoles/L(*3)115Pinus species leaf and twig oil and extractCAS No 94266-48-5Peroxide value less than 10 mmoles/L(*3)116Pinus cembra leaf and twig oil and extractCAS No 92202-04-5Peroxide value less than 10 mmoles/L(*3)117Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6Peroxide value less than 10 mmoles/L(*3)118Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9Peroxide value less than 10 mmoles/L(*3)119Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)120Thuja Occidentalis Stem OilCAS No 90131-58-1Peroxide value less than 10 mmoles/L(*3)1213-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)Peroxide value less than 10 mmoles/L(*3)122Cedrus atlantica wood oil and extractCAS No 92201-55-3Peroxide value less than 10 mmoles/L(*3)123Cupressus sempervirens leaf oil and extractCAS No 84696-07-1Peroxide value less than 10 mmoles/L(*3)124Turpentine gum (Pinusspp.)CAS No 9005-90-7Peroxide value less than 10 mmoles/L(*3)125Turpentine oil and rectified oilCAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)126Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2Peroxide value less than 10 mmoles/L(*3)127Terpene alcohols acetatesCAS No 69103-01-1Peroxide value less than 10 mmoles/L(*3)128Terpene hydrocarbonsCAS No 68956-56-9Peroxide value less than 10 mmoles/L(*3)129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7Peroxide value less than 10 mmoles/L(*3)130Terpene terpenoids sinpineCAS No 68917-63-5Peroxide value less than 10 mmoles/L(*3)131α-TerpineneCAS No 99-86-5p-Mentha-1,3-dienePeroxide value less than 10 mmoles/L(*3)132γ-TerpineneCAS No 99-85-4p-Mentha-1,4-dienePeroxide value less than 10 mmoles/L(*3)133TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-dienePeroxide value less than 10 mmoles/L(*3)134Acetyl hexamethyl indanCAS No 15323-35-0(a)Leave-on products(a)2 %1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone(b)Rinse-off products135Allyl butyrateCAS No 2051-78-72-Propenyl ButanoateLevel of free allyl alcohol in the ester should be less than 0,1 %136Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoateLevel of free allyl alcohol in the ester should be less than 0,1 %137Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl CyclohexaneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %138Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-CyclohexanepropanoateLevel of free allyl alcohol in the ester should be less than 0,1 %139Allyl heptanoateCAS No 142-19-82-Propenyl heptanoateLevel of free allyl alcohol in the ester should be less than 0,1 %140Allyl caproateCAS No 123-68-2Allyl hexanoateLevel of free allyl alcohol in the ester should be less than 0,1 %141Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoateLevel of free allyl alcohol in the ester should be less than 0,1 %142Allyl octanoateCAS No 4230-97-12-Allyl caprylateLevel of free allyl alcohol in the ester should be less than 0,1 %143Allyl phenoxyacetateCAS No 7493-74-52-Propenyl PhenoxyacetateLevel of free allyl alcohol in the ester should be less than 0,1 %144Allyl phenylacetateCAS No 1797-74-62-Propenyl BenzeneacetateLevel of free allyl alcohol in the ester should be less than 0,1 %145Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3Level of free allyl alcohol in the ester should be less than 0,1 %146Allyl cyclohexyloxyacetateCAS No 68901-15-5Level of free allyl alcohol in the ester should be less than 0,1 %147Allyl isoamyloxyacetateCAS No 67634-00-8Level of free allyl alcohol in the ester should be less than 0,1 %148Allyl 2-methylbutoxyacetateCAS No 67634-01-9Level of free allyl alcohol in the ester should be less than 0,1 %149Allyl nonanoateCAS No 7493-72-3Level of free allyl alcohol in the ester should be less than 0,1 %150Allyl propionateCAS No 2408-20-0Level of free allyl alcohol in the ester should be less than 0,1 %151Allyl trimethylhexanoateCAS No 68132-80-9Level of free allyl alcohol in the ester should be less than 0,1 %152Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate)0,002 %This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate)153AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one0,1 %154Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru)0,4 %1554-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde0,6 %156Cuminum cyminum fruit oil and extractCAS No 84775-51-9(a)Leave-on products(b)Rinse-off products(a)0,4 % of Cumin oil157cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone)(a)Oral products(b)Other products(b)0,02 %158trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone)(a)Oral products(b)Other products(b)0,02 %159trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone)0,02 %160Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)(a)Oral products(b)Other products(b)0,02 %161Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone)(a)Oral products(b)Other products(b)0,02 %162cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone)(a)Oral products(b)Other products(b)0,02 %163trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone)(a)Oral products(b)Other products(b)0,02 %164Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(b)0,02 %165trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone)(a)Oral products(b)Other products(b)0,02 %166trans-2-hexenalCAS No 6728-26-3(a)Oral products(b)Other products(b)0,002 %167l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-dienePeroxide value less than 20 mmoles/L(*3)168dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene)Peroxide value less than 20 mmoles/L(*3)169PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al(a)Oral products(b)Other products(b)0,1 %170IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate0,1 %171Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde0,5 %1723-methylnon-2-enenitrileCAS No 53153-66-50,2 %173Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate(a)Oral products(b)Other products(b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)174Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate(a)Oral products(b)Other products(b)0,3 %175PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide(a)Oral products(b)Other products(b)0,01 %176IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol0,5 %1772-Hexylidene cyclopentanoneCAS No 17373-89-6(a)Oral products(b)Other products(b)0,06 %178Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one(a)Oral products(b)Other products(b)0,002 %179p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde0,2 %180Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax)0,6 %181Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax)0,6 %182Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN)All cosmetic products, with the exception of oral products(a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 %183Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-10,6 %184Opopanax chironium resinCAS No 93384-32-80,6 % | Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label | Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements | a | b | c | d | e | f | ‘103 | Abies alba cone oil and extractCAS No 90028-76-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 104 | Abies alba needle oil and extractCAS No 90028-76-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 105 | Abies pectinata needle oil and extractCAS No 92128-34-2 | | | Peroxide value less than 10 mmoles/L(*3) | | 106 | Abies sibirica needle oil and extractCAS No 91697-89-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 107 | Abies balsamea needle oil and extractCAS No 85085-34-3 | | | Peroxide value less than 10 mmoles/L(*3) | | 108 | Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 | | | Peroxide value less than 10 mmoles/L(*3) | | 109 | Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 | | | Peroxide value less than 10 mmoles/L(*3) | | 110 | Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 111 | Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 | | | Peroxide value less than 10 mmoles/L(*3) | | 112 | Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 | | | Peroxide value less than 10 mmoles/L(*3) | | 113 | Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 | | | Peroxide value less than 10 mmoles/L(*3) | | 114 | Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 | | | Peroxide value less than 10 mmoles/L(*3) | | 115 | Pinus species leaf and twig oil and extractCAS No 94266-48-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 116 | Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 117 | Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 | | | Peroxide value less than 10 mmoles/L(*3) | | 118 | Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 | | | Peroxide value less than 10 mmoles/L(*3) | | 119 | Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 120 | Thuja Occidentalis Stem OilCAS No 90131-58-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 121 | 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) | | | Peroxide value less than 10 mmoles/L(*3) | | 122 | Cedrus atlantica wood oil and extractCAS No 92201-55-3 | | | Peroxide value less than 10 mmoles/L(*3) | | 123 | Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 124 | Turpentine gum (Pinusspp.)CAS No 9005-90-7 | | | Peroxide value less than 10 mmoles/L(*3) | | 125 | Turpentine oil and rectified oilCAS No 8006-64-2 | | | Peroxide value less than 10 mmoles/L(*3) | | 126 | Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 | | | Peroxide value less than 10 mmoles/L(*3) | | 127 | Terpene alcohols acetatesCAS No 69103-01-1 | | | Peroxide value less than 10 mmoles/L(*3) | | 128 | Terpene hydrocarbonsCAS No 68956-56-9 | | | Peroxide value less than 10 mmoles/L(*3) | | 129 | Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 | | | Peroxide value less than 10 mmoles/L(*3) | | 130 | Terpene terpenoids sinpineCAS No 68917-63-5 | | | Peroxide value less than 10 mmoles/L(*3) | | 131 | α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene | | | Peroxide value less than 10 mmoles/L(*3) | | 132 | γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene | | | Peroxide value less than 10 mmoles/L(*3) | | 133 | TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene | | | Peroxide value less than 10 mmoles/L(*3) | | 134 | Acetyl hexamethyl indanCAS No 15323-35-0 | (a)Leave-on products | (a) | Leave-on products | (a)2 % | (a) | 2 % | | | 1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone | (b)Rinse-off products | (b) | Rinse-off products | 135 | Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 136 | Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 137 | Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 138 | Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 139 | Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 140 | Allyl caproateCAS No 123-68-2Allyl hexanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 141 | Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 142 | Allyl octanoateCAS No 4230-97-12-Allyl caprylate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 143 | Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 144 | Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 145 | Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 146 | Allyl cyclohexyloxyacetateCAS No 68901-15-5 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 147 | Allyl isoamyloxyacetateCAS No 67634-00-8 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 148 | Allyl 2-methylbutoxyacetateCAS No 67634-01-9 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 149 | Allyl nonanoateCAS No 7493-72-3 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 150 | Allyl propionateCAS No 2408-20-0 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 151 | Allyl trimethylhexanoateCAS No 68132-80-9 | | | Level of free allyl alcohol in the ester should be less than 0,1 % | | 152 | Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) | | 0,002 % | This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate) | | 153 | AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one | | 0,1 % | | | 154 | Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) | | 0,4 % | | | 155 | 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde | | 0,6 % | | | 156 | Cuminum cyminum fruit oil and extractCAS No 84775-51-9 | (a)Leave-on products(b)Rinse-off products | (a) | Leave-on products | (b) | Rinse-off products | (a)0,4 % of Cumin oil | (a) | 0,4 % of Cumin oil | | | 157 | cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 158 | trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 159 | trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) | | 0,02 % | | | 160 | Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 161 | Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 162 | cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 163 | trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 164 | Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one | | (b)0,02 % | (b) | 0,02 % | | | 165 | trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 % | 166 | trans-2-hexenalCAS No 6728-26-3 | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,002 % | (b) | 0,002 % | 167 | l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene | | | Peroxide value less than 20 mmoles/L(*3) | | 168 | dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) | | | Peroxide value less than 20 mmoles/L(*3) | | 169 | PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,1 % | (b) | 0,1 % | 170 | IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate | | 0,1 % | | | 171 | Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde | | 0,5 % | | | 172 | 3-methylnon-2-enenitrileCAS No 53153-66-5 | | 0,2 % | | | 173 | Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (b) | 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | 174 | Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,3 % | (b) | 0,3 % | 175 | PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,01 % | (b) | 0,01 % | 176 | IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol | | 0,5 % | | | 177 | 2-Hexylidene cyclopentanoneCAS No 17373-89-6 | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,06 % | (b) | 0,06 % | 178 | Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one | (a)Oral products | (a) | Oral products | | | | (b)Other products | (b) | Other products | (b)0,002 % | (b) | 0,002 % | 179 | p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde | | 0,2 % | | | 180 | Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) | | 0,6 % | | | 181 | Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) | | 0,6 % | | | 182 | Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) | All cosmetic products, with the exception of oral products | (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % | (a) | leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % | (b) | rinse-off products: 0,2 % | | | 183 | Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 | | 0,6 % | | | 184 | Opopanax chironium resinCAS No 93384-32-8 | | 0,6 % | |
Reference number | Substance | Restrictions | Conditions of use and warnings which must be printed on the label
Field of application and/or use | Maximum authorised concentration in the finished cosmetic product | Other limitations and requirements
a | b | c | d | e | f
‘103 | Abies alba cone oil and extractCAS No 90028-76-5 | | | Peroxide value less than 10 mmoles/L(*3) |
104 | Abies alba needle oil and extractCAS No 90028-76-5 | | | Peroxide value less than 10 mmoles/L(*3) |
105 | Abies pectinata needle oil and extractCAS No 92128-34-2 | | | Peroxide value less than 10 mmoles/L(*3) |
106 | Abies sibirica needle oil and extractCAS No 91697-89-1 | | | Peroxide value less than 10 mmoles/L(*3) |
107 | Abies balsamea needle oil and extractCAS No 85085-34-3 | | | Peroxide value less than 10 mmoles/L(*3) |
108 | Pinus mugo pumilio leaf and twig oil and extractCAS No 90082-73-8 | | | Peroxide value less than 10 mmoles/L(*3) |
109 | Pinus mugo leaf and twig oil and extractCAS No 90082-72-7 | | | Peroxide value less than 10 mmoles/L(*3) |
110 | Pinus sylvestris leaf and twig oil and extractCAS No 84012-35-1 | | | Peroxide value less than 10 mmoles/L(*3) |
111 | Pinus nigra leaf and twig oil and extractCAS No 90082-74-9 | | | Peroxide value less than 10 mmoles/L(*3) |
112 | Pinus palustris leaf and twig oil and extractCAS No 97435-14-8 | | | Peroxide value less than 10 mmoles/L(*3) |
113 | Pinus pinaster leaf and twig oil and extractCAS No 90082-75-0 | | | Peroxide value less than 10 mmoles/L(*3) |
114 | Pinus pumila leaf and twig oil and extractCAS No 97676-05-6 | | | Peroxide value less than 10 mmoles/L(*3) |
115 | Pinus species leaf and twig oil and extractCAS No 94266-48-5 | | | Peroxide value less than 10 mmoles/L(*3) |
116 | Pinus cembra leaf and twig oil and extractCAS No 92202-04-5 | | | Peroxide value less than 10 mmoles/L(*3) |
117 | Pinus cembra leaf and twig extract acetylatedCAS No 94334-26-6 | | | Peroxide value less than 10 mmoles/L(*3) |
118 | Picea Mariana Leaf Oil and ExtractCAS No 91722-19-9 | | | Peroxide value less than 10 mmoles/L(*3) |
119 | Thuja Occidentalis Leaf Oil and ExtractCAS No 90131-58-1 | | | Peroxide value less than 10 mmoles/L(*3) |
120 | Thuja Occidentalis Stem OilCAS No 90131-58-1 | | | Peroxide value less than 10 mmoles/L(*3) |
121 | 3-CareneCAS No 13466-78-93,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) | | | Peroxide value less than 10 mmoles/L(*3) |
122 | Cedrus atlantica wood oil and extractCAS No 92201-55-3 | | | Peroxide value less than 10 mmoles/L(*3) |
123 | Cupressus sempervirens leaf oil and extractCAS No 84696-07-1 | | | Peroxide value less than 10 mmoles/L(*3) |
124 | Turpentine gum (Pinusspp.)CAS No 9005-90-7 | | | Peroxide value less than 10 mmoles/L(*3) |
125 | Turpentine oil and rectified oilCAS No 8006-64-2 | | | Peroxide value less than 10 mmoles/L(*3) |
126 | Turpentine, steam distilled (Pinusspp.)CAS No 8006-64-2 | | | Peroxide value less than 10 mmoles/L(*3) |
127 | Terpene alcohols acetatesCAS No 69103-01-1 | | | Peroxide value less than 10 mmoles/L(*3) |
128 | Terpene hydrocarbonsCAS No 68956-56-9 | | | Peroxide value less than 10 mmoles/L(*3) |
129 | Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 167, 168 and 88 of this Annex III, part 1CAS No 65996-98-7 | | | Peroxide value less than 10 mmoles/L(*3) |
130 | Terpene terpenoids sinpineCAS No 68917-63-5 | | | Peroxide value less than 10 mmoles/L(*3) |
131 | α-TerpineneCAS No 99-86-5p-Mentha-1,3-diene | | | Peroxide value less than 10 mmoles/L(*3) |
132 | γ-TerpineneCAS No 99-85-4p-Mentha-1,4-diene | | | Peroxide value less than 10 mmoles/L(*3) |
133 | TerpinoleneCAS No 586-62-9p-Mentha-1,4(8)-diene | | | Peroxide value less than 10 mmoles/L(*3) |
134 | Acetyl hexamethyl indanCAS No 15323-35-0 | (a)Leave-on products | (a) | Leave-on products | (a)2 % | (a) | 2 % | |
(a) | Leave-on products
(a) | 2 %
1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone | (b)Rinse-off products | (b) | Rinse-off products
(b) | Rinse-off products
135 | Allyl butyrateCAS No 2051-78-72-Propenyl Butanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
136 | Allyl cinnamateCAS No 1866-31-52-Propenyl 3-Phenyl-2-propenoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
137 | Allyl cyclohexylacetateCAS No 4728-82-92-Propenyl Cyclohexaneacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
138 | Allyl cyclohexylpropionateCAS No 2705-87-52-Propenyl 3-Cyclohexanepropanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
139 | Allyl heptanoateCAS No 142-19-82-Propenyl heptanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
140 | Allyl caproateCAS No 123-68-2Allyl hexanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
141 | Allyl isovalerateCAS No 2835-39-42-Propenyl 3-Methyl-butanoate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
142 | Allyl octanoateCAS No 4230-97-12-Allyl caprylate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
143 | Allyl phenoxyacetateCAS No 7493-74-52-Propenyl Phenoxyacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
144 | Allyl phenylacetateCAS No 1797-74-62-Propenyl Benzeneacetate | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
145 | Allyl 3,5,5-trimethylhexanoateCAS No 71500-37-3 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
146 | Allyl cyclohexyloxyacetateCAS No 68901-15-5 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
147 | Allyl isoamyloxyacetateCAS No 67634-00-8 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
148 | Allyl 2-methylbutoxyacetateCAS No 67634-01-9 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
149 | Allyl nonanoateCAS No 7493-72-3 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
150 | Allyl propionateCAS No 2408-20-0 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
151 | Allyl trimethylhexanoateCAS No 68132-80-9 | | | Level of free allyl alcohol in the ester should be less than 0,1 % |
152 | Allyl heptine carbonateCAS No 73157-43-4(allyl oct-2-ynoate) | | 0,002 % | This material should not be used in combination with any other 2-alkynoic acid ester (e.g methyl heptine carbonate) |
153 | AmylcyclopentenoneCAS No 25564-22-12-Pentylcyclopent-2-en-1-one | | 0,1 % | |
154 | Myroxylon balsamum var pereirae.extracts anddistillatesCAS No 8007-00-9Balsam Peru oil, absolute and anhydrol(Balsam Oil Peru) | | 0,4 % | |
155 | 4-tert.-ButyldihydrocinnamaldehydeCAS No 18127-01-03-(4-tert-Butylphenyl)propion-aldehyde | | 0,6 % | |
156 | Cuminum cyminum fruit oil and extractCAS No 84775-51-9 | (a)Leave-on products(b)Rinse-off products | (a) | Leave-on products | (b) | Rinse-off products | (a)0,4 % of Cumin oil | (a) | 0,4 % of Cumin oil | |
(a) | Leave-on products
(b) | Rinse-off products
(a) | 0,4 % of Cumin oil
157 | cis-Rose ketone-1(*4)CAS No 23726-94-5(Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(cis-α-Damascone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
158 | trans-Roseketone-2(*4)CAS No 23726-91-2(E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(trans-β-Damascone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
159 | trans-Roseketone-5(*4)CAS No 39872-57-6(E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one(Isodamascone) | | 0,02 % | |
160 | Rose ketone-4(*4)CAS No 23696-85-71-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
161 | Rose ketone-3(*4)CAS No 57378-68-41-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(Delta-Damascone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
162 | cis-Rose ketone-2(*4)CAS No 23726-92-31-(2,6,6-Trimethyl-l-cyclohexen-1-yl)-2-buten-l-one(cis-β-Damascone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
163 | trans-Rose ketone-1(*4)CAS No 24720-09-01-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one(trans-α-Damascone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
164 | Rose ketone-5(*4)CAS No 33673-71-11-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-l-one | | (b)0,02 % | (b) | 0,02 % | |
(b) | 0,02 %
165 | trans-Roseketone-3(*4)CAS No 71048-82-31-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-l-one(trans-delta-Damascone) | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,02 % | (b) | 0,02 %
(b) | Other products
(b) | 0,02 %
166 | trans-2-hexenalCAS No 6728-26-3 | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,002 % | (b) | 0,002 %
(b) | Other products
(b) | 0,002 %
167 | l-LimoneneCAS No 5989-54-8(S)-p-Mentha-1,8-diene | | | Peroxide value less than 20 mmoles/L(*3) |
168 | dl-Limonene (racemic)CAS No 138-86-31,8(9)-p-Menthadiene; p-Mentha-1,8-diene(Dipentene) | | | Peroxide value less than 20 mmoles/L(*3) |
169 | PerillaldehydeCAS No 2111-75-3p-Mentha-1,8-dien-7-al | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,1 % | (b) | 0,1 %
(b) | Other products
(b) | 0,1 %
170 | IsobergamateCAS No 68683-20-5Menthadiene-7-methyl formate | | 0,1 % | |
171 | Methoxy dicyclopentadiene carboxaldehydeCAS No 86803-90-9Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde | | 0,5 % | |
172 | 3-methylnon-2-enenitrileCAS No 53153-66-5 | | 0,2 % | |
173 | Methyl octine carbonateCAS No 111-80-8Methyl non-2-ynoate | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %) | (b) | 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
(b) | Other products
(b) | 0,002 % when used aloneWhen present in combination with methyl heptine carbonate, the combined level in the finished product should not exceed 0,01 % (of which methyl octine carbonate should not be more than 0,002 %)
174 | Amylvinylcarbinyl acetateCAS No 2442-10-61-Octen-3-yl acetate | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,3 % | (b) | 0,3 %
(b) | Other products
(b) | 0,3 %
175 | PropylidenephthalideCAS No 17369-59-43-Propylidenephthalide | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,01 % | (b) | 0,01 %
(b) | Other products
(b) | 0,01 %
176 | IsocyclogeraniolCAS No 68527-77-52,4,6-Trimethyl-3-cyclohexene-1-methanol | | 0,5 % | |
177 | 2-Hexylidene cyclopentanoneCAS No 17373-89-6 | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,06 % | (b) | 0,06 %
(b) | Other products
(b) | 0,06 %
178 | Methyl heptadienoneCAS No 1604-28-06-Methyl-3,5-heptadien-2-one | (a)Oral products | (a) | Oral products | | |
(a) | Oral products
(b)Other products | (b) | Other products | (b)0,002 % | (b) | 0,002 %
(b) | Other products
(b) | 0,002 %
179 | p-methylhydrocinnamic aldehydeCAS No 5406-12-2Cresylpropionalde-hydep-Methyldihydrocinnamaldehyde | | 0,2 % | |
180 | Liquidambar orientalis Balsam oil and extractCAS No 94891-27-7(styrax) | | 0,6 % | |
181 | Liquidambar styraciflua balsam oil and extractCAS No 8046-19-3(styrax) | | 0,6 % | |
182 | Acetyl hexamethyl tetralinCAS No 21145-77-7CAS No 1506-02-11-(5,6,7,8-Tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one(AHTN) | All cosmetic products, with the exception of oral products | (a)leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %(b)rinse-off products: 0,2 % | (a) | leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 % | (b) | rinse-off products: 0,2 % | |
(a) | leave-on products: 0,1 %except:hydroalcoholic products: 1 %fine fragrance: 2,5 %fragrance cream:0,5 %
(b) | rinse-off products: 0,2 %
183 | Commiphora erythreaengler var.glabrescensengler gum extract and oilCAS No 93686-00-1 | | 0,6 % | |
184 | Opopanax chironium resinCAS No 93384-32-8 | | 0,6 % | |
(*1) As a preservative, see Annex VI, Part 1, No 34.
(*2) This limit applies to the substance and not to the finished cosmetic product.’

(*3) This limit applies to the substance and not to the finished cosmetic product.
(*4) The sum of those substances used in combination should not exceed the limits given in column d.’

Pending: 32008L0038

January 16, 2026
6.3.2008 EN Official Journal of the European Union L 62/9
(1) Commission Directive 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) Directive 93/74/EEC provides for the establishment of a positive list of the intended uses of animal feedingstuffs for particular nutritional purposes. That list must indicate the precise use, that is to say, the particular nutritional purpose, the essential nutritional characteristics, the labelling declarations and where appropriate the special labelling requirements.
(3) Certain nutritional purposes cannot be included at present in the list of intended uses due to the absence of Community methods of control for the energy value in pet foods and for dietary fibre in feedingstuffs. This list must be completed as soon as these methods have been adopted.
(4) The established list may be modified, where appropriate, following developments in scientific and technical knowledge.
(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,
1. Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4.
2. Where a group of additives is mentioned in column 2 or column 4 of Part B the additive(s) used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the Council(1)as corresponding to the specified essential characteristic.
3. Where the source(s) of ingredients or of analytical constituents is (are) required in column 4 of Part B, the manufacturer must make a precise declaration (e.g. specific name of the ingredient(s), animal species or part of the animal) allowing the evaluation of conformity of the feedingstuff with the corresponding essential nutritional characteristics.
4. Where the declaration of a substance, also authorised as an additive, is required in column 4 of Part B and is accompanied by the expression ‘total’ the declared content must refer to, as appropriate, the quantity naturally present where none is added or, by derogation from Council Directive 70/524/EEC(2), the total quantity of the substance naturally present and the amount added as an additive.
5. The declarations required in column 4 of Part B with the reference ‘if added’ are compulsory where the ingredient or the additive has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose.
6. The declarations to be given in accordance with column 4 of Part B concerning analytical constituents and additives must be quantitative.
7. The recommended period of use indicated in column 5 of part B indicates a range within which the nutritional purpose should normally be achieved. Manufacturers can refer to more precise periods of use, within the fixed limits.
8. Where a feedingstuff is intended to meet more than one particular nutritional purpose, it must comply with the corresponding entries in Part B.
9. In the case of complementary feedingstuffs intended for particular nutritional purposes guidance on the balance of the daily ration must be provided in the instructions for use contained on the label.
Particular nutritional purpose Essential nutritional characteristics Species or category of animals Labelling declarations Recommended length of time Other provisions
(1) (2) (3) (4) (5) (6)
Support of renal function in the case of chronic renal insufficiency(3) Low level of phosphorus and restricted level of protein but of high quality Dogs and cats —Protein source(s)—Calcium—Phosphorus—Potassium—Sodium—Content of essential fatty acids (if added) — Protein source(s) — Calcium — Phosphorus — Potassium — Sodium — Content of essential fatty acids (if added) Initially up to 6 months(4) Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— Protein source(s)
— Calcium
— Phosphorus
— Potassium
— Sodium
— Content of essential fatty acids (if added)
Dissolution of struvite stones(5) —Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality — Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality Dogs —Protein source(s)—Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Urine acidifying substances — Protein source(s) — Calcium — Phosphorus — Sodium — Magnesium — Potassium — Chlorides — Sulphur — Urine acidifying substances 5 to 12 weeks Indicate in the instructions for use:‘Water should be available at all times.’Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use.’
— Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality
— Protein source(s)
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Urine acidifying substances
—Urine acidifying properties and low level of magnesium — Urine acidifying properties and low level of magnesium Cats —Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Total taurine—Urine acidifying substances — Calcium — Phosphorus — Sodium — Magnesium — Potassium — Chlorides — Sulphur — Total taurine — Urine acidifying substances
— Urine acidifying properties and low level of magnesium
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Total taurine
— Urine acidifying substances
Reduction of struvite stone recurrence(5) Urine acidifying properties and moderate level of magnesium Dogs and cats —Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Urine acidifying substances — Calcium — Phosphorus — Sodium — Magnesium — Potassium — Chlorides — Sulphur — Urine acidifying substances Up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use.’
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Urine acidifying substances
Reduction of urate stones formation Low level of purines, low level of protein but of high quality Dogs and cats Protein source(s) Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use.’
Reduction of oxalate stones formation Low level of calcium, low level of vitamin D, and urine alkalising properties Dogs and cats —Phosphorus—Calcium—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Total vitamin D—Hydroxyproline—Urine alkalising substances — Phosphorus — Calcium — Sodium — Magnesium — Potassium — Chlorides — Sulphur — Total vitamin D — Hydroxyproline — Urine alkalising substances Up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use.’
— Phosphorus
— Calcium
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Total vitamin D
— Hydroxyproline
— Urine alkalising substances
Reduction of cystine stones formation Low level of protein, moderate level of sulphur amino acids and urine alkalising properties Dogs and cats —Total sulphur amino acids—Sodium—Potassium—Chlorides—Sulphur—Urine alkalising substances — Total sulphur amino acids — Sodium — Potassium — Chlorides — Sulphur — Urine alkalising substances Initially up to 1 year Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Total sulphur amino acids
— Sodium
— Potassium
— Chlorides
— Sulphur
— Urine alkalising substances
Reduction of ingredient and nutrient intolerances(6) —Selected protein source(s) — Selected protein source(s) Dogs and cats —Protein source(s)—Content of essential fatty acids (if added) — Protein source(s) — Content of essential fatty acids (if added) 3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely
— Selected protein source(s)
— Protein source(s)
— Content of essential fatty acids (if added)
and/or
—Selected carbohydrate source(s) — Selected carbohydrate source(s) —Carbohydrate source(s)—Content of essential fatty acids (if added) — Carbohydrate source(s) — Content of essential fatty acids (if added)
— Selected carbohydrate source(s)
— Carbohydrate source(s)
— Content of essential fatty acids (if added)
Reduction of acute intestinal absorptive disorders Increased level of electrolytes and highly digestible ingredients Dogs and cats —Highly digestible ingredients including their treatment if appropriate—Sodium—Potassium—Source(s) of mucilaginous substances (if added) — Highly digestible ingredients including their treatment if appropriate — Sodium — Potassium — Source(s) of mucilaginous substances (if added) 1 to 2 weeks Indicate on the package, container or label:—‘During periods of and recovery from acute diarrhoea.’—‘It is recommended that a veterinarian's opinion be sought before use.’ — ‘During periods of and recovery from acute diarrhoea.’ — ‘It is recommended that a veterinarian's opinion be sought before use.’
— Highly digestible ingredients including their treatment if appropriate
— Sodium
— Potassium
— Source(s) of mucilaginous substances (if added)
— ‘During periods of and recovery from acute diarrhoea.’
— ‘It is recommended that a veterinarian's opinion be sought before use.’
Compensation for maldigestion(7) Highly digestible ingredients and low level of fat Dogs and cats Highly digestible ingredients including their treatment if appropriate 3 to 12 weeks, but lifetime in the case of chronic pancreatic insufficiency Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use.’
Support of heart function in the case of chronic cardiac insufficiency Low level of sodium and increased K/Na ratio Dogs and cats —Sodium—Potassium—Magnesium — Sodium — Potassium — Magnesium Initially up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Sodium
— Potassium
— Magnesium
Regulation of glucose supply (Diabetes mellitus) Low level of rapid glucose-releasing carbohydrates Dogs and cats —Carbohydrate source(s)—Treatment of carbohydrates if appropriate—Starch—Total sugar—Fructose (if added)—Content of essential fatty acids (if added)—Source(s) of short and medium chain fatty acids (if added) — Carbohydrate source(s) — Treatment of carbohydrates if appropriate — Starch — Total sugar — Fructose (if added) — Content of essential fatty acids (if added) — Source(s) of short and medium chain fatty acids (if added) Initially up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Carbohydrate source(s)
— Treatment of carbohydrates if appropriate
— Starch
— Total sugar
— Fructose (if added)
— Content of essential fatty acids (if added)
— Source(s) of short and medium chain fatty acids (if added)
Support of liver function in the case of chronic liver insufficiency —High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates — High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates Dogs —Protein source(s)—Content of essential fatty acids—Highly digestible carbohydrates including their treatment if appropriate—Sodium—Total copper — Protein source(s) — Content of essential fatty acids — Highly digestible carbohydrates including their treatment if appropriate — Sodium — Total copper Initially up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates
— Protein source(s)
— Content of essential fatty acids
— Highly digestible carbohydrates including their treatment if appropriate
— Sodium
— Total copper
—High quality protein, moderate level of protein and high level of essential fatty acids — High quality protein, moderate level of protein and high level of essential fatty acids Cats —Protein source(s)—Content of essential fatty acids—Sodium—Total copper — Protein source(s) — Content of essential fatty acids — Sodium — Total copper Initially up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— High quality protein, moderate level of protein and high level of essential fatty acids
— Protein source(s)
— Content of essential fatty acids
— Sodium
— Total copper
Regulation of lipid metabolism in the case of hyperlipidaemia Low level of fat and high level of essential fatty acids Dogs and cats —Content of essential fatty acids—Content of n-3 fatty acids (if added) — Content of essential fatty acids — Content of n-3 fatty acids (if added) Initially up to 2 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Content of essential fatty acids
— Content of n-3 fatty acids (if added)
Reduction of copper in the liver Low level of copper Dogs Total copper Initially up to 6 months Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
Reduction of excessive body weight Low energy density Dogs and cats Energy value Until target body weight is achieved In the instructions for use an appropriate daily intake must be recommended.
Nutritional restoration, convalescence(8) High energy density, high concentrations of essential nutrients and highly digestible ingredients Dogs and cats —Highly digestible ingredients, including their treatment if appropriate—Energy value—Content of n-3 and n-6 fatty acids (if added) — Highly digestible ingredients, including their treatment if appropriate — Energy value — Content of n-3 and n-6 fatty acids (if added) Until restoration is achieved In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:‘Administration under veterinary supervision.’
— Highly digestible ingredients, including their treatment if appropriate
— Energy value
— Content of n-3 and n-6 fatty acids (if added)
Support of skin function in the case of dermatosis and excessive loss of hair High level of essential fatty acids Dogs and cats Content of essential fatty acids Up to 2 months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use.’
Reduction of the risk of milk fever —Low level of calcium — Low level of calcium Dairy cows —Calcium—Phosphorus—Magnesium — Calcium — Phosphorus — Magnesium 1 to 4 weeks before calving Indicate in the instructions for use:‘Stop feeding after calving’
— Low level of calcium
— Calcium
— Phosphorus
— Magnesium
and/or
—Low cations/anions ratio — Low cations/anions ratio —Calcium—Phosphorus—Sodium—Potassium—Chlorides—Sulphur — Calcium — Phosphorus — Sodium — Potassium — Chlorides — Sulphur 1 to 4 weeks before calving Indicate in the instructions for use:‘Stop feeding after calving’
— Low cations/anions ratio
— Calcium
— Phosphorus
— Sodium
— Potassium
— Chlorides
— Sulphur
or
—High level of zeolite (synthetic sodium aluminium silicate) — High level of zeolite (synthetic sodium aluminium silicate) Content of synthetic sodium aluminium silicate The 2 weeks before calving Indicate in the instructions for use:—‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’—‘Stop feeding after calving’ — ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’ — ‘Stop feeding after calving’
— High level of zeolite (synthetic sodium aluminium silicate)
— ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’
— ‘Stop feeding after calving’
or
—High level of calcium in the form of highly available calcium salts — High level of calcium in the form of highly available calcium salts Total calcium content, sources and respective quantity of calcium Star at first signs of parturition to two days subsequent to parturition Indicate on the package, container or label:—The instruction of use i.e. the number of applications and the time before and after calving.—The text ‘It is recommended that a nutritional expert's opinion be sought before use’ — The instruction of use i.e. the number of applications and the time before and after calving. — The text ‘It is recommended that a nutritional expert's opinion be sought before use’
— High level of calcium in the form of highly available calcium salts
— The instruction of use i.e. the number of applications and the time before and after calving.
— The text ‘It is recommended that a nutritional expert's opinion be sought before use’
Reduction of the risk of ketosis(9)(10) Ingredients providing glucogenic energy sources Dairy cows and ewes —Ingredients providing glucogenic energy sources—Propan-1,2-diol (if added as a glucose precursor)—Glycerol (if added as a glucose precursor) — Ingredients providing glucogenic energy sources — Propan-1,2-diol (if added as a glucose precursor) — Glycerol (if added as a glucose precursor) 3 to 6 weeks after calving(11)Last 6 weeks before and the first 3 weeks after lambing(12)
— Ingredients providing glucogenic energy sources
— Propan-1,2-diol (if added as a glucose precursor)
— Glycerol (if added as a glucose precursor)
Reduction of the risk of tetany (hypomagnesaemia) High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium Ruminants —Starch—Total sugars—Magnesium—Sodium—Potassium — Starch — Total sugars — Magnesium — Sodium — Potassium 3 to 10 weeks during periods of fast grass growth In the instructions for use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily available energy sources.In the case of feedingstuffs for ovines indicate on the package, container or label:‘Especially for lactating ewes.’
— Starch
— Total sugars
— Magnesium
— Sodium
— Potassium
Reduction of the risk of acidosis Low level of easily fermentable carbohydrates and high buffering capacity Ruminants —Starch—Total sugars — Starch — Total sugars Maximum 2 months(13) In the instructions for use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily fermentable carbohydrate sources.In the case of feedingstuffs for dairy cows indicate on the package, container or label:‘Especially for high yielding cows.’In the case of feedingstuffs for ruminants for fattening indicate on the package, container or label:‘Especially for intensively fed.’(14)
— Starch
— Total sugars
Stabilisation of water and electrolyte balance Predominantly electrolytes and easily absorbable carbohydrates CalvesPigletsLambsKidsFoals —Carbohydrate source(s)—Sodium—Potassium—Chlorides — Carbohydrate source(s) — Sodium — Potassium — Chlorides 1 to 7 days (1 to 3 days if fed exclusively) Indicate on the package, container or label:—‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’—‘It is recommended that a veterinarian's opinion be sought before use.’ — ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’ — ‘It is recommended that a veterinarian's opinion be sought before use.’
— Carbohydrate source(s)
— Sodium
— Potassium
— Chlorides
— ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’
— ‘It is recommended that a veterinarian's opinion be sought before use.’
Reduction of the risk of urinary calculi Low level of phosphorus, magnesium, and urine acidifying properties Ruminants —Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Urine acidifying substances — Calcium — Phosphorus — Sodium — Magnesium — Potassium — Chlorides — Sulphur — Urine acidifying substances Up to 6 weeks Indicate on the package, container or label:‘Especially for intensively fed young animals.’Indicate in the instructions for use:‘Water should be available at all times.’
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Urine acidifying substances
Reduction of stress reactions —High level magnesium — High level magnesium Pigs —Magnesium — Magnesium 1 to 7 days Guidance shall be provided on the situation in which the use of this feed is appropriate.
— High level magnesium
— Magnesium
and/or
—Highly digestible ingredients — Highly digestible ingredients —Highly digestible ingredients including their treatment if appropriate—Content of n-3 fatty acids (if added) — Highly digestible ingredients including their treatment if appropriate — Content of n-3 fatty acids (if added)
— Highly digestible ingredients
— Highly digestible ingredients including their treatment if appropriate
— Content of n-3 fatty acids (if added)
Stabilisation of physiological digestion —Low buffering capacity, and highly digestible ingredients — Low buffering capacity, and highly digestible ingredients Piglets —Highly digestible ingredients including their treatment if appropriate—Buffering capacity—Source(s) of astringent substances (if added)—Source(s) of mucilaginous substances (if added) — Highly digestible ingredients including their treatment if appropriate — Buffering capacity — Source(s) of astringent substances (if added) — Source(s) of mucilaginous substances (if added) 2 to 4 weeks Indicate on the package, container or label:‘In case of risk of, during periods of, or recovery from, digestive disturbance.’
— Low buffering capacity, and highly digestible ingredients
— Highly digestible ingredients including their treatment if appropriate
— Buffering capacity
— Source(s) of astringent substances (if added)
— Source(s) of mucilaginous substances (if added)
—Highly digestible ingredients — Highly digestible ingredients Pigs —Highly digestible ingredients including their treatment if appropriate—Source(s) of astringent substances (if added)—Source(s) of mucilaginous substances (if added) — Highly digestible ingredients including their treatment if appropriate — Source(s) of astringent substances (if added) — Source(s) of mucilaginous substances (if added)
— Highly digestible ingredients
— Highly digestible ingredients including their treatment if appropriate
— Source(s) of astringent substances (if added)
— Source(s) of mucilaginous substances (if added)
Reduction of the risk of constipation Ingredients stimulating intestinal passage Sows Ingredients stimulating intestinal passage 10 to 14 days before and 10 to 14 days after farrowing
Reduction of the risk of fatty liver syndrome Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids Laying hens —Energy value (calculated according to EC method)—Percentage of metabolisable energy from lipids—Content of poly-unsaturated fatty acids — Energy value (calculated according to EC method) — Percentage of metabolisable energy from lipids — Content of poly-unsaturated fatty acids Up to 12 weeks
— Energy value (calculated according to EC method)
— Percentage of metabolisable energy from lipids
— Content of poly-unsaturated fatty acids
Compensation for malabsorption Low level of saturated fatty acids and high level of fat soluble vitamins Poultry excluding geese and pigeons —Percentage of saturated fatty acids in relation to total fatty acids—Total vitamin A—Total vitamin D—Total vitamin E—Total vitamin K — Percentage of saturated fatty acids in relation to total fatty acids — Total vitamin A — Total vitamin D — Total vitamin E — Total vitamin K During the first 2 weeks after hatching
— Percentage of saturated fatty acids in relation to total fatty acids
— Total vitamin A
— Total vitamin D
— Total vitamin E
— Total vitamin K
Compensation for chronic insufficiency of small intestine function Highly precaecally digestible carbohydrates proteins and fats Equines(15) —Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate — Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate Initially up to six months Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which it should be fed including many small meals per day.Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate
Compensation for chronic digestive disorders of large intestine Highly digestible fibre Equines —Fibre source(s)—Content of n-3 fatty acids (if added) — Fibre source(s) — Content of n-3 fatty acids (if added) Initially up to six months Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which the feed should be fed.Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Fibre source(s)
— Content of n-3 fatty acids (if added)
Reduction of stress reactions Highly digestible ingredients Equines —Magnesium—Highly digestible ingredients including their treatment if appropriate—Content of n-3 fatty acids (if added) — Magnesium — Highly digestible ingredients including their treatment if appropriate — Content of n-3 fatty acids (if added) Two to four weeks Guidance shall be provided on the precise situations in which the use of the feed is appropriate.
— Magnesium
— Highly digestible ingredients including their treatment if appropriate
— Content of n-3 fatty acids (if added)
Compensation of electrolyte loss in the cases of heavy sweating Predominantly electrolytes and easily absorbable carbohydrates Equines —Calcium—Sodium—Magnesium—Potassium—Chlorides—Glucose — Calcium — Sodium — Magnesium — Potassium — Chlorides — Glucose One to three days Guidance shall be provided on the situations in which the use of the feed is appropriate.When the feed corresponds to a significant part of the daily ration, guidance should be provided to prevent the risk of abrupt changes in the nature of the feed.Indicate on the instructions for use:‘Water should be available at all times.’
— Calcium
— Sodium
— Magnesium
— Potassium
— Chlorides
— Glucose
Nutritional restoration, convalescence High concentration of essential nutrients and highly digestible ingredients Equines —Highly digestible ingredients, including their treatment if appropriate—Content of n-3 and n-6 fatty acids (if added) — Highly digestible ingredients, including their treatment if appropriate — Content of n-3 and n-6 fatty acids (if added) Until restoration is achieved Guidance shall be provided on the situations in which the use of the feed is appropriate.In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:‘Administration under veterinary supervision.’
— Highly digestible ingredients, including their treatment if appropriate
— Content of n-3 and n-6 fatty acids (if added)
Support of liver function in the case of chronic liver insufficiency Low level of protein but of high quality and highly digestible carbohydrates Equines —Protein and fibre sources—Highly digestible carbohydrates including their treatment if appropriate—Methionine—Choline—Content of n-3 fatty acids (if added) — Protein and fibre sources — Highly digestible carbohydrates including their treatment if appropriate — Methionine — Choline — Content of n-3 fatty acids (if added) Initially up to six months Guidance should be provided on the manner in which the feed should be fed including many small meals per day.Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’
— Protein and fibre sources
— Highly digestible carbohydrates including their treatment if appropriate
— Methionine
— Choline
— Content of n-3 fatty acids (if added)
Support of renal function in the case of chronic renal insufficiency Low level of protein but of high quality and low level of phosphorus Equines —Protein source(s)—Calcium—Phosphorus—Potassium—Magnesium—Sodium — Protein source(s) — Calcium — Phosphorus — Potassium — Magnesium — Sodium Initially up to six months Indicate on the package, container or label:‘It is recommended that a veterinarian's opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— Protein source(s)
— Calcium
— Phosphorus
— Potassium
— Magnesium
— Sodium
— Protein source(s)
— Calcium
— Phosphorus
— Potassium
— Sodium
— Content of essential fatty acids (if added)
— Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality
— Protein source(s)
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Urine acidifying substances
— Urine acidifying properties and low level of magnesium
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Total taurine
— Urine acidifying substances
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Urine acidifying substances
— Phosphorus
— Calcium
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Total vitamin D
— Hydroxyproline
— Urine alkalising substances
— Total sulphur amino acids
— Sodium
— Potassium
— Chlorides
— Sulphur
— Urine alkalising substances
— Selected protein source(s)
— Protein source(s)
— Content of essential fatty acids (if added)
— Selected carbohydrate source(s)
— Carbohydrate source(s)
— Content of essential fatty acids (if added)
— Highly digestible ingredients including their treatment if appropriate
— Sodium
— Potassium
— Source(s) of mucilaginous substances (if added)
— ‘During periods of and recovery from acute diarrhoea.’
— ‘It is recommended that a veterinarian's opinion be sought before use.’
— Sodium
— Potassium
— Magnesium
— Carbohydrate source(s)
— Treatment of carbohydrates if appropriate
— Starch
— Total sugar
— Fructose (if added)
— Content of essential fatty acids (if added)
— Source(s) of short and medium chain fatty acids (if added)
— High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates
— Protein source(s)
— Content of essential fatty acids
— Highly digestible carbohydrates including their treatment if appropriate
— Sodium
— Total copper
— High quality protein, moderate level of protein and high level of essential fatty acids
— Protein source(s)
— Content of essential fatty acids
— Sodium
— Total copper
— Content of essential fatty acids
— Content of n-3 fatty acids (if added)
— Highly digestible ingredients, including their treatment if appropriate
— Energy value
— Content of n-3 and n-6 fatty acids (if added)
— Low level of calcium
— Calcium
— Phosphorus
— Magnesium
— Low cations/anions ratio
— Calcium
— Phosphorus
— Sodium
— Potassium
— Chlorides
— Sulphur
— High level of zeolite (synthetic sodium aluminium silicate)
— ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’
— ‘Stop feeding after calving’
— High level of calcium in the form of highly available calcium salts
— The instruction of use i.e. the number of applications and the time before and after calving.
— The text ‘It is recommended that a nutritional expert's opinion be sought before use’
— Ingredients providing glucogenic energy sources
— Propan-1,2-diol (if added as a glucose precursor)
— Glycerol (if added as a glucose precursor)
— Starch
— Total sugars
— Magnesium
— Sodium
— Potassium
— Starch
— Total sugars
— Carbohydrate source(s)
— Sodium
— Potassium
— Chlorides
— ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’
— ‘It is recommended that a veterinarian's opinion be sought before use.’
— Calcium
— Phosphorus
— Sodium
— Magnesium
— Potassium
— Chlorides
— Sulphur
— Urine acidifying substances
— High level magnesium
— Magnesium
— Highly digestible ingredients
— Highly digestible ingredients including their treatment if appropriate
— Content of n-3 fatty acids (if added)
— Low buffering capacity, and highly digestible ingredients
— Highly digestible ingredients including their treatment if appropriate
— Buffering capacity
— Source(s) of astringent substances (if added)
— Source(s) of mucilaginous substances (if added)
— Highly digestible ingredients
— Highly digestible ingredients including their treatment if appropriate
— Source(s) of astringent substances (if added)
— Source(s) of mucilaginous substances (if added)
— Energy value (calculated according to EC method)
— Percentage of metabolisable energy from lipids
— Content of poly-unsaturated fatty acids
— Percentage of saturated fatty acids in relation to total fatty acids
— Total vitamin A
— Total vitamin D
— Total vitamin E
— Total vitamin K
— Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate
— Fibre source(s)
— Content of n-3 fatty acids (if added)
— Magnesium
— Highly digestible ingredients including their treatment if appropriate
— Content of n-3 fatty acids (if added)
— Calcium
— Sodium
— Magnesium
— Potassium
— Chlorides
— Glucose
— Highly digestible ingredients, including their treatment if appropriate
— Content of n-3 and n-6 fatty acids (if added)
— Protein and fibre sources
— Highly digestible carbohydrates including their treatment if appropriate
— Methionine
— Choline
— Content of n-3 fatty acids (if added)
— Protein source(s)
— Calcium
— Phosphorus
— Potassium
— Magnesium
— Sodium
Commission Directive 94/39/EC (OJ L 207, 10.8.1994, p. 20)
Commission Directive 95/9/EC (OJ L 91, 22.4.1995, p. 35)
Commission Directive 2002/1/EC (OJ L 5, 9.1.2002, p. 8)
Commission Directive 2008/4/EC (OJ L 6, 10.1.2008, p. 4)
Directive Time-limit for transposition
94/39/EC 30 June 1995
95/9/EC 30 June 1995
2002/1/EC 20 November 2002
2008/4/EC 30 July 2008
Directive 94/39/EC This Directive
Article 1 Article 1
Article 2 —
— Article 2
Article 3 Article 3
— 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 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes(1), and in particular Article 6(a) thereof,
(1) Commission Directive 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) Directive 93/74/EEC provides for the establishment of a positive list of the intended uses of animal feedingstuffs for particular nutritional purposes. That list must indicate the precise use, that is to say, the particular nutritional purpose, the essential nutritional characteristics, the labelling declarations and where appropriate the special labelling requirements.
(3) Certain nutritional purposes cannot be included at present in the list of intended uses due to the absence of Community methods of control for the energy value in pet foods and for dietary fibre in feedingstuffs. This list must be completed as soon as these methods have been adopted.
(4) The established list may be modified, where appropriate, following developments in scientific and technical knowledge.
(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
Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of Annex I to this Directive and if they fulfil the other provisions laid down in that Part of Annex I.
Furthermore, the Member States shall ensure that the provisions under ‘General provisions’ of Part A of Annex I are complied with.

Article 2
Directive 94/39/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 31 July 2008.

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 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular nutritional purposes(1), and in particular Article 6(a) thereof,
(1) Commission Directive 94/39/EC of 25 July 1994 establishing a list of intended uses of animal feedingstuffs for particular nutritional purposes(2)has been substantially amended several times(3). In the interests of clarity and rationality the said Directive should be codified.
(2) Directive 93/74/EEC provides for the establishment of a positive list of the intended uses of animal feedingstuffs for particular nutritional purposes. That list must indicate the precise use, that is to say, the particular nutritional purpose, the essential nutritional characteristics, the labelling declarations and where appropriate the special labelling requirements.
(3) Certain nutritional purposes cannot be included at present in the list of intended uses due to the absence of Community methods of control for the energy value in pet foods and for dietary fibre in feedingstuffs. This list must be completed as soon as these methods have been adopted.
(4) The established list may be modified, where appropriate, following developments in scientific and technical knowledge.
(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:
Member States shall require that feedingstuffs intended for particular nutritional purposes within the meaning of Directive 93/74/EEC shall be marketed only if their intended uses are included in Part B of Annex I to this Directive and if they fulfil the other provisions laid down in that Part of Annex I.
Furthermore, the Member States shall ensure that the provisions under ‘General provisions’ of Part A of Annex I are complied with.
Directive 94/39/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 31 July 2008.
This Directive is addressed to the Member States.

PART A

ANNEX IGeneral provisions
| 1. | Where there is more than one group of nutritional characteristics indicated in column 2 of Part B, denoted by ‘and/or’, for the same nutritional purpose, the manufacturer has the option to use either or both groups of essential characteristics, in order to achieve the nutritional purpose defined in column 1. For each option the corresponding labelling declarations are given opposite in column 4.
| 2. | Where a group of additives is mentioned in column 2 or column 4 of Part B the additive(s) used must be authorised in Regulation (EC) No 1831/2003 of the European Parliament and of the Council(1)as corresponding to the specified essential characteristic.
| 3. | Where the source(s) of ingredients or of analytical constituents is (are) required in column 4 of Part B, the manufacturer must make a precise declaration (e.g. specific name of the ingredient(s), animal species or part of the animal) allowing the evaluation of conformity of the feedingstuff with the corresponding essential nutritional characteristics.
| 4. | Where the declaration of a substance, also authorised as an additive, is required in column 4 of Part B and is accompanied by the expression ‘total’ the declared content must refer to, as appropriate, the quantity naturally present where none is added or, by derogation from Council Directive 70/524/EEC(2), the total quantity of the substance naturally present and the amount added as an additive.
| 5. | The declarations required in column 4 of Part B with the reference ‘if added’ are compulsory where the ingredient or the additive has been incorporated or increased specifically to enable the achievement of the particular nutritional purpose.
| 6. | The declarations to be given in accordance with column 4 of Part B concerning analytical constituents and additives must be quantitative.
| 7. | The recommended period of use indicated in column 5 of part B indicates a range within which the nutritional purpose should normally be achieved. Manufacturers can refer to more precise periods of use, within the fixed limits.
| 8. | Where a feedingstuff is intended to meet more than one particular nutritional purpose, it must comply with the corresponding entries in Part B.
| 9. | In the case of complementary feedingstuffs intended for particular nutritional purposes guidance on the balance of the daily ration must be provided in the instructions for use contained on the label.PART BList of intended uses
Particular nutritional purpose | Essential nutritional characteristics | Species or category of animals | Labelling declarations | Recommended length of time | Other provisions
(1) | (2) | (3) | (4) | (5) | (6)
Support of renal function in the case of chronic renal insufficiency(3) | Low level of phosphorus and restricted level of protein but of high quality | Dogs and cats | —Protein source(s)—Calcium—Phosphorus—Potassium—Sodium—Content of essential fatty acids (if added) | — | Protein source(s) | — | Calcium | — | Phosphorus | — | Potassium | — | Sodium | — | Content of essential fatty acids (if added) | Initially up to 6 months(4) | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— | Protein source(s)
— | Calcium
— | Phosphorus
— | Potassium
— | Sodium
— | Content of essential fatty acids (if added)
Dissolution of struvite stones(5) | —Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality | — | Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality | Dogs | —Protein source(s)—Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Urine acidifying substances | — | Protein source(s) | — | Calcium | — | Phosphorus | — | Sodium | — | Magnesium | — | Potassium | — | Chlorides | — | Sulphur | — | Urine acidifying substances | 5 to 12 weeks | Indicate in the instructions for use:‘Water should be available at all times.’Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use.’
— | Urine acidifying properties, low level of magnesium, and restricted level of protein but of high quality
— | Protein source(s)
— | Calcium
— | Phosphorus
— | Sodium
— | Magnesium
— | Potassium
— | Chlorides
— | Sulphur
— | Urine acidifying substances
—Urine acidifying properties and low level of magnesium | — | Urine acidifying properties and low level of magnesium | Cats | —Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Total taurine—Urine acidifying substances | — | Calcium | — | Phosphorus | — | Sodium | — | Magnesium | — | Potassium | — | Chlorides | — | Sulphur | — | Total taurine | — | Urine acidifying substances
— | Urine acidifying properties and low level of magnesium
— | Calcium
— | Phosphorus
— | Sodium
— | Magnesium
— | Potassium
— | Chlorides
— | Sulphur
— | Total taurine
— | Urine acidifying substances
Reduction of struvite stone recurrence(5) | Urine acidifying properties and moderate level of magnesium | Dogs and cats | —Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Urine acidifying substances | — | Calcium | — | Phosphorus | — | Sodium | — | Magnesium | — | Potassium | — | Chlorides | — | Sulphur | — | Urine acidifying substances | Up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use.’
— | Calcium
— | Phosphorus
— | Sodium
— | Magnesium
— | Potassium
— | Chlorides
— | Sulphur
— | Urine acidifying substances
Reduction of urate stones formation | Low level of purines, low level of protein but of high quality | Dogs and cats | Protein source(s) | Up to 6 months but lifetime use in cases of irreversible disturbance of uric acid metabolism | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use.’
Reduction of oxalate stones formation | Low level of calcium, low level of vitamin D, and urine alkalising properties | Dogs and cats | —Phosphorus—Calcium—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Total vitamin D—Hydroxyproline—Urine alkalising substances | — | Phosphorus | — | Calcium | — | Sodium | — | Magnesium | — | Potassium | — | Chlorides | — | Sulphur | — | Total vitamin D | — | Hydroxyproline | — | Urine alkalising substances | Up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use.’
— | Phosphorus
— | Calcium
— | Sodium
— | Magnesium
— | Potassium
— | Chlorides
— | Sulphur
— | Total vitamin D
— | Hydroxyproline
— | Urine alkalising substances
Reduction of cystine stones formation | Low level of protein, moderate level of sulphur amino acids and urine alkalising properties | Dogs and cats | —Total sulphur amino acids—Sodium—Potassium—Chlorides—Sulphur—Urine alkalising substances | — | Total sulphur amino acids | — | Sodium | — | Potassium | — | Chlorides | — | Sulphur | — | Urine alkalising substances | Initially up to 1 year | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Total sulphur amino acids
— | Sodium
— | Potassium
— | Chlorides
— | Sulphur
— | Urine alkalising substances
Reduction of ingredient and nutrient intolerances(6) | —Selected protein source(s) | — | Selected protein source(s) | Dogs and cats | —Protein source(s)—Content of essential fatty acids (if added) | — | Protein source(s) | — | Content of essential fatty acids (if added) | 3 to 8 weeks: if signs of intolerance disappear this feed can be used indefinitely |
— | Selected protein source(s)
— | Protein source(s)
— | Content of essential fatty acids (if added)
and/or |
—Selected carbohydrate source(s) | — | Selected carbohydrate source(s) | —Carbohydrate source(s)—Content of essential fatty acids (if added) | — | Carbohydrate source(s) | — | Content of essential fatty acids (if added)
— | Selected carbohydrate source(s)
— | Carbohydrate source(s)
— | Content of essential fatty acids (if added)
Reduction of acute intestinal absorptive disorders | Increased level of electrolytes and highly digestible ingredients | Dogs and cats | —Highly digestible ingredients including their treatment if appropriate—Sodium—Potassium—Source(s) of mucilaginous substances (if added) | — | Highly digestible ingredients including their treatment if appropriate | — | Sodium | — | Potassium | — | Source(s) of mucilaginous substances (if added) | 1 to 2 weeks | Indicate on the package, container or label:—‘During periods of and recovery from acute diarrhoea.’—‘It is recommended that a veterinarian’s opinion be sought before use.’ | — | ‘During periods of and recovery from acute diarrhoea.’ | — | ‘It is recommended that a veterinarian’s opinion be sought before use.’
— | Highly digestible ingredients including their treatment if appropriate
— | Sodium
— | Potassium
— | Source(s) of mucilaginous substances (if added)
— | ‘During periods of and recovery from acute diarrhoea.’
— | ‘It is recommended that a veterinarian’s opinion be sought before use.’
Compensation for maldigestion(7) | Highly digestible ingredients and low level of fat | Dogs and cats | Highly digestible ingredients including their treatment if appropriate | 3 to 12 weeks, but lifetime in the case of chronic pancreatic insufficiency | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use.’
Support of heart function in the case of chronic cardiac insufficiency | Low level of sodium and increased K/Na ratio | Dogs and cats | —Sodium—Potassium—Magnesium | — | Sodium | — | Potassium | — | Magnesium | Initially up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Sodium
— | Potassium
— | Magnesium
Regulation of glucose supply (Diabetes mellitus) | Low level of rapid glucose-releasing carbohydrates | Dogs and cats | —Carbohydrate source(s)—Treatment of carbohydrates if appropriate—Starch—Total sugar—Fructose (if added)—Content of essential fatty acids (if added)—Source(s) of short and medium chain fatty acids (if added) | — | Carbohydrate source(s) | — | Treatment of carbohydrates if appropriate | — | Starch | — | Total sugar | — | Fructose (if added) | — | Content of essential fatty acids (if added) | — | Source(s) of short and medium chain fatty acids (if added) | Initially up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Carbohydrate source(s)
— | Treatment of carbohydrates if appropriate
— | Starch
— | Total sugar
— | Fructose (if added)
— | Content of essential fatty acids (if added)
— | Source(s) of short and medium chain fatty acids (if added)
Support of liver function in the case of chronic liver insufficiency | —High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates | — | High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates | Dogs | —Protein source(s)—Content of essential fatty acids—Highly digestible carbohydrates including their treatment if appropriate—Sodium—Total copper | — | Protein source(s) | — | Content of essential fatty acids | — | Highly digestible carbohydrates including their treatment if appropriate | — | Sodium | — | Total copper | Initially up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— | High quality protein, moderate level of protein, high level of essential fatty acids and high level of highly digestible carbohydrates
— | Protein source(s)
— | Content of essential fatty acids
— | Highly digestible carbohydrates including their treatment if appropriate
— | Sodium
— | Total copper
—High quality protein, moderate level of protein and high level of essential fatty acids | — | High quality protein, moderate level of protein and high level of essential fatty acids | Cats | —Protein source(s)—Content of essential fatty acids—Sodium—Total copper | — | Protein source(s) | — | Content of essential fatty acids | — | Sodium | — | Total copper | Initially up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— | High quality protein, moderate level of protein and high level of essential fatty acids
— | Protein source(s)
— | Content of essential fatty acids
— | Sodium
— | Total copper
Regulation of lipid metabolism in the case of hyperlipidaemia | Low level of fat and high level of essential fatty acids | Dogs and cats | —Content of essential fatty acids—Content of n-3 fatty acids (if added) | — | Content of essential fatty acids | — | Content of n-3 fatty acids (if added) | Initially up to 2 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Content of essential fatty acids
— | Content of n-3 fatty acids (if added)
Reduction of copper in the liver | Low level of copper | Dogs | Total copper | Initially up to 6 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
Reduction of excessive body weight | Low energy density | Dogs and cats | Energy value | Until target body weight is achieved | In the instructions for use an appropriate daily intake must be recommended.
Nutritional restoration, convalescence(8) | High energy density, high concentrations of essential nutrients and highly digestible ingredients | Dogs and cats | —Highly digestible ingredients, including their treatment if appropriate—Energy value—Content of n-3 and n-6 fatty acids (if added) | — | Highly digestible ingredients, including their treatment if appropriate | — | Energy value | — | Content of n-3 and n-6 fatty acids (if added) | Until restoration is achieved | In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:‘Administration under veterinary supervision.’
— | Highly digestible ingredients, including their treatment if appropriate
— | Energy value
— | Content of n-3 and n-6 fatty acids (if added)
Support of skin function in the case of dermatosis and excessive loss of hair | High level of essential fatty acids | Dogs and cats | Content of essential fatty acids | Up to 2 months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use.’
Reduction of the risk of milk fever | —Low level of calcium | — | Low level of calcium | Dairy cows | —Calcium—Phosphorus—Magnesium | — | Calcium | — | Phosphorus | — | Magnesium | 1 to 4 weeks before calving | Indicate in the instructions for use:‘Stop feeding after calving’
— | Low level of calcium
— | Calcium
— | Phosphorus
— | Magnesium
and/or | | |
—Low cations/anions ratio | — | Low cations/anions ratio | —Calcium—Phosphorus—Sodium—Potassium—Chlorides—Sulphur | — | Calcium | — | Phosphorus | — | Sodium | — | Potassium | — | Chlorides | — | Sulphur | 1 to 4 weeks before calving | Indicate in the instructions for use:‘Stop feeding after calving’
— | Low cations/anions ratio
— | Calcium
— | Phosphorus
— | Sodium
— | Potassium
— | Chlorides
— | Sulphur
or | | |
—High level of zeolite (synthetic sodium aluminium silicate) | — | High level of zeolite (synthetic sodium aluminium silicate) | Content of synthetic sodium aluminium silicate | The 2 weeks before calving | Indicate in the instructions for use:—‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’—‘Stop feeding after calving’ | — | ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’ | — | ‘Stop feeding after calving’
— | High level of zeolite (synthetic sodium aluminium silicate)
— | ‘The amount of feed shall be restricted to ensure that a daily intake of 500 g sodium aluminium-silicate per animal is not exceeded.’
— | ‘Stop feeding after calving’
or | | |
—High level of calcium in the form of highly available calcium salts | — | High level of calcium in the form of highly available calcium salts | Total calcium content, sources and respective quantity of calcium | Star at first signs of parturition to two days subsequent to parturition | Indicate on the package, container or label:—The instruction of use i.e. the number of applications and the time before and after calving.—The text ‘It is recommended that a nutritional expert’s opinion be sought before use’ | — | The instruction of use i.e. the number of applications and the time before and after calving. | — | The text ‘It is recommended that a nutritional expert’s opinion be sought before use’
— | High level of calcium in the form of highly available calcium salts
— | The instruction of use i.e. the number of applications and the time before and after calving.
— | The text ‘It is recommended that a nutritional expert’s opinion be sought before use’
Reduction of the risk of ketosis(9)(10) | Ingredients providing glucogenic energy sources | Dairy cows and ewes | —Ingredients providing glucogenic energy sources—Propan-1,2-diol (if added as a glucose precursor)—Glycerol (if added as a glucose precursor) | — | Ingredients providing glucogenic energy sources | — | Propan-1,2-diol (if added as a glucose precursor) | — | Glycerol (if added as a glucose precursor) | 3 to 6 weeks after calving(11)Last 6 weeks before and the first 3 weeks after lambing(12) |
— | Ingredients providing glucogenic energy sources
— | Propan-1,2-diol (if added as a glucose precursor)
— | Glycerol (if added as a glucose precursor)
Reduction of the risk of tetany (hypomagnesaemia) | High level of magnesium, easily available carbohydrates, moderate level of protein and low level of potassium | Ruminants | —Starch—Total sugars—Magnesium—Sodium—Potassium | — | Starch | — | Total sugars | — | Magnesium | — | Sodium | — | Potassium | 3 to 10 weeks during periods of fast grass growth | In the instructions for use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily available energy sources.In the case of feedingstuffs for ovines indicate on the package, container or label:‘Especially for lactating ewes.’
— | Starch
— | Total sugars
— | Magnesium
— | Sodium
— | Potassium
Reduction of the risk of acidosis | Low level of easily fermentable carbohydrates and high buffering capacity | Ruminants | —Starch—Total sugars | — | Starch | — | Total sugars | Maximum 2 months(13) | In the instructions for use guidance shall be provided on the balance of the daily ration, with regard to the inclusion of fibre and easily fermentable carbohydrate sources.In the case of feedingstuffs for dairy cows indicate on the package, container or label:‘Especially for high yielding cows.’In the case of feedingstuffs for ruminants for fattening indicate on the package, container or label:‘Especially for intensively fed.’(14)
— | Starch
— | Total sugars
Stabilisation of water and electrolyte balance | Predominantly electrolytes and easily absorbable carbohydrates | CalvesPigletsLambsKidsFoals | —Carbohydrate source(s)—Sodium—Potassium—Chlorides | — | Carbohydrate source(s) | — | Sodium | — | Potassium | — | Chlorides | 1 to 7 days (1 to 3 days if fed exclusively) | Indicate on the package, container or label:—‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’—‘It is recommended that a veterinarian’s opinion be sought before use.’ | — | ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’ | — | ‘It is recommended that a veterinarian’s opinion be sought before use.’
— | Carbohydrate source(s)
— | Sodium
— | Potassium
— | Chlorides
— | ‘In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea).’
— | ‘It is recommended that a veterinarian’s opinion be sought before use.’
Reduction of the risk of urinary calculi | Low level of phosphorus, magnesium, and urine acidifying properties | Ruminants | —Calcium—Phosphorus—Sodium—Magnesium—Potassium—Chlorides—Sulphur—Urine acidifying substances | — | Calcium | — | Phosphorus | — | Sodium | — | Magnesium | — | Potassium | — | Chlorides | — | Sulphur | — | Urine acidifying substances | Up to 6 weeks | Indicate on the package, container or label:‘Especially for intensively fed young animals.’Indicate in the instructions for use:‘Water should be available at all times.’
— | Calcium
— | Phosphorus
— | Sodium
— | Magnesium
— | Potassium
— | Chlorides
— | Sulphur
— | Urine acidifying substances
Reduction of stress reactions | —High level magnesium | — | High level magnesium | Pigs | —Magnesium | — | Magnesium | 1 to 7 days | Guidance shall be provided on the situation in which the use of this feed is appropriate.
— | High level magnesium
— | Magnesium
and/or |
—Highly digestible ingredients | — | Highly digestible ingredients | —Highly digestible ingredients including their treatment if appropriate—Content of n-3 fatty acids (if added) | — | Highly digestible ingredients including their treatment if appropriate | — | Content of n-3 fatty acids (if added)
— | Highly digestible ingredients
— | Highly digestible ingredients including their treatment if appropriate
— | Content of n-3 fatty acids (if added)
Stabilisation of physiological digestion | —Low buffering capacity, and highly digestible ingredients | — | Low buffering capacity, and highly digestible ingredients | Piglets | —Highly digestible ingredients including their treatment if appropriate—Buffering capacity—Source(s) of astringent substances (if added)—Source(s) of mucilaginous substances (if added) | — | Highly digestible ingredients including their treatment if appropriate | — | Buffering capacity | — | Source(s) of astringent substances (if added) | — | Source(s) of mucilaginous substances (if added) | 2 to 4 weeks | Indicate on the package, container or label:‘In case of risk of, during periods of, or recovery from, digestive disturbance.’
— | Low buffering capacity, and highly digestible ingredients
— | Highly digestible ingredients including their treatment if appropriate
— | Buffering capacity
— | Source(s) of astringent substances (if added)
— | Source(s) of mucilaginous substances (if added)
—Highly digestible ingredients | — | Highly digestible ingredients | Pigs | —Highly digestible ingredients including their treatment if appropriate—Source(s) of astringent substances (if added)—Source(s) of mucilaginous substances (if added) | — | Highly digestible ingredients including their treatment if appropriate | — | Source(s) of astringent substances (if added) | — | Source(s) of mucilaginous substances (if added)
— | Highly digestible ingredients
— | Highly digestible ingredients including their treatment if appropriate
— | Source(s) of astringent substances (if added)
— | Source(s) of mucilaginous substances (if added)
Reduction of the risk of constipation | Ingredients stimulating intestinal passage | Sows | Ingredients stimulating intestinal passage | 10 to 14 days before and 10 to 14 days after farrowing |
Reduction of the risk of fatty liver syndrome | Low energy and high proportion of metabolisable energy from lipids with high level of polyunsaturated fatty acids | Laying hens | —Energy value (calculated according to EC method)—Percentage of metabolisable energy from lipids—Content of poly-unsaturated fatty acids | — | Energy value (calculated according to EC method) | — | Percentage of metabolisable energy from lipids | — | Content of poly-unsaturated fatty acids | Up to 12 weeks |
— | Energy value (calculated according to EC method)
— | Percentage of metabolisable energy from lipids
— | Content of poly-unsaturated fatty acids
Compensation for malabsorption | Low level of saturated fatty acids and high level of fat soluble vitamins | Poultry excluding geese and pigeons | —Percentage of saturated fatty acids in relation to total fatty acids—Total vitamin A—Total vitamin D—Total vitamin E—Total vitamin K | — | Percentage of saturated fatty acids in relation to total fatty acids | — | Total vitamin A | — | Total vitamin D | — | Total vitamin E | — | Total vitamin K | During the first 2 weeks after hatching |
— | Percentage of saturated fatty acids in relation to total fatty acids
— | Total vitamin A
— | Total vitamin D
— | Total vitamin E
— | Total vitamin K
Compensation for chronic insufficiency of small intestine function | Highly precaecally digestible carbohydrates proteins and fats | Equines(15) | —Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate | — | Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate | Initially up to six months | Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which it should be fed including many small meals per day.Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Source(s) of highly digestible carbohydrates, proteins and fats, including their treatment if appropriate
Compensation for chronic digestive disorders of large intestine | Highly digestible fibre | Equines | —Fibre source(s)—Content of n-3 fatty acids (if added) | — | Fibre source(s) | — | Content of n-3 fatty acids (if added) | Initially up to six months | Guidance should be provided on the situations in which the use of the feed is appropriate and the manner in which the feed should be fed.Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Fibre source(s)
— | Content of n-3 fatty acids (if added)
Reduction of stress reactions | Highly digestible ingredients | Equines | —Magnesium—Highly digestible ingredients including their treatment if appropriate—Content of n-3 fatty acids (if added) | — | Magnesium | — | Highly digestible ingredients including their treatment if appropriate | — | Content of n-3 fatty acids (if added) | Two to four weeks | Guidance shall be provided on the precise situations in which the use of the feed is appropriate.
— | Magnesium
— | Highly digestible ingredients including their treatment if appropriate
— | Content of n-3 fatty acids (if added)
Compensation of electrolyte loss in the cases of heavy sweating | Predominantly electrolytes and easily absorbable carbohydrates | Equines | —Calcium—Sodium—Magnesium—Potassium—Chlorides—Glucose | — | Calcium | — | Sodium | — | Magnesium | — | Potassium | — | Chlorides | — | Glucose | One to three days | Guidance shall be provided on the situations in which the use of the feed is appropriate.When the feed corresponds to a significant part of the daily ration, guidance should be provided to prevent the risk of abrupt changes in the nature of the feed.Indicate on the instructions for use:‘Water should be available at all times.’
— | Calcium
— | Sodium
— | Magnesium
— | Potassium
— | Chlorides
— | Glucose
Nutritional restoration, convalescence | High concentration of essential nutrients and highly digestible ingredients | Equines | —Highly digestible ingredients, including their treatment if appropriate—Content of n-3 and n-6 fatty acids (if added) | — | Highly digestible ingredients, including their treatment if appropriate | — | Content of n-3 and n-6 fatty acids (if added) | Until restoration is achieved | Guidance shall be provided on the situations in which the use of the feed is appropriate.In the case of feedingstuffs specially presented to be given via tubing, indicate on the package, container or label:‘Administration under veterinary supervision.’
— | Highly digestible ingredients, including their treatment if appropriate
— | Content of n-3 and n-6 fatty acids (if added)
Support of liver function in the case of chronic liver insufficiency | Low level of protein but of high quality and highly digestible carbohydrates | Equines | —Protein and fibre sources—Highly digestible carbohydrates including their treatment if appropriate—Methionine—Choline—Content of n-3 fatty acids (if added) | — | Protein and fibre sources | — | Highly digestible carbohydrates including their treatment if appropriate | — | Methionine | — | Choline | — | Content of n-3 fatty acids (if added) | Initially up to six months | Guidance should be provided on the manner in which the feed should be fed including many small meals per day.Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’
— | Protein and fibre sources
— | Highly digestible carbohydrates including their treatment if appropriate
— | Methionine
— | Choline
— | Content of n-3 fatty acids (if added)
Support of renal function in the case of chronic renal insufficiency | Low level of protein but of high quality and low level of phosphorus | Equines | —Protein source(s)—Calcium—Phosphorus—Potassium—Magnesium—Sodium | — | Protein source(s) | — | Calcium | — | Phosphorus | — | Potassium | — | Magnesium | — | Sodium | Initially up to six months | Indicate on the package, container or label:‘It is recommended that a veterinarian’s opinion be sought before use or before extending the period of use.’Indicate in the instructions for use:‘Water should be available at all times.’
— | Protein source(s)
— | Calcium
— | Phosphorus
— | Potassium
— | Magnesium
— | Sodium
(1)
OJ L 268, 18.10.2003, p. 29.
(2)
OJ L 270, 14.12.1970, p. 1.
(3) If appropriate the manufacturer may also recommend use of temporary renal insufficiency.
(4) If the feedingstuff is recommended for temporary renal insufficiency the recommended period for use shall be two to four weeks.
(5) In the case of feedingstuffs for cats, ‘feline lower urinary tract disease’ or ‘feline urological syndrome — FUS’ may complete the particular nutritional purpose.
(6) In the case of feedingstuffs for a particular intolerance reference to the specific intolerance can replace ‘ingredient and nutrient’.
(7) The manufacturer may complete the particular nutritional purpose with the reference: ‘exocrine pancreatic insufficiency’.
(8) In the case of feedingstuffs for cats, the manufacturer may complete the particular nutritional purpose with a reference to ‘Feline hepatic lipidosis’.
(9) The term ‘ketosis’ may be replaced by ‘acetonaemia’.
(10) The manufacturers may also recommend the use for ketosis recuperation.
(11) In the case of feedingstuffs for dairy cows.
(12) In the case of feedingstuffs for ewes.
(13) In the case of feedingstuffs for dairy cows: ‘maximum two months from the start of lactation’.
(14) Indicate the category of ruminants concerned.
(15) In the case of feedingstuffs specially prepared to meet the specific conditions of very old animals (easily ingestible ingredients) a reference to ‘old animals’ shall complete the indication of the species or category of animals.

PART A

ANNEX IIRepealed Directive with list of its successive amendments(referred to in Article 2)
Commission Directive 94/39/EC | (OJ L 207, 10.8.1994, p. 20)
Commission Directive 95/9/EC | (OJ L 91, 22.4.1995, p. 35)
Commission Directive 2002/1/EC | (OJ L 5, 9.1.2002, p. 8)
Commission Directive 2008/4/EC | (OJ L 6, 10.1.2008, p. 4)PART BList of time-limits for transposition into national law(referred to in Article 2)
Directive | Time-limit for transposition
94/39/EC | 30 June 1995
95/9/EC | 30 June 1995
2002/1/EC | 20 November 2002
2008/4/EC | 30 July 2008
ANNEX IIICorrelation table
Directive 94/39/EC | This Directive
Article 1 | Article 1
Article 2 | —
— | Article 2
Article 3 | Article 3
— | Article 4
Annex | Annex I
— | Annex II
— | Annex III

Pending: 32008L0005

January 16, 2026
31.1.2008 EN Official Journal of the European Union L 27/12
(1) Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) In order to ensure that consumers receive adequate information, it is necessary to provide for compulsory indication, for certain foodstuffs, of other particulars in addition to those provided for in Article 3 of Directive 2000/13/EC.
(3) Packaging gases used in packaging certain foodstuffs should not be regarded as ingredients for the purposes of Article 6(1) of Directive 2000/13/EC and therefore should not be included in the list of ingredients on the label.
(4) However, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf life than similar products packaged differently.
(5) With a view to providing adequate consumer information, the labelling of foodstuffs which contain sweeteners should bear details to that effect.
(6) Moreover, warnings should also be given on the labelling of foodstuffs containing certain categories of sweetener.
(7) Furthermore, it is necessary to provide labelling which gives the consumers clear information on the presence of glycyrrhizinic acid or its ammonium salt in confectionery and beverages. In the case of high contents of glycyrrhizinic acid or its ammonium salt in those products, the consumers, and in particular those suffering from hypertension, should in addition be informed that excessive intake should be avoided. To ensure a good understanding of such information by the consumers, the well known term ‘liquorice’ should be preferably used.
(8) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on the Food Chain and Animal Health.
(9) 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,
Type or category of foodstuff Particulars
Foodstuffs whose durability has been extended by means of packaging gases authorised pursuant to Council Directive 89/107/EEC(1) ‘Packaged in a protective atmosphere’
Foodstuffs containing a sweetener or sweeteners as authorised by Directive 94/35/EC ‘with sweetener(s)’That particular shall accompany the name under which the product is sold, as laid down in Article 5 of Directive 2000/13/EC
Foodstuffs containing both an added sugar or sugars and a sweetener or sweeteners as authorised by Directive 94/35/EC ‘with sugar(s) and sweetener(s)’That particular shall accompany the name under which the product is sold as laid down in Article 5 of Directive 2000/13/EC
Foodstuffs containing aspartame ‘contains a source of phenylalanine’
Foodstuffs containing more than 10 % added polyols ‘excessive consumption may produce laxative effects’
Confectionery or beverages containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plantGlycyrrhiza glabra, at concentration of 100 mg/kg or 10 mg/l or above. The terms ‘contains liquorice’ shall be added immediately after the list of ingredients, unless the term ‘liquorice’ is already included in the list of ingredients or in the name under which the product is sold. In the absence of a list of ingredients, the particular shall be placed near the name under which the product is sold.
Confectionery containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plantGlycyrrhiza glabraat concentrations of 4 g/kg or above. The following message must be added after the list of ingredients: ‘contains liquorice – people suffering from hypertension should avoid excessive consumption’. In the absence of a list of ingredients, the particular shall be placed near the name under which the product is sold.
Beverages containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plantGlycyrrhiza glabraat concentrations of 50 mg/l or above, or of 300 mg/l or above in the case of beverages containing more than 1,2 % by volume of alcohol(2). The following message must be added after the list of ingredients: ‘contains liquorice – people suffering from hypertension should avoid excessive consumption’. In the absence of a list of ingredients, the particular shall be placed near the name under which the product is sold.
Commission Directive 94/54/EC (OJ L 300, 23.11.1994, p. 14)
Council Directive 96/21/EC (OJ L 88, 5.4.1996, p. 5)
Commission Directive 2004/77/EC (OJ L 162, 30.4.2004, p. 76)
Directive Time-limit for transposition
94/54/EC 30 June 1995(*1)
96/21/EC 30 June 1996(*2)
2004/77/EC 20 May 2005(*3)
— permit trade in products complying with this Directive no later than 1 July 1995,
— prohibit trade in products not complying with this Directive with effect from 1 January 1997; however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.’
— allow trade in products complying with this Directive by 1 July 1996 at the latest;
— prohibit trade in products not complying with this Directive from 1 July 1997. However, products placed on the market or labelled before that date which do not comply with this Directive may be marketed until stocks are exhausted.’
Directive 94/54/EC This Directive
Article 1 Article 1
Article 2 —
— Article 2
Article 3 Article 3
— 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 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1), and in particular Article 4(2) thereof,
Having regard to Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs(2), and in particular Article 6 thereof,
(1) Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) In order to ensure that consumers receive adequate information, it is necessary to provide for compulsory indication, for certain foodstuffs, of other particulars in addition to those provided for in Article 3 of Directive 2000/13/EC.
(3) Packaging gases used in packaging certain foodstuffs should not be regarded as ingredients for the purposes of Article 6(1) of Directive 2000/13/EC and therefore should not be included in the list of ingredients on the label.
(4) However, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf life than similar products packaged differently.
(5) With a view to providing adequate consumer information, the labelling of foodstuffs which contain sweeteners should bear details to that effect.
(6) Moreover, warnings should also be given on the labelling of foodstuffs containing certain categories of sweetener.
(7) Furthermore, it is necessary to provide labelling which gives the consumers clear information on the presence of glycyrrhizinic acid or its ammonium salt in confectionery and beverages. In the case of high contents of glycyrrhizinic acid or its ammonium salt in those products, the consumers, and in particular those suffering from hypertension, should in addition be informed that excessive intake should be avoided. To ensure a good understanding of such information by the consumers, the well known term ‘liquorice’ should be preferably used.
(8) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on the Food Chain and Animal Health.
(9) 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
Without prejudice to the provisions of Article 3 of Directive 2000/13/EC, the labelling of the foodstuffs listed in Annex I to this Directive shall include additional particulars, as set out in that Annex.

Article 2
Directive 94/54/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 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1), and in particular Article 4(2) thereof,
Having regard to Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs(2), and in particular Article 6 thereof,
(1) Commission Directive 94/54/EC of 18 November 1994 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Council Directive 79/112/EEC(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) In order to ensure that consumers receive adequate information, it is necessary to provide for compulsory indication, for certain foodstuffs, of other particulars in addition to those provided for in Article 3 of Directive 2000/13/EC.
(3) Packaging gases used in packaging certain foodstuffs should not be regarded as ingredients for the purposes of Article 6(1) of Directive 2000/13/EC and therefore should not be included in the list of ingredients on the label.
(4) However, consumers should be informed of the use of such gases inasmuch as this information enables them to understand why the foodstuff they have purchased has a longer shelf life than similar products packaged differently.
(5) With a view to providing adequate consumer information, the labelling of foodstuffs which contain sweeteners should bear details to that effect.
(6) Moreover, warnings should also be given on the labelling of foodstuffs containing certain categories of sweetener.
(7) Furthermore, it is necessary to provide labelling which gives the consumers clear information on the presence of glycyrrhizinic acid or its ammonium salt in confectionery and beverages. In the case of high contents of glycyrrhizinic acid or its ammonium salt in those products, the consumers, and in particular those suffering from hypertension, should in addition be informed that excessive intake should be avoided. To ensure a good understanding of such information by the consumers, the well known term ‘liquorice’ should be preferably used.
(8) The measures provided for in this Directive are in conformity with the opinion of the Standing Committee on the Food Chain and Animal Health.
(9) 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:
Without prejudice to the provisions of Article 3 of Directive 2000/13/EC, the labelling of the foodstuffs listed in Annex I to this Directive shall include additional particulars, as set out in that Annex.
Directive 94/54/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.
ANNEX IList of foodstuffs for which the labelling must include one or more additional particulars
Type or category of foodstuff | Particulars
Foodstuffs whose durability has been extended by means of packaging gases authorised pursuant to Council Directive 89/107/EEC(1) | ‘Packaged in a protective atmosphere’
Foodstuffs containing a sweetener or sweeteners as authorised by Directive 94/35/EC | ‘with sweetener(s)’That particular shall accompany the name under which the product is sold, as laid down in Article 5 of Directive 2000/13/EC
Foodstuffs containing both an added sugar or sugars and a sweetener or sweeteners as authorised by Directive 94/35/EC | ‘with sugar(s) and sweetener(s)’That particular shall accompany the name under which the product is sold as laid down in Article 5 of Directive 2000/13/EC
Foodstuffs containing aspartame | ‘contains a source of phenylalanine’
Foodstuffs containing more than 10 % added polyols | ‘excessive consumption may produce laxative effects’
Confectionery or beverages containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plantGlycyrrhiza glabra, at concentration of 100 mg/kg or 10 mg/l or above. | The terms ‘contains liquorice’ shall be added immediately after the list of ingredients, unless the term ‘liquorice’ is already included in the list of ingredients or in the name under which the product is sold. In the absence of a list of ingredients, the particular shall be placed near the name under which the product is sold.
Confectionery containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plantGlycyrrhiza glabraat concentrations of 4 g/kg or above. | The following message must be added after the list of ingredients: ‘contains liquorice – people suffering from hypertension should avoid excessive consumption’. In the absence of a list of ingredients, the particular shall be placed near the name under which the product is sold.
Beverages containing glycyrrhizinic acid or its ammonium salt due to the addition of the substance(s) as such or the liquorice plantGlycyrrhiza glabraat concentrations of 50 mg/l or above, or of 300 mg/l or above in the case of beverages containing more than 1,2 % by volume of alcohol(2). | The following message must be added after the list of ingredients: ‘contains liquorice – people suffering from hypertension should avoid excessive consumption’. In the absence of a list of ingredients, the particular shall be placed near the name under which the product is sold.
(1)
OJ L 40, 11.2.1989, p. 27.
(2) The level shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.

PART A

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

Commission Directive 94/54/EC | (OJ L 300, 23.11.1994, p. 14)
Council Directive 96/21/EC | (OJ L 88, 5.4.1996, p. 5)
Commission Directive 2004/77/EC | (OJ L 162, 30.4.2004, p. 76)PART BList of time-limits for transposition into national law
(referred to in Article 2)

Directive | Time-limit for transposition
94/54/EC | 30 June 1995(*1)
96/21/EC | 30 June 1996(*2)
2004/77/EC | 20 May 2005(*3)
(*1) In accordance with the first paragraph of Article 2 of Directive 94/54/EC:
‘Member States shall, where necessary, amend their laws, regulations and administrative provisions by 30 June 1995 in such a way so as to:
—
permit trade in products complying with this Directive no later than 1 July 1995,
—
prohibit trade in products not complying with this Directive with effect from 1 January 1997; however, trade in products placed on the market or labelled before that date and not conforming with this Directive may continue until stocks run out.’

(*2) In accordance with the first paragraph of Article 2 of Directive 96/21/EC:
‘Member States shall, where necessary, amend their laws, regulations and administrative provisions before 1 July 1996 so as to:
—
allow trade in products complying with this Directive by 1 July 1996 at the latest;
—
prohibit trade in products not complying with this Directive from 1 July 1997. However, products placed on the market or labelled before that date which do not comply with this Directive may be marketed until stocks are exhausted.’

(*3) In accordance with Article 2 of Directive 2004/77/EC:
‘1. The Member States shall permit trade in products which comply with this Directive from 20 May 2005 at the latest. 2. The Member States shall prohibit trade in products which do not comply with this Directive from 20 May 2006. However, products which do not comply with this Directive and which were labelled before 20 May 2006 shall be authorised while stocks last.’

ANNEX IIICorrelation table
Directive 94/54/EC | This Directive
Article 1 | Article 1
Article 2 | —
— | Article 2
Article 3 | Article 3
— | Article 4
Annex | Annex I
— | Annex II
— | Annex III

Pending: 32008L0001

January 16, 2026
29.1.2008 EN Official Journal of the European Union L 24/8
(1) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) The objectives and principles of the Community’s environment policy, as set out in Article 174 of the Treaty, consist in particular of preventing, reducing and as far as possible eliminating pollution by giving priority to intervention at source and ensuring prudent management of natural resources, in compliance with the ‘polluter pays’ principle and the principle of pollution prevention.
(3) The Fifth Environmental Action Programme, the broad outline of which was approved by the Council and the Representatives of the Governments of the Member States, meeting within the Council, in the Resolution of 1 February 1993 on a Community programme of policy and action in relation to the environment and sustainable development(5), accorded priority to integrated pollution control as an important part of the move towards a more sustainable balance between human activity and socioeconomic development, on the one hand, and the resources and regenerative capacity of nature, on the other.
(4) The implementation of an integrated approach to reduce pollution requires action at Community level in order to modify and supplement existing Community legislation concerning the prevention and control of pollution from industrial plants.
(5) Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants(6)introduced a general framework requiring authorisation prior to any operation or substantial modification of industrial installations which may cause air pollution.
(6) Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community(7)provides for an authorisation requirement for the discharge of those substances.
(7) Although Community legislation exists on the combating of air pollution and the prevention or minimisation of the discharge of dangerous substances into water, there is no comparable Community legislation aimed at preventing or minimising emissions into soil.
(8) Different approaches to controlling emissions into the air, water or soil separately may encourage the shifting of pollution between the various environmental media rather than protecting the environment as a whole.
(9) The objective of an integrated approach to pollution control is to prevent emissions into air, water or soil wherever this is practicable, taking into account waste management, and, where it is not, to minimise them in order to achieve a high level of protection for the environment as a whole.
(10) This Directive should establish a general framework for integrated pollution prevention and control. It should lay down the measures necessary to implement integrated pollution prevention and control in order to achieve a high level of protection for the environment as a whole. Application of the principle of sustainable development should be promoted by an integrated approach to pollution control.
(11) The provisions of this Directive should apply without prejudice to the provisions of Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(8). When information or conclusions obtained further to the application of that Directive have to be taken into consideration for the granting of authorisation, this Directive should not affect the implementation of Directive 85/337/EEC.
(12) Member States should take the necessary steps in order to ensure that the operator of the industrial activities referred to in this Directive is complying with the general principles of certain basic obligations. For that purpose it would suffice for the competent authorities to take those general principles into account when laying down the authorisation conditions.
(13) Some of the provisions adopted pursuant to this Directive must be applied to existing installations after 30 October 2007 and others had to be applied as from 30 October 1999.
(14) In order to tackle pollution problems more effectively and efficiently, environmental aspects should be taken into consideration by the operator. Those aspects should be communicated to the competent authority or authorities so that they can satisfy themselves, before granting a permit, that all appropriate preventive or pollution-control measures have been laid down. Very different application procedures may give rise to different levels of environmental protection and public awareness. Therefore, applications for permits under this Directive should include minimum data.
(15) Full coordination of the authorisation procedure and conditions between competent authorities should make it possible to achieve the highest practicable level of protection for the environment as a whole.
(16) The competent authority or authorities should grant or amend a permit only when integrated environmental protection measures for air, water and land have been laid down.
(17) The permit should include all necessary measures to fulfil the authorisation conditions in order thus to achieve a high level of protection for the environment as a whole. Without prejudice to the authorisation procedure, those measures may also be the subject of general binding requirements.
(18) Emission limit values, parameters or equivalent technical measures should be based on the best available techniques, without prescribing the use of one specific technique or technology and taking into consideration the technical characteristics of the installation concerned, its geographical location and local environmental conditions. In all cases the authorisation conditions should lay down provisions on minimising long-distance or transfrontier pollution and ensure a high level of protection for the environment as a whole.
(19) It is for the Member States to determine how the technical characteristics of the installation concerned, its geographical location and local environmental conditions can, where appropriate, be taken into consideration.
(20) When an environmental quality standard requires more stringent conditions than those that can be achieved by using the best available techniques, supplementary conditions should in particular be required by the permit, without prejudice to other measures that may be taken to comply with the environmental quality standards.
(21) Because best available techniques will change with time, particularly in the light of technical advances, the competent authorities should monitor or be informed of such progress.
(22) Changes to an installation may give rise to pollution. The competent authority or authorities should therefore be notified of any change which might affect the environment. Substantial changes to plant must be subject to the granting of prior authorisation in accordance with this Directive.
(23) The authorisation conditions should be periodically reviewed and if necessary updated. Under certain conditions, they should in any event be re-examined.
(24) Effective public participation in the taking of decisions should enable the public to express, and the decision-maker to take account of, opinions and concerns which may be relevant to those decisions, thereby increasing the accountability and transparency of the decision-making process and contributing to public awareness of environmental issues and support for the decisions taken. In particular, the public should have access to information on the operation of installations and their potential effect on the environment, and, before any decision is taken, to information relating to applications for permits for new installations or substantial changes and to the permits themselves, their updating and the relevant monitoring data.
(25) Participation, including participation by associations, organisations and groups, in particular non-governmental organisations promoting environmental protection, should accordingly be fostered, including by promoting environmental education of the public.
(26) On 25 June 1998 the Community signed the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Århus Convention). Among the objectives of the Århus Convention is the desire to guarantee rights of public participation in decision-making in environmental matters in order to contribute to the protection of the right to live in an environment which is adequate for personal health and well-being.
(27) The development and exchange of information at Community level about best available techniques should help to redress the technological imbalances in the Community, should promote the worldwide dissemination of limit values and techniques used in the Community and should help the Member States in the efficient implementation of this Directive.
(28) Reports on the implementation and effectiveness of this Directive should be drawn up regularly.
(29) This Directive is concerned with installations whose potential for pollution, and therefore transfrontier pollution, is significant. Transboundary consultation should be organised where applications relate to the licensing of new installations or substantial changes to installations which are likely to have significant negative environmental effects. The applications relating to such proposals or substantial changes should be available to the public of the Member State likely to be affected.
(30) The need for action may be identified at Community level to lay down emission limit values for certain categories of installation and pollutant covered by this Directive. The European Parliament and the Council should set such emission limit values in accordance with the provisions of the Treaty.
(31) The provisions of this Directive should apply without prejudice to Community provisions on health and safety at the workplace.
(32) 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 as set out in Annex VI, Part B,
1. ‘substance’ means any chemical element and its compounds, with the exception of radioactive substances within the meaning of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation(9)and genetically modified organisms within the meaning of Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms(10)and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(11);
2. ‘pollution’ means the direct or indirect introduction, as a result of human activity, of substances, vibrations, heat or noise into the air, water or land which may be harmful to human health or the quality of the environment, result in damage to material property, or impair or interfere with amenities and other legitimate uses of the environment;
3. ‘installation’ means a stationary technical unit where one or more activities listed in Annex I are carried out, and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution;
4. ‘existing installation’ means an installation which on 30 October 1999, in accordance with legislation existing before that date, was in operation or was authorised or, in the view of the competent authority, was the subject of a full request for authorisation, provided that that installation was put into operation no later than 30 October 2000;
5. ‘emission’ means the direct or indirect release of substances, vibrations, heat or noise from individual or diffuse sources in the installation into the air, water or land;
6. ‘emission limit values’ means the mass, expressed in terms of certain specific parameters, concentration and/or level of an emission, which may not be exceeded during one or more periods of time; emission limit values may also be laid down for certain groups, families or categories of substances, in particular for those listed in Annex III. The emission limit values for substances normally apply at the point where the emissions leave the installation, any dilution being disregarded when determining them; with regard to indirect releases into water, the effect of a water treatment plant may be taken into account when determining the emission limit values of the installation involved, provided that an equivalent level is guaranteed for the protection of the environment as a whole and provided this does not lead to higher levels of pollution in the environment, without prejudice to Directive 2006/11/ΕC or the Directives implementing it;
7. ‘environmental quality standard’ means the set of requirements which must be fulfilled at a given time by a given environment or particular part thereof, as set out in Community legislation;
8. ‘competent authority’ means the authority or authorities or bodies responsible under the legal provisions of the Member States for carrying out the obligations arising from this Directive;
9. ‘permit’ means that part or the whole of a written decision (or several such decisions) granting authorisation to operate all or part of an installation, subject to certain conditions which guarantee that the installation complies with the requirements of this Directive. A permit may cover one or more installations or parts of installations on the same site operated by the same operator;
10. ‘change in operation’ means a change in the nature or functioning, or an extension, of the installation which may have consequences for the environment;
11. ‘substantial change’ means a change in operation which, in the opinion of the competent authority, may have significant negative effects on human beings or the environment; for the purposes of this definition, any change to or extension of an operation shall be deemed to be substantial if the change or extension in itself meets the thresholds, if any, set out in Annex I;
12. ‘best available techniques’ means the most effective and advanced stage in the development of activities and their methods of operation which indicate the practical suitability of particular techniques for providing in principle the basis for emission limit values designed to prevent and, where that is not practicable, generally to reduce emissions and the impact on the environment as a whole:(a)‘techniques’ shall include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned;(b)‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator;(c)‘best’ means most effective in achieving a high general level of protection of the environment as a whole.In determining the best available techniques, special consideration should be given to the items listed in Annex IV; (a) ‘techniques’ shall include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned; (b) ‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator; (c) ‘best’ means most effective in achieving a high general level of protection of the environment as a whole.
(a) ‘techniques’ shall include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned;
(b) ‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator;
(c) ‘best’ means most effective in achieving a high general level of protection of the environment as a whole.
(a) ‘techniques’ shall include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned;
(b) ‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator;
(c) ‘best’ means most effective in achieving a high general level of protection of the environment as a whole.
13. ‘operator’ means any natural or legal person who operates or controls the installation or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the installation has been delegated;
14. ‘the public’ means one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups;
15. ‘the public concerned’ means the public affected or likely to be affected by, or having an interest in, the taking of a decision on the issuing or the updating of a permit or of permit conditions; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest.
(a) all the appropriate preventive measures are taken against pollution, in particular through application of the best available techniques;
(b) no significant pollution is caused;
(c) waste production is avoided in accordance with Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste(12); where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;
(d) energy is used efficiently;
(e) the necessary measures are taken to prevent accidents and limit their consequences;
(f) the necessary measures are taken upon definitive cessation of activities to avoid any pollution risk and return the site of operation to a satisfactory state.
(a) the installation and its activities;
(b) the raw and auxiliary materials, other substances and the energy used in or generated by the installation;
(c) the sources of emissions from the installation;
(d) the conditions of the site of the installation;
(e) the nature and quantities of foreseeable emissions from the installation into each medium as well as identification of significant effects of the emissions on the environment;
(f) the proposed technology and other techniques for preventing or, where this not possible, reducing emissions from the installation;
(g) where necessary, measures for the prevention and recovery of waste generated by the installation;
(h) further measures planned to comply with the general principles of the basic obligations of the operator as provided for in Article 3;
(i) measures planned to monitor emissions into the environment;
(j) the main alternatives, if any, studied by the applicant in outline.
(a) the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit;
(b) substantial changes in the best available techniques make it possible to reduce emissions significantly without imposing excessive costs;
(c) the operational safety of the process or activity requires other techniques to be used;
(d) new provisions of Community or national legislation so dictate.
(a) the conditions of the permit are complied with by the operator when operating the installation;
(b) the operator regularly informs the competent authority of the results of the monitoring of releases and without delay of any incident or accident significantly affecting the environment;
(c) operators of installations afford the representatives of the competent authority all necessary assistance to enable them to carry out any inspections within the installation, to take samples and to gather any information necessary for the performance of their duties for the purposes of this Directive.
(a) issuing a permit for new installations;
(b) issuing a permit for any substantial change;
(c) updating of a permit or permit conditions for an installation in accordance with Article 13(2)(a).
(a) the content of the decision, including a copy of the permit and of any conditions and any subsequent updates; and
(b) having examined the concerns and opinions expressed by the public concerned, the reasons and considerations on which the decision is based, including information on the public participation process.
(a) they have a sufficient interest; or
(b) they maintain the impairment of a right, where administrative procedural law of a Member State requires this as a precondition.
(a) the categories of installations listed in Annex I except for the landfills covered by points 5,1 and 5,4 of that Annex,and
(b) the polluting substances referred to in Annex III.
(a) hot-rolling mills with a capacity exceeding 20 tonnes of crude steel per hour;
(b) smitheries with hammers the energy of which exceeds 50 kilojoules per hammer, where the calorific power used exceeds 20 MW;
(c) application of protective fused metal coats with an input exceeding 2 tonnes of crude steel per hour.
(a) for the production of non-ferrous crude metals from ore, concentrates or secondary raw materials by metallurgical, chemical or electrolytic processes;
(b) for the smelting, including the alloyage, of non-ferrous metals, including recovered products, (refining, foundry casting, etc.) with a melting capacity exceeding 4 tonnes per day for lead and cadmium or 20 tonnes per day for all other metals.
(a) simple hydrocarbons (linear or cyclic, saturated or unsaturated, aliphatic or aromatic);
(b) oxygen-containing hydrocarbons such as alcohols, aldehydes, ketones, carboxylic acids, esters, acetates, ethers, peroxides, epoxy resins;
(c) sulphurous hydrocarbons;
(d) nitrogenous hydrocarbons such as amines, amides, nitrous compounds, nitro compounds or nitrate compounds, nitriles, cyanates, isocyanates;
(e) phosphorus-containing hydrocarbons;
(f) halogenic hydrocarbons;
(g) organometallic compounds;
(h) basic plastic materials (polymers, synthetic fibres and cellulose-based fibres);
(i) synthetic rubbers;
(j) dyes and pigments;
(k) surface-active agents and surfactants.
(a) gases, such as ammonia, chlorine or hydrogen chloride, fluorine or hydrogen fluoride, carbon oxides, sulphur compounds, nitrogen oxides, hydrogen, sulphur dioxide, carbonyl chloride;
(b) acids, such as chromic acid, hydrofluoric acid, phosphoric acid, nitric acid, hydrochloric acid, sulphuric acid, oleum, sulphurous acids;
(c) bases, such as ammonium hydroxide, potassium hydroxide, sodium hydroxide;
(d) salts, such as ammonium chloride, potassium chlorate, potassium carbonate, sodium carbonate, perborate, silver nitrate;
(e) non-metals, metal oxides or other inorganic compounds such as calcium carbide, silicon, silicon carbide.
(a) pulp from timber or other fibrous materials;
(b) paper and cardboard with a production capacity exceeding 20 tonnes per day.
(a) Slaughterhouses with a carcase production capacity greater than 50 tonnes per day.
(b) Treatment and processing intended for the production of food products from:—animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day,—vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis). — animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day, — vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis).
— animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day,
— vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis).
— animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day,
— vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis).
(c) Treatment and processing of milk, the quantity of milk received being greater than 200 tonnes per day (average value on an annual basis).
(a) 40 000 places for poultry;
(b) 2 000 places for production pigs (over 30 kg); or
(c) 750 places for sows.
1. Council Directive 87/217/EEC of 19 March 1987 on the prevention and reduction of environmental pollution by asbestos.
2. Council Directive 82/176/EEC of 22 March 1982 on limit values and quality objectives for mercury discharges by the chlor-alkali electrolysis industry.
3. Council Directive 83/513/EEC of 26 September 1983 on limit values and quality objectives for cadmium discharges.
4. Council Directive 84/156/EEC of 8 March 1984 on limit values and quality objectives for mercury discharges by sectors other than the chlor-alkali electrolysis industry.
5. Council Directive 84/491/EEC of 9 October 1984 on limit values and quality objectives for discharges of hexachlorocyclohexane.
6. Council Directive 86/280/EEC of 12 June 1986 on limit values and quality objectives for discharges of certain dangerous substances included in List I of the Annex to Directive 76/464/EEC.
7. Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste.
8. Council Directive 92/112/EEC of 15 December 1992 on procedures for harmonising the programmes for the reduction and eventual elimination of pollution caused by waste from the titanium dioxide industry.
9. Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants.
10. Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community.
11. Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste.
12. Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils.
13. Council Directive 91/689/EEC of 12 December 1991 on hazardous waste.
14. Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste.
1. Sulphur dioxide and other sulphur compounds.
2. Oxides of nitrogen and other nitrogen compounds.
3. Carbon monoxide.
4. Volatile organic compounds.
5. Metals and their compounds.
6. Dust.
7. Asbestos (suspended particulates, fibres).
8. Chlorine and its compounds.
9. Fluorine and its compounds.
10. Arsenic and its compounds.
11. Cyanides.
12. Substances and preparations which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction via the air.
13. Polychlorinated dibenzodioxins and polychlorinated dibenzofurans.
1. Organohalogen compounds and substances which may form such compounds in the aquatic environment.
2. Organophosphorus compounds.
3. Organotin compounds.
4. Substances and preparations which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction in or via the aquatic environment.
5. Persistent hydrocarbons and persistent and bioaccumulable organic toxic substances.
6. Cyanides.
7. Metals and their compounds.
8. Arsenic and its compounds.
9. Biocides and plant health products.
10. Materials in suspension.
11. Substances which contribute to eutrophication (in particular, nitrates and phosphates).
12. Substances which have an unfavourable influence on the oxygen balance (and can be measured using parameters such as BOD, COD, etc.).
1. the use of low-waste technology;
2. the use of less hazardous substances;
3. the furthering of recovery and recycling of substances generated and used in the process and of waste, where appropriate;
4. comparable processes, facilities or methods of operation which have been tried with success on an industrial scale;
5. technological advances and changes in scientific knowledge and understanding;
6. the nature, effects and volume of the emissions concerned;
7. the commissioning dates for new or existing installations;
8. the length of time needed to introduce the best available technique;
9. the consumption and nature of raw materials (including water) used in the process and energy efficiency;
10. the need to prevent or reduce to a minimum the overall impact of the emissions on the environment and the risks to it;
11. the need to prevent accidents and to minimise the consequences for the environment;
12. the information published by the Commission pursuant to Article 17(2), second subparagraph, or by international organisations.
1. The public shall be informed (by public notices or other appropriate means such as electronic media where available) of the following matters early in the procedure for the taking of a decision or, at the latest, as soon as the information can reasonably be provided:(a)the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1);(b)where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18;(c)details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions;(d)the nature of possible decisions or, where there is one, the draft decision;(e)where applicable, the details relating to a proposal for the updating of a permit or of permit conditions;(f)an indication of the times and places where, or means by which, the relevant information will be made available;(g)details of the arrangements for public participation and consultation made pursuant to point 5. (a) the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1); (b) where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18; (c) details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions; (d) the nature of possible decisions or, where there is one, the draft decision; (e) where applicable, the details relating to a proposal for the updating of a permit or of permit conditions; (f) an indication of the times and places where, or means by which, the relevant information will be made available; (g) details of the arrangements for public participation and consultation made pursuant to point 5.
(a) the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1);
(b) where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18;
(c) details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions;
(d) the nature of possible decisions or, where there is one, the draft decision;
(e) where applicable, the details relating to a proposal for the updating of a permit or of permit conditions;
(f) an indication of the times and places where, or means by which, the relevant information will be made available;
(g) details of the arrangements for public participation and consultation made pursuant to point 5.
(a) the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1);
(b) where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18;
(c) details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions;
(d) the nature of possible decisions or, where there is one, the draft decision;
(e) where applicable, the details relating to a proposal for the updating of a permit or of permit conditions;
(f) an indication of the times and places where, or means by which, the relevant information will be made available;
(g) details of the arrangements for public participation and consultation made pursuant to point 5.
2. Member States shall ensure that, within appropriate time-frames, the following is made available to the public concerned:(a)in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1;(b)in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1. (a) in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1; (b) in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1.
(a) in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1;
(b) in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1.
(a) in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1;
(b) in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1.
3. The public concerned shall be entitled to express comments and opinions to the competent authority before a decision is taken.
4. The results of the consultations held pursuant to this Annex must be taken into due account in the taking of a decision.
5. The detailed arrangements for informing the public (for example by bill posting within a certain radius or publication in local newspapers) and consulting the public concerned (for example by written submissions or by way of a public inquiry) shall be determined by the Member States. Reasonable time-frames for the different phases shall be provided, allowing sufficient time for informing the public and for the public concerned to prepare and participate effectively in environmental decision-making subject to the provisions of this Annex.
Council Directive 96/61/EC(OJ L 257, 10.10.1996, p. 26).
Directive 2003/35/EC of the European Parliament and of the Council(OJ L 156, 25.6.2003, p. 17). only Article 4 and Annex II
Directive 2003/87/EC of the European Parliament and of the Council(OJ L 275, 25.10.2003, p. 32). only Article 26
Regulation (EC) No 1882/2003 of the European Parliament and of the Council(OJ L 284, 31.10.2003, p. 1). only point (61) of Annex III
Regulation (EC) No 166/2006 of the European Parliament and of the Council(OJ L 33, 4.2.2006, p. 1). only Article 21(2)
Directive Time-limit for transposition
96/61/EC 30 October 1999
2003/35/EC 25 June 2005
2003/87/EC 31 December 2003
Directive 96/61/EC This Directive
Article 1 Article 1
Article 2, introductory words Article 2, introductory words
Article 2(1-9) Article 2(1-9)
Article 2(10)(a) Article 2(10)
Article 2(10)(b) Article 2(11)
Article 2(11), first subparagraph, introductory wording Article 2(12), first subparagraph, introductory wording
Article 2(11), first subparagraph, first indent Article 2(12), first subparagraph, (a)
Article 2(11), first subparagraph, second indent Article 2(12), first subparagraph, (b)
Article 2(11), first subparagraph, third indent Article 2(12), first subparagraph, (c)
Article 2(11), second subparagraph Article 2(12), second subparagraph
Article 2(12) Article 2(13)
Article 2(13) Article 2(14)
Article 2(14) Article 2(15)
Article 3, first subparagraph Article 3(1)
Article 3, second subparagraph Article 3(2)
Article 4 Article 4
Article 5 Article 5
Article 6(1), first subparagraph, introductory wording Article 6(1), first subparagraph, introductory wording
Article 6(1), first subparagraph, first to tenth indent Article 6(1), first subparagraph, (a) to (j)
Article 6(1), second subparagraph Article 6(1), second subparagraph
Article 6(2) Article 6(2)
Article 7 to 12 Article 7 to 12
Article 13(1) Article 13(1)
Article 13(2), introductory wording Article 13(2), introductory wording
Article 13(2), first to fourth indent Article 13(2)(a) to (d)
Article 14, introductory wording Article 14, introductory wording
Article 14, first to third indent Article 14(a) to (c)
Article 15(1), first subparagraph, introductory wording Article 15(1), first subparagraph, introductory wording
Article 15(1), first subparagraph, first to third indent Article 15(1), first subparagraph, (a) to (c)
Article 15(1), second subparagraph Article 15(1), second subparagraph
Article 15(2) Article 15(2)
Article 15(4) Article 15(3)
Article 15(5) Article 15(4)
Article 15a, first subparagraph, introductory and final words Article 16(1)
Article 15a, first subparagraph, (a) and (b) Article 16(1)(a) and (b)
Article 15a, second subparagraph Article 16(2)
Article 15a, third subparagraph, first and second sentence Article 16(3), first subparagraph
Article 15a, third subparagraph, third sentence Article 16(3), second subparagraph
Article 15a, fourth subparagraph Article 16(4), first subparagraph
Article 15a, fifth subparagraph Article 16(4), second subparagraph
Article 15a, sixth subparagraph Article 16(5)
Article 16 Article 17
Article 17 Article 18
Article 18(1), introductory and final words Article 19(1)
Article 18(1), first and second indent Article 19(1)(a) and (b)
Article 18(2), first subparagraph Article 19(2)
Article 18(2), second subparagraph Article 19(3)
Article 19 —
Article 20(1) Article 20(1)
Article 20(2) Article 20(2)
Article 20(3), first subparagraph Article 20(3), first subparagraph
Article 20(3), second subparagraph —
Article 20(3), third subparagraph Article 20(3), second subparagraph
Article 21(1) —
Article 21(2) Article 21
— Article 22
Article 22 Article 23
Article 23 Article 24
Annex I Annex I
Annex II Annex II
Annex III Annex III
Annex IV Annex IV
Annex V Annex V
— Annex VI
— Annex VII
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 175(1) 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) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) The objectives and principles of the Community’s environment policy, as set out in Article 174 of the Treaty, consist in particular of preventing, reducing and as far as possible eliminating pollution by giving priority to intervention at source and ensuring prudent management of natural resources, in compliance with the ‘polluter pays’ principle and the principle of pollution prevention.
(3) The Fifth Environmental Action Programme, the broad outline of which was approved by the Council and the Representatives of the Governments of the Member States, meeting within the Council, in the Resolution of 1 February 1993 on a Community programme of policy and action in relation to the environment and sustainable development(5), accorded priority to integrated pollution control as an important part of the move towards a more sustainable balance between human activity and socioeconomic development, on the one hand, and the resources and regenerative capacity of nature, on the other.
(4) The implementation of an integrated approach to reduce pollution requires action at Community level in order to modify and supplement existing Community legislation concerning the prevention and control of pollution from industrial plants.
(5) Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants(6)introduced a general framework requiring authorisation prior to any operation or substantial modification of industrial installations which may cause air pollution.
(6) Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community(7)provides for an authorisation requirement for the discharge of those substances.
(7) Although Community legislation exists on the combating of air pollution and the prevention or minimisation of the discharge of dangerous substances into water, there is no comparable Community legislation aimed at preventing or minimising emissions into soil.
(8) Different approaches to controlling emissions into the air, water or soil separately may encourage the shifting of pollution between the various environmental media rather than protecting the environment as a whole.
(9) The objective of an integrated approach to pollution control is to prevent emissions into air, water or soil wherever this is practicable, taking into account waste management, and, where it is not, to minimise them in order to achieve a high level of protection for the environment as a whole.
(10) This Directive should establish a general framework for integrated pollution prevention and control. It should lay down the measures necessary to implement integrated pollution prevention and control in order to achieve a high level of protection for the environment as a whole. Application of the principle of sustainable development should be promoted by an integrated approach to pollution control.
(11) The provisions of this Directive should apply without prejudice to the provisions of Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(8). When information or conclusions obtained further to the application of that Directive have to be taken into consideration for the granting of authorisation, this Directive should not affect the implementation of Directive 85/337/EEC.
(12) Member States should take the necessary steps in order to ensure that the operator of the industrial activities referred to in this Directive is complying with the general principles of certain basic obligations. For that purpose it would suffice for the competent authorities to take those general principles into account when laying down the authorisation conditions.
(13) Some of the provisions adopted pursuant to this Directive must be applied to existing installations after 30 October 2007 and others had to be applied as from 30 October 1999.
(14) In order to tackle pollution problems more effectively and efficiently, environmental aspects should be taken into consideration by the operator. Those aspects should be communicated to the competent authority or authorities so that they can satisfy themselves, before granting a permit, that all appropriate preventive or pollution-control measures have been laid down. Very different application procedures may give rise to different levels of environmental protection and public awareness. Therefore, applications for permits under this Directive should include minimum data.
(15) Full coordination of the authorisation procedure and conditions between competent authorities should make it possible to achieve the highest practicable level of protection for the environment as a whole.
(16) The competent authority or authorities should grant or amend a permit only when integrated environmental protection measures for air, water and land have been laid down.
(17) The permit should include all necessary measures to fulfil the authorisation conditions in order thus to achieve a high level of protection for the environment as a whole. Without prejudice to the authorisation procedure, those measures may also be the subject of general binding requirements.
(18) Emission limit values, parameters or equivalent technical measures should be based on the best available techniques, without prescribing the use of one specific technique or technology and taking into consideration the technical characteristics of the installation concerned, its geographical location and local environmental conditions. In all cases the authorisation conditions should lay down provisions on minimising long-distance or transfrontier pollution and ensure a high level of protection for the environment as a whole.
(19) It is for the Member States to determine how the technical characteristics of the installation concerned, its geographical location and local environmental conditions can, where appropriate, be taken into consideration.
(20) When an environmental quality standard requires more stringent conditions than those that can be achieved by using the best available techniques, supplementary conditions should in particular be required by the permit, without prejudice to other measures that may be taken to comply with the environmental quality standards.
(21) Because best available techniques will change with time, particularly in the light of technical advances, the competent authorities should monitor or be informed of such progress.
(22) Changes to an installation may give rise to pollution. The competent authority or authorities should therefore be notified of any change which might affect the environment. Substantial changes to plant must be subject to the granting of prior authorisation in accordance with this Directive.
(23) The authorisation conditions should be periodically reviewed and if necessary updated. Under certain conditions, they should in any event be re-examined.
(24) Effective public participation in the taking of decisions should enable the public to express, and the decision-maker to take account of, opinions and concerns which may be relevant to those decisions, thereby increasing the accountability and transparency of the decision-making process and contributing to public awareness of environmental issues and support for the decisions taken. In particular, the public should have access to information on the operation of installations and their potential effect on the environment, and, before any decision is taken, to information relating to applications for permits for new installations or substantial changes and to the permits themselves, their updating and the relevant monitoring data.
(25) Participation, including participation by associations, organisations and groups, in particular non-governmental organisations promoting environmental protection, should accordingly be fostered, including by promoting environmental education of the public.
(26) On 25 June 1998 the Community signed the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Århus Convention). Among the objectives of the Århus Convention is the desire to guarantee rights of public participation in decision-making in environmental matters in order to contribute to the protection of the right to live in an environment which is adequate for personal health and well-being.
(27) The development and exchange of information at Community level about best available techniques should help to redress the technological imbalances in the Community, should promote the worldwide dissemination of limit values and techniques used in the Community and should help the Member States in the efficient implementation of this Directive.
(28) Reports on the implementation and effectiveness of this Directive should be drawn up regularly.
(29) This Directive is concerned with installations whose potential for pollution, and therefore transfrontier pollution, is significant. Transboundary consultation should be organised where applications relate to the licensing of new installations or substantial changes to installations which are likely to have significant negative environmental effects. The applications relating to such proposals or substantial changes should be available to the public of the Member State likely to be affected.
(30) The need for action may be identified at Community level to lay down emission limit values for certain categories of installation and pollutant covered by this Directive. The European Parliament and the Council should set such emission limit values in accordance with the provisions of the Treaty.
(31) The provisions of this Directive should apply without prejudice to Community provisions on health and safety at the workplace.
(32) 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 as set out in Annex VI, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Purpose and scope
Article 1
The purpose of this Directive is to achieve integrated prevention and control of pollution arising from the activities listed in Annex I. It lays down measures designed to prevent or, where that is not practicable, to reduce emissions in the air, water and land from the abovementioned activities, including measures concerning waste, in order to achieve a high level of protection of the environment taken as a whole, without prejudice to Directive 85/337/EEC and other relevant Community provisions.

Definitions
Article 2
For the purposes of this Directive the following definitions shall apply:
1.
‘substance’ means any chemical element and its compounds, with the exception of radioactive substances within the meaning of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation(9)and genetically modified organisms within the meaning of Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms(10)and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(11);
2.
‘pollution’ means the direct or indirect introduction, as a result of human activity, of substances, vibrations, heat or noise into the air, water or land which may be harmful to human health or the quality of the environment, result in damage to material property, or impair or interfere with amenities and other legitimate uses of the environment;
3.
‘installation’ means a stationary technical unit where one or more activities listed in Annex I are carried out, and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution;
4.
‘existing installation’ means an installation which on 30 October 1999, in accordance with legislation existing before that date, was in operation or was authorised or, in the view of the competent authority, was the subject of a full request for authorisation, provided that that installation was put into operation no later than 30 October 2000;
5.
‘emission’ means the direct or indirect release of substances, vibrations, heat or noise from individual or diffuse sources in the installation into the air, water or land;
6.
‘emission limit values’ means the mass, expressed in terms of certain specific parameters, concentration and/or level of an emission, which may not be exceeded during one or more periods of time; emission limit values may also be laid down for certain groups, families or categories of substances, in particular for those listed in Annex III. The emission limit values for substances normally apply at the point where the emissions leave the installation, any dilution being disregarded when determining them; with regard to indirect releases into water, the effect of a water treatment plant may be taken into account when determining the emission limit values of the installation involved, provided that an equivalent level is guaranteed for the protection of the environment as a whole and provided this does not lead to higher levels of pollution in the environment, without prejudice to Directive 2006/11/ΕC or the Directives implementing it;
7.
‘environmental quality standard’ means the set of requirements which must be fulfilled at a given time by a given environment or particular part thereof, as set out in Community legislation;
8.
‘competent authority’ means the authority or authorities or bodies responsible under the legal provisions of the Member States for carrying out the obligations arising from this Directive;
9.
‘permit’ means that part or the whole of a written decision (or several such decisions) granting authorisation to operate all or part of an installation, subject to certain conditions which guarantee that the installation complies with the requirements of this Directive. A permit may cover one or more installations or parts of installations on the same site operated by the same operator;
10.
‘change in operation’ means a change in the nature or functioning, or an extension, of the installation which may have consequences for the environment;
11.
‘substantial change’ means a change in operation which, in the opinion of the competent authority, may have significant negative effects on human beings or the environment; for the purposes of this definition, any change to or extension of an operation shall be deemed to be substantial if the change or extension in itself meets the thresholds, if any, set out in Annex I;
12.
‘best available techniques’ means the most effective and advanced stage in the development of activities and their methods of operation which indicate the practical suitability of particular techniques for providing in principle the basis for emission limit values designed to prevent and, where that is not practicable, generally to reduce emissions and the impact on the environment as a whole:
(a)
‘techniques’ shall include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned;
(b)
‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator;
(c)
‘best’ means most effective in achieving a high general level of protection of the environment as a whole.
In determining the best available techniques, special consideration should be given to the items listed in Annex IV;
13.
‘operator’ means any natural or legal person who operates or controls the installation or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the installation has been delegated;
14.
‘the public’ means one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups;
15.
‘the public concerned’ means the public affected or likely to be affected by, or having an interest in, the taking of a decision on the issuing or the updating of a permit or of permit conditions; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest.

General principles governing the basic obligations of the operator
Article 3
1. Member States shall take the necessary measures to provide that the competent authorities ensure that installations are operated in such a way that:
(a)
all the appropriate preventive measures are taken against pollution, in particular through application of the best available techniques;
(b)
no significant pollution is caused;
(c)
waste production is avoided in accordance with Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste(12); where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;
(d)
energy is used efficiently;
(e)
the necessary measures are taken to prevent accidents and limit their consequences;
(f)
the necessary measures are taken upon definitive cessation of activities to avoid any pollution risk and return the site of operation to a satisfactory state.
2. For the purposes of compliance with this Article, it shall be sufficient if Member States ensure that the competent authorities take account of the general principles set out in paragraph 1 when they determine the conditions of the permit.

Permits for new installations
Article 4
Member States shall take the necessary measures to ensure that no new installation is operated without a permit issued in accordance with this Directive, without prejudice to the exceptions provided for in Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants(13).

Requirements for the granting of permits for existing installations
Article 5
1. Member States shall take the necessary measures to ensure that the competent authorities see to it, by means of permits in accordance with Articles 6 and 8 or, as appropriate, by reconsidering and, where necessary, by updating the conditions, that existing installations operate in accordance with the requirements of Articles 3, 7, 9, 10 and 13, Article 14(a) and (b) and Article 15(2) not later than 30 October 2007, without prejudice to specific Community legislation.
2. Member States shall take the necessary measures to apply the provisions of Articles 1, 2, 11 and 12, Article 14(c), Article 15(1) and (3), Articles 17, 18 and Article 19(2) to existing installations as from 30 October 1999.

Applications for permits
Article 6
1. Member States shall take the necessary measures to ensure that an application to the competent authority for a permit includes a description of:
(a)
the installation and its activities;
(b)
the raw and auxiliary materials, other substances and the energy used in or generated by the installation;
(c)
the sources of emissions from the installation;
(d)
the conditions of the site of the installation;
(e)
the nature and quantities of foreseeable emissions from the installation into each medium as well as identification of significant effects of the emissions on the environment;
(f)
the proposed technology and other techniques for preventing or, where this not possible, reducing emissions from the installation;
(g)
where necessary, measures for the prevention and recovery of waste generated by the installation;
(h)
further measures planned to comply with the general principles of the basic obligations of the operator as provided for in Article 3;
(i)
measures planned to monitor emissions into the environment;
(j)
the main alternatives, if any, studied by the applicant in outline.
An application for a permit shall also include a non-technical summary of the details referred to in points (a) to (j).
2. Where information supplied in accordance with the requirements provided for in Directive 85/337/EEC or a safety report prepared in accordance with Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances(14)or other information produced in response to other legislation fulfils any of the requirements of this Article, that information may be included in, or attached to, the application.

Integrated approach to issuing permits
Article 7
Member States shall take the measures necessary to ensure that the conditions of, and procedure for the grant of, the permit are fully coordinated where more than one competent authority is involved, in order to guarantee an effective integrated approach by all authorities competent for this procedure.

Decisions
Article 8
Without prejudice to other requirements laid down in national or Community legislation, the competent authority shall grant a permit containing conditions guaranteeing that the installation complies with the requirements of this Directive or, if it does not, shall refuse to grant the permit.
All permits granted and modified permits must include details of the arrangements made for air, water and land protection as referred to in this Directive.

Conditions of the permit
Article 9
1. Member States shall ensure that the permit includes all measures necessary for compliance with the requirements of Articles 3 and 10 for the granting of permits in order to achieve a high level of protection for the environment as a whole by means of protection of the air, water and land.
2. In the case of a new installation or a substantial change where Article 4 of Directive 85/337/EEC applies, any relevant information obtained or conclusion arrived at pursuant to Articles 5, 6 and 7 of that Directive shall be taken into consideration for the purposes of granting the permit.
3. The permit shall include emission limit values for polluting substances, in particular those listed in Annex III, likely to be emitted from the installation concerned in significant quantities, having regard to their nature and their potential to transfer pollution from one medium to another (water, air and land). If necessary, the permit shall include appropriate requirements ensuring protection of the soil and ground water and measures concerning the management of waste generated by the installation. Where appropriate, limit values may be supplemented or replaced by equivalent parameters or technical measures.
For installations under point 6.6 in Annex I, emission limit values laid down in accordance with this paragraph shall take into account practical considerations appropriate to these categories of installation.
Where emissions of a greenhouse gas from an installation are specified in Annex I to Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community(15)in relation to an activity carried out in that installation, the permit shall not include an emission limit value for direct emissions of that gas unless it is necessary to ensure that no significant local pollution is caused.
For activities listed in Annex I to Directive 2003/87/EC, Member States may choose not to impose requirements relating to energy efficiency in respect of combustion units or other units emitting carbon dioxide on the site.
Where necessary, the competent authorities shall amend the permit as appropriate.
The third, fourth and fifth subparagraphs shall not apply to installations temporarily excluded from the scheme for greenhouse gas emission allowance trading within the Community in accordance with Article 27 of Directive 2003/87/EC.
4. Without prejudice to Article 10, the emission limit values and the equivalent parameters and technical measures referred to in paragraph 3 shall be based on the best available techniques, without prescribing the use of any technique or specific technology, but taking into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions. In all circumstances, the conditions of the permit shall contain provisions on the minimisation of long-distance or transboundary pollution and ensure a high level of protection for the environment as a whole.
5. The permit shall contain suitable release monitoring requirements, specifying measurement methodology and frequency, evaluation procedure and an obligation to supply the competent authority with data required for checking compliance with the permit.
For installations under point 6.6 in Annex I, the measures referred to in this paragraph may take account of costs and benefits.
6. The permit shall contain measures relating to conditions other than normal operating conditions. Thus, where there is a risk that the environment may be affected, appropriate provision shall be made for start-up, leaks, malfunctions, momentary stoppages and definitive cessation of operations.
The permit may also contain temporary derogations from the requirements of paragraph 4 if a rehabilitation plan approved by the competent authority ensures that these requirements will be met within six months and if the project leads to a reduction of pollution.
7. The permit may contain such other specific conditions for the purposes of this Directive as the Member State or competent authority may think fit.
8. Without prejudice to the obligation to implement a permit procedure pursuant to this Directive, Member States may prescribe certain requirements for certain categories of installations in general binding rules instead of including them in individual permit conditions, provided that an integrated approach and an equivalent high level of environmental protection as a whole are ensured.

Best available techniques and environmental quality standards
Article 10
Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall in particular be required in the permit, without prejudice to other measures which might be taken to comply with environmental quality standards.

Developments in best available techniques
Article 11
Member States shall ensure that the competent authority follows or is informed of developments in best available techniques.

Changes by operators to installations
Article 12
1. Member States shall take the necessary measures to ensure that the operator informs the competent authorities of any planned change in the operation. Where appropriate, the competent authorities shall update the permit or the conditions.
2. Member States shall take the necessary measures to ensure that no substantial change planned by the operator is made without a permit issued in accordance with this Directive. The application for a permit and the decision by the competent authority must cover those parts of the installation and those aspects listed in Article 6 that may be affected by the change. The relevant provisions of Article 3, Articles 6 to 10 and Article 15(1), (2) and (3) shall applymutatis mutandis.

Reconsideration and updating of permit conditions by the competent authority
Article 13
1. Member States shall take the necessary measures to ensure that competent authorities periodically reconsider and, where necessary, update permit conditions.
2. The reconsideration shall be undertaken in any event where:
(a)
the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit;
(b)
substantial changes in the best available techniques make it possible to reduce emissions significantly without imposing excessive costs;
(c)
the operational safety of the process or activity requires other techniques to be used;
(d)
new provisions of Community or national legislation so dictate.

Compliance with permit conditions
Article 14
Member States shall take the necessary measures to ensure that:
(a)
the conditions of the permit are complied with by the operator when operating the installation;
(b)
the operator regularly informs the competent authority of the results of the monitoring of releases and without delay of any incident or accident significantly affecting the environment;
(c)
operators of installations afford the representatives of the competent authority all necessary assistance to enable them to carry out any inspections within the installation, to take samples and to gather any information necessary for the performance of their duties for the purposes of this Directive.

Access to information and public participation in the permit procedure
Article 15
1. Member States shall ensure that the public concerned is given early and effective opportunities to participate in the procedure for:
(a)
issuing a permit for new installations;
(b)
issuing a permit for any substantial change;
(c)
updating of a permit or permit conditions for an installation in accordance with Article 13(2)(a).
The procedure set out in Annex V shall apply for the purposes of such participation.
2. The results of monitoring of releases as required under the permit conditions referred to in Article 9 and held by the competent authority shall be made available to the public.
3. Paragraphs 1 and 2 shall apply subject to the restrictions laid down in Article 4(1), (2) and (4) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information(16).
4. When a decision has been taken, the competent authority shall inform the public in accordance with the appropriate procedures and shall make available to the public the following information:
(a)
the content of the decision, including a copy of the permit and of any conditions and any subsequent updates; and
(b)
having examined the concerns and opinions expressed by the public concerned, the reasons and considerations on which the decision is based, including information on the public participation process.

Access to justice
Article 16
1. Member States shall ensure that, in accordance with the relevant national legal system, members of the public concerned have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to the public participation provisions of this Directive when:
(a)
they have a sufficient interest; or
(b)
they maintain the impairment of a right, where administrative procedural law of a Member State requires this as a precondition.
2. Member States shall determine at what stage the decisions, acts or omissions may be challenged.
3. What constitutes a sufficient interest and impairment of a right shall be determined by the Member States, consistently with the objective of giving the public concerned wide access to justice. To this end, the interest of any non-governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed sufficient for the purpose of paragraph 1(a).
Such organisations shall also be deemed to have rights capable of being impaired for the purpose of paragraph 1(b).
4. The provisions of this Article shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law.
Any such procedure shall be fair, equitable, timely and not prohibitively expensive.
5. In order to further the effectiveness of the provisions of this Article, Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Exchange of information
Article 17
1. With a view to exchanging information, Member States shall take the necessary measures to send the Commission every three years, and for the first time before 30 April 2001, the available representative data on the limit values laid down by specific category of activities in accordance with Annex I and, if appropriate, the best available techniques from which those values are derived in accordance with, in particular, Article 9. On subsequent occasions the data shall be supplemented in accordance with the procedures laid down in paragraph 3 of this Article.
2. The Commission shall organise an exchange of information between Member States and the industries concerned on best available techniques, associated monitoring, and developments in them.
Every three years the Commission shall publish the results of the exchanges of information.
3. At intervals of three years, and for the first time for the period 30 October 1999 to 30 October 2002 inclusive, Member States shall send information to the Commission on the implementation of this Directive in the form of a report. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6(2) of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(17). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be submitted to the Commission within nine months of the end of the three-year period covered by it.
The Commission shall publish a Community report on the implementation of the Directive within nine months of receiving the reports from the Member States.
The Commission shall submit the Community report to the European Parliament and to the Council, accompanied by proposals if necessary.
4. Member States shall establish or designate the authority or authorities which are to be responsible for the exchange of information under paragraphs 1, 2 and 3 and shall inform the Commission accordingly.

Transboundary effects
Article 18
1. Where a Member State is aware that the operation of an installation is likely to have significant negative effects on the environment of another Member State, or where a Member State likely to be significantly affected so requests, the Member State in whose territory the application for a permit pursuant to Article 4 or Article 12(2) was submitted shall forward to the other Member State any information required to be given or made available pursuant to Annex V at the same time as it makes it available to its own nationals. Such information shall serve as a basis for any consultations necessary in the framework of the bilateral relations between the two Member States on a reciprocal and equivalent basis.
2. Within the framework of their bilateral relations, Member States shall see to it that in the cases referred to in paragraph 1 the applications are also made available for an appropriate period of time to the public of the Member State likely to be affected so that it will have the right to comment on them before the competent authority reaches its decision.
3. The results of any consultations pursuant to paragraphs 1 and 2 must be taken into consideration when the competent authority reaches a decision on the application.
4. The competent authority shall inform any Member State which has been consulted pursuant to paragraph 1 of the decision reached on the application and shall forward to it the information referred to in Article 15(4). That Member State shall take the measures necessary to ensure that that information is made available in an appropriate manner to the public concerned in its own territory.

Community emission limit values
Article 19
1. Where the need for Community action has been identified, on the basis, in particular, of the exchange of information provided for in Article 17, the European Parliament and the Council, acting on a proposal from the Commission, shall set emission limit values, in accordance with the procedures laid down in the Treaty, for:
(a)
the categories of installations listed in Annex I except for the landfills covered by points 5,1 and 5,4 of that Annex,
and
(b)
the polluting substances referred to in Annex III.
2. In the absence of Community emission limit values defined pursuant to this Directive, the relevant emission limit values contained in the Directives listed in Annex II and in other Community legislation shall be applied as minimum emission limit values pursuant to this Directive for the installations listed in Annex I.
3. Without prejudice to the requirements of this Directive, the technical requirements applicable for the landfills covered by points 5,1 and 5,4 of Annex I, have been fixed in Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(18).

Transitional provisions
Article 20
1. The provisions of Directive 84/360/EEC, the provisions of Articles 4, 5 and 6(2) of Directive 2006/11/EC and the relevant provisions concerning authorisation systems in the Directives listed in Annex II shall apply, without prejudice to the exceptions provided for in Directive 2001/80/EC, to existing installations in respect of activities listed in Annex I until the measures required pursuant to Article 5 of this Directive have been taken by the competent authorities.
2. The relevant provisions concerning authorisation systems in the Directives listed in Annex II shall not, in respect of the activities listed in Annex I, apply to installations which are not existing installations within the meaning of point 4 of Article 2.
3. Directive 84/360/EEC shall be repealed on 30 October 2007.
Acting on a proposal from the Commission, the Council or the European Parliament and the Council shall, where necessary, amend the relevant provisions of the Directives listed in Annex II in order to adapt them to the requirements of this Directive before 30 October 2007.

Communication
Article 21
Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.

Repeal
Article 22
Directive 96/61/EC, as amended by the acts listed in Annex VI, 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 as set out in Annex VI, 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 VII.

Entry into force
Article 23
This Directive shall enter into force on the 20th day following its publication in theOfficial Journal of the European Union.

Addressees
Article 24
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 175(1) 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) Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control(3)has been substantially amended several times(4). In the interests of clarity and rationality the said Directive should be codified.
(2) The objectives and principles of the Community’s environment policy, as set out in Article 174 of the Treaty, consist in particular of preventing, reducing and as far as possible eliminating pollution by giving priority to intervention at source and ensuring prudent management of natural resources, in compliance with the ‘polluter pays’ principle and the principle of pollution prevention.
(3) The Fifth Environmental Action Programme, the broad outline of which was approved by the Council and the Representatives of the Governments of the Member States, meeting within the Council, in the Resolution of 1 February 1993 on a Community programme of policy and action in relation to the environment and sustainable development(5), accorded priority to integrated pollution control as an important part of the move towards a more sustainable balance between human activity and socioeconomic development, on the one hand, and the resources and regenerative capacity of nature, on the other.
(4) The implementation of an integrated approach to reduce pollution requires action at Community level in order to modify and supplement existing Community legislation concerning the prevention and control of pollution from industrial plants.
(5) Council Directive 84/360/EEC of 28 June 1984 on the combating of air pollution from industrial plants(6)introduced a general framework requiring authorisation prior to any operation or substantial modification of industrial installations which may cause air pollution.
(6) Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community(7)provides for an authorisation requirement for the discharge of those substances.
(7) Although Community legislation exists on the combating of air pollution and the prevention or minimisation of the discharge of dangerous substances into water, there is no comparable Community legislation aimed at preventing or minimising emissions into soil.
(8) Different approaches to controlling emissions into the air, water or soil separately may encourage the shifting of pollution between the various environmental media rather than protecting the environment as a whole.
(9) The objective of an integrated approach to pollution control is to prevent emissions into air, water or soil wherever this is practicable, taking into account waste management, and, where it is not, to minimise them in order to achieve a high level of protection for the environment as a whole.
(10) This Directive should establish a general framework for integrated pollution prevention and control. It should lay down the measures necessary to implement integrated pollution prevention and control in order to achieve a high level of protection for the environment as a whole. Application of the principle of sustainable development should be promoted by an integrated approach to pollution control.
(11) The provisions of this Directive should apply without prejudice to the provisions of Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment(8). When information or conclusions obtained further to the application of that Directive have to be taken into consideration for the granting of authorisation, this Directive should not affect the implementation of Directive 85/337/EEC.
(12) Member States should take the necessary steps in order to ensure that the operator of the industrial activities referred to in this Directive is complying with the general principles of certain basic obligations. For that purpose it would suffice for the competent authorities to take those general principles into account when laying down the authorisation conditions.
(13) Some of the provisions adopted pursuant to this Directive must be applied to existing installations after 30 October 2007 and others had to be applied as from 30 October 1999.
(14) In order to tackle pollution problems more effectively and efficiently, environmental aspects should be taken into consideration by the operator. Those aspects should be communicated to the competent authority or authorities so that they can satisfy themselves, before granting a permit, that all appropriate preventive or pollution-control measures have been laid down. Very different application procedures may give rise to different levels of environmental protection and public awareness. Therefore, applications for permits under this Directive should include minimum data.
(15) Full coordination of the authorisation procedure and conditions between competent authorities should make it possible to achieve the highest practicable level of protection for the environment as a whole.
(16) The competent authority or authorities should grant or amend a permit only when integrated environmental protection measures for air, water and land have been laid down.
(17) The permit should include all necessary measures to fulfil the authorisation conditions in order thus to achieve a high level of protection for the environment as a whole. Without prejudice to the authorisation procedure, those measures may also be the subject of general binding requirements.
(18) Emission limit values, parameters or equivalent technical measures should be based on the best available techniques, without prescribing the use of one specific technique or technology and taking into consideration the technical characteristics of the installation concerned, its geographical location and local environmental conditions. In all cases the authorisation conditions should lay down provisions on minimising long-distance or transfrontier pollution and ensure a high level of protection for the environment as a whole.
(19) It is for the Member States to determine how the technical characteristics of the installation concerned, its geographical location and local environmental conditions can, where appropriate, be taken into consideration.
(20) When an environmental quality standard requires more stringent conditions than those that can be achieved by using the best available techniques, supplementary conditions should in particular be required by the permit, without prejudice to other measures that may be taken to comply with the environmental quality standards.
(21) Because best available techniques will change with time, particularly in the light of technical advances, the competent authorities should monitor or be informed of such progress.
(22) Changes to an installation may give rise to pollution. The competent authority or authorities should therefore be notified of any change which might affect the environment. Substantial changes to plant must be subject to the granting of prior authorisation in accordance with this Directive.
(23) The authorisation conditions should be periodically reviewed and if necessary updated. Under certain conditions, they should in any event be re-examined.
(24) Effective public participation in the taking of decisions should enable the public to express, and the decision-maker to take account of, opinions and concerns which may be relevant to those decisions, thereby increasing the accountability and transparency of the decision-making process and contributing to public awareness of environmental issues and support for the decisions taken. In particular, the public should have access to information on the operation of installations and their potential effect on the environment, and, before any decision is taken, to information relating to applications for permits for new installations or substantial changes and to the permits themselves, their updating and the relevant monitoring data.
(25) Participation, including participation by associations, organisations and groups, in particular non-governmental organisations promoting environmental protection, should accordingly be fostered, including by promoting environmental education of the public.
(26) On 25 June 1998 the Community signed the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Århus Convention). Among the objectives of the Århus Convention is the desire to guarantee rights of public participation in decision-making in environmental matters in order to contribute to the protection of the right to live in an environment which is adequate for personal health and well-being.
(27) The development and exchange of information at Community level about best available techniques should help to redress the technological imbalances in the Community, should promote the worldwide dissemination of limit values and techniques used in the Community and should help the Member States in the efficient implementation of this Directive.
(28) Reports on the implementation and effectiveness of this Directive should be drawn up regularly.
(29) This Directive is concerned with installations whose potential for pollution, and therefore transfrontier pollution, is significant. Transboundary consultation should be organised where applications relate to the licensing of new installations or substantial changes to installations which are likely to have significant negative environmental effects. The applications relating to such proposals or substantial changes should be available to the public of the Member State likely to be affected.
(30) The need for action may be identified at Community level to lay down emission limit values for certain categories of installation and pollutant covered by this Directive. The European Parliament and the Council should set such emission limit values in accordance with the provisions of the Treaty.
(31) The provisions of this Directive should apply without prejudice to Community provisions on health and safety at the workplace.
(32) 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 as set out in Annex VI, Part B,
HAVE ADOPTED THIS DIRECTIVE:

Purpose and scope

The purpose of this Directive is to achieve integrated prevention and control of pollution arising from the activities listed in Annex I. It lays down measures designed to prevent or, where that is not practicable, to reduce emissions in the air, water and land from the abovementioned activities, including measures concerning waste, in order to achieve a high level of protection of the environment taken as a whole, without prejudice to Directive 85/337/EEC and other relevant Community provisions.

Definitions

For the purposes of this Directive the following definitions shall apply:
1.
‘substance’ means any chemical element and its compounds, with the exception of radioactive substances within the meaning of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation(9)and genetically modified organisms within the meaning of Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms(10)and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(11);
2.
‘pollution’ means the direct or indirect introduction, as a result of human activity, of substances, vibrations, heat or noise into the air, water or land which may be harmful to human health or the quality of the environment, result in damage to material property, or impair or interfere with amenities and other legitimate uses of the environment;
3.
‘installation’ means a stationary technical unit where one or more activities listed in Annex I are carried out, and any other directly associated activities which have a technical connection with the activities carried out on that site and which could have an effect on emissions and pollution;
4.
‘existing installation’ means an installation which on 30 October 1999, in accordance with legislation existing before that date, was in operation or was authorised or, in the view of the competent authority, was the subject of a full request for authorisation, provided that that installation was put into operation no later than 30 October 2000;
5.
‘emission’ means the direct or indirect release of substances, vibrations, heat or noise from individual or diffuse sources in the installation into the air, water or land;
6.
‘emission limit values’ means the mass, expressed in terms of certain specific parameters, concentration and/or level of an emission, which may not be exceeded during one or more periods of time; emission limit values may also be laid down for certain groups, families or categories of substances, in particular for those listed in Annex III. The emission limit values for substances normally apply at the point where the emissions leave the installation, any dilution being disregarded when determining them; with regard to indirect releases into water, the effect of a water treatment plant may be taken into account when determining the emission limit values of the installation involved, provided that an equivalent level is guaranteed for the protection of the environment as a whole and provided this does not lead to higher levels of pollution in the environment, without prejudice to Directive 2006/11/ΕC or the Directives implementing it;
7.
‘environmental quality standard’ means the set of requirements which must be fulfilled at a given time by a given environment or particular part thereof, as set out in Community legislation;
8.
‘competent authority’ means the authority or authorities or bodies responsible under the legal provisions of the Member States for carrying out the obligations arising from this Directive;
9.
‘permit’ means that part or the whole of a written decision (or several such decisions) granting authorisation to operate all or part of an installation, subject to certain conditions which guarantee that the installation complies with the requirements of this Directive. A permit may cover one or more installations or parts of installations on the same site operated by the same operator;
10.
‘change in operation’ means a change in the nature or functioning, or an extension, of the installation which may have consequences for the environment;
11.
‘substantial change’ means a change in operation which, in the opinion of the competent authority, may have significant negative effects on human beings or the environment; for the purposes of this definition, any change to or extension of an operation shall be deemed to be substantial if the change or extension in itself meets the thresholds, if any, set out in Annex I;
12.
‘best available techniques’ means the most effective and advanced stage in the development of activities and their methods of operation which indicate the practical suitability of particular techniques for providing in principle the basis for emission limit values designed to prevent and, where that is not practicable, generally to reduce emissions and the impact on the environment as a whole:
(a)
‘techniques’ shall include both the technology used and the way in which the installation is designed, built, maintained, operated and decommissioned;
(b)
‘available techniques’ means those developed on a scale which allows implementation in the relevant industrial sector, under economically and technically viable conditions, taking into consideration the costs and advantages, whether or not the techniques are used or produced inside the Member State in question, as long as they are reasonably accessible to the operator;
(c)
‘best’ means most effective in achieving a high general level of protection of the environment as a whole.
In determining the best available techniques, special consideration should be given to the items listed in Annex IV;
13.
‘operator’ means any natural or legal person who operates or controls the installation or, where this is provided for in national legislation, to whom decisive economic power over the technical functioning of the installation has been delegated;
14.
‘the public’ means one or more natural or legal persons and, in accordance with national legislation or practice, their associations, organisations or groups;
15.
‘the public concerned’ means the public affected or likely to be affected by, or having an interest in, the taking of a decision on the issuing or the updating of a permit or of permit conditions; for the purposes of this definition, non-governmental organisations promoting environmental protection and meeting any requirements under national law shall be deemed to have an interest.

General principles governing the basic obligations of the operator

1. Member States shall take the necessary measures to provide that the competent authorities ensure that installations are operated in such a way that:
(a)
all the appropriate preventive measures are taken against pollution, in particular through application of the best available techniques;
(b)
no significant pollution is caused;
(c)
waste production is avoided in accordance with Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste(12); where waste is produced, it is recovered or, where that is technically and economically impossible, it is disposed of while avoiding or reducing any impact on the environment;
(d)
energy is used efficiently;
(e)
the necessary measures are taken to prevent accidents and limit their consequences;
(f)
the necessary measures are taken upon definitive cessation of activities to avoid any pollution risk and return the site of operation to a satisfactory state.
2. For the purposes of compliance with this Article, it shall be sufficient if Member States ensure that the competent authorities take account of the general principles set out in paragraph 1 when they determine the conditions of the permit.

Permits for new installations

Member States shall take the necessary measures to ensure that no new installation is operated without a permit issued in accordance with this Directive, without prejudice to the exceptions provided for in Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants(13).

Requirements for the granting of permits for existing installations

1. Member States shall take the necessary measures to ensure that the competent authorities see to it, by means of permits in accordance with Articles 6 and 8 or, as appropriate, by reconsidering and, where necessary, by updating the conditions, that existing installations operate in accordance with the requirements of Articles 3, 7, 9, 10 and 13, Article 14(a) and (b) and Article 15(2) not later than 30 October 2007, without prejudice to specific Community legislation.
2. Member States shall take the necessary measures to apply the provisions of Articles 1, 2, 11 and 12, Article 14(c), Article 15(1) and (3), Articles 17, 18 and Article 19(2) to existing installations as from 30 October 1999.

Applications for permits

1. Member States shall take the necessary measures to ensure that an application to the competent authority for a permit includes a description of:
(a)
the installation and its activities;
(b)
the raw and auxiliary materials, other substances and the energy used in or generated by the installation;
(c)
the sources of emissions from the installation;
(d)
the conditions of the site of the installation;
(e)
the nature and quantities of foreseeable emissions from the installation into each medium as well as identification of significant effects of the emissions on the environment;
(f)
the proposed technology and other techniques for preventing or, where this not possible, reducing emissions from the installation;
(g)
where necessary, measures for the prevention and recovery of waste generated by the installation;
(h)
further measures planned to comply with the general principles of the basic obligations of the operator as provided for in Article 3;
(i)
measures planned to monitor emissions into the environment;
(j)
the main alternatives, if any, studied by the applicant in outline.
An application for a permit shall also include a non-technical summary of the details referred to in points (a) to (j).
2. Where information supplied in accordance with the requirements provided for in Directive 85/337/EEC or a safety report prepared in accordance with Council Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous substances(14)or other information produced in response to other legislation fulfils any of the requirements of this Article, that information may be included in, or attached to, the application.

Integrated approach to issuing permits

Member States shall take the measures necessary to ensure that the conditions of, and procedure for the grant of, the permit are fully coordinated where more than one competent authority is involved, in order to guarantee an effective integrated approach by all authorities competent for this procedure.

Decisions

Without prejudice to other requirements laid down in national or Community legislation, the competent authority shall grant a permit containing conditions guaranteeing that the installation complies with the requirements of this Directive or, if it does not, shall refuse to grant the permit.
All permits granted and modified permits must include details of the arrangements made for air, water and land protection as referred to in this Directive.

Conditions of the permit

1. Member States shall ensure that the permit includes all measures necessary for compliance with the requirements of Articles 3 and 10 for the granting of permits in order to achieve a high level of protection for the environment as a whole by means of protection of the air, water and land.
2. In the case of a new installation or a substantial change where Article 4 of Directive 85/337/EEC applies, any relevant information obtained or conclusion arrived at pursuant to Articles 5, 6 and 7 of that Directive shall be taken into consideration for the purposes of granting the permit.
3. The permit shall include emission limit values for polluting substances, in particular those listed in Annex III, likely to be emitted from the installation concerned in significant quantities, having regard to their nature and their potential to transfer pollution from one medium to another (water, air and land). If necessary, the permit shall include appropriate requirements ensuring protection of the soil and ground water and measures concerning the management of waste generated by the installation. Where appropriate, limit values may be supplemented or replaced by equivalent parameters or technical measures.
For installations under point 6.6 in Annex I, emission limit values laid down in accordance with this paragraph shall take into account practical considerations appropriate to these categories of installation.
Where emissions of a greenhouse gas from an installation are specified in Annex I to Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a scheme for greenhouse gas emission allowance trading within the Community(15)in relation to an activity carried out in that installation, the permit shall not include an emission limit value for direct emissions of that gas unless it is necessary to ensure that no significant local pollution is caused.
For activities listed in Annex I to Directive 2003/87/EC, Member States may choose not to impose requirements relating to energy efficiency in respect of combustion units or other units emitting carbon dioxide on the site.
Where necessary, the competent authorities shall amend the permit as appropriate.
The third, fourth and fifth subparagraphs shall not apply to installations temporarily excluded from the scheme for greenhouse gas emission allowance trading within the Community in accordance with Article 27 of Directive 2003/87/EC.
4. Without prejudice to Article 10, the emission limit values and the equivalent parameters and technical measures referred to in paragraph 3 shall be based on the best available techniques, without prescribing the use of any technique or specific technology, but taking into account the technical characteristics of the installation concerned, its geographical location and the local environmental conditions. In all circumstances, the conditions of the permit shall contain provisions on the minimisation of long-distance or transboundary pollution and ensure a high level of protection for the environment as a whole.
5. The permit shall contain suitable release monitoring requirements, specifying measurement methodology and frequency, evaluation procedure and an obligation to supply the competent authority with data required for checking compliance with the permit.
For installations under point 6.6 in Annex I, the measures referred to in this paragraph may take account of costs and benefits.
6. The permit shall contain measures relating to conditions other than normal operating conditions. Thus, where there is a risk that the environment may be affected, appropriate provision shall be made for start-up, leaks, malfunctions, momentary stoppages and definitive cessation of operations.
The permit may also contain temporary derogations from the requirements of paragraph 4 if a rehabilitation plan approved by the competent authority ensures that these requirements will be met within six months and if the project leads to a reduction of pollution.
7. The permit may contain such other specific conditions for the purposes of this Directive as the Member State or competent authority may think fit.
8. Without prejudice to the obligation to implement a permit procedure pursuant to this Directive, Member States may prescribe certain requirements for certain categories of installations in general binding rules instead of including them in individual permit conditions, provided that an integrated approach and an equivalent high level of environmental protection as a whole are ensured.

Best available techniques and environmental quality standards

Where an environmental quality standard requires stricter conditions than those achievable by the use of the best available techniques, additional measures shall in particular be required in the permit, without prejudice to other measures which might be taken to comply with environmental quality standards.

Developments in best available techniques

Member States shall ensure that the competent authority follows or is informed of developments in best available techniques.

Changes by operators to installations

1. Member States shall take the necessary measures to ensure that the operator informs the competent authorities of any planned change in the operation. Where appropriate, the competent authorities shall update the permit or the conditions.
2. Member States shall take the necessary measures to ensure that no substantial change planned by the operator is made without a permit issued in accordance with this Directive. The application for a permit and the decision by the competent authority must cover those parts of the installation and those aspects listed in Article 6 that may be affected by the change. The relevant provisions of Article 3, Articles 6 to 10 and Article 15(1), (2) and (3) shall applymutatis mutandis.

Reconsideration and updating of permit conditions by the competent authority

1. Member States shall take the necessary measures to ensure that competent authorities periodically reconsider and, where necessary, update permit conditions.
2. The reconsideration shall be undertaken in any event where:
(a)
the pollution caused by the installation is of such significance that the existing emission limit values of the permit need to be revised or new such values need to be included in the permit;
(b)
substantial changes in the best available techniques make it possible to reduce emissions significantly without imposing excessive costs;
(c)
the operational safety of the process or activity requires other techniques to be used;
(d)
new provisions of Community or national legislation so dictate.

Compliance with permit conditions

Member States shall take the necessary measures to ensure that:
(a)
the conditions of the permit are complied with by the operator when operating the installation;
(b)
the operator regularly informs the competent authority of the results of the monitoring of releases and without delay of any incident or accident significantly affecting the environment;
(c)
operators of installations afford the representatives of the competent authority all necessary assistance to enable them to carry out any inspections within the installation, to take samples and to gather any information necessary for the performance of their duties for the purposes of this Directive.

Access to information and public participation in the permit procedure

1. Member States shall ensure that the public concerned is given early and effective opportunities to participate in the procedure for:
(a)
issuing a permit for new installations;
(b)
issuing a permit for any substantial change;
(c)
updating of a permit or permit conditions for an installation in accordance with Article 13(2)(a).
The procedure set out in Annex V shall apply for the purposes of such participation.
2. The results of monitoring of releases as required under the permit conditions referred to in Article 9 and held by the competent authority shall be made available to the public.
3. Paragraphs 1 and 2 shall apply subject to the restrictions laid down in Article 4(1), (2) and (4) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information(16).
4. When a decision has been taken, the competent authority shall inform the public in accordance with the appropriate procedures and shall make available to the public the following information:
(a)
the content of the decision, including a copy of the permit and of any conditions and any subsequent updates; and
(b)
having examined the concerns and opinions expressed by the public concerned, the reasons and considerations on which the decision is based, including information on the public participation process.

Access to justice

1. Member States shall ensure that, in accordance with the relevant national legal system, members of the public concerned have access to a review procedure before a court of law or another independent and impartial body established by law to challenge the substantive or procedural legality of decisions, acts or omissions subject to the public participation provisions of this Directive when:
(a)
they have a sufficient interest; or
(b)
they maintain the impairment of a right, where administrative procedural law of a Member State requires this as a precondition.
2. Member States shall determine at what stage the decisions, acts or omissions may be challenged.
3. What constitutes a sufficient interest and impairment of a right shall be determined by the Member States, consistently with the objective of giving the public concerned wide access to justice. To this end, the interest of any non-governmental organisation promoting environmental protection and meeting any requirements under national law shall be deemed sufficient for the purpose of paragraph 1(a).
Such organisations shall also be deemed to have rights capable of being impaired for the purpose of paragraph 1(b).
4. The provisions of this Article shall not exclude the possibility of a preliminary review procedure before an administrative authority and shall not affect the requirement of exhaustion of administrative review procedures prior to recourse to judicial review procedures, where such a requirement exists under national law.
Any such procedure shall be fair, equitable, timely and not prohibitively expensive.
5. In order to further the effectiveness of the provisions of this Article, Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

Exchange of information

1. With a view to exchanging information, Member States shall take the necessary measures to send the Commission every three years, and for the first time before 30 April 2001, the available representative data on the limit values laid down by specific category of activities in accordance with Annex I and, if appropriate, the best available techniques from which those values are derived in accordance with, in particular, Article 9. On subsequent occasions the data shall be supplemented in accordance with the procedures laid down in paragraph 3 of this Article.
2. The Commission shall organise an exchange of information between Member States and the industries concerned on best available techniques, associated monitoring, and developments in them.
Every three years the Commission shall publish the results of the exchanges of information.
3. At intervals of three years, and for the first time for the period 30 October 1999 to 30 October 2002 inclusive, Member States shall send information to the Commission on the implementation of this Directive in the form of a report. The report shall be drawn up on the basis of a questionnaire or outline drafted by the Commission in accordance with the procedure laid down in Article 6(2) of Council Directive 91/692/EEC of 23 December 1991 standardising and rationalising reports on the implementation of certain Directives relating to the environment(17). The questionnaire or outline shall be sent to the Member States six months before the start of the period covered by the report. The report shall be submitted to the Commission within nine months of the end of the three-year period covered by it.
The Commission shall publish a Community report on the implementation of the Directive within nine months of receiving the reports from the Member States.
The Commission shall submit the Community report to the European Parliament and to the Council, accompanied by proposals if necessary.
4. Member States shall establish or designate the authority or authorities which are to be responsible for the exchange of information under paragraphs 1, 2 and 3 and shall inform the Commission accordingly.

Transboundary effects

1. Where a Member State is aware that the operation of an installation is likely to have significant negative effects on the environment of another Member State, or where a Member State likely to be significantly affected so requests, the Member State in whose territory the application for a permit pursuant to Article 4 or Article 12(2) was submitted shall forward to the other Member State any information required to be given or made available pursuant to Annex V at the same time as it makes it available to its own nationals. Such information shall serve as a basis for any consultations necessary in the framework of the bilateral relations between the two Member States on a reciprocal and equivalent basis.
2. Within the framework of their bilateral relations, Member States shall see to it that in the cases referred to in paragraph 1 the applications are also made available for an appropriate period of time to the public of the Member State likely to be affected so that it will have the right to comment on them before the competent authority reaches its decision.
3. The results of any consultations pursuant to paragraphs 1 and 2 must be taken into consideration when the competent authority reaches a decision on the application.
4. The competent authority shall inform any Member State which has been consulted pursuant to paragraph 1 of the decision reached on the application and shall forward to it the information referred to in Article 15(4). That Member State shall take the measures necessary to ensure that that information is made available in an appropriate manner to the public concerned in its own territory.

Community emission limit values

1. Where the need for Community action has been identified, on the basis, in particular, of the exchange of information provided for in Article 17, the European Parliament and the Council, acting on a proposal from the Commission, shall set emission limit values, in accordance with the procedures laid down in the Treaty, for:
(a)
the categories of installations listed in Annex I except for the landfills covered by points 5,1 and 5,4 of that Annex,
and
(b)
the polluting substances referred to in Annex III.
2. In the absence of Community emission limit values defined pursuant to this Directive, the relevant emission limit values contained in the Directives listed in Annex II and in other Community legislation shall be applied as minimum emission limit values pursuant to this Directive for the installations listed in Annex I.
3. Without prejudice to the requirements of this Directive, the technical requirements applicable for the landfills covered by points 5,1 and 5,4 of Annex I, have been fixed in Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste(18).

Transitional provisions

1. The provisions of Directive 84/360/EEC, the provisions of Articles 4, 5 and 6(2) of Directive 2006/11/EC and the relevant provisions concerning authorisation systems in the Directives listed in Annex II shall apply, without prejudice to the exceptions provided for in Directive 2001/80/EC, to existing installations in respect of activities listed in Annex I until the measures required pursuant to Article 5 of this Directive have been taken by the competent authorities.
2. The relevant provisions concerning authorisation systems in the Directives listed in Annex II shall not, in respect of the activities listed in Annex I, apply to installations which are not existing installations within the meaning of point 4 of Article 2.
3. Directive 84/360/EEC shall be repealed on 30 October 2007.
Acting on a proposal from the Commission, the Council or the European Parliament and the Council shall, where necessary, amend the relevant provisions of the Directives listed in Annex II in order to adapt them to the requirements of this Directive before 30 October 2007.

Communication

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

Repeal

Directive 96/61/EC, as amended by the acts listed in Annex VI, 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 as set out in Annex VI, 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 VII.

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.

CATEGORIES OF INDUSTRIAL ACTIVITIES REFERRED TO IN ARTICLE 1

ANNEX I1. Installations or parts of installations used for research, development and testing of new products and processes are not covered by this Directive.
2. The threshold values given below generally refer to production capacities or outputs. Where one operator carries out several activities falling under the same subheading in the same installation or on the same site, the capacities of such activities are added together.
1. Energy industries1.1. Combustion installations with a rated thermal input exceeding 50 MW.
1.2. Mineral oil and gas refineries.
1.3. Coke ovens.
1.4. Coal gasification and liquefaction plants.
2. Production and processing of metals2.1. Metal ore (including sulphide ore) roasting or sintering installations.
2.2. Installations for the production of pig iron or steel (primary or secondary fusion) including continuous casting, with a capacity exceeding 2,5 tonnes per hour.
2.3. Installations for the processing of ferrous metals:

(a) | hot-rolling mills with a capacity exceeding 20 tonnes of crude steel per hour;
(b) | smitheries with hammers the energy of which exceeds 50 kilojoules per hammer, where the calorific power used exceeds 20 MW;
(c) | application of protective fused metal coats with an input exceeding 2 tonnes of crude steel per hour.2.4. Ferrous metal foundries with a production capacity exceeding 20 tonnes per day.
2.5. Installations:

(a) | for the production of non-ferrous crude metals from ore, concentrates or secondary raw materials by metallurgical, chemical or electrolytic processes;
(b) | for the smelting, including the alloyage, of non-ferrous metals, including recovered products, (refining, foundry casting, etc.) with a melting capacity exceeding 4 tonnes per day for lead and cadmium or 20 tonnes per day for all other metals.2.6. Installations for surface treatment of metals and plastic materials using an electrolytic or chemical process where the volume of the treatment vats exceeds 30 m3.
3. Mineral industry3.1. Installations for the production of cement clinker in rotary kilns with a production capacity exceeding 500 tonnes per day or lime in rotary kilns with a production capacity exceeding 50 tonnes per day or in other furnaces with a production capacity exceeding 50 tonnes per day.
3.2. Installations for the production of asbestos and the manufacture of asbestos-based products.
3.3. Installations for the manufacture of glass including glass fibre with a melting capacity exceeding 20 tonnes per day.
3.4. Installations for melting mineral substances including the production of mineral fibres with a melting capacity exceeding 20 tonnes per day.
3.5. Installations for the manufacture of ceramic products by firing, in particular roofing tiles, bricks, refractory bricks, tiles, stoneware or porcelain, with a production capacity exceeding 75 tonnes per day, and/or with a kiln capacity exceeding 4 m3and with a setting density per kiln exceeding 300 kg/m3.
4. Chemical industryProduction within the meaning of the categories of activities contained in this section means the production on an industrial scale by chemical processing of substances or groups of substances listed in points 4.1 to 4.6.
4.1. Chemical installations for the production of basic organic chemicals, such as:

(a) | simple hydrocarbons (linear or cyclic, saturated or unsaturated, aliphatic or aromatic);
(b) | oxygen-containing hydrocarbons such as alcohols, aldehydes, ketones, carboxylic acids, esters, acetates, ethers, peroxides, epoxy resins;
(c) | sulphurous hydrocarbons;
(d) | nitrogenous hydrocarbons such as amines, amides, nitrous compounds, nitro compounds or nitrate compounds, nitriles, cyanates, isocyanates;
(e) | phosphorus-containing hydrocarbons;
(f) | halogenic hydrocarbons;
(g) | organometallic compounds;
(h) | basic plastic materials (polymers, synthetic fibres and cellulose-based fibres);
(i) | synthetic rubbers;
(j) | dyes and pigments;
(k) | surface-active agents and surfactants.4.2. Chemical installations for the production of basic inorganic chemicals, such as:

(a) | gases, such as ammonia, chlorine or hydrogen chloride, fluorine or hydrogen fluoride, carbon oxides, sulphur compounds, nitrogen oxides, hydrogen, sulphur dioxide, carbonyl chloride;
(b) | acids, such as chromic acid, hydrofluoric acid, phosphoric acid, nitric acid, hydrochloric acid, sulphuric acid, oleum, sulphurous acids;
(c) | bases, such as ammonium hydroxide, potassium hydroxide, sodium hydroxide;
(d) | salts, such as ammonium chloride, potassium chlorate, potassium carbonate, sodium carbonate, perborate, silver nitrate;
(e) | non-metals, metal oxides or other inorganic compounds such as calcium carbide, silicon, silicon carbide.4.3. Chemical installations for the production of phosphorous-, nitrogen- or potassium-based fertilisers (simple or compound fertilisers).
4.4. Chemical installations for the production of basic plant health products and of biocides.
4.5. Installations using a chemical or biological process for the production of basic pharmaceutical products.
4.6. Chemical installations for the production of explosives.
5. Waste managementWithout prejudice to Article 11 of Directive 2006/12/EC or Article 3 of Council Directive 91/689/EEC of 12 December 1991 on hazardous waste(1):
5.1. Installations for the disposal or recovery of hazardous waste as defined in the list referred to in Article 1(4) of Directive 91/689/EEC, as defined in Annexes II A and II B (operations R1, R5, R6, R8 and R9) to Directive 2006/12/EC and in Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils(2), with a capacity exceeding 10 tonnes per day.
5.2. Installations for the incineration of municipal waste (household waste and similar commercial, industrial and institutional wastes) with a capacity exceeding 3 tonnes per hour.
5.3. Installations for the disposal of non-hazardous waste as defined in Annex II A to Directive 2006/12/EC under headings D8 and D9, with a capacity exceeding 50 tonnes per day.
5.4. Landfills receiving more than 10 tonnes per day or with a total capacity exceeding 25 000 tonnes, excluding landfills of inert waste.
6. Other activities6.1. Industrial plants for the production of:

(a) | pulp from timber or other fibrous materials;
(b) | paper and cardboard with a production capacity exceeding 20 tonnes per day.6.2. Plants for the pre-treatment (operations such as washing, bleaching, mercerisation) or dyeing of fibres or textiles where the treatment capacity exceeds 10 tonnes per day.
6.3. Plants for the tanning of hides and skins where the treatment capacity exceeds 12 tonnes of finished products per day.
6.4.

(a) | Slaughterhouses with a carcase production capacity greater than 50 tonnes per day.
(b) | Treatment and processing intended for the production of food products from:—animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day,—vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis). | — | animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day, | — | vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis).
— | animal raw materials (other than milk) with a finished product production capacity greater than 75 tonnes per day,
— | vegetable raw materials with a finished product production capacity greater than 300 tonnes per day (average value on a quarterly basis).
(c) | Treatment and processing of milk, the quantity of milk received being greater than 200 tonnes per day (average value on an annual basis).6.5. Installations for the disposal or recycling of animal carcases and animal waste with a treatment capacity exceeding 10 tonnes per day.
6.6. Installations for the intensive rearing of poultry or pigs with more than:

(a) | 40 000 places for poultry;
(b) | 2 000 places for production pigs (over 30 kg); or
(c) | 750 places for sows.6.7. Installations for the surface treatment of substances, objects or products using organic solvents, in particular for dressing, printing, coating, degreasing, waterproofing, sizing, painting, cleaning or impregnating, with a consumption capacity of more than 150 kg per hour or more than 200 tonnes per year.
6.8. Installations for the production of carbon (hard-burnt coal) or electrographite by means of incineration or graphitisation.

(1)
OJ L 377, 31.12.1991, p. 20. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).
(2)
OJ L 194, 25.7.1975, p. 23. Directive as last amended by Directive 2000/76/EC of the European Parliament and of the Council (OJ L 332, 28.12.2000, p. 91).

LIST OF THE DIRECTIVES REFERRED TO IN ARTICLES 19(2), (3) AND 20

ANNEX II
1. | Council Directive 87/217/EEC of 19 March 1987 on the prevention and reduction of environmental pollution by asbestos.
2. | Council Directive 82/176/EEC of 22 March 1982 on limit values and quality objectives for mercury discharges by the chlor-alkali electrolysis industry.
3. | Council Directive 83/513/EEC of 26 September 1983 on limit values and quality objectives for cadmium discharges.
4. | Council Directive 84/156/EEC of 8 March 1984 on limit values and quality objectives for mercury discharges by sectors other than the chlor-alkali electrolysis industry.
5. | Council Directive 84/491/EEC of 9 October 1984 on limit values and quality objectives for discharges of hexachlorocyclohexane.
6. | Council Directive 86/280/EEC of 12 June 1986 on limit values and quality objectives for discharges of certain dangerous substances included in List I of the Annex to Directive 76/464/EEC.
7. | Directive 2000/76/EC of the European Parliament and of the Council of 4 December 2000 on the incineration of waste.
8. | Council Directive 92/112/EEC of 15 December 1992 on procedures for harmonising the programmes for the reduction and eventual elimination of pollution caused by waste from the titanium dioxide industry.
9. | Directive 2001/80/EC of the European Parliament and of the Council of 23 October 2001 on the limitation of emissions of certain pollutants into the air from large combustion plants.
10. | Directive 2006/11/EC of the European Parliament and of the Council of 15 February 2006 on pollution caused by certain dangerous substances discharged into the aquatic environment of the Community.
11. | Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste.
12. | Council Directive 75/439/EEC of 16 June 1975 on the disposal of waste oils.
13. | Council Directive 91/689/EEC of 12 December 1991 on hazardous waste.
14. | Council Directive 1999/31/EC of 26 April 1999 on the landfill of waste.

INDICATIVE LIST OF THE MAIN POLLUTING SUBSTANCES TO BE TAKEN INTO ACCOUNT IF THEY ARE RELEVANT FOR FIXING EMISSION LIMIT VALUES

ANNEX IIIAir
| 1. | Sulphur dioxide and other sulphur compounds.
| 2. | Oxides of nitrogen and other nitrogen compounds.
| 3. | Carbon monoxide.
| 4. | Volatile organic compounds.
| 5. | Metals and their compounds.
| 6. | Dust.
| 7. | Asbestos (suspended particulates, fibres).
| 8. | Chlorine and its compounds.
| 9. | Fluorine and its compounds.
| 10. | Arsenic and its compounds.
| 11. | Cyanides.
| 12. | Substances and preparations which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction via the air.
| 13. | Polychlorinated dibenzodioxins and polychlorinated dibenzofurans.Water
| 1. | Organohalogen compounds and substances which may form such compounds in the aquatic environment.
| 2. | Organophosphorus compounds.
| 3. | Organotin compounds.
| 4. | Substances and preparations which have been proved to possess carcinogenic or mutagenic properties or properties which may affect reproduction in or via the aquatic environment.
| 5. | Persistent hydrocarbons and persistent and bioaccumulable organic toxic substances.
| 6. | Cyanides.
| 7. | Metals and their compounds.
| 8. | Arsenic and its compounds.
| 9. | Biocides and plant health products.
| 10. | Materials in suspension.
| 11. | Substances which contribute to eutrophication (in particular, nitrates and phosphates).
| 12. | Substances which have an unfavourable influence on the oxygen balance (and can be measured using parameters such as BOD, COD, etc.).
ANNEX IVConsiderations to be taken into account generally or in specific cases when determining best available techniques, as defined in Article 2(12), bearing in mind the likely costs and benefits of a measure and the principles of precaution and prevention:

1. | the use of low-waste technology;
2. | the use of less hazardous substances;
3. | the furthering of recovery and recycling of substances generated and used in the process and of waste, where appropriate;
4. | comparable processes, facilities or methods of operation which have been tried with success on an industrial scale;
5. | technological advances and changes in scientific knowledge and understanding;
6. | the nature, effects and volume of the emissions concerned;
7. | the commissioning dates for new or existing installations;
8. | the length of time needed to introduce the best available technique;
9. | the consumption and nature of raw materials (including water) used in the process and energy efficiency;
10. | the need to prevent or reduce to a minimum the overall impact of the emissions on the environment and the risks to it;
11. | the need to prevent accidents and to minimise the consequences for the environment;
12. | the information published by the Commission pursuant to Article 17(2), second subparagraph, or by international organisations.

PUBLIC PARTICIPATION IN DECISION-MAKING

ANNEX V
| 1. | The public shall be informed (by public notices or other appropriate means such as electronic media where available) of the following matters early in the procedure for the taking of a decision or, at the latest, as soon as the information can reasonably be provided:(a)the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1);(b)where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18;(c)details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions;(d)the nature of possible decisions or, where there is one, the draft decision;(e)where applicable, the details relating to a proposal for the updating of a permit or of permit conditions;(f)an indication of the times and places where, or means by which, the relevant information will be made available;(g)details of the arrangements for public participation and consultation made pursuant to point 5. | (a) | the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1); | (b) | where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18; | (c) | details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions; | (d) | the nature of possible decisions or, where there is one, the draft decision; | (e) | where applicable, the details relating to a proposal for the updating of a permit or of permit conditions; | (f) | an indication of the times and places where, or means by which, the relevant information will be made available; | (g) | details of the arrangements for public participation and consultation made pursuant to point 5.
(a) | the application for a permit or, as the case may be, the proposal for the updating of a permit or of permit conditions in accordance with Article 15(1), including the description of the elements listed in Article 6(1);
(b) | where applicable, the fact that a decision is subject to a national or transboundary environmental impact assessment or to consultations between Member States in accordance with Article 18;
(c) | details of the competent authorities responsible for taking the decision, those from which relevant information can be obtained, those to which comments or questions can be submitted, and details of the time schedule for transmitting comments or questions;
(d) | the nature of possible decisions or, where there is one, the draft decision;
(e) | where applicable, the details relating to a proposal for the updating of a permit or of permit conditions;
(f) | an indication of the times and places where, or means by which, the relevant information will be made available;
(g) | details of the arrangements for public participation and consultation made pursuant to point 5.
| 2. | Member States shall ensure that, within appropriate time-frames, the following is made available to the public concerned:(a)in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1;(b)in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1. | (a) | in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1; | (b) | in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1.
(a) | in accordance with national legislation, the main reports and advice issued to the competent authority or authorities at the time when the public concerned were informed in accordance with point 1;
(b) | in accordance with the provisions of Directive 2003/4/EC, information other than that referred to in point 1 which is relevant for the decision in accordance with Article 8 and which only becomes available after the time the public concerned was informed in accordance with point 1.
| 3. | The public concerned shall be entitled to express comments and opinions to the competent authority before a decision is taken.
| 4. | The results of the consultations held pursuant to this Annex must be taken into due account in the taking of a decision.
| 5. | The detailed arrangements for informing the public (for example by bill posting within a certain radius or publication in local newspapers) and consulting the public concerned (for example by written submissions or by way of a public inquiry) shall be determined by the Member States. Reasonable time-frames for the different phases shall be provided, allowing sufficient time for informing the public and for the public concerned to prepare and participate effectively in environmental decision-making subject to the provisions of this Annex.
ANNEX VIPART ARepealed Directive with its successive amendments (referred to in Article 22)
Council Directive 96/61/EC(OJ L 257, 10.10.1996, p. 26). |
Directive 2003/35/EC of the European Parliament and of the Council(OJ L 156, 25.6.2003, p. 17). | only Article 4 and Annex II
Directive 2003/87/EC of the European Parliament and of the Council(OJ L 275, 25.10.2003, p. 32). | only Article 26
Regulation (EC) No 1882/2003 of the European Parliament and of the Council(OJ L 284, 31.10.2003, p. 1). | only point (61) of Annex III
Regulation (EC) No 166/2006 of the European Parliament and of the Council(OJ L 33, 4.2.2006, p. 1). | only Article 21(2)
PART BList of time-limits for transposition into national law (referred to in Article 22)
Directive | Time-limit for transposition
96/61/EC | 30 October 1999
2003/35/EC | 25 June 2005
2003/87/EC | 31 December 2003
ANNEX VIICORRELATION TABLE
Directive 96/61/EC | This Directive
Article 1 | Article 1
Article 2, introductory words | Article 2, introductory words
Article 2(1-9) | Article 2(1-9)
Article 2(10)(a) | Article 2(10)
Article 2(10)(b) | Article 2(11)
Article 2(11), first subparagraph, introductory wording | Article 2(12), first subparagraph, introductory wording
Article 2(11), first subparagraph, first indent | Article 2(12), first subparagraph, (a)
Article 2(11), first subparagraph, second indent | Article 2(12), first subparagraph, (b)
Article 2(11), first subparagraph, third indent | Article 2(12), first subparagraph, (c)
Article 2(11), second subparagraph | Article 2(12), second subparagraph
Article 2(12) | Article 2(13)
Article 2(13) | Article 2(14)
Article 2(14) | Article 2(15)
Article 3, first subparagraph | Article 3(1)
Article 3, second subparagraph | Article 3(2)
Article 4 | Article 4
Article 5 | Article 5
Article 6(1), first subparagraph, introductory wording | Article 6(1), first subparagraph, introductory wording
Article 6(1), first subparagraph, first to tenth indent | Article 6(1), first subparagraph, (a) to (j)
Article 6(1), second subparagraph | Article 6(1), second subparagraph
Article 6(2) | Article 6(2)
Article 7 to 12 | Article 7 to 12
Article 13(1) | Article 13(1)
Article 13(2), introductory wording | Article 13(2), introductory wording
Article 13(2), first to fourth indent | Article 13(2)(a) to (d)
Article 14, introductory wording | Article 14, introductory wording
Article 14, first to third indent | Article 14(a) to (c)
Article 15(1), first subparagraph, introductory wording | Article 15(1), first subparagraph, introductory wording
Article 15(1), first subparagraph, first to third indent | Article 15(1), first subparagraph, (a) to (c)
Article 15(1), second subparagraph | Article 15(1), second subparagraph
Article 15(2) | Article 15(2)
Article 15(4) | Article 15(3)
Article 15(5) | Article 15(4)
Article 15a, first subparagraph, introductory and final words | Article 16(1)
Article 15a, first subparagraph, (a) and (b) | Article 16(1)(a) and (b)
Article 15a, second subparagraph | Article 16(2)
Article 15a, third subparagraph, first and second sentence | Article 16(3), first subparagraph
Article 15a, third subparagraph, third sentence | Article 16(3), second subparagraph
Article 15a, fourth subparagraph | Article 16(4), first subparagraph
Article 15a, fifth subparagraph | Article 16(4), second subparagraph
Article 15a, sixth subparagraph | Article 16(5)
Article 16 | Article 17
Article 17 | Article 18
Article 18(1), introductory and final words | Article 19(1)
Article 18(1), first and second indent | Article 19(1)(a) and (b)
Article 18(2), first subparagraph | Article 19(2)
Article 18(2), second subparagraph | Article 19(3)
Article 19 | —
Article 20(1) | Article 20(1)
Article 20(2) | Article 20(2)
Article 20(3), first subparagraph | Article 20(3), first subparagraph
Article 20(3), second subparagraph | —
Article 20(3), third subparagraph | Article 20(3), second subparagraph
Article 21(1) | —
Article 21(2) | Article 21
— | Article 22
Article 22 | Article 23
Article 23 | Article 24
Annex I | Annex I
Annex II | Annex II
Annex III | Annex III
Annex IV | Annex IV
Annex V | Annex V
— | Annex VI
— | Annex VII

Pending: 32007L0068

January 16, 2026
28.11.2007 EN Official Journal of the European Union L 310/11
(1) Annex IIIa to Directive 2000/13/EC establishes a list of food ingredients which must be indicated on the label of foodstuffs as they are likely to cause adverse reactions in susceptible individuals.
(2) Directive 2000/13/EC provides for the possibility of excluding from the labelling requirement ingredients or substances derived from ingredients listed in Annex IIIa for which it has been scientifically established that they are not likely, under specific circumstances, to trigger adverse reactions.
(3) Commission Directive 2005/26/EC(2)establishes the list of food ingredients or substances provisionally excluded from the labelling requirement until the 25 November 2007.
(4) A number of applications for permanent exemption from the labelling requirement have been submitted to the European Food Safety Authority (EFSA). Those applications concern substances for which provisional exemptions were granted by Directive 2005/26/EC. On the basis of the EFSA opinions and other available information, it can be concluded that certain ingredients or substances derived from those ingredients listed in Annex IIIa to Directive 2000/13/EC are not likely, under specific circumstances, to cause adverse reactions in susceptible individuals.
(5) Those ingredients or substances derived from those ingredients should therefore be permanently excluded from Annex IIIa to Directive 2000/13/EC.
(6) Annex IIIa of Directive 2000/13/EC should be amended accordingly.
(7) Directive 2005/26/EC should be repealed on 26 November 2007 in view of the deadline set by Article 6(11), second subparagraph of Directive 2000/13/EC.
(8) In order to avoid disruption of the market, it is necessary for this Directive to apply from the 26 November 2007.
(9) It was expected that this Directive could be adopted and published well in advance of the date of 26 November 2007 in order to give time to the industry to adapt to the new rules. Since this has not been possible in practice, temporary measures appear therefore necessary to facilitate the application of the new rules. Indeed changes in labelling rules will affect industry, mainly small and medium enterprises, which need an adaptation period to smooth the transition towards new labelling requirements.
(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,
1. Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof, except:(a)wheat-based glucose syrups including dextrose(1);(b)wheat-based maltodextrins(1);(c)glucose syrups based on barley;(d)cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages. (a) wheat-based glucose syrups including dextrose(1); (b) wheat-based maltodextrins(1); (c) glucose syrups based on barley; (d) cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
(a) wheat-based glucose syrups including dextrose(1);
(b) wheat-based maltodextrins(1);
(c) glucose syrups based on barley;
(d) cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
(a) wheat-based glucose syrups including dextrose(1);
(b) wheat-based maltodextrins(1);
(c) glucose syrups based on barley;
(d) cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
2. Crustaceans and products thereof.
3. Eggs and products thereof.
4. Fish and products thereof, except:(a)fish gelatine used as carrier for vitamin or carotenoid preparations;(b)fish gelatine or Isinglass used as fining agent in beer and wine. (a) fish gelatine used as carrier for vitamin or carotenoid preparations; (b) fish gelatine or Isinglass used as fining agent in beer and wine.
(a) fish gelatine used as carrier for vitamin or carotenoid preparations;
(b) fish gelatine or Isinglass used as fining agent in beer and wine.
(a) fish gelatine used as carrier for vitamin or carotenoid preparations;
(b) fish gelatine or Isinglass used as fining agent in beer and wine.
5. Peanuts and products thereof.
6. Soybeans and products thereof, except:(a)fully refined soybean oil and fat(1);(b)natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources;(c)vegetable oils derived phytosterols and phytosterol esters from soybean sources;(d)plant stanol ester produced from vegetable oil sterols from soybean sources. (a) fully refined soybean oil and fat(1); (b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources; (c) vegetable oils derived phytosterols and phytosterol esters from soybean sources; (d) plant stanol ester produced from vegetable oil sterols from soybean sources.
(a) fully refined soybean oil and fat(1);
(b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources;
(c) vegetable oils derived phytosterols and phytosterol esters from soybean sources;
(d) plant stanol ester produced from vegetable oil sterols from soybean sources.
(a) fully refined soybean oil and fat(1);
(b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources;
(c) vegetable oils derived phytosterols and phytosterol esters from soybean sources;
(d) plant stanol ester produced from vegetable oil sterols from soybean sources.
7. Milk and products thereof (including lactose), except:(a)whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;(b)lactitol. (a) whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages; (b) lactitol.
(a) whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;
(b) lactitol.
(a) whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;
(b) lactitol.
8. Nuts, i.e. almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoiesis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia nuts and Queensland nuts (Macadamia ternifolia), and products thereof, except:(a)nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages. (a) nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
(a) nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
(a) nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
9. Celery and products thereof.
10. Mustard and products thereof.
11. Sesame seeds and products thereof.
12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.
13. Lupin and products thereof.
14. Molluscs and products thereof.’
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1), and in particular third subparagraph of Article 6(11) and Article 21 thereof,
(1) Annex IIIa to Directive 2000/13/EC establishes a list of food ingredients which must be indicated on the label of foodstuffs as they are likely to cause adverse reactions in susceptible individuals.
(2) Directive 2000/13/EC provides for the possibility of excluding from the labelling requirement ingredients or substances derived from ingredients listed in Annex IIIa for which it has been scientifically established that they are not likely, under specific circumstances, to trigger adverse reactions.
(3) Commission Directive 2005/26/EC(2)establishes the list of food ingredients or substances provisionally excluded from the labelling requirement until the 25 November 2007.
(4) A number of applications for permanent exemption from the labelling requirement have been submitted to the European Food Safety Authority (EFSA). Those applications concern substances for which provisional exemptions were granted by Directive 2005/26/EC. On the basis of the EFSA opinions and other available information, it can be concluded that certain ingredients or substances derived from those ingredients listed in Annex IIIa to Directive 2000/13/EC are not likely, under specific circumstances, to cause adverse reactions in susceptible individuals.
(5) Those ingredients or substances derived from those ingredients should therefore be permanently excluded from Annex IIIa to Directive 2000/13/EC.
(6) Annex IIIa of Directive 2000/13/EC should be amended accordingly.
(7) Directive 2005/26/EC should be repealed on 26 November 2007 in view of the deadline set by Article 6(11), second subparagraph of Directive 2000/13/EC.
(8) In order to avoid disruption of the market, it is necessary for this Directive to apply from the 26 November 2007.
(9) It was expected that this Directive could be adopted and published well in advance of the date of 26 November 2007 in order to give time to the industry to adapt to the new rules. Since this has not been possible in practice, temporary measures appear therefore necessary to facilitate the application of the new rules. Indeed changes in labelling rules will affect industry, mainly small and medium enterprises, which need an adaptation period to smooth the transition towards new labelling requirements.
(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 IIIa to Directive 2000/13/EC is replaced by the text in the Annex to this Directive as from 26 November 2007.

Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 May 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and 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
Directive 2005/26/EC shall be repealed on 26 November 2007.
Member States shall allow foodstuffs placed on the market or labelled before 31 May 2009 that comply with the provisions of Directive 2005/26/EC to be marketed until stocks are exhausted.

Article 4
This Directive shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.

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 Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs(1), and in particular third subparagraph of Article 6(11) and Article 21 thereof,
(1) Annex IIIa to Directive 2000/13/EC establishes a list of food ingredients which must be indicated on the label of foodstuffs as they are likely to cause adverse reactions in susceptible individuals.
(2) Directive 2000/13/EC provides for the possibility of excluding from the labelling requirement ingredients or substances derived from ingredients listed in Annex IIIa for which it has been scientifically established that they are not likely, under specific circumstances, to trigger adverse reactions.
(3) Commission Directive 2005/26/EC(2)establishes the list of food ingredients or substances provisionally excluded from the labelling requirement until the 25 November 2007.
(4) A number of applications for permanent exemption from the labelling requirement have been submitted to the European Food Safety Authority (EFSA). Those applications concern substances for which provisional exemptions were granted by Directive 2005/26/EC. On the basis of the EFSA opinions and other available information, it can be concluded that certain ingredients or substances derived from those ingredients listed in Annex IIIa to Directive 2000/13/EC are not likely, under specific circumstances, to cause adverse reactions in susceptible individuals.
(5) Those ingredients or substances derived from those ingredients should therefore be permanently excluded from Annex IIIa to Directive 2000/13/EC.
(6) Annex IIIa of Directive 2000/13/EC should be amended accordingly.
(7) Directive 2005/26/EC should be repealed on 26 November 2007 in view of the deadline set by Article 6(11), second subparagraph of Directive 2000/13/EC.
(8) In order to avoid disruption of the market, it is necessary for this Directive to apply from the 26 November 2007.
(9) It was expected that this Directive could be adopted and published well in advance of the date of 26 November 2007 in order to give time to the industry to adapt to the new rules. Since this has not been possible in practice, temporary measures appear therefore necessary to facilitate the application of the new rules. Indeed changes in labelling rules will affect industry, mainly small and medium enterprises, which need an adaptation period to smooth the transition towards new labelling requirements.
(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 IIIa to Directive 2000/13/EC is replaced by the text in the Annex to this Directive as from 26 November 2007.
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 May 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and 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.
Directive 2005/26/EC shall be repealed on 26 November 2007.
Member States shall allow foodstuffs placed on the market or labelled before 31 May 2009 that comply with the provisions of Directive 2005/26/EC to be marketed until stocks are exhausted.
This Directive shall enter into force on the day following that of its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.
ANNEX
‘ANNEX IIIa
Ingredients referred to in Article 6(3a), (10) and (11) 1. Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof, except:
(a) wheat-based glucose syrups including dextrose (1);
(b) wheat-based maltodextrins (1);
(c) glucose syrups based on barley;
(d) cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages. 2. Crustaceans and products thereof. 3. Eggs and products thereof. 4. Fish and products thereof, except:
(a) fish gelatine used as carrier for vitamin or carotenoid preparations;
(b) fish gelatine or Isinglass used as fining agent in beer and wine. 5. Peanuts and products thereof. 6. Soybeans and products thereof, except:
(a) fully refined soybean oil and fat (1);
(b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources;
(c) vegetable oils derived phytosterols and phytosterol esters from soybean sources;
(d) plant stanol ester produced from vegetable oil sterols from soybean sources. 7. Milk and products thereof (including lactose), except:
(a) whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;
(b) lactitol. 8. Nuts, i.e. almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoiesis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia nuts and Queensland nuts (Macadamia ternifolia), and products thereof, except:
(a) nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages. 9. Celery and products thereof. 10. Mustard and products thereof. 11. Sesame seeds and products thereof. 12. Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2. 13. Lupin and products thereof. 14. Molluscs and products thereof.’

(1) And products thereof, insofar as the process that they have undergone is not likely to increase the level of allergenicity assessed by the EFSA for the relevant product from which they originated.

Pending: 32007L0058

January 16, 2026
3.12.2007 EN Official Journal of the European Union L 315/44
(1) Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways(4)was designed to facilitate the adaptation of the Community’s railways to the requirements of the single market and to improve their efficiency.
(2) Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure(5)concerns the principles and procedures to be applied with regard to the setting and charging of railway infrastructure charges and the allocation of railway infrastructure capacity.
(3) In its White Paper European transport policy for 2010: time to decide, the Commission announced its intention to continue building the internal market in rail services by proposing to open up the market in international passenger services.
(4) The aim of this Directive is to address the opening of the market for international rail passenger services within the Community, and it should therefore not concern services between a Member State and a third country. In addition, Member States should be able to exclude from the scope of this Directive services transiting the Community.
(5) International rail services currently present a very contrasting picture. Long-distance services (for instance night trains) are in difficulty and several of them have recently been withdrawn by the railway undertakings operating them in order to limit losses. The market for international high-speed services, on the other hand, has seen a sharp increase in traffic and will continue its vigorous development with the doubling and interconnection of the trans-European high-speed network by 2010. Nevertheless, there is strong competitive pressure from low-cost airlines in both cases. It is therefore essential to stimulate new initiatives by promoting competition between railway undertakings.
(6) It is not possible to open up the market in international passenger services without detailed provisions on infrastructure access, substantial progress on interoperability and a strict framework for rail safety at national and European level. All of these elements are now in place following the transposition of Directive 2001/12/EC(6)of the European Parliament and of the Council of 26 February 2001 amending Council Directive 91/440/EEC, Directive 2004/51/EC(7)of the European Parliament and of the Council of 29 April 2004 amending Council Directive 91/440/EEC, Directive 2001/13/EC(8)of the European Parliament and of the Council of 26 February 2001 amending Council Directive 95/18/EC, Directive 2001/14/EC, and Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways(9). It is necessary for this new regulatory framework to be supported by established, consolidated practice by the proposed date for opening up the market for international passenger services. This will require a certain time. The target date for opening up the market should therefore be 1 January 2010.
(7) The number of railway services without intermediate stops is very limited. In the case of journeys with intermediate stops, it is essential to authorise new market entrants to pick up and set down passengers along the route in order to ensure that such operations have a realistic chance of being economically viable and to avoid placing potential competitors at a disadvantage to existing operators, which have the right to pick up and set down passengers along the route. This right should be without prejudice to Community and national regulations concerning competition policy.
(8) The introduction of new, open-access, international services with intermediate stops should not be used to bring about the opening of the market for domestic passenger services, but should merely be focused on stops that are ancillary to the international route. On that basis, their introduction should concern services whose principal purpose is to carry passengers travelling on an international journey. The determination of whether that is the service’s principal purpose should take into account criteria such as the proportion of turnover, and of volume, derived from transport of domestic or international passengers, and the length of the service. This determination should be made by the respective national regulatory body at the request of an interested party.
(9) Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road(10)authorises Member States and local authorities to award public service contracts. These contracts may contain exclusive rights to operate certain services. It is therefore necessary to ensure that the provisions of that Regulation are consistent with the principle of opening up international passenger services to competition.
(10) Opening up international passenger services, which include the right to pick up passengers at any station located on the route of an international service and to set them down at another, including stations located in the same Member State, to competition may have implications for the organisation and financing of rail passenger services provided under a public service contract. Member States should have the possibility to limit the right of access to the market where this right would compromise the economic equilibrium of these public service contracts and where approval is given by the relevant regulatory body referred to in Article 30 of Directive 2001/14/EC on the basis of an objective economic analysis, following a request from the competent authorities that awarded the public service contract.
(11) Some Member States have already moved towards opening up the market for rail passenger services by transparent, open competitive tendering for the provision of certain such services. They should not have to provide full open access to international passenger services, since this competition for the right to use certain rail routes has involved a sufficient test of the market value of running those services.
(12) The assessment of whether the economic equilibrium of the public service contract could be compromised should take into account predetermined criteria such as the impact on the profitability of any services which are included in a public service contract, including consequential impacts on the net cost to the competent public authority that awarded the contract, passenger demand, ticket pricing, ticketing arrangements, location and number of stops on both sides of the border and timing and frequency of the proposed new service. Respecting such an assessment and the decision of the relevant regulatory body, Member States might authorise, modify or deny the right of access for the international passenger service sought, including the levying of a charge on the operator of a new international passenger service, in line with the economic analysis and in accordance with Community law and the principles of equality and non-discrimination.
(13) In order to contribute to the operation of passenger services on lines fulfilling a public service obligation, Member States should be able to authorise the authorities responsible for those services to impose a levy on passenger services which fall within the jurisdiction of those authorities. That levy should contribute to the financing of public service obligations laid down in public service contracts awarded in conformity with Community law. It should be imposed in accordance with Community law, and in particular with the principles of fairness, transparency, non-discrimination and proportionality.
(14) The regulatory body should function in a way which avoids any conflict of interests and any possible involvement in the award of the public service contract under consideration. In particular, if for organisational or legal purposes it is closely linked to the competent authority involved in the award of the public service contract under consideration, its functional independence should be ensured. The competence of the regulatory body should be extended to allow the assessment of the purpose of an international service and, where appropriate, the potential economic impact on existing public service contracts.
(15) This Directive constitutes a further phase of the opening of the rail market. Some Member States have already opened up the market for international passenger services on their territory. In this context, this Directive should not be understood as creating obligations for those Member States to grant, before 1 January 2010, access rights to railway undertakings licensed in a Member State where similar rights are not granted.
(16) In order to encourage investment for services using specialised infrastructure, such as high-speed railway lines, applicants need to be able to plan and require legal certainty reflecting the substantial long-term investment involved. It should therefore be possible for those undertakings normally to conclude framework agreements with a term of up to 15 years.
(17) The national regulatory bodies should, on the basis of Article 31 of Directive 2001/14/EC, exchange information and, where relevant in individual cases, coordinate the principles and practice of assessing whether the economic equilibrium of a public service contract is compromised. They should progressively develop guidelines based on their experience.
(18) The application of this Directive should be evaluated on the basis of a report to be presented by the Commission two years after the date of opening up the market in international passenger services. This report should also assess the development of the market, including the state of the preparation of a further opening-up of the passenger rail market. In this report the Commission should also analyse the different models for organising this market and the impact of this Directive on public service contracts and their financing. In so doing, the Commission should take into account the implementation of Regulation (EC) No 1370/2007 and the intrinsic differences between Member States (density of networks, number of passengers, average travel distance). In its report the Commission should, if appropriate, propose complementary measures to facilitate any such opening, and should assess the impact of any such measures.
(19) The measures necessary for the implementation of Directives 91/440/EEC and 2001/14/EC 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(11).
(20) In particular, the Commission should be empowered to adapt the Annexes to those Directives. Since those measures are of general scope and are designed to amend non-essential elements of those Directives, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(21) A Member State which has no railway system, and no immediate prospect of having one, would be under a disproportionate and pointless obligation if it had to transpose and implement Directives 91/440/EEC and 2001/14/EC. Therefore, such Member States should be exempted, for as long as they have no railway system, from the obligation to transpose and implement these Directives.
(22) Since the objective of this Directive, namely the development of the Community’s railways, cannot be sufficiently achieved by the Member States, given the need to ensure fair and non-discriminatory conditions of access to infrastructure and to take account of the obviously international dimension of the way in which important parts of the rail networks operate, as well as the need for coordinated transnational action, and can therefore 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 that objective.
(23) In accordance with point 34 of the Interinstitutional Agreement on better law-making(12), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
(24) Directives 91/440/EEC and 2001/14/EC should therefore be amended accordingly,
1. the following paragraph shall be added to Article 2:‘4.   Member States may exclude from the scope of this Directive any railway service carried out in transit through the Community and which begins and ends outside the Community territory.’;
2. the fourth indent of Article 3 shall be deleted;
3. the following indent shall be inserted in Article 3 after the fifth indent:‘—“international passenger service” shall mean a passenger service where the train crosses at least one border of a Member State and where the principal purpose of the service is to carry passengers between stations located in different Member States; the train may be joined and/or split, and the different sections may have different origins and destinations, provided that all carriages cross at least one border’; ‘— “international passenger service” shall mean a passenger service where the train crosses at least one border of a Member State and where the principal purpose of the service is to carry passengers between stations located in different Member States; the train may be joined and/or split, and the different sections may have different origins and destinations, provided that all carriages cross at least one border’;
‘— “international passenger service” shall mean a passenger service where the train crosses at least one border of a Member State and where the principal purpose of the service is to carry passengers between stations located in different Member States; the train may be joined and/or split, and the different sections may have different origins and destinations, provided that all carriages cross at least one border’;
‘— “international passenger service” shall mean a passenger service where the train crosses at least one border of a Member State and where the principal purpose of the service is to carry passengers between stations located in different Member States; the train may be joined and/or split, and the different sections may have different origins and destinations, provided that all carriages cross at least one border’;
4. the following indent shall be inserted in Article 3 after the sixth indent:‘—“transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’; ‘— “transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
‘— “transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
‘— “transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
5. the first indent of Article 5(3) shall be deleted;
6. the phrase ‘and international groupings’ shall be deleted in Article 8(1);
7. Article 10(1) shall be deleted;
8. the following paragraphs shall be inserted in Article 10:‘3a.   Railway undertakings within the scope of Article 2 shall be granted by 1 January 2010 the right of access to the infrastructure in all Member States for the purpose of operating an international passenger service. Railway undertakings shall, in the course of an international passenger service, have the right to pick up passengers at any station located on the international route and set them down at another, including stations located in the same Member State.The right of access to the infrastructure of the Member States for which the share of international carriage of passengers by train constitutes more than half of the passenger turnover of railway undertakings in that Member State shall be granted by 1 January 2012.Whether the principal purpose of the service is to carry passengers between stations located in different Member States shall be determined by the relevant regulatory body or bodies referred to in Article 30 of Directive 2001/14/EC following a request from the relevant competent authorities and/or interested railway undertakings.3b.   Member States may limit the right of access defined in paragraph 3a on services between a place of departure and a destination which are covered by one or more public service contracts conforming to the Community legislation in force. Such limitation may not have the effect of restricting the right to pick up passengers at any station located on the route of an international service and to set them down at another, including stations located in the same Member State, except where the exercise of this right would compromise the economic equilibrium of a public service contract.Whether the economic equilibrium would be compromised shall be determined by the relevant regulatory body or bodies referred to in Article 30 of Directive 2001/14/EC on the basis of an objective economic analysis and based on pre-determined criteria, following a request from:—the competent authority or competent authorities that awarded the public service contract,—any other interested competent authority with the right to limit access under this Article,—the infrastructure manager, or—the railway undertaking performing the public service contract.The competent authorities and the railway undertakings providing the public services shall provide the relevant regulatory body or bodies with the information reasonably required to reach a decision. The regulatory body shall consider the information provided, consulting all the relevant parties as appropriate, and shall inform the relevant parties of its reasoned decision within a pre-determined, reasonable time, and, in any case, within two months of receipt of all relevant information. The regulatory body shall give the grounds for its decision and specify the time period within which, and the conditions under which,—the relevant competent authority or competent authorities,—the infrastructure manager,—the railway undertaking performing the public service contract, or—the railway undertaking seeking access;may request a reconsideration of the decision.3c.   Member States may also limit the right to pick up and set down passengers at stations within the same Member State on the route of an international passenger service where an exclusive right to convey passengers between those stations has been granted under a concession contract awarded before 4 December 2007 on the basis of a fair competitive tendering procedure and in accordance with the relevant principles of Community law. This limitation may continue for the original duration of the contract, or 15 years, whichever is the shorter.3d.   The provisions of this Directive shall not require a Member State to grant, before 1 January 2010, the right of access referred to in paragraph 3a to railway undertakings and their directly or indirectly controlled subsidiaries, licensed in a Member State where access rights of a similar nature are not granted.3e.   Member States shall take the necessary measures to ensure that the decisions referred to in paragraphs 3b, 3c and 3d are subject to judicial review.3f.   Without prejudice to paragraph 3b, Member States may, under the conditions laid down in this Article, authorise the authority responsible for rail passenger transport to impose a levy on railway undertakings providing passenger services for the operation of routes which fall within the jurisdiction of that authority and which are operated between two stations in that Member State.In that case, railway undertakings providing domestic or international rail passenger transport services shall be subject to the same levy on the operation of routes which fall within the jurisdiction of that authority.The levy is intended to compensate the authority for public service obligations laid down in public service contracts awarded in conformity with Community law. The revenue raised from such levy and paid as compensation may not exceed what is necessary to cover all or part of the cost incurred in the relevant public service obligations taking into account the relevant receipts and a reasonable profit for discharging those obligations.The levy shall be imposed in accordance with Community law, and shall respect in particular the principles of fairness, transparency, non-discrimination and proportionality, in particular between the average price of the service to the passenger and the level of the levy. The total levies imposed pursuant to this paragraph shall not endanger the economic viability of the rail passenger transport service on which they are imposed.The relevant authorities shall keep the information necessary to ensure that the origin of the levies and their use can be traced. Member States shall provide the Commission with this information.’; — the competent authority or competent authorities that awarded the public service contract, — any other interested competent authority with the right to limit access under this Article, — the infrastructure manager, or — the railway undertaking performing the public service contract. — the relevant competent authority or competent authorities, — the infrastructure manager, — the railway undertaking performing the public service contract, or — the railway undertaking seeking access;
— the competent authority or competent authorities that awarded the public service contract,
— any other interested competent authority with the right to limit access under this Article,
— the infrastructure manager, or
— the railway undertaking performing the public service contract.
— the relevant competent authority or competent authorities,
— the infrastructure manager,
— the railway undertaking performing the public service contract, or
— the railway undertaking seeking access;
— the competent authority or competent authorities that awarded the public service contract,
— any other interested competent authority with the right to limit access under this Article,
— the infrastructure manager, or
— the railway undertaking performing the public service contract.
— the relevant competent authority or competent authorities,
— the infrastructure manager,
— the railway undertaking performing the public service contract, or
— the railway undertaking seeking access;
9. Article 10(8) shall be replaced by the following:‘8.   By 1 January 2009, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Directive.This report shall address:—the implementation of this Directive in the Member States, and in particular its impact in the Member States as referred to in the second subparagraph of paragraph 3a and the effective working of the various bodies involved;—market developments, in particular international traffic trends, activities and market share of all market actors, including new entrants.’; — the implementation of this Directive in the Member States, and in particular its impact in the Member States as referred to in the second subparagraph of paragraph 3a and the effective working of the various bodies involved; — market developments, in particular international traffic trends, activities and market share of all market actors, including new entrants.’;
— the implementation of this Directive in the Member States, and in particular its impact in the Member States as referred to in the second subparagraph of paragraph 3a and the effective working of the various bodies involved;
— market developments, in particular international traffic trends, activities and market share of all market actors, including new entrants.’;
— the implementation of this Directive in the Member States, and in particular its impact in the Member States as referred to in the second subparagraph of paragraph 3a and the effective working of the various bodies involved;
— market developments, in particular international traffic trends, activities and market share of all market actors, including new entrants.’;
10. the following paragraph shall be added to Article 10:‘9.   By 31 December 2012, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of the provisions of paragraphs 3a to 3f.The application of this Directive shall be evaluated on the basis of a report to be presented by the Commission two years after the date of the opening-up of the market in international passenger services.This report shall also assess the development of the market, including the state of the preparation of a further opening-up of the rail market. In its report the Commission shall also analyse the different models for organising this market and the impact of this Directive on public service contracts and their financing. In so doing, the Commission shall take into account the implementation of Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70(*1)and the intrinsic differences between Member States (density of networks, number of passengers, average travel distance). In its report the Commission shall, if appropriate, propose complementary measures to facilitate any such opening, and shall assess the impact of any such measures.(*1)OJ L 315, 3.12.2007, p. 1.’ "
11. Article 11(2) shall be replaced by the following:‘2.   Measures designed to amend non-essential elements of this Directive and relating to the adaptation of the Annexes thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11a(3).’;
12. Article 11a(3) shall be replaced by the following:‘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.’;
13. the following subparagraph shall be added to Article 15:‘The obligations for transposition and implementation of this Directive shall not apply to Cyprus and Malta for as long as no railway system is established within their territory.’
1. the following point shall be added to Article 1(3):‘(e)transport operations in the form of railway services which are carried out in transit through the Community.’; ‘(e) transport operations in the form of railway services which are carried out in transit through the Community.’;
‘(e) transport operations in the form of railway services which are carried out in transit through the Community.’;
‘(e) transport operations in the form of railway services which are carried out in transit through the Community.’;
2. the following point shall be added to Article 2:‘(n)“transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’; ‘(n) “transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
‘(n) “transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
‘(n) “transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
3. the following paragraph shall be added to Article 13:‘4.   When an applicant intends to request infrastructure capacity with a view to operating an international passenger service as defined in Article 3 of Directive 91/440/EEC, it shall inform the infrastructure managers and the regulatory bodies concerned. In order to enable the assessment of the purpose of the international service to carry passengers between stations located in different Member States, and the potential economic impact on existing public service contracts, regulatory bodies shall ensure that any competent authority that has awarded a rail passenger service defined in a public service contract, any other interested competent authority with a right to limit access under Article 10(3b) of Directive 91/440/EEC and any railway undertaking performing the public service contract on the route of this international passenger service is informed.’;
4. Article 17(5) shall be replaced by the following:‘5.   Framework agreements shall in principle cover a period of five years, renewable for periods equal to their original duration. The infrastructure manager may agree to a shorter or longer period in specific cases. Any period longer than five years shall be justified by the existence of commercial contracts, specialised investments or risks.5a.   For services using specialised infrastructure referred to in Article 24 which requires substantial and long-term investment, duly justified by the applicant, framework agreements may be for a period of 15 years. Any period longer than 15 years shall be permissible only in exceptional cases, in particular where there is large-scale, long-term investment, and particularly where such investment is covered by contractual commitments including a multi-annual amortisation plan.The applicant's requirements may in this case call for detailed definition of the capacity characteristics — including the frequency, volume and quality of train paths — which are to be provided to the applicant for the duration of the framework agreement. The infrastructure manager may reduce reserved capacity which, over a period of at least one month, has been used less than the threshold quota provided for in Article 27.As from 1 January 2010, an initial framework agreement may be drawn up for a period of five years, renewable once, on the basis of the capacity characteristics used by applicants operating services before 1 January 2010, in order to take account of specialised investments or the existence of commercial contracts. The regulatory body referred to in Article 30 shall be responsible for authorising the entry into force of such an agreement.’;
5. the following sentence shall be inserted before the final sentence of Article 30(1):‘It shall furthermore be functionally independent from any competent authority involved in the award of a public service contract.’;
6. Article 34(3) shall be replaced by the following:‘3.   Measures designed to amend non-essential elements of this Directive and relating to the adaptation of the Annexes thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).’;
7. Article 35(3) shall be replaced by the following:‘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.’;
8. the following subparagraph shall be added to Article 38:‘The obligations for transposition and implementation of this Directive shall not apply to Cyprus and Malta for as long as no railway system is established within their territory.’
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 71 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Having regard to the opinion of the Committee of the Regions(2),
Acting in accordance with the procedure referred to in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 31 July 2007(3),
(1) Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways(4)was designed to facilitate the adaptation of the Community’s railways to the requirements of the single market and to improve their efficiency.
(2) Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure(5)concerns the principles and procedures to be applied with regard to the setting and charging of railway infrastructure charges and the allocation of railway infrastructure capacity.
(3) In its White Paper European transport policy for 2010: time to decide, the Commission announced its intention to continue building the internal market in rail services by proposing to open up the market in international passenger services.
(4) The aim of this Directive is to address the opening of the market for international rail passenger services within the Community, and it should therefore not concern services between a Member State and a third country. In addition, Member States should be able to exclude from the scope of this Directive services transiting the Community.
(5) International rail services currently present a very contrasting picture. Long-distance services (for instance night trains) are in difficulty and several of them have recently been withdrawn by the railway undertakings operating them in order to limit losses. The market for international high-speed services, on the other hand, has seen a sharp increase in traffic and will continue its vigorous development with the doubling and interconnection of the trans-European high-speed network by 2010. Nevertheless, there is strong competitive pressure from low-cost airlines in both cases. It is therefore essential to stimulate new initiatives by promoting competition between railway undertakings.
(6) It is not possible to open up the market in international passenger services without detailed provisions on infrastructure access, substantial progress on interoperability and a strict framework for rail safety at national and European level. All of these elements are now in place following the transposition of Directive 2001/12/EC(6)of the European Parliament and of the Council of 26 February 2001 amending Council Directive 91/440/EEC, Directive 2004/51/EC(7)of the European Parliament and of the Council of 29 April 2004 amending Council Directive 91/440/EEC, Directive 2001/13/EC(8)of the European Parliament and of the Council of 26 February 2001 amending Council Directive 95/18/EC, Directive 2001/14/EC, and Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways(9). It is necessary for this new regulatory framework to be supported by established, consolidated practice by the proposed date for opening up the market for international passenger services. This will require a certain time. The target date for opening up the market should therefore be 1 January 2010.
(7) The number of railway services without intermediate stops is very limited. In the case of journeys with intermediate stops, it is essential to authorise new market entrants to pick up and set down passengers along the route in order to ensure that such operations have a realistic chance of being economically viable and to avoid placing potential competitors at a disadvantage to existing operators, which have the right to pick up and set down passengers along the route. This right should be without prejudice to Community and national regulations concerning competition policy.
(8) The introduction of new, open-access, international services with intermediate stops should not be used to bring about the opening of the market for domestic passenger services, but should merely be focused on stops that are ancillary to the international route. On that basis, their introduction should concern services whose principal purpose is to carry passengers travelling on an international journey. The determination of whether that is the service’s principal purpose should take into account criteria such as the proportion of turnover, and of volume, derived from transport of domestic or international passengers, and the length of the service. This determination should be made by the respective national regulatory body at the request of an interested party.
(9) Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road(10)authorises Member States and local authorities to award public service contracts. These contracts may contain exclusive rights to operate certain services. It is therefore necessary to ensure that the provisions of that Regulation are consistent with the principle of opening up international passenger services to competition.
(10) Opening up international passenger services, which include the right to pick up passengers at any station located on the route of an international service and to set them down at another, including stations located in the same Member State, to competition may have implications for the organisation and financing of rail passenger services provided under a public service contract. Member States should have the possibility to limit the right of access to the market where this right would compromise the economic equilibrium of these public service contracts and where approval is given by the relevant regulatory body referred to in Article 30 of Directive 2001/14/EC on the basis of an objective economic analysis, following a request from the competent authorities that awarded the public service contract.
(11) Some Member States have already moved towards opening up the market for rail passenger services by transparent, open competitive tendering for the provision of certain such services. They should not have to provide full open access to international passenger services, since this competition for the right to use certain rail routes has involved a sufficient test of the market value of running those services.
(12) The assessment of whether the economic equilibrium of the public service contract could be compromised should take into account predetermined criteria such as the impact on the profitability of any services which are included in a public service contract, including consequential impacts on the net cost to the competent public authority that awarded the contract, passenger demand, ticket pricing, ticketing arrangements, location and number of stops on both sides of the border and timing and frequency of the proposed new service. Respecting such an assessment and the decision of the relevant regulatory body, Member States might authorise, modify or deny the right of access for the international passenger service sought, including the levying of a charge on the operator of a new international passenger service, in line with the economic analysis and in accordance with Community law and the principles of equality and non-discrimination.
(13) In order to contribute to the operation of passenger services on lines fulfilling a public service obligation, Member States should be able to authorise the authorities responsible for those services to impose a levy on passenger services which fall within the jurisdiction of those authorities. That levy should contribute to the financing of public service obligations laid down in public service contracts awarded in conformity with Community law. It should be imposed in accordance with Community law, and in particular with the principles of fairness, transparency, non-discrimination and proportionality.
(14) The regulatory body should function in a way which avoids any conflict of interests and any possible involvement in the award of the public service contract under consideration. In particular, if for organisational or legal purposes it is closely linked to the competent authority involved in the award of the public service contract under consideration, its functional independence should be ensured. The competence of the regulatory body should be extended to allow the assessment of the purpose of an international service and, where appropriate, the potential economic impact on existing public service contracts.
(15) This Directive constitutes a further phase of the opening of the rail market. Some Member States have already opened up the market for international passenger services on their territory. In this context, this Directive should not be understood as creating obligations for those Member States to grant, before 1 January 2010, access rights to railway undertakings licensed in a Member State where similar rights are not granted.
(16) In order to encourage investment for services using specialised infrastructure, such as high-speed railway lines, applicants need to be able to plan and require legal certainty reflecting the substantial long-term investment involved. It should therefore be possible for those undertakings normally to conclude framework agreements with a term of up to 15 years.
(17) The national regulatory bodies should, on the basis of Article 31 of Directive 2001/14/EC, exchange information and, where relevant in individual cases, coordinate the principles and practice of assessing whether the economic equilibrium of a public service contract is compromised. They should progressively develop guidelines based on their experience.
(18) The application of this Directive should be evaluated on the basis of a report to be presented by the Commission two years after the date of opening up the market in international passenger services. This report should also assess the development of the market, including the state of the preparation of a further opening-up of the passenger rail market. In this report the Commission should also analyse the different models for organising this market and the impact of this Directive on public service contracts and their financing. In so doing, the Commission should take into account the implementation of Regulation (EC) No 1370/2007 and the intrinsic differences between Member States (density of networks, number of passengers, average travel distance). In its report the Commission should, if appropriate, propose complementary measures to facilitate any such opening, and should assess the impact of any such measures.
(19) The measures necessary for the implementation of Directives 91/440/EEC and 2001/14/EC 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(11).
(20) In particular, the Commission should be empowered to adapt the Annexes to those Directives. Since those measures are of general scope and are designed to amend non-essential elements of those Directives, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(21) A Member State which has no railway system, and no immediate prospect of having one, would be under a disproportionate and pointless obligation if it had to transpose and implement Directives 91/440/EEC and 2001/14/EC. Therefore, such Member States should be exempted, for as long as they have no railway system, from the obligation to transpose and implement these Directives.
(22) Since the objective of this Directive, namely the development of the Community’s railways, cannot be sufficiently achieved by the Member States, given the need to ensure fair and non-discriminatory conditions of access to infrastructure and to take account of the obviously international dimension of the way in which important parts of the rail networks operate, as well as the need for coordinated transnational action, and can therefore 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 that objective.
(23) In accordance with point 34 of the Interinstitutional Agreement on better law-making(12), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
(24) Directives 91/440/EEC and 2001/14/EC should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:

Article 1
Directive 91/440/EEC is hereby amended as follows:
1.
the following paragraph shall be added to Article 2:
‘4. Member States may exclude from the scope of this Directive any railway service carried out in transit through the Community and which begins and ends outside the Community territory.’;
2.
the fourth indent of Article 3 shall be deleted;
3.
the following indent shall be inserted in Article 3 after the fifth indent:
‘—
“international passenger service” shall mean a passenger service where the train crosses at least one border of a Member State and where the principal purpose of the service is to carry passengers between stations located in different Member States; the train may be joined and/or split, and the different sections may have different origins and destinations, provided that all carriages cross at least one border’;
4.
the following indent shall be inserted in Article 3 after the sixth indent:
‘—
“transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
5.
the first indent of Article 5(3) shall be deleted;
6.
the phrase ‘and international groupings’ shall be deleted in Article 8(1);
7.
Article 10(1) shall be deleted;
8.
the following paragraphs shall be inserted in Article 10:
‘3a. Railway undertakings within the scope of Article 2 shall be granted by 1 January 2010 the right of access to the infrastructure in all Member States for the purpose of operating an international passenger service. Railway undertakings shall, in the course of an international passenger service, have the right to pick up passengers at any station located on the international route and set them down at another, including stations located in the same Member State.
The right of access to the infrastructure of the Member States for which the share of international carriage of passengers by train constitutes more than half of the passenger turnover of railway undertakings in that Member State shall be granted by 1 January 2012.
Whether the principal purpose of the service is to carry passengers between stations located in different Member States shall be determined by the relevant regulatory body or bodies referred to in Article 30 of Directive 2001/14/EC following a request from the relevant competent authorities and/or interested railway undertakings.
3b. Member States may limit the right of access defined in paragraph 3a on services between a place of departure and a destination which are covered by one or more public service contracts conforming to the Community legislation in force. Such limitation may not have the effect of restricting the right to pick up passengers at any station located on the route of an international service and to set them down at another, including stations located in the same Member State, except where the exercise of this right would compromise the economic equilibrium of a public service contract.
Whether the economic equilibrium would be compromised shall be determined by the relevant regulatory body or bodies referred to in Article 30 of Directive 2001/14/EC on the basis of an objective economic analysis and based on pre-determined criteria, following a request from:
—
the competent authority or competent authorities that awarded the public service contract,
—
any other interested competent authority with the right to limit access under this Article,
—
the infrastructure manager, or
—
the railway undertaking performing the public service contract.
The competent authorities and the railway undertakings providing the public services shall provide the relevant regulatory body or bodies with the information reasonably required to reach a decision. The regulatory body shall consider the information provided, consulting all the relevant parties as appropriate, and shall inform the relevant parties of its reasoned decision within a pre-determined, reasonable time, and, in any case, within two months of receipt of all relevant information. The regulatory body shall give the grounds for its decision and specify the time period within which, and the conditions under which,
—
the relevant competent authority or competent authorities,
—
the infrastructure manager,
—
the railway undertaking performing the public service contract, or
—
the railway undertaking seeking access;
may request a reconsideration of the decision.
3c. Member States may also limit the right to pick up and set down passengers at stations within the same Member State on the route of an international passenger service where an exclusive right to convey passengers between those stations has been granted under a concession contract awarded before 4 December 2007 on the basis of a fair competitive tendering procedure and in accordance with the relevant principles of Community law. This limitation may continue for the original duration of the contract, or 15 years, whichever is the shorter.
3d. The provisions of this Directive shall not require a Member State to grant, before 1 January 2010, the right of access referred to in paragraph 3a to railway undertakings and their directly or indirectly controlled subsidiaries, licensed in a Member State where access rights of a similar nature are not granted.
3e. Member States shall take the necessary measures to ensure that the decisions referred to in paragraphs 3b, 3c and 3d are subject to judicial review.
3f. Without prejudice to paragraph 3b, Member States may, under the conditions laid down in this Article, authorise the authority responsible for rail passenger transport to impose a levy on railway undertakings providing passenger services for the operation of routes which fall within the jurisdiction of that authority and which are operated between two stations in that Member State.
In that case, railway undertakings providing domestic or international rail passenger transport services shall be subject to the same levy on the operation of routes which fall within the jurisdiction of that authority.
The levy is intended to compensate the authority for public service obligations laid down in public service contracts awarded in conformity with Community law. The revenue raised from such levy and paid as compensation may not exceed what is necessary to cover all or part of the cost incurred in the relevant public service obligations taking into account the relevant receipts and a reasonable profit for discharging those obligations.
The levy shall be imposed in accordance with Community law, and shall respect in particular the principles of fairness, transparency, non-discrimination and proportionality, in particular between the average price of the service to the passenger and the level of the levy. The total levies imposed pursuant to this paragraph shall not endanger the economic viability of the rail passenger transport service on which they are imposed.
The relevant authorities shall keep the information necessary to ensure that the origin of the levies and their use can be traced. Member States shall provide the Commission with this information.’;
9.
Article 10(8) shall be replaced by the following:
‘8. By 1 January 2009, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Directive.
This report shall address:
—
the implementation of this Directive in the Member States, and in particular its impact in the Member States as referred to in the second subparagraph of paragraph 3a and the effective working of the various bodies involved;
—
market developments, in particular international traffic trends, activities and market share of all market actors, including new entrants.’;
10.
the following paragraph shall be added to Article 10:
‘9. By 31 December 2012, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of the provisions of paragraphs 3a to 3f.
The application of this Directive shall be evaluated on the basis of a report to be presented by the Commission two years after the date of the opening-up of the market in international passenger services.
This report shall also assess the development of the market, including the state of the preparation of a further opening-up of the rail market. In its report the Commission shall also analyse the different models for organising this market and the impact of this Directive on public service contracts and their financing. In so doing, the Commission shall take into account the implementation of Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70(*1)and the intrinsic differences between Member States (density of networks, number of passengers, average travel distance). In its report the Commission shall, if appropriate, propose complementary measures to facilitate any such opening, and shall assess the impact of any such measures.
11.
Article 11(2) shall be replaced by the following:
‘2. Measures designed to amend non-essential elements of this Directive and relating to the adaptation of the Annexes thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11a(3).’;
12.
Article 11a(3) shall be replaced by the following:
‘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.’;
13.
the following subparagraph shall be added to Article 15:
‘The obligations for transposition and implementation of this Directive shall not apply to Cyprus and Malta for as long as no railway system is established within their territory.’

Article 2
Directive 2001/14/EC is hereby amended as follows:
1.
the following point shall be added to Article 1(3):
‘(e)
transport operations in the form of railway services which are carried out in transit through the Community.’;
2.
the following point shall be added to Article 2:
‘(n)
“transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
3.
the following paragraph shall be added to Article 13:
‘4. When an applicant intends to request infrastructure capacity with a view to operating an international passenger service as defined in Article 3 of Directive 91/440/EEC, it shall inform the infrastructure managers and the regulatory bodies concerned. In order to enable the assessment of the purpose of the international service to carry passengers between stations located in different Member States, and the potential economic impact on existing public service contracts, regulatory bodies shall ensure that any competent authority that has awarded a rail passenger service defined in a public service contract, any other interested competent authority with a right to limit access under Article 10(3b) of Directive 91/440/EEC and any railway undertaking performing the public service contract on the route of this international passenger service is informed.’;
4.
Article 17(5) shall be replaced by the following:
‘5. Framework agreements shall in principle cover a period of five years, renewable for periods equal to their original duration. The infrastructure manager may agree to a shorter or longer period in specific cases. Any period longer than five years shall be justified by the existence of commercial contracts, specialised investments or risks.
5a. For services using specialised infrastructure referred to in Article 24 which requires substantial and long-term investment, duly justified by the applicant, framework agreements may be for a period of 15 years. Any period longer than 15 years shall be permissible only in exceptional cases, in particular where there is large-scale, long-term investment, and particularly where such investment is covered by contractual commitments including a multi-annual amortisation plan.
The applicant’s requirements may in this case call for detailed definition of the capacity characteristics — including the frequency, volume and quality of train paths — which are to be provided to the applicant for the duration of the framework agreement. The infrastructure manager may reduce reserved capacity which, over a period of at least one month, has been used less than the threshold quota provided for in Article 27.
As from 1 January 2010, an initial framework agreement may be drawn up for a period of five years, renewable once, on the basis of the capacity characteristics used by applicants operating services before 1 January 2010, in order to take account of specialised investments or the existence of commercial contracts. The regulatory body referred to in Article 30 shall be responsible for authorising the entry into force of such an agreement.’;
5.
the following sentence shall be inserted before the final sentence of Article 30(1):
‘It shall furthermore be functionally independent from any competent authority involved in the award of a public service contract.’;
6.
Article 34(3) shall be replaced by the following:
‘3. Measures designed to amend non-essential elements of this Directive and relating to the adaptation of the Annexes thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).’;
7.
Article 35(3) shall be replaced by the following:
‘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.’;
8.
the following subparagraph shall be added to Article 38:
‘The obligations for transposition and implementation of this Directive shall not apply to Cyprus and Malta for as long as no railway system is established within their territory.’

Article 3
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 4 June 2009. They shall forthwith communicate to the Commission the text of those measures.
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be determined by the Member States.
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.
3. The provisions of points 2, 5, 6 and 7 of Article 1 shall apply from 1 January 2010.

Article 4
This Directive shall enter into force on the day following its publication in theOfficial Journal of the European Union.

Article 5
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 71 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee(1),
Having regard to the opinion of the Committee of the Regions(2),
Acting in accordance with the procedure referred to in Article 251 of the Treaty, in the light of the joint text approved by the Conciliation Committee on 31 July 2007(3),
(1) Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways(4)was designed to facilitate the adaptation of the Community’s railways to the requirements of the single market and to improve their efficiency.
(2) Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure(5)concerns the principles and procedures to be applied with regard to the setting and charging of railway infrastructure charges and the allocation of railway infrastructure capacity.
(3) In its White Paper European transport policy for 2010: time to decide, the Commission announced its intention to continue building the internal market in rail services by proposing to open up the market in international passenger services.
(4) The aim of this Directive is to address the opening of the market for international rail passenger services within the Community, and it should therefore not concern services between a Member State and a third country. In addition, Member States should be able to exclude from the scope of this Directive services transiting the Community.
(5) International rail services currently present a very contrasting picture. Long-distance services (for instance night trains) are in difficulty and several of them have recently been withdrawn by the railway undertakings operating them in order to limit losses. The market for international high-speed services, on the other hand, has seen a sharp increase in traffic and will continue its vigorous development with the doubling and interconnection of the trans-European high-speed network by 2010. Nevertheless, there is strong competitive pressure from low-cost airlines in both cases. It is therefore essential to stimulate new initiatives by promoting competition between railway undertakings.
(6) It is not possible to open up the market in international passenger services without detailed provisions on infrastructure access, substantial progress on interoperability and a strict framework for rail safety at national and European level. All of these elements are now in place following the transposition of Directive 2001/12/EC(6)of the European Parliament and of the Council of 26 February 2001 amending Council Directive 91/440/EEC, Directive 2004/51/EC(7)of the European Parliament and of the Council of 29 April 2004 amending Council Directive 91/440/EEC, Directive 2001/13/EC(8)of the European Parliament and of the Council of 26 February 2001 amending Council Directive 95/18/EC, Directive 2001/14/EC, and Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community’s railways(9). It is necessary for this new regulatory framework to be supported by established, consolidated practice by the proposed date for opening up the market for international passenger services. This will require a certain time. The target date for opening up the market should therefore be 1 January 2010.
(7) The number of railway services without intermediate stops is very limited. In the case of journeys with intermediate stops, it is essential to authorise new market entrants to pick up and set down passengers along the route in order to ensure that such operations have a realistic chance of being economically viable and to avoid placing potential competitors at a disadvantage to existing operators, which have the right to pick up and set down passengers along the route. This right should be without prejudice to Community and national regulations concerning competition policy.
(8) The introduction of new, open-access, international services with intermediate stops should not be used to bring about the opening of the market for domestic passenger services, but should merely be focused on stops that are ancillary to the international route. On that basis, their introduction should concern services whose principal purpose is to carry passengers travelling on an international journey. The determination of whether that is the service’s principal purpose should take into account criteria such as the proportion of turnover, and of volume, derived from transport of domestic or international passengers, and the length of the service. This determination should be made by the respective national regulatory body at the request of an interested party.
(9) Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road(10)authorises Member States and local authorities to award public service contracts. These contracts may contain exclusive rights to operate certain services. It is therefore necessary to ensure that the provisions of that Regulation are consistent with the principle of opening up international passenger services to competition.
(10) Opening up international passenger services, which include the right to pick up passengers at any station located on the route of an international service and to set them down at another, including stations located in the same Member State, to competition may have implications for the organisation and financing of rail passenger services provided under a public service contract. Member States should have the possibility to limit the right of access to the market where this right would compromise the economic equilibrium of these public service contracts and where approval is given by the relevant regulatory body referred to in Article 30 of Directive 2001/14/EC on the basis of an objective economic analysis, following a request from the competent authorities that awarded the public service contract.
(11) Some Member States have already moved towards opening up the market for rail passenger services by transparent, open competitive tendering for the provision of certain such services. They should not have to provide full open access to international passenger services, since this competition for the right to use certain rail routes has involved a sufficient test of the market value of running those services.
(12) The assessment of whether the economic equilibrium of the public service contract could be compromised should take into account predetermined criteria such as the impact on the profitability of any services which are included in a public service contract, including consequential impacts on the net cost to the competent public authority that awarded the contract, passenger demand, ticket pricing, ticketing arrangements, location and number of stops on both sides of the border and timing and frequency of the proposed new service. Respecting such an assessment and the decision of the relevant regulatory body, Member States might authorise, modify or deny the right of access for the international passenger service sought, including the levying of a charge on the operator of a new international passenger service, in line with the economic analysis and in accordance with Community law and the principles of equality and non-discrimination.
(13) In order to contribute to the operation of passenger services on lines fulfilling a public service obligation, Member States should be able to authorise the authorities responsible for those services to impose a levy on passenger services which fall within the jurisdiction of those authorities. That levy should contribute to the financing of public service obligations laid down in public service contracts awarded in conformity with Community law. It should be imposed in accordance with Community law, and in particular with the principles of fairness, transparency, non-discrimination and proportionality.
(14) The regulatory body should function in a way which avoids any conflict of interests and any possible involvement in the award of the public service contract under consideration. In particular, if for organisational or legal purposes it is closely linked to the competent authority involved in the award of the public service contract under consideration, its functional independence should be ensured. The competence of the regulatory body should be extended to allow the assessment of the purpose of an international service and, where appropriate, the potential economic impact on existing public service contracts.
(15) This Directive constitutes a further phase of the opening of the rail market. Some Member States have already opened up the market for international passenger services on their territory. In this context, this Directive should not be understood as creating obligations for those Member States to grant, before 1 January 2010, access rights to railway undertakings licensed in a Member State where similar rights are not granted.
(16) In order to encourage investment for services using specialised infrastructure, such as high-speed railway lines, applicants need to be able to plan and require legal certainty reflecting the substantial long-term investment involved. It should therefore be possible for those undertakings normally to conclude framework agreements with a term of up to 15 years.
(17) The national regulatory bodies should, on the basis of Article 31 of Directive 2001/14/EC, exchange information and, where relevant in individual cases, coordinate the principles and practice of assessing whether the economic equilibrium of a public service contract is compromised. They should progressively develop guidelines based on their experience.
(18) The application of this Directive should be evaluated on the basis of a report to be presented by the Commission two years after the date of opening up the market in international passenger services. This report should also assess the development of the market, including the state of the preparation of a further opening-up of the passenger rail market. In this report the Commission should also analyse the different models for organising this market and the impact of this Directive on public service contracts and their financing. In so doing, the Commission should take into account the implementation of Regulation (EC) No 1370/2007 and the intrinsic differences between Member States (density of networks, number of passengers, average travel distance). In its report the Commission should, if appropriate, propose complementary measures to facilitate any such opening, and should assess the impact of any such measures.
(19) The measures necessary for the implementation of Directives 91/440/EEC and 2001/14/EC 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(11).
(20) In particular, the Commission should be empowered to adapt the Annexes to those Directives. Since those measures are of general scope and are designed to amend non-essential elements of those Directives, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
(21) A Member State which has no railway system, and no immediate prospect of having one, would be under a disproportionate and pointless obligation if it had to transpose and implement Directives 91/440/EEC and 2001/14/EC. Therefore, such Member States should be exempted, for as long as they have no railway system, from the obligation to transpose and implement these Directives.
(22) Since the objective of this Directive, namely the development of the Community’s railways, cannot be sufficiently achieved by the Member States, given the need to ensure fair and non-discriminatory conditions of access to infrastructure and to take account of the obviously international dimension of the way in which important parts of the rail networks operate, as well as the need for coordinated transnational action, and can therefore 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 that objective.
(23) In accordance with point 34 of the Interinstitutional Agreement on better law-making(12), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.
(24) Directives 91/440/EEC and 2001/14/EC should therefore be amended accordingly,
HAVE ADOPTED THIS DIRECTIVE:
Directive 91/440/EEC is hereby amended as follows:
1.
the following paragraph shall be added to Article 2:
‘4. Member States may exclude from the scope of this Directive any railway service carried out in transit through the Community and which begins and ends outside the Community territory.’;
2.
the fourth indent of Article 3 shall be deleted;
3.
the following indent shall be inserted in Article 3 after the fifth indent:
‘—
“international passenger service” shall mean a passenger service where the train crosses at least one border of a Member State and where the principal purpose of the service is to carry passengers between stations located in different Member States; the train may be joined and/or split, and the different sections may have different origins and destinations, provided that all carriages cross at least one border’;
4.
the following indent shall be inserted in Article 3 after the sixth indent:
‘—
“transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
5.
the first indent of Article 5(3) shall be deleted;
6.
the phrase ‘and international groupings’ shall be deleted in Article 8(1);
7.
Article 10(1) shall be deleted;
8.
the following paragraphs shall be inserted in Article 10:
‘3a. Railway undertakings within the scope of Article 2 shall be granted by 1 January 2010 the right of access to the infrastructure in all Member States for the purpose of operating an international passenger service. Railway undertakings shall, in the course of an international passenger service, have the right to pick up passengers at any station located on the international route and set them down at another, including stations located in the same Member State.
The right of access to the infrastructure of the Member States for which the share of international carriage of passengers by train constitutes more than half of the passenger turnover of railway undertakings in that Member State shall be granted by 1 January 2012.
Whether the principal purpose of the service is to carry passengers between stations located in different Member States shall be determined by the relevant regulatory body or bodies referred to in Article 30 of Directive 2001/14/EC following a request from the relevant competent authorities and/or interested railway undertakings.
3b. Member States may limit the right of access defined in paragraph 3a on services between a place of departure and a destination which are covered by one or more public service contracts conforming to the Community legislation in force. Such limitation may not have the effect of restricting the right to pick up passengers at any station located on the route of an international service and to set them down at another, including stations located in the same Member State, except where the exercise of this right would compromise the economic equilibrium of a public service contract.
Whether the economic equilibrium would be compromised shall be determined by the relevant regulatory body or bodies referred to in Article 30 of Directive 2001/14/EC on the basis of an objective economic analysis and based on pre-determined criteria, following a request from:
—
the competent authority or competent authorities that awarded the public service contract,
—
any other interested competent authority with the right to limit access under this Article,
—
the infrastructure manager, or
—
the railway undertaking performing the public service contract.
The competent authorities and the railway undertakings providing the public services shall provide the relevant regulatory body or bodies with the information reasonably required to reach a decision. The regulatory body shall consider the information provided, consulting all the relevant parties as appropriate, and shall inform the relevant parties of its reasoned decision within a pre-determined, reasonable time, and, in any case, within two months of receipt of all relevant information. The regulatory body shall give the grounds for its decision and specify the time period within which, and the conditions under which,
—
the relevant competent authority or competent authorities,
—
the infrastructure manager,
—
the railway undertaking performing the public service contract, or
—
the railway undertaking seeking access;
may request a reconsideration of the decision.
3c. Member States may also limit the right to pick up and set down passengers at stations within the same Member State on the route of an international passenger service where an exclusive right to convey passengers between those stations has been granted under a concession contract awarded before 4 December 2007 on the basis of a fair competitive tendering procedure and in accordance with the relevant principles of Community law. This limitation may continue for the original duration of the contract, or 15 years, whichever is the shorter.
3d. The provisions of this Directive shall not require a Member State to grant, before 1 January 2010, the right of access referred to in paragraph 3a to railway undertakings and their directly or indirectly controlled subsidiaries, licensed in a Member State where access rights of a similar nature are not granted.
3e. Member States shall take the necessary measures to ensure that the decisions referred to in paragraphs 3b, 3c and 3d are subject to judicial review.
3f. Without prejudice to paragraph 3b, Member States may, under the conditions laid down in this Article, authorise the authority responsible for rail passenger transport to impose a levy on railway undertakings providing passenger services for the operation of routes which fall within the jurisdiction of that authority and which are operated between two stations in that Member State.
In that case, railway undertakings providing domestic or international rail passenger transport services shall be subject to the same levy on the operation of routes which fall within the jurisdiction of that authority.
The levy is intended to compensate the authority for public service obligations laid down in public service contracts awarded in conformity with Community law. The revenue raised from such levy and paid as compensation may not exceed what is necessary to cover all or part of the cost incurred in the relevant public service obligations taking into account the relevant receipts and a reasonable profit for discharging those obligations.
The levy shall be imposed in accordance with Community law, and shall respect in particular the principles of fairness, transparency, non-discrimination and proportionality, in particular between the average price of the service to the passenger and the level of the levy. The total levies imposed pursuant to this paragraph shall not endanger the economic viability of the rail passenger transport service on which they are imposed.
The relevant authorities shall keep the information necessary to ensure that the origin of the levies and their use can be traced. Member States shall provide the Commission with this information.’;
9.
Article 10(8) shall be replaced by the following:
‘8. By 1 January 2009, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Directive.
This report shall address:
—
the implementation of this Directive in the Member States, and in particular its impact in the Member States as referred to in the second subparagraph of paragraph 3a and the effective working of the various bodies involved;
—
market developments, in particular international traffic trends, activities and market share of all market actors, including new entrants.’;
10.
the following paragraph shall be added to Article 10:
‘9. By 31 December 2012, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of the provisions of paragraphs 3a to 3f.
The application of this Directive shall be evaluated on the basis of a report to be presented by the Commission two years after the date of the opening-up of the market in international passenger services.
This report shall also assess the development of the market, including the state of the preparation of a further opening-up of the rail market. In its report the Commission shall also analyse the different models for organising this market and the impact of this Directive on public service contracts and their financing. In so doing, the Commission shall take into account the implementation of Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70(*1)and the intrinsic differences between Member States (density of networks, number of passengers, average travel distance). In its report the Commission shall, if appropriate, propose complementary measures to facilitate any such opening, and shall assess the impact of any such measures.
11.
Article 11(2) shall be replaced by the following:
‘2. Measures designed to amend non-essential elements of this Directive and relating to the adaptation of the Annexes thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 11a(3).’;
12.
Article 11a(3) shall be replaced by the following:
‘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.’;
13.
the following subparagraph shall be added to Article 15:
‘The obligations for transposition and implementation of this Directive shall not apply to Cyprus and Malta for as long as no railway system is established within their territory.’
Directive 2001/14/EC is hereby amended as follows:
1.
the following point shall be added to Article 1(3):
‘(e)
transport operations in the form of railway services which are carried out in transit through the Community.’;
2.
the following point shall be added to Article 2:
‘(n)
“transit” shall mean the crossing of the Community territory which is carried out without loading or unloading of goods, and/or without picking up of passengers nor setting them down in the Community territory.’;
3.
the following paragraph shall be added to Article 13:
‘4. When an applicant intends to request infrastructure capacity with a view to operating an international passenger service as defined in Article 3 of Directive 91/440/EEC, it shall inform the infrastructure managers and the regulatory bodies concerned. In order to enable the assessment of the purpose of the international service to carry passengers between stations located in different Member States, and the potential economic impact on existing public service contracts, regulatory bodies shall ensure that any competent authority that has awarded a rail passenger service defined in a public service contract, any other interested competent authority with a right to limit access under Article 10(3b) of Directive 91/440/EEC and any railway undertaking performing the public service contract on the route of this international passenger service is informed.’;
4.
Article 17(5) shall be replaced by the following:
‘5. Framework agreements shall in principle cover a period of five years, renewable for periods equal to their original duration. The infrastructure manager may agree to a shorter or longer period in specific cases. Any period longer than five years shall be justified by the existence of commercial contracts, specialised investments or risks.
5a. For services using specialised infrastructure referred to in Article 24 which requires substantial and long-term investment, duly justified by the applicant, framework agreements may be for a period of 15 years. Any period longer than 15 years shall be permissible only in exceptional cases, in particular where there is large-scale, long-term investment, and particularly where such investment is covered by contractual commitments including a multi-annual amortisation plan.
The applicant’s requirements may in this case call for detailed definition of the capacity characteristics — including the frequency, volume and quality of train paths — which are to be provided to the applicant for the duration of the framework agreement. The infrastructure manager may reduce reserved capacity which, over a period of at least one month, has been used less than the threshold quota provided for in Article 27.
As from 1 January 2010, an initial framework agreement may be drawn up for a period of five years, renewable once, on the basis of the capacity characteristics used by applicants operating services before 1 January 2010, in order to take account of specialised investments or the existence of commercial contracts. The regulatory body referred to in Article 30 shall be responsible for authorising the entry into force of such an agreement.’;
5.
the following sentence shall be inserted before the final sentence of Article 30(1):
‘It shall furthermore be functionally independent from any competent authority involved in the award of a public service contract.’;
6.
Article 34(3) shall be replaced by the following:
‘3. Measures designed to amend non-essential elements of this Directive and relating to the adaptation of the Annexes thereto shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 35(3).’;
7.
Article 35(3) shall be replaced by the following:
‘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.’;
8.
the following subparagraph shall be added to Article 38:
‘The obligations for transposition and implementation of this Directive shall not apply to Cyprus and Malta for as long as no railway system is established within their territory.’
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 4 June 2009. They shall forthwith communicate to the Commission the text of those measures.
When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The methods of making such reference shall be determined by the Member States.
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.
3. The provisions of points 2, 5, 6 and 7 of Article 1 shall apply from 1 January 2010.
This Directive shall enter into force on the day following its publication in theOfficial Journal of the European Union.
This Directive is addressed to the Member States.

Pending: 32007L0054

January 16, 2026
30.8.2007 EN Official Journal of the European Union L 226/21
(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.
(5) However 4,4′-Diaminodiphenylamine and its salts; 4-Diethylamino-o-toluidine and its salts; N,N-Diethyl-p-phenylenediamine and its salts; N,N-Dimethyl-p-phenylenediamine and its salts; and Toluene-3,4-Diamine and its salts, are currently listed under reference numbers 8 and 9 in Annex III, Part 1, which are general entries. Therefore they should be expressly deleted from general entries in Annex III. It is appropriate to list them in Annex II instead. Those annexes should therefore be amended accordingly.
(6) Directive 76/768/EEC should therefore be amended accordingly.
(7) 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 1244 to 1328 are added:Ref. NoChemical name/INCI-name‘12441-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products12452,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products12465-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products12473,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products12483,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products1249Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products12503-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products12512-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products1252C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products12531,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products12541,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products1255Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products1256N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products12574-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products12583,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products12593(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products12602,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products1261Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products12622-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products12632,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products12642,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products12652,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products12663(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products12672-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products1268(μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products12693-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products12702-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products1271Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products12723H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products12733H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products1274Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products1275Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products1276Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products12776-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products12781-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products1279Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products1280Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products12814-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products12824-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products12831-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products1284N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products1285N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products1286N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products12872-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products1288N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products12893-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products12904-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products1291(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products12925-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products1293m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products12941,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products12952,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products12964,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products1297Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products1298Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products1299Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products13009,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products13011,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products13021,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products13031-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products1304N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products1305[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products1306Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products13074,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products13085-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products13094,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products13104-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products1311N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products1312N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products1313Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products13142,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products13156-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products1316Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products13172-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products13182-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products13192-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products1320Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products13216-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products1322Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products13233-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products13243-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products13252-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products13263-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products13273-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products1328Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’ Ref. No Chemical name/INCI-name ‘1244 1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products 1245 2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products 1246 5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products 1247 3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products 1248 3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products 1249 Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products 1250 3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products 1251 2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products 1252 C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products 1253 1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products 1254 1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products 1255 Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products 1256 N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products 1257 4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products 1258 3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products 1259 3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products 1260 2,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products 1261 Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products 1262 2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products 1263 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products 1264 2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products 1265 2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products 1266 3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products 1267 2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products 1268 (μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products 1269 3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products 1270 2-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products 1271 Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products 1272 3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products 1273 3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products 1274 Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products 1275 Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products 1276 Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products 1277 6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products 1278 1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products 1279 Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products 1280 Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products 1281 4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products 1282 4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products 1283 1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products 1284 N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products 1285 N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products 1286 N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products 1287 2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products 1288 N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products 1289 3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products 1290 4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products 1291 (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products 1292 5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products 1293 m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products 1294 1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products 1295 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products 1296 4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products 1297 Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products 1298 Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products 1299 Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products 1300 9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products 1301 1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products 1302 1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products 1303 1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products 1304 N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products 1305 [6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products 1306 Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products 1307 4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products 1308 5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products 1309 4,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products 1310 4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products 1311 N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products 1312 N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products 1313 Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products 1314 2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products 1315 6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products 1316 Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products 1317 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products 1318 2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products 1319 2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products 1320 Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products 1321 6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products 1322 Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products 1323 3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products 1324 3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products 1325 2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products 1326 3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products 1327 3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products 1328 Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’
Ref. No Chemical name/INCI-name
‘1244 1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products
1245 2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products
1246 5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products
1247 3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products
1248 3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products
1249 Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products
1250 3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products
1251 2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products
1252 C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products
1253 1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products
1254 1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products
1255 Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products
1256 N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products
1257 4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products
1258 3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products
1259 3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1260 2,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products
1261 Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products
1262 2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products
1263 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
1264 2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products
1265 2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products
1266 3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products
1267 2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products
1268 (μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products
1269 3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products
1270 2-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products
1271 Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products
1272 3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1273 3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1274 Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products
1275 Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products
1276 Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products
1277 6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products
1278 1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products
1279 Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products
1280 Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products
1281 4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products
1282 4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products
1283 1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products
1284 N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products
1285 N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products
1286 N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products
1287 2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products
1288 N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products
1289 3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products
1290 4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products
1291 (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products
1292 5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1293 m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products
1294 1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products
1295 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products
1296 4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products
1297 Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products
1298 Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products
1299 Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products
1300 9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products
1301 1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products
1302 1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products
1303 1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products
1304 N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products
1305 [6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products
1306 Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products
1307 4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products
1308 5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products
1309 4,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products
1310 4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products
1311 N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products
1312 N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products
1313 Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products
1314 2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products
1315 6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products
1316 Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products
1317 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products
1318 2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products
1319 2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products
1320 Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products
1321 6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products
1322 Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products
1323 3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products
1324 3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products
1325 2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products
1326 3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products
1327 3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products
1328 Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’
Ref. No Chemical name/INCI-name
‘1244 1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products
1245 2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products
1246 5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products
1247 3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products
1248 3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products
1249 Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products
1250 3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products
1251 2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products
1252 C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products
1253 1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products
1254 1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products
1255 Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products
1256 N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products
1257 4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products
1258 3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products
1259 3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1260 2,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products
1261 Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products
1262 2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products
1263 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
1264 2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products
1265 2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products
1266 3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products
1267 2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products
1268 (μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products
1269 3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products
1270 2-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products
1271 Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products
1272 3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1273 3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1274 Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products
1275 Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products
1276 Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products
1277 6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products
1278 1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products
1279 Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products
1280 Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products
1281 4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products
1282 4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products
1283 1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products
1284 N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products
1285 N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products
1286 N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products
1287 2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products
1288 N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products
1289 3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products
1290 4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products
1291 (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products
1292 5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1293 m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products
1294 1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products
1295 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products
1296 4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products
1297 Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products
1298 Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products
1299 Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products
1300 9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products
1301 1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products
1302 1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products
1303 1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products
1304 N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products
1305 [6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products
1306 Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products
1307 4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products
1308 5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products
1309 4,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products
1310 4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products
1311 N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products
1312 N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products
1313 Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products
1314 2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products
1315 6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products
1316 Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products
1317 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products
1318 2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products
1319 2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products
1320 Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products
1321 6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products
1322 Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products
1323 3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products
1324 3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products
1325 2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products
1326 3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products
1327 3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products
1328 Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’
(2) Annex III is amended as follows:(a)Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.(b)In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted. (a) Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. (i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’. (ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. (b) In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted.
(a) Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. (i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’. (ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.
(ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(b) In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted.
(a) Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. (i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’. (ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.
(ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.
(ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(b) In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 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.
(5) However 4,4′-Diaminodiphenylamine and its salts; 4-Diethylamino-o-toluidine and its salts; N,N-Diethyl-p-phenylenediamine and its salts; N,N-Dimethyl-p-phenylenediamine and its salts; and Toluene-3,4-Diamine and its salts, are currently listed under reference numbers 8 and 9 in Annex III, Part 1, which are general entries. Therefore they should be expressly deleted from general entries in Annex III. It is appropriate to list them in Annex II instead. Those annexes should therefore be amended accordingly.
(6) Directive 76/768/EEC should therefore be amended accordingly.
(7) 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 18 March 2008 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 18 June 2008. 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 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.
(5) However 4,4′-Diaminodiphenylamine and its salts; 4-Diethylamino-o-toluidine and its salts; N,N-Diethyl-p-phenylenediamine and its salts; N,N-Dimethyl-p-phenylenediamine and its salts; and Toluene-3,4-Diamine and its salts, are currently listed under reference numbers 8 and 9 in Annex III, Part 1, which are general entries. Therefore they should be expressly deleted from general entries in Annex III. It is appropriate to list them in Annex II instead. Those annexes should therefore be amended accordingly.
(6) Directive 76/768/EEC should therefore be amended accordingly.
(7) 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 18 March 2008 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 18 June 2008. 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.
ANNEXDirective 76/768/EEC is amended as follows:

(1) | In Annex II, the following reference numbers 1244 to 1328 are added:Ref. NoChemical name/INCI-name‘12441-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products12452,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products12465-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products12473,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products12483,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products1249Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products12503-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products12512-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products1252C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products12531,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products12541,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products1255Ethanol, 2,2′-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products1256N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products12574-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products12583,3′-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products12593(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products12602,2′-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products1261Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products12622-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products12632,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products12642,2′-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products12652,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products12663(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products12672-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products1268(μ-((7,7′-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products12693-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products12702-Naphthalenesulfonic acid, 7,7′-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products1271Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products12723H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products12733H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products1274Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products1275Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products1276Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products12776-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products12781-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products1279Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products1280Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products12814-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products12824-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products12831-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products1284N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products1285N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products1286N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products12872-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products1288N,N’-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products12893-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products12904-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products1291(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products12925-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products1293m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products12941,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products12952,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products12964,4′-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products1297Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products1298Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products1299Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products13009,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products13011,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products13021,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products13031-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products1304N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products1305[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products1306Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products13074,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products13085-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products13094,4′-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products13104-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products1311N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products1312N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products1313Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products13142,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products13156-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products1316Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products13172-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products13182-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products13192-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products1320Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products13216-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products1322Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products13233-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products13243-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products13252-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products13263-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products13273-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products1328Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’ | Ref. No | Chemical name/INCI-name | ‘1244 | 1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products | 1245 | 2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products | 1246 | 5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products | 1247 | 3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products | 1248 | 3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products | 1249 | Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products | 1250 | 3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products | 1251 | 2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products | 1252 | C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products | 1253 | 1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products | 1254 | 1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products | 1255 | Ethanol, 2,2′-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products | 1256 | N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products | 1257 | 4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products | 1258 | 3,3′-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products | 1259 | 3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products | 1260 | 2,2′-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products | 1261 | Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products | 1262 | 2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products | 1263 | 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products | 1264 | 2,2′-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products | 1265 | 2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products | 1266 | 3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products | 1267 | 2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products | 1268 | (μ-((7,7′-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products | 1269 | 3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products | 1270 | 2-Naphthalenesulfonic acid, 7,7′-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products | 1271 | Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products | 1272 | 3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products | 1273 | 3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products | 1274 | Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products | 1275 | Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products | 1276 | Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products | 1277 | 6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products | 1278 | 1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products | 1279 | Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products | 1280 | Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products | 1281 | 4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products | 1282 | 4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products | 1283 | 1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products | 1284 | N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products | 1285 | N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products | 1286 | N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products | 1287 | 2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products | 1288 | N,N’-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products | 1289 | 3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products | 1290 | 4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products | 1291 | (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products | 1292 | 5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products | 1293 | m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products | 1294 | 1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products | 1295 | 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products | 1296 | 4,4′-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products | 1297 | Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products | 1298 | Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products | 1299 | Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products | 1300 | 9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products | 1301 | 1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products | 1302 | 1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products | 1303 | 1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products | 1304 | N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products | 1305 | [6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products | 1306 | Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products | 1307 | 4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products | 1308 | 5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products | 1309 | 4,4′-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products | 1310 | 4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products | 1311 | N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products | 1312 | N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products | 1313 | Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products | 1314 | 2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products | 1315 | 6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products | 1316 | Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products | 1317 | 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products | 1318 | 2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products | 1319 | 2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products | 1320 | Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products | 1321 | 6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products | 1322 | Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products | 1323 | 3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products | 1324 | 3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products | 1325 | 2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products | 1326 | 3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products | 1327 | 3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products | 1328 | Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’
Ref. No | Chemical name/INCI-name
‘1244 | 1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in hair dye products
1245 | 2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in hair dye products
1246 | 5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in hair dye products
1247 | 3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye products
1248 | 3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair dye products
1249 | Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye products
1250 | 3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in hair dye products
1251 | 2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products
1252 | C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye products
1253 | 1,3,5-Trihydroxybenzene (CAS No 108-73-6) (Phloroglucinol) and its salts, when used as a substance in hair dye products
1254 | 1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye products
1255 | Ethanol, 2,2′-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (CAS No 68478-64-8) (CAS 158571-58-5) (HC Blue No 5) and its salts, when used as a substance in hair dye products
1256 | N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair dye products
1257 | 4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair dye products
1258 | 3,3′-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products
1259 | 3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1260 | 2,2′-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8) (Disperse Brown 1) and its salts, when used as a substance in hair dye products
1261 | Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its salts, when used as a substance in hair dye products
1262 | 2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7) (Pigment Yellow 73) and its salts, when used as a substance in hair dye products
1263 | 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (CAS No 6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products
1264 | 2,2′-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products
1265 | 2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products
1266 | 3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products
1267 | 2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]- and its salts, when used as a substance in hair dye products
1268 | (μ-((7,7′-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products
1269 | 3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products
1270 | 2-Naphthalenesulfonic acid, 7,7′-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, (CAS No 25188-41-4) and its salts, when used as a substance in hair dye products
1271 | Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl- and its salts, when used as a substance in hair dye products
1272 | 3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1273 | 3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its salts, when used as a substance in hair dye products
1274 | Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in hair dye products
1275 | Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a substance in hair dye products
1276 | Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products
1277 | 6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8) (Solvent Yellow 44) and its salts, when used as a substance in hair dye products
1278 | 1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and its salts, when used as a substance in hair dye products
1279 | Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in hair dye products
1280 | Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and its salts, when used as a substance in hair dye products
1281 | 4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as a substance in hair dye products
1282 | 4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair dye products
1283 | 1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its salts, when used as a substance in hair dye products
1284 | N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a substance in hair dye products
1285 | N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and its salts, when used as a substance in hair dye products
1286 | N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow No 3) and its salts, when used as a substance in hair dye products
1287 | 2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance in hair dye products
1288 | N,N’-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts, when used as a substance in hair dye products
1289 | 3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and its salts, when used as a substance in hair dye products
1290 | 4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1) (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products
1291 | (8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in hair dye products
1292 | 5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products
1293 | m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance in hair dye products
1294 | 1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products
1295 | 2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts, when used as a substance in hair dye products
1296 | 4,4′-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (CAS No 4482-25-1) (Basic Brown 4) and its salts, when used as a substance in hair dye products
1297 | Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products
1298 | Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl- and its salts, when used as a substance in hair dye products
1299 | Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products
1300 | 9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and its derivatives and salts, when used as a substance in hair dye products
1301 | 1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its salts, when used as a substance in hair dye products
1302 | 1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue 7) and its salts, when used as a substance in hair dye products
1303 | 1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products
1304 | N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye products
1305 | [6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (CAS No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products
1306 | Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products
1307 | 4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products
1308 | 5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a substance in hair dye products
1309 | 4,4′-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair dye products
1310 | 4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair dye products
1311 | N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in hair dye products
1312 | N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in hair dye products
1313 | Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye products
1314 | 2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts, when used as a substance in hair dye products
1315 | 6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye products
1316 | Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a substance in hair dye products
1317 | 2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye products
1318 | 2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when used as a substance in hair dye products
1319 | 2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair dye products
1320 | Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a substance in hair dye products
1321 | 6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair dye products
1322 | Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair dye products
1323 | 3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-2) and its salts, when used as a substance in hair dye products
1324 | 3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow No 6) and its salts, when used as a substance in hair dye products
1325 | 2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts, when used as a substance in hair dye products
1326 | 3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 173994-75-7) and its salts, when used as a substance in hair dye products
1327 | 3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol (CAS No 114087-41-1) and its salts, when used as a substance in hair dye products
1328 | Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’
(2) | Annex III is amended as follows:(a)Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.(b)In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted. | (a) | Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. | (i) | in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’. | (ii) | in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. | (b) | In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted.
(a) | Part 1 is amended as follows:(i)in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.(ii)in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’. | (i) | in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’. | (ii) | in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(i) | in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this Annex’ are replaced by the following ‘p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.
(ii) | in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II’.
(b) | In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted.