Pending: 32002D0272

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Article 4 and Article 6(1) thereof,Whereas:(1) Under Regulation (EC) No 1980/2000 the Community eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Regulation (EC) No 1980/2000 provides that specific eco-label criteria are to be established according to product groups.(3) The measures provided for in this Decision are based on the draft criteria developed by the European Union Eco-labelling Board established under Article 13 of Regulation (EC) No 1980/2000.(4) The measures provided for in this Decision are in accordance with the opinion of the committee instituted by Article 17 of Regulation (EC) No 1980/2000,

Article 1
In order to be awarded the Community eco-label under Regulation (EC) No 1980/2000, a hard floor covering must fall within the product group “hard floor coverings” as defined in Article 2 of this Decision and must comply with the ecological criteria set out in the Annex.

Article 2
The product group “hard floor-coverings” shall comprise the following hard products for internal/external flooring use, without any relevant structural function: natural stones, agglomerated stones, concrete paving units, terrazzo tiles, ceramic tiles and clay tiles.

Article 3
For administrative purposes the code number assigned to the product group “hard floor-coverings” shall be “021”.

Article 4
This Decision shall apply from 1 April 2002 until 31 March 2006. If on 31 March 2006, revised criteria for this product group have not been adopted, this Decision shall apply until 31 March 2007.

Article 5
This Decision is addressed to the Member States.
Done at Brussels, 25 March 2002.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Article 4 and Article 6(1) thereof,Whereas:(1) Under Regulation (EC) No 1980/2000 the Community eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Regulation (EC) No 1980/2000 provides that specific eco-label criteria are to be established according to product groups.(3) The measures provided for in this Decision are based on the draft criteria developed by the European Union Eco-labelling Board established under Article 13 of Regulation (EC) No 1980/2000.(4) The measures provided for in this Decision are in accordance with the opinion of the committee instituted by Article 17 of Regulation (EC) No 1980/2000,
In order to be awarded the Community eco-label under Regulation (EC) No 1980/2000, a hard floor covering must fall within the product group “hard floor coverings” as defined in Article 2 of this Decision and must comply with the ecological criteria set out in the Annex.
The product group “hard floor-coverings” shall comprise the following hard products for internal/external flooring use, without any relevant structural function: natural stones, agglomerated stones, concrete paving units, terrazzo tiles, ceramic tiles and clay tiles.
For administrative purposes the code number assigned to the product group “hard floor-coverings” shall be “021”.
This Decision shall apply from 1 April 2002 until 31 March 2006. If on 31 March 2006, revised criteria for this product group have not been adopted, this Decision shall apply until 31 March 2007.
This Decision is addressed to the Member States.
Done at Brussels, 25 March 2002.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
The aims of the criteria
These criteria aim in particular at promoting:
– the reduction of impacts on habitats and associated resources,
– the reduction of energy consumption,
– the reduction of discharges of toxic or otherwise polluting substances into the environment,
– the reduction of use of dangerous substances,
– information that will enable the consumer to use the product in an efficient way which minimises the whole environmental impact.
The criteria are set at levels that promote the labelling of hard floor-coverings that are produced with low environmental impact.
Assessment and verification requirements
The specific assessment and verification requirements are indicated within each criterion.
The product group is structured in the following way (CEN definitions are reported in brackets) and can be subdivided into 2 major subgroups, “natural products” and “processed products” as follows.
Natural stones (CEN TC 246) are pieces of naturally occurring rock, and include marble, granite and other natural stones. “Other” natural stones refers to natural stones whose technical characteristics are on the whole different from those of marble and granite as defined by CEN/TC 246/N.237 prEN 12670 “Natural stones – Terminology”. Generally, such stones do not readily take a mirror polish and are not always extracted by blocks: sandstone, quartzite, slate, tuff, schist.
The group of “processed stones” can be divided into hardened and fired products. Hardened products are agglomerated stones, concrete paving units and terrazzo tiles. Fired products are ceramic tiles and clay tiles.
Agglomerated Stones are industrial products manufactured from a mixture of aggregates, mainly from natural stone grit, and a binder as defined by CEN/TC 246-229. The grit is normally composed of marble and granite quarry granulate and the binder is made from artificial components as unsaturated polyester resin or hydraulic cement. This group includes also artificial stones and compacted marble.
Concrete paving units are products for outer floor-coverings obtained by mixing sands, gravel, cement, inorganic pigments and additives, and vibro-compression as defined by CEN/TC 178. This group also includes concrete flags and concrete tiles.
Terrazzo tiles are a suitably compacted element of uniform shape and thickness, which meets specific geometrical requirements as defined by CEN/TC 229. The tiles are single or dual-layered. The single-layered are tiles completely made of granulates or chipping of a suitable aggregate, embedded in grey and white cement and water. The dual-layered tiles are terrazzo tiles made up of the first face or wear layer (with single-layered composition) and a second layer, known as backing or base concrete layer, whose surface is not exposed during normal use and which may be partially removed. Ceramic tiles are thin slabs from clays and/or other inorganic raw materials, such as feldspar and quartz as defined by CEN/TC 67. They are usually shaped by extruding or pressing at room temperature, dried and subsequently fired at temperatures sufficient to develop the required properties. Tiles can be glazed or unglazed, are non-combustible and generally unaffected by light.
Clay tiles are units which satisfy certain shape and dimensional requirements, used for the surface course of pavements and manufactured predominantly from clay or other materials, with or without additions as defined by CEN. The specific weight of such tiles shall not exceed 40 kg/m2.
Where so indicated, certain criteria apply specifically to one of the above subgroups. If no particular mention is given, the criterion applies to all products. Details on calculation procedures are given in the Technical Appendix.
Where appropriate, test methods other than those indicated for each criterion may be used if their equivalence is accepted by the competent body assessing the application.
Where possible, testing should be performed by appropriately accredited laboratories or laboratories that meet the general requirements expressed in standard EN ISO 17025.
Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.
The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO14001, when assessing applications and monitoring compliance with the criteria(note:
it is not required to implement such management schemes).
1. Raw materials extraction
1.1. Extraction management (for natural products only)
The overall extraction management score for natural stones shall be calculated as the total score based on a matrix of 9 main indicators (I). The final score results from the sum of the individual scores given to each indicator, after multiplication by a corrective weighting (W) if appropriate (see Technical Appendix – A1 for calculation procedures). Quarries shall reach a weighted score of at least 25 points. The score for each indicator shall be within the bounds indicated by the exclusion hurdle (where one is given).
In addition, all of the following conditions shall be met:
– there shall be no interference with any deep confined waterbed (see Technical Appendix – A1),
– there shall be no interference with surface water-bodies with civil catching or springs, or if the water-body is included in the Register of Protected Areas established by a Member State according to Directive 2000/60/EC of the European Parliament and the Council of 23 October 2000 establishing a framework for Community action in the field of water policy(1) or if the watercourse’s average flow is >5 m3/s (see Technical Appendix – A1),
– there shall be a waste water recovery closed system for avoiding sawing waste dispersion to the environment and to feed the recycling loop. Water shall be contained in close proximity to the place where it is used in quarrying operations and then it shall be conveyed by closed pipes to the suitable processing plant. After clearing, water shall be recycled.
Assessment and verification: the applicant shall provide the calculation of the weighted overall extraction management score, and related data for each of the nine indicators (showing amongst others that each score is within the bounds of the corresponding exclusion hurdle, if one is given), according to the following matrix and to the corresponding instructions in the Technical Appendix – A1. The applicant shall also provide appropriate documentation and/or declarations that prove compliance with all of the abovementioned criteria.
List of weights (to be used only where specified):
W1. Nature conservation: If the quarry area is located in:
– notified sites of Community importance pursuant to Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora(2), and its subsequent amendments,
– or in Natura 2000 network areas, composed of the special protection areas pursuant to Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds(3), and its subsequent amendments, and those areas under Directive 92/43/EEC together,
– or in equivalent areas located outside the European Community that fall under the corresponding provisions of the United Nations’ Convention on Biological Diversity(4),
then W1 is relevant to the following indicators: rehabilitation simultaneity degree (I.2), air quality (I.6), water quality (I.7), noise (I.8), visual impact (I.9). The same rules shall apply if the quarry is outside such sites but could have significant effects on them, either individually or in combination with other plans and projects(5). The corresponding specific weight is 0,3.
Assessment and verification: the applicant shall provide a declaration accompanied by appropriate documentation to show if the quarry area is located in or adjacent to sites of Community importance pursuant to the Directives 92/43/EEC and 79/409/EEC, as detailed above. The sites forming the Natura 2000 network areas are listed and reported on maps drawn up by the Member States. In areas outside the European Community, the applicant shall provide a declaration accompanied by appropriate documentation to show if the quarry area is located in or adjacent to protected areas as determined under the United Nations’ Convention on Biological Diversity 1992.
W2. Soil protection: for rehabilitation simultaneity degree (I.2) and water quality (I.7) indicators, three different values of weights are considered, as a function of land use potentialities (see Technical Appendix – A1 for details):
Assessment and verification: the applicant shall provide appropriate documentation, including a map, of the land capability classification of the quarry site.
W3. Population density of settlements which lie within a 5 km radius (distance) from the quarry site: rehabilitation simultaneity degree (I.2), air quality (I.6), water quality (I.7) and noise (I.8), visual impact (I.9) indicators are weighted in function of three density ranges:
Assessment and verification: the applicant shall provide a map and appropriate documentation to verify the population density of settlements lying within 5 km radius (distance) from the quarry border (authorised area). In the case of existing quarries and expanding settlements in the area concerned, the weight factor indicated in brackets shall be used. This does not refer to major extensions of the already authorised area of such quarries ( >75 %).
W4. If the quarry interferes with surface water-bodies (average flow < 5 m3/s) there is a weight of 0,5 on both the indicators about water recycling ratio (I.1) and water quality (I.7).
Assessment and verification: the applicant shall provide appropriate documentation to show whether or not there is any interference between the quarry and the surface water-body.
1.2. Extraction management (for processed products only)
The raw materials used in the production of processed hard floor-coverings shall comply with the following requirements for the related extraction activities:
Assessment and verification: the applicant shall provide the related data and documents including a map of the area.
2. Raw materials selection (for all flooring products)
No substances or preparations that are assigned, or may be assigned at the time of application, any of the following risk phrases (or combinations thereof):
R45 (may cause cancer);

Pending: 32002D0231

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Article 4 and Article 6(1) thereof,Whereas:(1) Under Regulation (EC) No 1980/2000 the Community eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Regulation (EC) No 1980/2000 provides that specific eco-label criteria are to be established according to product groups.(3) It also provides that the review of the eco-label criteria, as well as of the assessment and verification requirements related to the criteria, is to take place in due time before the end of the period of validity of the criteria specified for each product group. That review is to result in a proposal for prolongation, withdrawal or revision.(4) It is appropriate to revise the ecological criteria that were established by Commission Decision 1999/179/EC of 17 February 1999 establishing the ecological criteria for the award of the Community eco-label to footwear(2) in order to reflect the developments in the market. At the same time, the period of validity of that Decision as extended by Decision 2001/832/EC(3) should be modified.(5) A new Commission Decision should be adopted establishing the specific ecological criteria for this product group, which will be valid for a period of five years.(6) It is appropriate that, for a limited period of not more than 12 months, both the new criteria established by this Decision and the criteria established by Decision 1999/179/EC should be valid concurrently, in order to allow sufficient time for companies that have been awarded or that have applied for the award of the eco-label for their products, prior to the date of application of this Decision, to adapt those products to comply with the new criteria.(7) The measures provided for in this Decision are based on the draft criteria developed by the European Union Eco-Labelling Board established under Article 13 of Regulation (EC) No 1980/2000.(8) The measures provided for in this Decision are in accordance with the opinion of the committee instituted by Article 17 of Regulation (EC) No 1980/2000,

Article 1
In order to be awarded the Community eco-label under Regulation (EC) No 1980/2000, footwear must fall within the product group “footwear” as defined in Article 2, and must comply with the ecological criteria set out in the Annex to this Decision.

Article 2
The product group “footwear” shall comprise:
All articles of clothing designed to protect or cover the foot, with a fixed outer sole which comes into contact with the ground.

Article 3
For administrative purposes the code number assigned to the product group “footwear” shall be “017”.

Article 5
This Decision shall apply from 1 April 2002 until 31 March 2006. If on 31 March 2006 revised criteria have not been adopted, this Decision shall apply until 31 March 2007.
Producers of products falling within the product group “footwear” which have already been awarded the eco-label before 1 April 2002 may continue to use that label until 31 March 2003.
Producers of products falling within the product group “footwear” which have already applied for the award of the eco-label before 1 April 2002 may be awarded the eco-label under the terms Decision 1999/179/EC until 31 March 2003.
From 1 April 2002, new applications for the award of the eco-label for the product group “footwear” shall satisfy the criteria set out in this Decision.

Article 6
This Decision is addressed to the Member States.
Done at Brussels, 18 March 2002.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 57, 5.3.1999, p. 31.
(3) OJ L 310, 28.11.2001, p. 30.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Article 4 and Article 6(1) thereof,Whereas:(1) Under Regulation (EC) No 1980/2000 the Community eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Regulation (EC) No 1980/2000 provides that specific eco-label criteria are to be established according to product groups.(3) It also provides that the review of the eco-label criteria, as well as of the assessment and verification requirements related to the criteria, is to take place in due time before the end of the period of validity of the criteria specified for each product group. That review is to result in a proposal for prolongation, withdrawal or revision.(4) It is appropriate to revise the ecological criteria that were established by Commission Decision 1999/179/EC of 17 February 1999 establishing the ecological criteria for the award of the Community eco-label to footwear(2) in order to reflect the developments in the market. At the same time, the period of validity of that Decision as extended by Decision 2001/832/EC(3) should be modified.(5) A new Commission Decision should be adopted establishing the specific ecological criteria for this product group, which will be valid for a period of five years.(6) It is appropriate that, for a limited period of not more than 12 months, both the new criteria established by this Decision and the criteria established by Decision 1999/179/EC should be valid concurrently, in order to allow sufficient time for companies that have been awarded or that have applied for the award of the eco-label for their products, prior to the date of application of this Decision, to adapt those products to comply with the new criteria.(7) The measures provided for in this Decision are based on the draft criteria developed by the European Union Eco-Labelling Board established under Article 13 of Regulation (EC) No 1980/2000.(8) The measures provided for in this Decision are in accordance with the opinion of the committee instituted by Article 17 of Regulation (EC) No 1980/2000,
In order to be awarded the Community eco-label under Regulation (EC) No 1980/2000, footwear must fall within the product group “footwear” as defined in Article 2, and must comply with the ecological criteria set out in the Annex to this Decision.
The product group “footwear” shall comprise:
All articles of clothing designed to protect or cover the foot, with a fixed outer sole which comes into contact with the ground.
For administrative purposes the code number assigned to the product group “footwear” shall be “017”.
This Decision shall apply from 1 April 2002 until 31 March 2006. If on 31 March 2006 revised criteria have not been adopted, this Decision shall apply until 31 March 2007.
Producers of products falling within the product group “footwear” which have already been awarded the eco-label before 1 April 2002 may continue to use that label until 31 March 2003.
Producers of products falling within the product group “footwear” which have already applied for the award of the eco-label before 1 April 2002 may be awarded the eco-label under the terms Decision 1999/179/EC until 31 March 2003.
From 1 April 2002, new applications for the award of the eco-label for the product group “footwear” shall satisfy the criteria set out in this Decision.
This Decision is addressed to the Member States.
Done at Brussels, 18 March 2002.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 57, 5.3.1999, p. 31.
(3) OJ L 310, 28.11.2001, p. 30.
The aims of the criteria
These criteria aim in particular at:
– limiting the levels of toxic residues,
– limiting the emissions of volatile organic compounds, and
– promoting a more durable product.
The criteria are set at levels that promote the labelling of footwear which has a lower environmental impact.
Assessment and verification requirements
The specific assessment and verification requirements are indicated within each criterion.
Where appropriate, test methods other than those indicated for each criterion may be used if their equivalence is accepted by the competent body assessing the application.
The functional unit is one pair of shoes. Requirements are based on shoe size 40 Paris point. For children’s shoes the requirements apply for a size 32 Paris point (or the largest size in the case of maximum sizes smaller than 32 Paris point).
Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.
The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria (note:
it is not required to implement such management schemes).
1. Residues in the final product
(a) The average concentration of residues of Chromium (VI) in the final product shall not exceed 10 ppm and the residues of Arsenic, Cadmium and Lead shall not be detected in the final product (using the method specified below).
Assessment and verification: the applicant and/or his supplier(s) shall provide a test report, using the following test methods):
Cr(VI): CEN TC 309 WI 065 – 4.2 or DS/EN 420 or DIN 53314: 1996-04 (note:
difficulties in measurement due to interferences may be encountered when analysing certain coloured leather);
Cd, Pb, As: CEN TC 309 WI 065 – 4.3 Sample preparation: (1) Separate the upper components from the bottom components. (2) Grind completely the upper components and the bottom components, keeping both separate. (3) Analyse a sample of each of these two preparations. (4) The substances in each of these two samples shall not be detectable.
(b) The amount of free and partially hydrolysable formaldehyde of the textile components of the footwear shall not exceed 75 ppm and of the leather components shall not exceed 150 ppm.
Assessment and verification: the applicant and/or his supplier(s) shall provide a test report, using the following test methods: Textiles: CEN TC 309 WI 065 – 4.4; Leather: CEN TC 309 WI 065 – 4.4.
2. Emissions from the production of material
(a) The waste water from leather tanning sites and from the textile industries shall be treated, either by an in-house or municipal waste water treatment plant/facility, so as to achieve a reduction of the COD content of at least 85 %.
Assessment and verification: the applicant shall provide a test report and complementary data, using the following test method: COD: ISO 6060 Water quality, determination of chemical oxygen demand.
(b) Tannery waste water after treatment shall contain less than 5 mg Chromium (III)/l.
Assessment and verification: the applicant shall provide a test report and complementary data, using the following test methods: ISO 9174 or EN 1233 or EN ISO 11885 for Cr.
3. Use of harmful substances (up until purchase)
(a) Pentachlorophenol (PCP) and Tetrachlorophenol (TCP) and its salts and esters shall not be used.
Assessment and verification: the applicant and/or his supplier(s) shall provide a declaration that the materials do not contain such chlorophenols. Should a verification of this declaration be carried out, the following test methods shall be used: CEN TC 309 WI 065 – 4.5: Textiles: limit value 0,05 ppm; Leather: limit value 5 ppm.
(b) No azo dyes shall be used that may cleave to any of the following aromatic amines:
Assessment and verification: the applicant and/or his supplier(s) shall provide a declaration that such azo dyes have not been used. Should a verification of this declaration be carried out, the following test method shall be used: CEN TC 309 WI 065 – 4.5:
Textiles: limit 30 ppm. (note:
false positives are possible for 4-aminoazobenzene and confirmation is therefore recommended);
Leather: limit 30 ppm. (note:
false positives are possible for 4-aminoazobenzene, 4-aminodiphenyl and 2-naphthylamine and confirmation is therefore recommended).
(c) The following N-Nitrosamines shall not be detected in rubber.
N-nitrosodimethylamine (NDMA)
N-nitrosodiethylamine (NDEA)
N-nitrosodipropylamine (NDPA)
N-nitrosodibutylamine (NDBA)
N-nitrosopiperidine (NPIP)
N-nitrosopyrrolidine (NPYR)
N-nitrosomorpholine (NMOR)
N-nitroso N-methyl N-phenylamine (NMPhA)
N-nitroso N-ethyl N-phenylamine (NEPhA)
Assessment and verification: the applicant shall provide a test report, using the following test method: EN 12868 (1999-12).
(d) C10-C13 chloralkanes shall not be used in leather, rubber or textile components.
Assessment and verification: the applicant and/or his supplier(s) shall provide a declaration that such chloralkanes have not been used.
4. Use of volatile organic compounds (VOCs) during final assembly of shoes
The total use of VOCs during final footwear production, for the following categories, shall not exceed on average:

Pending: 32002D0225

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs(1), as last amended by Directive 97/79/EC(2), and in particular Chapter V, paragraphs 3 and 5, of the Annex thereto,Whereas:(1) Chapter V, point 7, of the Annex to Directive 91/492/EEC provides that the customary biological testing methods must not give a positive result to the presence of diarrhetic shellfish poisoning (DSP) in the edible parts of molluscs (the whole body or any part edible separately).(2) It has been scientifically proven that certain marine biotoxins such as those of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid (OA) and dinophysistoxins (DTXs)) and also yessotoxins (YTXs), pectenotoxins (PTXs) and azaspiracids (AZAs), pose a serious hazard to human health when present above certain limits in bivalve molluscs, echinoderms, tunicates or marine gastropods.(3) In the light of recent scientific studies it is now possible to establish maximum levels and methods of analysis for those biotoxins.(4) Maximum levels and methods of analysis should be harmonised and be implemented by the Member States in order to protect human health.(5) In addition to biological testing methods, alternative detection methods such as chemical methods and in vitro assays should be accepted if it is demonstrated that the performance of the chosen methods is not less effective than the performance of the biological method and that their implementation provides an equivalent level of public health protection.(6) The proposed maximum levels are based on provisional data and should be re-evaluated when new scientific evidence becomes available.(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,HAS ADOPTED THIS DECISION:Article 1This Decision lays down the maximum levels for the marine biotoxins of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid and dinophysistoxins), yessotoxins, pectenotoxins and azaspiracids and the methods of analysis to be used for their detection. It applies to bivalve molluscs, echinoderms, tunicates and marine gastropods that are intended for immediate human consumption or for further processing before consumption.Article 2The maximum level of okadaic acid, dinophysistoxins and pectenotoxins together in the animals referred to in

Article 1
This Decision lays down the maximum levels for the marine biotoxins of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid and dinophysistoxins), yessotoxins, pectenotoxins and azaspiracids and the methods of analysis to be used for their detection. It applies to bivalve molluscs, echinoderms, tunicates and marine gastropods that are intended for immediate human consumption or for further processing before consumption.

Article 2
The maximum level of okadaic acid, dinophysistoxins and pectenotoxins together in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 160 μg of okadaic acid equivalents/kg. The methods of analysis are set out in the Annex.

Article 3
The maximum level of yessotoxins in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 1 mg of yessotoxin equivalent/kg. The methods of analysis are set out in the Annex.

Article 4
The maximum level of Azaspiracids in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 160 μg of azaspiracid equivalents/kg. The methods of analysis are set out in the Annex.

Article 5
When the results of the analyses performed demonstrate discrepancies between the different methods, the mouse bioassay should be considered as the reference method.

Article 6
This Decision is addressed to the Member States.
Done at Brussels, 15 March 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 268, 24.9.1991, p. 1.
(2) OJ L 24, 30.1.1998, p. 31.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/492/EEC of 15 July 1991 laying down the health conditions for the production and the placing on the market of live bivalve molluscs(1), as last amended by Directive 97/79/EC(2), and in particular Chapter V, paragraphs 3 and 5, of the Annex thereto,Whereas:(1) Chapter V, point 7, of the Annex to Directive 91/492/EEC provides that the customary biological testing methods must not give a positive result to the presence of diarrhetic shellfish poisoning (DSP) in the edible parts of molluscs (the whole body or any part edible separately).(2) It has been scientifically proven that certain marine biotoxins such as those of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid (OA) and dinophysistoxins (DTXs)) and also yessotoxins (YTXs), pectenotoxins (PTXs) and azaspiracids (AZAs), pose a serious hazard to human health when present above certain limits in bivalve molluscs, echinoderms, tunicates or marine gastropods.(3) In the light of recent scientific studies it is now possible to establish maximum levels and methods of analysis for those biotoxins.(4) Maximum levels and methods of analysis should be harmonised and be implemented by the Member States in order to protect human health.(5) In addition to biological testing methods, alternative detection methods such as chemical methods and in vitro assays should be accepted if it is demonstrated that the performance of the chosen methods is not less effective than the performance of the biological method and that their implementation provides an equivalent level of public health protection.(6) The proposed maximum levels are based on provisional data and should be re-evaluated when new scientific evidence becomes available.(7) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,HAS ADOPTED THIS DECISION:Article 1This Decision lays down the maximum levels for the marine biotoxins of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid and dinophysistoxins), yessotoxins, pectenotoxins and azaspiracids and the methods of analysis to be used for their detection. It applies to bivalve molluscs, echinoderms, tunicates and marine gastropods that are intended for immediate human consumption or for further processing before consumption.Article 2The maximum level of okadaic acid, dinophysistoxins and pectenotoxins together in the animals referred to in
This Decision lays down the maximum levels for the marine biotoxins of the diarrhetic shellfish poisoning (DSP) complex (okadaic acid and dinophysistoxins), yessotoxins, pectenotoxins and azaspiracids and the methods of analysis to be used for their detection. It applies to bivalve molluscs, echinoderms, tunicates and marine gastropods that are intended for immediate human consumption or for further processing before consumption.
The maximum level of okadaic acid, dinophysistoxins and pectenotoxins together in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 160 μg of okadaic acid equivalents/kg. The methods of analysis are set out in the Annex.
The maximum level of yessotoxins in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 1 mg of yessotoxin equivalent/kg. The methods of analysis are set out in the Annex.
The maximum level of Azaspiracids in the animals referred to in Article 1 (the whole body or any part edible separately) shall be 160 μg of azaspiracid equivalents/kg. The methods of analysis are set out in the Annex.
When the results of the analyses performed demonstrate discrepancies between the different methods, the mouse bioassay should be considered as the reference method.
This Decision is addressed to the Member States.
Done at Brussels, 15 March 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 268, 24.9.1991, p. 1.
(2) OJ L 24, 30.1.1998, p. 31.
Detection methods
Biological methods
A series of mouse bioassay procedures, differing in the test portion (hepatopancreas or whole body) and in the solvents used for the extraction and purification steps, can be used for detection of the toxins mentioned in Article 1. Sensitivity and selectivity depend on the choice of the solvents used for the extraction and purification steps and this should be taken into account when making a decision on the method to be used, in order to cover the full range of toxins.
A single mouse bioassay involving acetone extraction can be used to detect okadaic acid, dinophysistoxins, pectenotoxins and yessotoxins. This assay may be complemented if necessary with liquid/liquid partition steps with ethyl acetate/water or dichloromethane/water to remove potential interferences. Azaspiracids detection at the regulatory levels by means of this procedure requires the use of the whole body as the test portion.
Three mice should be used for each test. The death of two out of three mice within 24 hours after inoculation into each of them of an extract equivalent to 5 g of hepatopancreas or 25 g whole body should be considered as a positive result for the presence of one or more of the toxins mentioned in Article 1 at levels above those established in Article 2, 3 and 4.
A mouse bioassay with acetone extraction followed by liquid/liquid partition with diethylether can be used to detect okadaic acid, dinophysistoxins, pectenotoxins and azaspiracids but it cannot be used to detect yessotoxins as losses of these toxins may take place during the partition step. Three mice should be used for each test. The death of two out of three mice within 24 hours after inoculation into each of them of an extract equivalent to 5 g of hepatopancreas or 25 g whole body should be considered as a positive result for the presence of okadaic acid, dinophysistoxins, pectenotoxins and azaspiracids at levels above those established in Article 2 and 4.
The rat bioassay can detect okadaic acid, dinophysistoxins and azaspiracids. Three rats should be used for each test. A diarrhetic response in any of the three rats is considered a positive result for the presence of okadaic acid, dinophysistoxins and azaspiracids at levels above those mentioned in Article 2 and 4.
Alternative detection methods
A series of methods such as high performance liquid chromatography (HPLC) with fluorimetric detection, liquid chromatography (LC)-mass spectrometry (MS), inmunoassays and functional assays such as the phosphatase inhibition assay can be used as alternative or complementary methods to the biological testing methods, provided that either alone or combined they can detect at least the following analogues, that they are not less effective than the biological methods and that their implementation provides an equivalent level of public health protection:
– okadaic acid and dinophysistoxins: an hydrolysis step may be required in order to detect the presence of DTX3,
– pectenotoxins: PTX1 and PTX2,
– yessotoxins: YTX, 45 OH YTX, homo YTX, and 45 OH homo YTX,
– azaspiracids: AZA1, AZA2 and AZA3.
If new analogues of public health significance are discovered they should be included in the analysis. Standards will have to be available before chemical analysis will be possible. Total toxicity will be calculated using conversion factors based on the toxicity data available for each toxin.
The performance characteristics of these methods should be defined after validation following an internationally agreed protocol.

Pending: 32002D0161

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(1), and in particular Article 16(1), Article 20(1) and Article 25(3) thereof,Whereas:(1) Classical swine fever was confirmed in the feral pig population in Rhineland-Pfalz, Germany, in 1999.(2) By means of Decision 1999/335/EC(2), the Commission approved the plan presented by Germany for the eradication of classical swine fever in feral pigs in Rhineland-Pfalz.(3) Despite the measures so far adopted, the disease has continued to spread and has also been confirmed in the feral pig population in Saarland. Outbreaks of classical swine fever have also occurred in pig holdings in Rhineland-Pfalz in 2001 and 2002, probably related with the disease in feral pigs.(4) In accordance with Articles 16 and 20 of Directive 2001/89/EC, German authorities have submitted plans for the eradication of classical swine fever in feral pigs in Saarland and for an emergency vaccination of the feral pigs in Rhineland-Pfalz and Saarland.(5) German authorities have authorised the use of a live attenuated vaccine against classical swine fever (C strain) to be used for the immunisation of feral pigs by means of oral baits.(6) In this context vaccination of feral pigs is considered to be an effective tool to supplement other disease control measures.(7) The submitted plans have been examined and found to comply with the provisions of Directive 2001/89/EC.(8) It is appropriate to establish further detailed conditions on trade of live pigs and certain pig products from the areas of Germany in which the evolution of the disease will probably be influenced by the vaccination.(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,

Article 1
The plan submitted by Germany for the eradication of classical swine fever in feral pigs in Saarland is hereby approved.

Article 2
The plans submitted by Germany for emergency vaccination of feral pigs in Rhineland-Pfalz and Saarland are hereby approved.

Article 3
1. Germany shall ensure that no live pigs, porcine semen, ova or embryos of swine are dispatched from the areas described in the Annex.
2. However, Germany may grant derogations to the prohibitions established in paragraph 1 for consignments of pigs, porcine semen, ova or embryos of swine to be dispatched to other areas of Germany, provided that no pigs, porcine semen, ova or embryos of swine are then dispatched from the holding of destination to any other further destination outside Germany for a 30-day period after the introduction of pigs or the use of the semen, ova or embryos in the recipient sows.

Article 4
1. The health certificate provided for in Council Directive 64/432/EEC(3) accompanying pigs dispatched from Germany must be completed by the following: “Animals in accordance with Commission Decision 2002/161/EC”.
2. The health certificate provided for in Council Directive 90/429/EEC(4) accompanying boar semen dispatched from Germany must be completed by the following: “Semen in accordance with Commission Decision 2002/161/EC”.
3. The health certificate provided for in Commission Decision 95/483/EC(5) accompanying embryos and ova of swine dispatched from Germany must be completed by the following: “Embryos/ova(6) in accordance with Commission Decision 2002/161/EC.”

Article 5
Germany shall ensure that all feral pigs found dead or shot in the area described in the Annex are removed in accordance with Article 16(3)(k) of Directive 2001/89/EC.

Article 6
Germany shall bring into force the laws, regulations and administrative provisions for implementing the plans referred to in Articles 1 and 2 from the date of adoption of this Decision.

Article 7
This Decision is addressed to the Federal Republic of Germany.
Done at Brussels, 22 February 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 316, 1.12.2001, p. 5.
(2) OJ L 126, 20.5.1999, p. 21.
(3) OJ 121, 29.7.1964, p. 1977/64.
(4) OJ L 224, 18.8.1990, p. 62.
(5) OJ L 275, 18.11.1995, p. 30.
(6) Delete as appropriate.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever(1), and in particular Article 16(1), Article 20(1) and Article 25(3) thereof,Whereas:(1) Classical swine fever was confirmed in the feral pig population in Rhineland-Pfalz, Germany, in 1999.(2) By means of Decision 1999/335/EC(2), the Commission approved the plan presented by Germany for the eradication of classical swine fever in feral pigs in Rhineland-Pfalz.(3) Despite the measures so far adopted, the disease has continued to spread and has also been confirmed in the feral pig population in Saarland. Outbreaks of classical swine fever have also occurred in pig holdings in Rhineland-Pfalz in 2001 and 2002, probably related with the disease in feral pigs.(4) In accordance with Articles 16 and 20 of Directive 2001/89/EC, German authorities have submitted plans for the eradication of classical swine fever in feral pigs in Saarland and for an emergency vaccination of the feral pigs in Rhineland-Pfalz and Saarland.(5) German authorities have authorised the use of a live attenuated vaccine against classical swine fever (C strain) to be used for the immunisation of feral pigs by means of oral baits.(6) In this context vaccination of feral pigs is considered to be an effective tool to supplement other disease control measures.(7) The submitted plans have been examined and found to comply with the provisions of Directive 2001/89/EC.(8) It is appropriate to establish further detailed conditions on trade of live pigs and certain pig products from the areas of Germany in which the evolution of the disease will probably be influenced by the vaccination.(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
The plan submitted by Germany for the eradication of classical swine fever in feral pigs in Saarland is hereby approved.
The plans submitted by Germany for emergency vaccination of feral pigs in Rhineland-Pfalz and Saarland are hereby approved.
1. Germany shall ensure that no live pigs, porcine semen, ova or embryos of swine are dispatched from the areas described in the Annex.
2. However, Germany may grant derogations to the prohibitions established in paragraph 1 for consignments of pigs, porcine semen, ova or embryos of swine to be dispatched to other areas of Germany, provided that no pigs, porcine semen, ova or embryos of swine are then dispatched from the holding of destination to any other further destination outside Germany for a 30-day period after the introduction of pigs or the use of the semen, ova or embryos in the recipient sows.
1. The health certificate provided for in Council Directive 64/432/EEC(3) accompanying pigs dispatched from Germany must be completed by the following: “Animals in accordance with Commission Decision 2002/161/EC”.
2. The health certificate provided for in Council Directive 90/429/EEC(4) accompanying boar semen dispatched from Germany must be completed by the following: “Semen in accordance with Commission Decision 2002/161/EC”.
3. The health certificate provided for in Commission Decision 95/483/EC(5) accompanying embryos and ova of swine dispatched from Germany must be completed by the following: “Embryos/ova(6) in accordance with Commission Decision 2002/161/EC.”
Germany shall ensure that all feral pigs found dead or shot in the area described in the Annex are removed in accordance with Article 16(3)(k) of Directive 2001/89/EC.
Germany shall bring into force the laws, regulations and administrative provisions for implementing the plans referred to in Articles 1 and 2 from the date of adoption of this Decision.
This Decision is addressed to the Federal Republic of Germany.
Done at Brussels, 22 February 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 316, 1.12.2001, p. 5.
(2) OJ L 126, 20.5.1999, p. 21.
(3) OJ 121, 29.7.1964, p. 1977/64.
(4) OJ L 224, 18.8.1990, p. 62.
(5) OJ L 275, 18.11.1995, p. 30.
(6) Delete as appropriate.
Rhineland-Pfalz
The Kreise: Ahrweiler, Bernkastel-Wittlich, Birkenfeld, Bitburg-Pruem, Cochem-Zell, Daun, Mayen-Koblenz, Stadt Koblenz, Stadt Trier.
In the Kreis Kusel: Reichweiler, Pfeffelbach, Thallichtenberg, Körborn, Dennweiler-Frohnbach, Oberalben, Ulmet, Rathsweiler, Niederalben, Homberg.
In the Kreis Birkenfeld: verbandsfr. Gemeinde Idar-Oberstein, Mackenrodt, Hettenrodt, Kirchweiler, Veitsrodt, Herborn, Mörschied, Weiden, Oberhosenbach, Wickenrodt, Sonnschied.
In the Kreis Bad Kreuznach: Bruschied, Schneppenbach, Hennweiler, Kellenbach, Königsau, Schwarzerden, Staatswald Entenpfuhl, Winterbach.
In the Kreis Rhein-Hunsrück: Riesweiler, Argenthal, Schnorbach, Mörschbach, Rheinböllen.
In the Kreis Mainz-Bingen: Breitscheid, Stadt Bacharach.
In the Kreis Trier-Saarburg: Taben-Rodt, Kastel-Staadt, Serrig, Stadt Saarburg, Ayl, Kanzem, Stadt Konz, Wasserliesch, Oberbillig.
In the Kreise Merzig-Wadern: Mettlach, Merzig, Beckingen, Losheim, Weiskirchen, Wadern.
In the Kreis Saarlouis: Dillingen, Bous, Ensdorf, Schwalbach, Saarwellingen, Nalbach, Lebach, Schmelz, Saarlouis.
In the Kreis Sankt Wendel: Nonnweiler, Nohfelden, Tholey.
NorthRhine-Westfalen
In the Kreis Euskirchen: Dahlem and Blankenheim.

Pending: 32002D0016

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to 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(1), and in particular Article 26(4) thereof,Whereas:(1) Pursuant to Directive 95/46/EC Member States are required to provide that a transfer of personal data to a third country may only take place if the third country in question ensures an adequate level of data protection and the Member States’ laws, which comply with the other provisions of the Directive, are respected prior to the transfer.(2) However, Article 26(2) of Directive 95/46/EC provides that Member States may authorise, subject to certain safeguards, a transfer or a set of transfers of personal data to third countries which do not ensure an adequate level of protection. Such safeguards may in particular result from appropriate contractual clauses.(3) Pursuant to Directive 95/46/EC the level of data protection should be assessed in the light of all the circumstances surrounding the data transfer operation or set of data transfer operations. The Working Party on the Protection of Individuals with regard to the Processing of Personal Data established under that Directive(2) has issued guidelines to aid with the assessment(3).(4) The standard contractual clauses relate only to data protection. The data exporter and the data importer are free to include any other clauses on business related issues which they consider as being pertinent for the contract as long as they do not contradict the standard contractual clauses.(5) This Decision should be without prejudice to national authorisations Member States may grant in accordance with national provisions implementing Article 26(2) of Directive 95/46/EC. This Decision only has the effect of requiring the Member States not to refuse to recognise as providing adequate safeguards the contractual clauses set out in it and does not therefore have any effect on other contractual clauses.(6) The scope of this Decision is limited to establishing that the clauses which it sets out may be used by a data controller established in the Community in order to adduce adequate safeguards within the meaning of Article 26(2) of Directive 95/46/EC for the transfer of personal data to a processor established in a third country.(7) This Decision should implement the obligation provided for in Article 17(3) of Directive 95/46/EC and does not prejudice the content of the contracts or legal acts established pursuant to that provision. However, some of the standard contractual clauses, in particular as regards the data exporter’s obligations, should be included in order to increase clarity as to the provisions which may be contained in a contract between a controller and a processor.(8) Supervisory authorities of the Member States play a key role in this contractual mechanism in ensuring that personal data are adequately protected after the transfer. In exceptional cases where data exporters refuse or are unable to instruct the data importer properly, with an imminent risk of grave harm to the data subjects, the standard contractual clauses should allow the supervisory authorities to audit data importers and, where appropriate, take decisions which are binding on data importers. The supervisory authorities should have the power to prohibit or suspend a data transfer or a set of transfers based on the standard contractual clauses in those exceptional cases where it is established that a transfer on contractual basis is likely to have a substantial adverse effect on the warranties and obligations providing adequate protection for the data subject.(9) The Commission may also consider in the future whether standard contractual clauses for the transfer of personal data to data processors established in third countries not offering an adequate level of data protection, submitted by business organisations or other interested parties, offer adequate safeguards in accordance with Article 26(2) of Directive 95/46/EC.(10) A disclosure of personal data to a data processor established outside the Community is an international transfer protected under Chapter IV of Directive 95/46/EC. Consequently, this Decision does not cover the transfer of personal data by controllers established in the Community to controllers established outside the Community who fall within the scope of Commission Decision 2001/497/EC of 15 June 2001 on standard contractual clauses for the transfer of personal data to third countries, under Directive 95/46/EC(4).(11) The standard contractual clauses should provide for the technical and organisational security measures ensuring a level of security appropriate to the risks represented by the processing and the nature of the data to be protected that a data processor established in a third country not providing adequate protection must apply. Parties should make provision in the contract for those technical and organisational measures which, having regard to applicable data protection law, the state of the art and the cost of their implementation, are necessary in order to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access or any other unlawful forms of processing.(12) In order to facilitate data flows from the Community, it is desirable that processors providing data processing services to several data controllers in the Community be allowed to apply the same technical and organisational security measures irrespective of the Member State from which the data transfer originates, in particular in those cases where the data importer receives data for further processing from different establishments of the data exporter in the Community, in which case the law of the designated Member State of establishment should apply.(13) It is appropriate to lay down the minimum information that the parties must specify in the contract dealing with the transfer. Member States should retain the power to particularise the information the parties are required to provide. The operation of this Decision should be reviewed in the light of experience.(14) The data importer should process the transferred personal data only on behalf of the data exporter and in accordance with his instructions and the obligations contained in the clauses. In particular the data importer should not disclose the personal data to a third party unless in accordance with certain conditions. The data exporter should instruct the data importer throughout the duration of the data processing Services to process the data in accordance with his instructions, the applicable data protection laws and the obligations contained in the clauses. The transfer of personal data to processors established outside the Community does not prejudice the fact that the processing activities should be governed in any case by the applicable data protection law.(15) The standard contractual clauses should be enforceable not only by the organisations which are parties to the contract, but also by the data subjects, in particular where the data subjects suffer damage as a consequence of a breach of the contract.(16) The data subject should be entitled to take action and, where appropriate, receive compensation from the data exporter who is the data controller of the personal data transferred. Exceptionally, the data subject should also be entitled to take action, and, where appropriate, receive compensation from the data importer in those cases, arising out of a breach by the data importer of any of his obligations referred to in the second paragraph of clause 3, where the data exporter has factually disappeared or has ceased to exist in law or has become insolvent.(17) In the event of a dispute between a data subject, who invokes the third-party beneficiary clause and the data importer, which is not amicably resolved, the data importer should agree to provide the data subject with the choice between mediation, arbitration or litigation. The extent to which the data subject will have an effective choice should depend on the availability of reliable and recognised systems of mediation and arbitration. Mediation by the data protection supervisory authorities of the Member State in which the data exporter is established should be an option where they provide such a service.(18) The contract should be governed by the law of the Member State in which the data exporter is established enabling a third-party beneficiary to enforce a contract. Data subjects should be allowed to be represented by associations or other bodies if they so wish and if authorised by national law.(19) The Working Party on the Protection of Individuals with regard to the processing of Personal Data established under Article 29 of Directive 95/46/EC has delivered an opinion on the level of protection provided under the standard contractual clauses annexed to this Decision, which has been taken into account in the preparation of this Decision(5).(20) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 31 of Directive 95/46/EC,

Article 1
The standard contractual clauses set out in the Annex are considered as offering adequate safeguards with respect to the protection of the privacy and fundamental rights and freedoms of individuals and as regards the exercise of the corresponding rights as required by Article 26(2) of Directive 95/46/EC.

Article 2
This Decision concerns only the adequacy of protection provided by the standard contractual clauses set out in the Annex for the transfer of personal data to processors. It does not affect the application of other national provisions implementing Directive 95/46/EC that pertain to the processing of personal data within the Member States.
This Decision shall apply to the transfer of personal data by controllers established in the Community to recipients established outside the territory of the Community who act only as processors.

Article 3
For the purposes of this Decision:
(a) the definitions in Directive 95/46/EC shall apply;
(b) “special categories of data” means the data referred to in Article 8 of that Directive;
(c) “supervisory authority” means the authority referred to in Article 28 of that Directive;
(d) “data exporter” means the controller who transfers the personal data;
(e) “data importer” means the processor established in a third country who agrees to receive from the data exporter personal data intended for processing on the data exporter’s behalf after the transfer in accordance with his instructions and the terms of this Decision and who is not subject to a third country’s system ensuring adequate protection;
(f) “applicable data protection law” means the legislation protecting the fundamental rights and freedoms of natural persons and, in particular, their right to privacy with respect to the processing of personal data applicable to a data controller in the Member State in which the data exporter is established;
(g) “technical and organisational security measures” means those measures aimed at protecting personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing.

Article 4
1. Without prejudice to their powers to take action to ensure compliance with national provisions adopted pursuant to Chapters II, III, V and VI of Directive 95/46/EC, the competent authorities in the Member States may exercise their existing powers to prohibit or suspend data flows to third countries in order to protect individuals with regard to the processing of their personal data in cases where:
(a) it is established that the law to which the data importer is subject imposes upon him requirements to derogate from the applicable data protection law which go beyond the restrictions necessary in a democratic society as provided for in Article 13 of Directive 95/46/EC where those requirements are likely to have a substantial adverse effect on the guarantees provided by the applicable data protection law and the standard contractual clauses; or
(b) a competent authority has established that the data importer has not respected the contractual clauses in the Annex; or
(c) there is a substantial likelihood that the standard contractual clauses in the Annex are not being or will not be complied with and the continuing transfer would create an imminent risk of grave harm to the data subjects.
2. The prohibition or suspension pursuant to paragraph 1 shall be lifted as soon as the reasons for the suspension or prohibition no longer exist.
3. When Member States adopt measures pursuant to paragraphs 1 and 2, they shall, without delay, inform the Commission which will forward the information to the other Member States.

Article 5
The Commission shall evaluate the operation of this Decision on the basis of available information three years after its notification to the Member States. It shall submit a report on the findings to the Committee established under Article 31 of Directive 95/46/EC. It shall include any evidence that could affect the evaluation concerning the adequacy of the standard contractual clauses in the Annex and any evidence that this Decision is being applied in a discriminatory way.

Article 6
This Decision shall apply from 3 April 2002.

Article 7
This Decision is addressed to the Member States.
Done at Brussels, 27 December 2001.
For the Commission
Frederik Bolkestein
Member of the Commission
(1) OJ L 281, 23.11.1995, p. 31.
(2) The web address of the Working Party is:
http://europa.eu.int/comm/internal_market/en/dataprot/wpdocs/index.htm.
(3) WP 4 (5020/97): “First orientations on Transfers of Personal Data to Third Countries – Possible Ways Forward in Assessing Adequacy”, a discussion document adopted by the Working Party on 26 June 1997.
WP 7 (5057/97): Working document: “Judging industry self-regulation: when does it make a meaningful contribution to the level of data protection in a third country?”, adopted by the Working Party on 14 January 1998.
WP 9 (5005/98): Working Document: “Preliminary views on the use of contractual provisions in the context of transfers of personal data to third countries”, adopted by the Working Party on 22 April 1998.
WP 12: Transfers of personal data to third countries: Applying Articles 25 and 26 of the EU data protection directive, adopted by the Working Party on 24 July 1998, available on the website
“http://europa.eu.int/comm/internal_market/en/dataprot/wpdocs/wp12en.htm” hosted by the European Commission.
(4) OJ L 181, 4.7.2001, p. 19.
(5) Opinion No 7/2001 adopted by the Working Party on 13 September 2001 (DG MARKT….), available on the website “Europa” hosted by the European Commission.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to 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(1), and in particular Article 26(4) thereof,Whereas:(1) Pursuant to Directive 95/46/EC Member States are required to provide that a transfer of personal data to a third country may only take place if the third country in question ensures an adequate level of data protection and the Member States’ laws, which comply with the other provisions of the Directive, are respected prior to the transfer.(2) However, Article 26(2) of Directive 95/46/EC provides that Member States may authorise, subject to certain safeguards, a transfer or a set of transfers of personal data to third countries which do not ensure an adequate level of protection. Such safeguards may in particular result from appropriate contractual clauses.(3) Pursuant to Directive 95/46/EC the level of data protection should be assessed in the light of all the circumstances surrounding the data transfer operation or set of data transfer operations. The Working Party on the Protection of Individuals with regard to the Processing of Personal Data established under that Directive(2) has issued guidelines to aid with the assessment(3).(4) The standard contractual clauses relate only to data protection. The data exporter and the data importer are free to include any other clauses on business related issues which they consider as being pertinent for the contract as long as they do not contradict the standard contractual clauses.(5) This Decision should be without prejudice to national authorisations Member States may grant in accordance with national provisions implementing Article 26(2) of Directive 95/46/EC. This Decision only has the effect of requiring the Member States not to refuse to recognise as providing adequate safeguards the contractual clauses set out in it and does not therefore have any effect on other contractual clauses.(6) The scope of this Decision is limited to establishing that the clauses which it sets out may be used by a data controller established in the Community in order to adduce adequate safeguards within the meaning of Article 26(2) of Directive 95/46/EC for the transfer of personal data to a processor established in a third country.(7) This Decision should implement the obligation provided for in Article 17(3) of Directive 95/46/EC and does not prejudice the content of the contracts or legal acts established pursuant to that provision. However, some of the standard contractual clauses, in particular as regards the data exporter’s obligations, should be included in order to increase clarity as to the provisions which may be contained in a contract between a controller and a processor.(8) Supervisory authorities of the Member States play a key role in this contractual mechanism in ensuring that personal data are adequately protected after the transfer. In exceptional cases where data exporters refuse or are unable to instruct the data importer properly, with an imminent risk of grave harm to the data subjects, the standard contractual clauses should allow the supervisory authorities to audit data importers and, where appropriate, take decisions which are binding on data importers. The supervisory authorities should have the power to prohibit or suspend a data transfer or a set of transfers based on the standard contractual clauses in those exceptional cases where it is established that a transfer on contractual basis is likely to have a substantial adverse effect on the warranties and obligations providing adequate protection for the data subject.(9) The Commission may also consider in the future whether standard contractual clauses for the transfer of personal data to data processors established in third countries not offering an adequate level of data protection, submitted by business organisations or other interested parties, offer adequate safeguards in accordance with Article 26(2) of Directive 95/46/EC.(10) A disclosure of personal data to a data processor established outside the Community is an international transfer protected under Chapter IV of Directive 95/46/EC. Consequently, this Decision does not cover the transfer of personal data by controllers established in the Community to controllers established outside the Community who fall within the scope of Commission Decision 2001/497/EC of 15 June 2001 on standard contractual clauses for the transfer of personal data to third countries, under Directive 95/46/EC(4).(11) The standard contractual clauses should provide for the technical and organisational security measures ensuring a level of security appropriate to the risks represented by the processing and the nature of the data to be protected that a data processor established in a third country not providing adequate protection must apply. Parties should make provision in the contract for those technical and organisational measures which, having regard to applicable data protection law, the state of the art and the cost of their implementation, are necessary in order to protect personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access or any other unlawful forms of processing.(12) In order to facilitate data flows from the Community, it is desirable that processors providing data processing services to several data controllers in the Community be allowed to apply the same technical and organisational security measures irrespective of the Member State from which the data transfer originates, in particular in those cases where the data importer receives data for further processing from different establishments of the data exporter in the Community, in which case the law of the designated Member State of establishment should apply.(13) It is appropriate to lay down the minimum information that the parties must specify in the contract dealing with the transfer. Member States should retain the power to particularise the information the parties are required to provide. The operation of this Decision should be reviewed in the light of experience.(14) The data importer should process the transferred personal data only on behalf of the data exporter and in accordance with his instructions and the obligations contained in the clauses. In particular the data importer should not disclose the personal data to a third party unless in accordance with certain conditions. The data exporter should instruct the data importer throughout the duration of the data processing Services to process the data in accordance with his instructions, the applicable data protection laws and the obligations contained in the clauses. The transfer of personal data to processors established outside the Community does not prejudice the fact that the processing activities should be governed in any case by the applicable data protection law.(15) The standard contractual clauses should be enforceable not only by the organisations which are parties to the contract, but also by the data subjects, in particular where the data subjects suffer damage as a consequence of a breach of the contract.(16) The data subject should be entitled to take action and, where appropriate, receive compensation from the data exporter who is the data controller of the personal data transferred. Exceptionally, the data subject should also be entitled to take action, and, where appropriate, receive compensation from the data importer in those cases, arising out of a breach by the data importer of any of his obligations referred to in the second paragraph of clause 3, where the data exporter has factually disappeared or has ceased to exist in law or has become insolvent.(17) In the event of a dispute between a data subject, who invokes the third-party beneficiary clause and the data importer, which is not amicably resolved, the data importer should agree to provide the data subject with the choice between mediation, arbitration or litigation. The extent to which the data subject will have an effective choice should depend on the availability of reliable and recognised systems of mediation and arbitration. Mediation by the data protection supervisory authorities of the Member State in which the data exporter is established should be an option where they provide such a service.(18) The contract should be governed by the law of the Member State in which the data exporter is established enabling a third-party beneficiary to enforce a contract. Data subjects should be allowed to be represented by associations or other bodies if they so wish and if authorised by national law.(19) The Working Party on the Protection of Individuals with regard to the processing of Personal Data established under Article 29 of Directive 95/46/EC has delivered an opinion on the level of protection provided under the standard contractual clauses annexed to this Decision, which has been taken into account in the preparation of this Decision(5).(20) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 31 of Directive 95/46/EC,
The standard contractual clauses set out in the Annex are considered as offering adequate safeguards with respect to the protection of the privacy and fundamental rights and freedoms of individuals and as regards the exercise of the corresponding rights as required by Article 26(2) of Directive 95/46/EC.
This Decision concerns only the adequacy of protection provided by the standard contractual clauses set out in the Annex for the transfer of personal data to processors. It does not affect the application of other national provisions implementing Directive 95/46/EC that pertain to the processing of personal data within the Member States.
This Decision shall apply to the transfer of personal data by controllers established in the Community to recipients established outside the territory of the Community who act only as processors.
For the purposes of this Decision:
(a) the definitions in Directive 95/46/EC shall apply;
(b) “special categories of data” means the data referred to in Article 8 of that Directive;
(c) “supervisory authority” means the authority referred to in Article 28 of that Directive;
(d) “data exporter” means the controller who transfers the personal data;
(e) “data importer” means the processor established in a third country who agrees to receive from the data exporter personal data intended for processing on the data exporter’s behalf after the transfer in accordance with his instructions and the terms of this Decision and who is not subject to a third country’s system ensuring adequate protection;
(f) “applicable data protection law” means the legislation protecting the fundamental rights and freedoms of natural persons and, in particular, their right to privacy with respect to the processing of personal data applicable to a data controller in the Member State in which the data exporter is established;
(g) “technical and organisational security measures” means those measures aimed at protecting personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, in particular where the processing involves the transmission of data over a network, and against all other unlawful forms of processing.
1. Without prejudice to their powers to take action to ensure compliance with national provisions adopted pursuant to Chapters II, III, V and VI of Directive 95/46/EC, the competent authorities in the Member States may exercise their existing powers to prohibit or suspend data flows to third countries in order to protect individuals with regard to the processing of their personal data in cases where:
(a) it is established that the law to which the data importer is subject imposes upon him requirements to derogate from the applicable data protection law which go beyond the restrictions necessary in a democratic society as provided for in Article 13 of Directive 95/46/EC where those requirements are likely to have a substantial adverse effect on the guarantees provided by the applicable data protection law and the standard contractual clauses; or
(b) a competent authority has established that the data importer has not respected the contractual clauses in the Annex; or
(c) there is a substantial likelihood that the standard contractual clauses in the Annex are not being or will not be complied with and the continuing transfer would create an imminent risk of grave harm to the data subjects.
2. The prohibition or suspension pursuant to paragraph 1 shall be lifted as soon as the reasons for the suspension or prohibition no longer exist.
3. When Member States adopt measures pursuant to paragraphs 1 and 2, they shall, without delay, inform the Commission which will forward the information to the other Member States.
The Commission shall evaluate the operation of this Decision on the basis of available information three years after its notification to the Member States. It shall submit a report on the findings to the Committee established under Article 31 of Directive 95/46/EC. It shall include any evidence that could affect the evaluation concerning the adequacy of the standard contractual clauses in the Annex and any evidence that this Decision is being applied in a discriminatory way.
This Decision shall apply from 3 April 2002.
This Decision is addressed to the Member States.
Done at Brussels, 27 December 2001.
For the Commission
Frederik Bolkestein
Member of the Commission
(1) OJ L 281, 23.11.1995, p. 31.
(2) The web address of the Working Party is:
http://europa.eu.int/comm/internal_market/en/dataprot/wpdocs/index.htm.
(3) WP 4 (5020/97): “First orientations on Transfers of Personal Data to Third Countries – Possible Ways Forward in Assessing Adequacy”, a discussion document adopted by the Working Party on 26 June 1997.
WP 7 (5057/97): Working document: “Judging industry self-regulation: when does it make a meaningful contribution to the level of data protection in a third country?”, adopted by the Working Party on 14 January 1998.
WP 9 (5005/98): Working Document: “Preliminary views on the use of contractual provisions in the context of transfers of personal data to third countries”, adopted by the Working Party on 22 April 1998.
WP 12: Transfers of personal data to third countries: Applying Articles 25 and 26 of the EU data protection directive, adopted by the Working Party on 24 July 1998, available on the website
“http://europa.eu.int/comm/internal_market/en/dataprot/wpdocs/wp12en.htm” hosted by the European Commission.
(4) OJ L 181, 4.7.2001, p. 19.
(5) Opinion No 7/2001 adopted by the Working Party on 13 September 2001 (DG MARKT….), available on the website “Europa” hosted by the European Commission.
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Pending: 32001D0844

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 218(2) thereof,Having regard to the Treaty establishing the European Coal and Steel Community, and in particular Article 16 thereof,Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 131 thereof,Having regard to the Treaty on European Union, and in particular Article 28(1) and Article 41(1) thereof,HAS DECIDED AS FOLLOWS:Article 1The Commission’s provisions on security, the text of which is annexed to this Decision, are hereby added to the Commission’s Rules of Procedure as an annex.Article 2This Decision shall enter into force on the day of its publication in the Official Journal of the European Communities.It shall apply from 1 December 2001.Done at Brussels, 29 November 2001.For the CommissionThe PresidentRomano ProdiANNEXCOMMISSION PROVISIONS ON SECURITYWhereas:(1) In order to develop Commission activities in areas which require a degree of confidentiality, it is appropriate to establish a comprehensive security system applicable to the Commission, the other institutions, bodies, offices and agencies established by virtue or on the basis of the EC Treaty or the Treaty on European Union, the Member States, as well as any other recipient of European Union classified information, hereafter referred to as “EU classified information”.(2) In order to safeguard the effectiveness of the security system thus established, the Commission will make EU classified information available only to those outside bodies which offer guarantees that they have taken all measures necessary to apply rules strictly equivalent to these provisions.(3) These provisions are taken without prejudice to Regulation No 3 of 31 July 1958 implementing Article 24 of the Treaty establishing the European Atomic Energy Community(1), to Council Regulation (EC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities(2) and to Commission Decision C (95) 1510 final of 23 November 1995 on the protection of informatics systems.(4) The Commission’s security system is based on the principles put forward in Council Decision 2001/264/EC of 19 March 2001 adopting the Council’s security regulations(3) with a view to ensuring a smooth functioning of the decision-making process of the Union.(5) The Commission underlines the importance of associating, where appropriate, the other institutions with the rules and standards of confidentiality which are necessary in order to protect the interests of the Union and its Member States.(6) The Commission recognises the need to create its own concept of security, taking into consideration all elements of security and the specific character of the Commission as an institution.(7) These provisions are taken without prejudice to Article 255 of the Treaty and to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(4);Article 1The Commission’s rules on security are set out in the Annex.Article 21. The Member of the Commission responsible for security matters shall take appropriate measures to ensure that, when handling EU classified information, the rules referred to in

Article 1
The Commission’s provisions on security, the text of which is annexed to this Decision, are hereby added to the Commission’s Rules of Procedure as an annex.

Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Communities.
It shall apply from 1 December 2001.
Done at Brussels, 29 November 2001.
For the Commission
The President
Romano Prodi

Article 3
Third states, international organisations and other bodies shall be allowed to receive EU classified information on the condition that they ensure that, when such information is handled, rules strictly equivalent to those referred to in Article 1 are respected.

Article 4
In keeping with the basic principles and minimum standards of security contained in Part I of the Annex, the Member of the Commission responsible for security matters may take measures in accordance with Part II of the Annex.

Article 5
As from the date of their application, these provisions shall replace:
(a) Commission Decision C (94) 3282 of 30 November 1994 on the security measures applicable to classified information produced or transmitted in connection with activities of the European Union;
(b) Commission Decision C (99) 423 of 25 February 1999 relating to the procedures whereby officials and other employees of the European Commission may be allowed access to classified information held by the Commission.

Article 6
As from the date of application of these provisions, all classified information held by the Commission until that date, with the exception of Euratom classified information, shall:
(a) if created by the Commission, be considered to be reclassified “EU RESTRICTED” by default, unless its author decides to give it another classification by 31 January 2002. In such case the author shall inform all addressees of the document concerned;
(b) if created by authors outside the Commission, retain its original classification and thus be treated as EU classified information of the equivalent level, unless the author agrees to declassification or downgrading of the information.
(1) OJ L 17/58, 6.10.1958, p. 406/58.
(2) OJ L 151, 15.6.1990, p. 1.
(3) OJ L 101, 11.4.2001, p. 1.
(4) OJ L 145, 31.5.2001, p. 43.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community, and in particular Article 218(2) thereof,Having regard to the Treaty establishing the European Coal and Steel Community, and in particular Article 16 thereof,Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 131 thereof,Having regard to the Treaty on European Union, and in particular Article 28(1) and Article 41(1) thereof,HAS DECIDED AS FOLLOWS:Article 1The Commission’s provisions on security, the text of which is annexed to this Decision, are hereby added to the Commission’s Rules of Procedure as an annex.Article 2This Decision shall enter into force on the day of its publication in the Official Journal of the European Communities.It shall apply from 1 December 2001.Done at Brussels, 29 November 2001.For the CommissionThe PresidentRomano ProdiANNEXCOMMISSION PROVISIONS ON SECURITYWhereas:(1) In order to develop Commission activities in areas which require a degree of confidentiality, it is appropriate to establish a comprehensive security system applicable to the Commission, the other institutions, bodies, offices and agencies established by virtue or on the basis of the EC Treaty or the Treaty on European Union, the Member States, as well as any other recipient of European Union classified information, hereafter referred to as “EU classified information”.(2) In order to safeguard the effectiveness of the security system thus established, the Commission will make EU classified information available only to those outside bodies which offer guarantees that they have taken all measures necessary to apply rules strictly equivalent to these provisions.(3) These provisions are taken without prejudice to Regulation No 3 of 31 July 1958 implementing Article 24 of the Treaty establishing the European Atomic Energy Community(1), to Council Regulation (EC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities(2) and to Commission Decision C (95) 1510 final of 23 November 1995 on the protection of informatics systems.(4) The Commission’s security system is based on the principles put forward in Council Decision 2001/264/EC of 19 March 2001 adopting the Council’s security regulations(3) with a view to ensuring a smooth functioning of the decision-making process of the Union.(5) The Commission underlines the importance of associating, where appropriate, the other institutions with the rules and standards of confidentiality which are necessary in order to protect the interests of the Union and its Member States.(6) The Commission recognises the need to create its own concept of security, taking into consideration all elements of security and the specific character of the Commission as an institution.(7) These provisions are taken without prejudice to Article 255 of the Treaty and to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(4);Article 1The Commission’s rules on security are set out in the Annex.Article 21. The Member of the Commission responsible for security matters shall take appropriate measures to ensure that, when handling EU classified information, the rules referred to in
The Commission’s provisions on security, the text of which is annexed to this Decision, are hereby added to the Commission’s Rules of Procedure as an annex.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Communities.
It shall apply from 1 December 2001.
Done at Brussels, 29 November 2001.
For the Commission
The President
Romano Prodi
Third states, international organisations and other bodies shall be allowed to receive EU classified information on the condition that they ensure that, when such information is handled, rules strictly equivalent to those referred to in Article 1 are respected.
In keeping with the basic principles and minimum standards of security contained in Part I of the Annex, the Member of the Commission responsible for security matters may take measures in accordance with Part II of the Annex.
As from the date of their application, these provisions shall replace:
(a) Commission Decision C (94) 3282 of 30 November 1994 on the security measures applicable to classified information produced or transmitted in connection with activities of the European Union;
(b) Commission Decision C (99) 423 of 25 February 1999 relating to the procedures whereby officials and other employees of the European Commission may be allowed access to classified information held by the Commission.
As from the date of application of these provisions, all classified information held by the Commission until that date, with the exception of Euratom classified information, shall:
(a) if created by the Commission, be considered to be reclassified “EU RESTRICTED” by default, unless its author decides to give it another classification by 31 January 2002. In such case the author shall inform all addressees of the document concerned;
(b) if created by authors outside the Commission, retain its original classification and thus be treated as EU classified information of the equivalent level, unless the author agrees to declassification or downgrading of the information.
(1) OJ L 17/58, 6.10.1958, p. 406/58.
(2) OJ L 151, 15.6.1990, p. 1.
(3) OJ L 101, 11.4.2001, p. 1.
(4) OJ L 145, 31.5.2001, p. 43.
COMMISSION PROVISIONS ON SECURITY
(1) In order to develop Commission activities in areas which require a degree of confidentiality, it is appropriate to establish a comprehensive security system applicable to the Commission, the other institutions, bodies, offices and agencies established by virtue or on the basis of the EC Treaty or the Treaty on European Union, the Member States, as well as any other recipient of European Union classified information, hereafter referred to as “EU classified information”.
(2) In order to safeguard the effectiveness of the security system thus established, the Commission will make EU classified information available only to those outside bodies which offer guarantees that they have taken all measures necessary to apply rules strictly equivalent to these provisions.
(3) These provisions are taken without prejudice to Regulation No 3 of 31 July 1958 implementing Article 24 of the Treaty establishing the European Atomic Energy Community(1), to Council Regulation (EC) No 1588/90 of 11 June 1990 on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities(2) and to Commission Decision C (95) 1510 final of 23 November 1995 on the protection of informatics systems.
(4) The Commission’s security system is based on the principles put forward in Council Decision 2001/264/EC of 19 March 2001 adopting the Council’s security regulations(3) with a view to ensuring a smooth functioning of the decision-making process of the Union.
(5) The Commission underlines the importance of associating, where appropriate, the other institutions with the rules and standards of confidentiality which are necessary in order to protect the interests of the Union and its Member States.
(6) The Commission recognises the need to create its own concept of security, taking into consideration all elements of security and the specific character of the Commission as an institution.
(7) These provisions are taken without prejudice to Article 255 of the Treaty and to Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents(4);
RULES ON SECURITY
PART I: BASIC PRINCIPLES AND MINIMUM STANDARDS OF SECURITY
1. INTRODUCTION
These provisions lay down the basic principles and minimum standards of security to be respected in an appropriate manner by the Commission in all its places of employment, as well as by all recipients of EUCI, so that security is safeguarded and each may be assured that a common standard of protection is established.
2. GENERAL PRINCIPLES
The Commission’s security policy forms an integral part of its general internal management policy and is thus based on the principles governing its general policy.
These principles include legality, transparency, accountability and subsidiarity (proportionality).
Legality indicates the need to stay strictly within the legal framework in executing security functions and the need to conform to the legal requirements. It also means that responsibilities in the domain of security have to be based on proper legal provisions. The provisions in the Staff Regulations fully apply, notably its Article 17 on the obligation of staff to exercise discretion with regard to Commission information and its Title VI on disciplinary measures. Finally it means that breaches of security within the responsibility of the Commission have to be dealt with in a manner consistent with Commission policy on disciplinary actions and with its policy on cooperation with Member States in the area of criminal justice.
Transparency indicates the need for clarity regarding all security rules and provisions, for balance between the different services and the different domains (physical security versus information protection etc.) and the need for a consistent and structured security awareness policy. It also defines a need for clear written guidelines for implementing security measures.
Accountability means that responsibilities in the domain of security will be clearly defined. Moreover it indicates the need to test regularly whether these responsibilities have been correctly executed.
Subsidiarity, or proportionality, means that security shall be organised on the lowest possible level and as close as possible to the Directorates General and services of the Commission. It also indicates that security activities shall be limited to only those elements that really need it. And finally it means that security measures shall be proportional to the interests to be protected and to the actual or potential threat to these interests, allowing for a defence which causes the least possible disruption.
3. FOUNDATIONS OF SECURITY
The foundations of sound security are:
(a) Within each Member State, a national security organisation responsible for:
1. The collection and recording of intelligence on espionage, sabotage, terrorism and other subversive activities, and
2. Providing information and advice to its governments, and through it, to the Commission, on the nature of the threats to security and the means of protection against them.
(b) Within each Member State, and within the Commission, a technical INFOSEC authority (IA) responsible for working with the security authority concerned to provide information and advice on technical threats to security and the means for protection against them;
(c) Regular collaboration among government departments and the appropriate services of the European institutions to order to establish and recommend, as appropriate:
1. What persons, information and resources need to be protected, and
2. Common standards of protection.
(d) Close cooperation between the Commission Security Office and the security services of the other European institutions and with the NATO Office of Security (NOS).
4. PRINCIPLES OF INFORMATION SECURITY
4.1. Objectives
Information security has the following principal objectives:
(a) To safeguard EU classified information (EUCI) from espionage, compromise or unauthorised disclosure;
(b) To safeguard EU information handled in communications and information systems and networks, against threats to its confidentiality, integrity and availability;
(c) To safeguard Commission premises housing EU information from sabotage and malicious wilful damage;
(d) In the event of failure, to assess the damage caused, limit its consequences and adopt the necessary remedial measures.
4.2. Definitions
Throughout these rules:
(a) The term “EU classified information” (EUCI) means any information and material, an unauthorised disclosure of which could cause varying degrees of prejudice to EU interests, or to one or more of its Member States, whether such information originates within the EU or is received from Member States, third States or international organisations.
(b) The term “document” means any letter, note, minute, report, memorandum, signal/message, sketch, photograph, slide, film, map, chart, plan, notebook, stencil, carbon, typewriter or printer ribbon, tape, cassette, computer disk, CD-ROM, or other physical medium on which information has been recorded.
(c) The term “material” means “document” as defined in b) and also any item of equipment, either manufactured or in the process of manufacture.
(d) The term “need to know” means the need of an individual employee to have access to EU classified information in order to be able to perform a function or a task.
(e) “Authorisation” means a decision by the President of the Commission to grant an individual access to EUCI up to a specific level, on the basis of a positive result of a security screening (vetting), carried out by a National Security Authority under national law.
(f) The term “classification” means the allocation of an appropriate level of security to information the unauthorised disclosure of which might cause a certain degree of prejudice to Commission or to Member State interests.
(g) The term “downgrading” (déclassement) means a reduction in the level of classification.
(h) The term “declassification” (déclassification) means the removal of any classification.
(i) The term “originator” means the duly authorised author of a classified document. Within the Commission, Heads of departements may authorize their staff to originate EUCI.
(j) The term “Commission departments” means Commission departments and services, including the cabinets, in all places of employment, including Joint Research Centre, Representations and Offices in the Union and Delegations in third countries.
4.3. Classification
(a) Where confidentiality is concerned, care and experience are needed in the selection of information and material to be protected and the assessment of the degree of protection it requires. It is fundamental that the degree of protection should correspond to the security criticality of the individual piece of information and material to be protected. In order to ensure the smooth flow of information, steps shall be taken to avoid both overclassification and underclassification.
(b) The classification system is the instrument for giving effect to these principles; a similar system of classification shall be followed in planning and organising ways to counter espionage, sabotage, terrorism and other threats so that the greatest measure of protection is given to the most important premises housing classified information and to the most sensitive points within them.
(c) Responsibility for classifying information lies solely with the originator of that information.
(d) The level of classification may solely be based on the content of that information.
(e) Where a number of items of information is grouped together, the classification level to be applied to the whole shall at least be as high as the highest classification. A collection of information may however be given a higher classification than its constituent parts.
(f) Classifications shall be assigned only when necessary and for as long as necessary.
4.4. Aims of security measures
The security measures shall:
(a) Extend to all persons having access to classified information, classified information-carrying media, all premises containing such information and important installations.

Pending: 32001D0699

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(1), and in particular Article 22(1) thereof,Whereas:(1) In accordance with Article 22 of Directive 97/78/EC the necessary measures must be adopted as regards the import of certain products from third countries where any cause likely to constitute a serious danger for animal or human health appears or is spreading.(2) The presence of chloramphenicol has been detected in shrimps intended for human consumption and imported from China and Vietnam.(3) Since the presence of chloramphenicol on food presents a potential risk for human health, the consignments of shrimps originating or coming from China and Vietnam shall be sampled in order to demonstrate their wholesomeness.(4) Council Directive 92/59/EEC of 29 June 1992 on general products safety has set up the Rapid Alert System for Food(2).(5) This Decision will be reviewed in the light of the guarantees offered by the competent authorities of China and Vietnam and on the basis of the results of the test carried out by Member States.(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,HAS ADOPTED THIS DECISION:Article 1This Decision shall apply to shrimps intended for human consumption coming from or originating in China and Vietnam.Article 21. Member States shall, using appropriate sampling plans and detection methods, subject each consignment of shrimps originating or coming from China and Vietnam to a chemical test in order to ensure that the products concerned do not present a hazard to human health. This test must be carried out, in particular, with a view to detect the presence of chloramphenicol.2. Member States shall inform immediately the Commission of the results of the test referred to in paragraph 1, making use of the Rapid Alert System for Food, set up by Directive 92/59/EEC.Article 3Member States shall not authorise the importation into their territory or the consignment to another Member State of the products referred to in

Article 1
This Decision shall apply to shrimps intended for human consumption coming from or originating in China and Vietnam.

Article 2
1. Member States shall, using appropriate sampling plans and detection methods, subject each consignment of shrimps originating or coming from China and Vietnam to a chemical test in order to ensure that the products concerned do not present a hazard to human health. This test must be carried out, in particular, with a view to detect the presence of chloramphenicol.
2. Member States shall inform immediately the Commission of the results of the test referred to in paragraph 1, making use of the Rapid Alert System for Food, set up by Directive 92/59/EEC.

Article 3
Member States shall not authorise the importation into their territory or the consignment to another Member State of the products referred to in Article 1 unless the results of the checks referred to in Article 2 are favourable.

Article 4
All expenditures incurred by the application of this Decision shall be charged to the consignor, the consignee or their agent.

Article 5
Member States shall modify the measures they apply to trade to bring them into line with this Decision. They shall immediately inform the Commission thereof.

Article 6
This Decision shall be reviewed on the basis of the guarantees provided by the Chinese and Vietnamese competent authorities and on the basis of the results of the tests referred to in Article 2.

Article 7
This Decision is addressed to the Member States.
Done at Brussels, 19 September 2001.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 24, 30.1.1998, p. 9.
(2) OJ L 228, 11.8.1992, p. 24.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries(1), and in particular Article 22(1) thereof,Whereas:(1) In accordance with Article 22 of Directive 97/78/EC the necessary measures must be adopted as regards the import of certain products from third countries where any cause likely to constitute a serious danger for animal or human health appears or is spreading.(2) The presence of chloramphenicol has been detected in shrimps intended for human consumption and imported from China and Vietnam.(3) Since the presence of chloramphenicol on food presents a potential risk for human health, the consignments of shrimps originating or coming from China and Vietnam shall be sampled in order to demonstrate their wholesomeness.(4) Council Directive 92/59/EEC of 29 June 1992 on general products safety has set up the Rapid Alert System for Food(2).(5) This Decision will be reviewed in the light of the guarantees offered by the competent authorities of China and Vietnam and on the basis of the results of the test carried out by Member States.(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,HAS ADOPTED THIS DECISION:Article 1This Decision shall apply to shrimps intended for human consumption coming from or originating in China and Vietnam.Article 21. Member States shall, using appropriate sampling plans and detection methods, subject each consignment of shrimps originating or coming from China and Vietnam to a chemical test in order to ensure that the products concerned do not present a hazard to human health. This test must be carried out, in particular, with a view to detect the presence of chloramphenicol.2. Member States shall inform immediately the Commission of the results of the test referred to in paragraph 1, making use of the Rapid Alert System for Food, set up by Directive 92/59/EEC.Article 3Member States shall not authorise the importation into their territory or the consignment to another Member State of the products referred to in
This Decision shall apply to shrimps intended for human consumption coming from or originating in China and Vietnam.
1. Member States shall, using appropriate sampling plans and detection methods, subject each consignment of shrimps originating or coming from China and Vietnam to a chemical test in order to ensure that the products concerned do not present a hazard to human health. This test must be carried out, in particular, with a view to detect the presence of chloramphenicol.
2. Member States shall inform immediately the Commission of the results of the test referred to in paragraph 1, making use of the Rapid Alert System for Food, set up by Directive 92/59/EEC.
Member States shall not authorise the importation into their territory or the consignment to another Member State of the products referred to in Article 1 unless the results of the checks referred to in Article 2 are favourable.
All expenditures incurred by the application of this Decision shall be charged to the consignor, the consignee or their agent.
Member States shall modify the measures they apply to trade to bring them into line with this Decision. They shall immediately inform the Commission thereof.
This Decision shall be reviewed on the basis of the guarantees provided by the Chinese and Vietnamese competent authorities and on the basis of the results of the tests referred to in Article 2.
This Decision is addressed to the Member States.
Done at Brussels, 19 September 2001.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 24, 30.1.1998, p. 9.
(2) OJ L 228, 11.8.1992, p. 24.

Pending: 32001D0689

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Articles 3, 4 and 6 thereof,Whereas:(1) Article 3 of Regulation (EC) No 1980/2000 provides that the eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Article 4 of Regulation (EC) No 1980/2000 provides that specific eco-label criteria shall be established according to product groups.(3) Article 4 of Regulation (EC) No 1980/2000 provides that the review of the eco-label criteria as well as of the assessment and verification requirements related to the criteria shall take place in due time before the end of the period of validity of the criteria specified for each product group and shall result in a proposal for prolongation, withdrawal or revision.(4) By Decision 98/483/EC(2), the Commission established ecological criteria for the award of the Community eco-label to dishwashers, which, according to Article 3 thereof, as amended by Decision 2001/397/EC(3), expire on 31 January 2003.(5) It is appropriate to revise the definition of the product group and the ecological criteria that were established by Decision 98/483/EC in order to reflect the developments in the market.(6) It is appropriate to adopt a new Commission Decision establishing the specific ecological criteria for this product group, which will be valid for a period of five years.(7) It is appropriate that, for a limited period of not more than 12 months, both the new criteria established by this Decision and the criteria previously established by Decision 98/483/EC, are valid concurrently, in order to allow sufficient time for companies that have been awarded the eco-label for their products prior to the adoption of this new Decision to adapt these products to comply with the new criteria.(8) The measures set out in this Decision have been developed and adopted under the procedures for the setting of eco-label criteria as laid down in Article 6 of Regulation (EC) No 1980/2000,(9) The measures set out in this Decision are in accordance with the opinion of the committee set up under Article 17 of Regulation (EC) No 1980/2000,HAS ADOPTED THIS DECISION:Article 1The product group “dishwashers” (hereinafter referred to as “the product group”) shall mean: “Electric mains-operated household dishwashers sold to the general public. Appliances that may also use other energy sources, such as batteries, or have no internal heat source, are excluded.”Article 2The environmental performance of the product group as defined in

Article 1
The product group “dishwashers” (hereinafter referred to as “the product group”) shall mean: “Electric mains-operated household dishwashers sold to the general public. Appliances that may also use other energy sources, such as batteries, or have no internal heat source, are excluded.”

Article 2
The environmental performance of the product group as defined in Article 1 shall be assessed by reference to the specific ecological criteria set out in the Annex.

Article 3
The product group definition and the criteria for the product group shall be valid for five years from the date on which this Decision takes effect.
The period of validity of the product group definition and the criteria established by Decision 98/483/EC shall be modified to expire 12 months after the date on which this Decision takes effect.

Article 4
For administrative purposes the code number assigned to the product group shall be “002”.

Article 5
This Decision is addressed to the Member States.
Done at Brussels, 28 August 2001.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 216, 4.8.1998, p. 12.
(3) OJ L 139, 23.5.2001, p. 21.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Articles 3, 4 and 6 thereof,Whereas:(1) Article 3 of Regulation (EC) No 1980/2000 provides that the eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Article 4 of Regulation (EC) No 1980/2000 provides that specific eco-label criteria shall be established according to product groups.(3) Article 4 of Regulation (EC) No 1980/2000 provides that the review of the eco-label criteria as well as of the assessment and verification requirements related to the criteria shall take place in due time before the end of the period of validity of the criteria specified for each product group and shall result in a proposal for prolongation, withdrawal or revision.(4) By Decision 98/483/EC(2), the Commission established ecological criteria for the award of the Community eco-label to dishwashers, which, according to Article 3 thereof, as amended by Decision 2001/397/EC(3), expire on 31 January 2003.(5) It is appropriate to revise the definition of the product group and the ecological criteria that were established by Decision 98/483/EC in order to reflect the developments in the market.(6) It is appropriate to adopt a new Commission Decision establishing the specific ecological criteria for this product group, which will be valid for a period of five years.(7) It is appropriate that, for a limited period of not more than 12 months, both the new criteria established by this Decision and the criteria previously established by Decision 98/483/EC, are valid concurrently, in order to allow sufficient time for companies that have been awarded the eco-label for their products prior to the adoption of this new Decision to adapt these products to comply with the new criteria.(8) The measures set out in this Decision have been developed and adopted under the procedures for the setting of eco-label criteria as laid down in Article 6 of Regulation (EC) No 1980/2000,(9) The measures set out in this Decision are in accordance with the opinion of the committee set up under Article 17 of Regulation (EC) No 1980/2000,HAS ADOPTED THIS DECISION:Article 1The product group “dishwashers” (hereinafter referred to as “the product group”) shall mean: “Electric mains-operated household dishwashers sold to the general public. Appliances that may also use other energy sources, such as batteries, or have no internal heat source, are excluded.”Article 2The environmental performance of the product group as defined in
The product group “dishwashers” (hereinafter referred to as “the product group”) shall mean: “Electric mains-operated household dishwashers sold to the general public. Appliances that may also use other energy sources, such as batteries, or have no internal heat source, are excluded.”
The environmental performance of the product group as defined in Article 1 shall be assessed by reference to the specific ecological criteria set out in the Annex.
The product group definition and the criteria for the product group shall be valid for five years from the date on which this Decision takes effect.
The period of validity of the product group definition and the criteria established by Decision 98/483/EC shall be modified to expire 12 months after the date on which this Decision takes effect.
For administrative purposes the code number assigned to the product group shall be “002”.
This Decision is addressed to the Member States.
Done at Brussels, 28 August 2001.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 216, 4.8.1998, p. 12.
(3) OJ L 139, 23.5.2001, p. 21.
In order to qualify for the eco-label, a dishwasher (hereinafter referred to as “the product”) must fall within the product group as defined in Article 1, and must comply with the criteria of this Annex, with tests carried out on application as indicated in the criteria. Where appropriate, other test methods may be used if their equivalence is accepted by the competent body assessing the application. Where no tests are mentioned, or are mentioned as being for use in verification or monitoring, competent bodies should rely as appropriate on declarations and documentation provided by the applicant and/or independent verifications.
The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex (Note: it is not required to implement such management schemes.)
These criteria aim in particular at promoting:
– reduction of environmental damage or risks related to the use of energy (global warming, acidification, depletion of non-renewable resources) by reducing energy consumption,
– reduction of environmental damage related to the use of natural resources by reducing water consumption.
The criteria encourage the implementation of best practice (optimal environmental use) and enhance consumers’ environmental awareness. Furthermore, marking the plastic components encourages the recycling of the machine.
The criteria are set at levels that promote the labelling of dishwashers that have a lower environmental impact, in particular during their use.
ECOLOGICAL CRITERIA
1. Energy efficiency
(a) Dishwashers with 10 or more place settings shall have an energy efficiency index lower than 0,58 as defined in Annex IV to Commission Directive 97/17/EC of 16 April 1997 implementing Council Directive 92/75/EEC with regard to energy labelling of household dishwashers(1), using the same test method EN 50242 and programme cycle as chosen for Directive 97/17/EC.
Dishwashers with less than 10 place settings but more than five place settings shall have an energy efficiency index lower than 0,64 as defined in Annex IV to Directive 97/17/EC, using the same test method EN 50242 and programme cycle as chosen for Directive 97/17/EC.
Dishwashers with five or fewer place settings shall have an energy efficiency index lower than 0,76 as defined in Annex IV to Directive 97/17/EC, using the same test method EN 50242 and programme cycle as chosen for Directive 97/17/EC.
The applicant shall provide a copy of the technical documentation referred to in Article 2(1) of Directive 97/17/EC. This documentation shall include the reports of at least three measurements of energy consumption made according to EN 50242, using the same programme cycle as chosen for Directive 97/17/EC. The arithmetic mean of these measurements shall be less or equal to the above requirement. The value declared on the energy label shall not be lower than this mean value, and the energy efficiency class indicated on the energy label shall correspond to this mean value.
In case of verification, which is not required on application, competent bodies shall take into consideration the tolerances and control procedures laid down in EN 50242.
(b) The dishwasher shall be suitable for connection to a hot-fill water supply.
The applicant shall declare the compliance of the product with this requirement.
2. Water consumption
The water consumption of the dishwasher (expressed as W(measured)) shall be lower or equal to the threshold as defined by the equation below using the same test method EN 50242 and programme cycle as chosen for Directive 97/17/EC:
W(measured) <= (0,625 × S) + 9,25
W(measured)= the measured water consumption of the dishwasher in litres per cycle, expressed to the first decimal,
S= the applicable number of standard place settings of the dishwasher.
The applicant shall provide a copy of the technical documentation referred to in Article 2(1) of Directive 97/17/EC. This documentation shall include the reports of at least three measurements of water consumption made according to EN 50242, using the same programme cycle as chosen for Directive 97/17/EC. The arithmetic mean of these measurements shall be less or equal to the above requirement. The value declared on the energy label shall not be lower than this mean value.
In case of verification, which is not required on application, competent bodies shall take into consideration the tolerances and control procedures laid down in EN 50242.
3. Prevention of excessive use of detergent
The appliance shall have clear volumetric markings on the detergent dispenser allowing the user to adjust the detergent quantity used according to the type and amount of load and its degree of soil.
The applicant shall declare the compliance of the product with this requirement.
(a) Airborne noise from the appliance, counted as sound power, shall not exceed 53 dB (A) for free standing models and 50 dB (A) for built-in models. The noise emissions shall be measured according to EN 50242/EN 60704-2-3/EN 60704-3, using the same test method and programme cycle as chosen for Directive 97/17/EC.
(b) Information about the noise level of the machine shall be provided in a way clearly visible to the consumer. This shall be done by the incorporation of this information in the energy label for dishwashers.
The applicant shall provide a copy of the technical documentation referred to in Article 2(1) of Directive 97/17/EC. This documentation shall include the reports of at least three measurements of noise made according to EN 50242, using the same programme cycle as chosen for Directive 97/17/EC. The declared noise shall be derived from these measurements as laid down in the standards referred to in EN 50242, and shall appear on the energy label.
In case of verification, which is not required on application, competent bodies shall take into consideration the tolerances and control procedures laid down in EN 50242.
5. Take-back and recycling
(a) The manufacturer shall offer the take-back, free of charge, for recycling of the dishwasher and of components being replaced by himself or by any commissioned company, except for dishwashers which contain components which do not belong to the dishwasher.
(b) Plastic parts heavier than 50 grams shall have a permanent marking identifying the material, in conformity with ISO 11469. This requirement does not apply to extruded plastic parts.
(c) Plastic parts heavier than 25 grams shall not contain the following flame retardants:
(d) Plastic parts heavier than 25 grams shall not contain flame retardant substances or preparations containing substances that are or may be assigned any of the risk phrases R45 (may cause cancer), R46 (may cause heritable genetic damage), R50 (very toxic to aquatic organisms), R51 (toxic to aquatic organisms), R52 (harmful to aquatic organisms), R53 (may cause long-term adverse effects in the aquatic environment), R60 (may impair fertility) or R61 (may cause harm to the unborn child), or any combinations of risk phrases containing any of the above risk phrases, as defined in Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(2), and its subsequent amendments.
This requirement does not apply to flame retardants that on application change their chemical nature to no longer warrant classification under any of the R-phrases listed above, and where less than 0,1 % of the flame retardant in the treated part remains in the form as before application.
(e) The manufacturer shall take into account disassembly when designing and shall check the disassembly of the dishwasher and provide a disassembly report that shall be made available to third parties on request. Amongst others, the report shall confirm that:
– joints are easy to find and accessible,
– electronic assemblies are easy to find and to dismantle,
– the product is easy to dismantle by using commonly available tools,
– incompatible and hazardous materials are separable.
The applicant shall declare the compliance of the product with these requirements. The applicant shall provide to the competent body assessing the application a copy of the disassembly report. The applicant and/or his supplier or suppliers, as appropriate, shall indicate to this competent body which flame retardants, if any, have been used in or on plastic parts heavier than 25 grams.
6. Life-time extension
(a) The manufacturer shall offer a commercial guarantee to ensure that the dishwasher will function for at least two years. This guarantee shall be valid from the date of delivery to the customer.
(b) The availability of compatible replacement parts shall be guaranteed for 12 years from the time that production ceases.
The applicant shall declare the compliance of the product with these requirements.
7. Appliance design
(a) The appliance shall allow the user to select a program for washing a standard load using detergents that work best at temperatures lower than 65 °C.
(b) The appliance shall have clear markings identifying the appropriate settings for the programmes available (e.g. standard, low-temperature, half-load, lightly or heavily soiled load, etc.)
(c) Where applicable, the appliance shall allow the salt dosing to be adjusted to the local water hardness, and shall have a salt refill indicator.

Pending: 32001D0688

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Articles 3, 4 and 6 thereof,Whereas:(1) Article 3 of Regulation (EC) No 1980/2000 provides that the eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Article 4 of Regulation (EC) No 1980/2000 provides that specific eco-label criteria shall be established according to product groups.(3) Article 4 of Regulation (EC) No 1980/2000 provides that the review of the eco-label criteria as well as of the assessment and verification requirements related to the criteria shall take place in due time before the end of the period of validity of the criteria specified for each product group and shall result in a proposal for prolongation, withdrawal or revision.(4) By Decision 98/488/EC(2), the Commission established ecological criteria for the award of the Community eco-label to soil improvers, which, according to Article 3 thereof, as amended by Decision 2001/157/EC(3), expire on 30 September 2002.(5) It is appropriate to revise the definition of the product group and the ecological criteria that were established by Decision 98/488/EC in order to reflect the developments in the market.(6) It is appropriate to adopt a new Commission Decision establishing the specific ecological criteria for this product group, which will be valid for a period of five years.(7) It is appropriate that, for a limited period of not more than 12 months, both the new criteria established by this Decision and the criteria previously established by Decision 98/488/EC, are valid concurrently, in order to allow sufficient time for companies that have been awarded the eco-label for their products prior to the adoption of this new Decision to adapt these products to comply with the new criteria.(8) The measures set out in this Decision have been developed and adopted under the procedures for the setting of eco-label criteria as laid down in Article 6 of Regulation (EC) No 1980/2000.(9) The measures set out in this Decision are in accordance with the opinion of the committee set up under Article 17 of Regulation (EC) No 1980/2000,HAS ADOPTED THIS DECISION:Article 1The product group “soil improvers and growing media” (hereinafter referred to as “the product group”) shall comprise:- soil improvers: materials to be added to the soil in situ primarily to maintain or improve its physical properties, and which may improve its chemical and/or biological properties or activity,- growing media: material, other than soils in situ, in which plants are grown.Article 2The environmental performance of the product group as defined in

Article 1
The product group “soil improvers and growing media” (hereinafter referred to as “the product group”) shall comprise:
– soil improvers: materials to be added to the soil in situ primarily to maintain or improve its physical properties, and which may improve its chemical and/or biological properties or activity,
– growing media: material, other than soils in situ, in which plants are grown.

Article 2
The environmental performance of the product group as defined in Article 1 shall be assessed by reference to the specific ecological criteria set out in the Annex.

Article 3
The product group definition and the criteria for the product group shall be valid for five years from the date on which this Decision takes effect.
The period of validity of the product group definition and the criteria established by Decision 98/488/EC shall be modified to expire 12 months after the date on which this Decision takes effect.

Article 4
For administrative purposes the code number assigned to the product group shall be “003”.

Article 5
This Decision is addressed to the Member States.
Done at Brussels, 28 August 2001.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 219, 7.8.1998, p. 39.
(3) OJ L 57, 27.2.2001, p. 51.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme(1), and in particular Articles 3, 4 and 6 thereof,Whereas:(1) Article 3 of Regulation (EC) No 1980/2000 provides that the eco-label may be awarded to a product possessing characteristics which enable it to contribute significantly to improvements in relation to key environmental aspects.(2) Article 4 of Regulation (EC) No 1980/2000 provides that specific eco-label criteria shall be established according to product groups.(3) Article 4 of Regulation (EC) No 1980/2000 provides that the review of the eco-label criteria as well as of the assessment and verification requirements related to the criteria shall take place in due time before the end of the period of validity of the criteria specified for each product group and shall result in a proposal for prolongation, withdrawal or revision.(4) By Decision 98/488/EC(2), the Commission established ecological criteria for the award of the Community eco-label to soil improvers, which, according to Article 3 thereof, as amended by Decision 2001/157/EC(3), expire on 30 September 2002.(5) It is appropriate to revise the definition of the product group and the ecological criteria that were established by Decision 98/488/EC in order to reflect the developments in the market.(6) It is appropriate to adopt a new Commission Decision establishing the specific ecological criteria for this product group, which will be valid for a period of five years.(7) It is appropriate that, for a limited period of not more than 12 months, both the new criteria established by this Decision and the criteria previously established by Decision 98/488/EC, are valid concurrently, in order to allow sufficient time for companies that have been awarded the eco-label for their products prior to the adoption of this new Decision to adapt these products to comply with the new criteria.(8) The measures set out in this Decision have been developed and adopted under the procedures for the setting of eco-label criteria as laid down in Article 6 of Regulation (EC) No 1980/2000.(9) The measures set out in this Decision are in accordance with the opinion of the committee set up under Article 17 of Regulation (EC) No 1980/2000,HAS ADOPTED THIS DECISION:Article 1The product group “soil improvers and growing media” (hereinafter referred to as “the product group”) shall comprise:- soil improvers: materials to be added to the soil in situ primarily to maintain or improve its physical properties, and which may improve its chemical and/or biological properties or activity,- growing media: material, other than soils in situ, in which plants are grown.Article 2The environmental performance of the product group as defined in
The product group “soil improvers and growing media” (hereinafter referred to as “the product group”) shall comprise:
– soil improvers: materials to be added to the soil in situ primarily to maintain or improve its physical properties, and which may improve its chemical and/or biological properties or activity,
– growing media: material, other than soils in situ, in which plants are grown.
The environmental performance of the product group as defined in Article 1 shall be assessed by reference to the specific ecological criteria set out in the Annex.
The product group definition and the criteria for the product group shall be valid for five years from the date on which this Decision takes effect.
The period of validity of the product group definition and the criteria established by Decision 98/488/EC shall be modified to expire 12 months after the date on which this Decision takes effect.
For administrative purposes the code number assigned to the product group shall be “003”.
This Decision is addressed to the Member States.
Done at Brussels, 28 August 2001.
For the Commission
Margot Wallström
Member of the Commission
(1) OJ L 237, 21.9.2000, p. 1.
(2) OJ L 219, 7.8.1998, p. 39.
(3) OJ L 57, 27.2.2001, p. 51.
In order to qualify for the eco-label, a soil improver or growing media (hereinafter referred to as “the product” or “products”) must fall within the product group as defined in Article 1, and must comply with the criteria of this Annex, with tests carried out on application as indicated in the criteria.
Testing shall where applicable be carried out in accordance with test methods developed by Technical Committee CEN 223 “Soil improvers and growing media”.
Sampling shall be carried out in accordance with methodologies set out by CEN/TC 223 (WG 3) as specified and approved by CEN in EN 12579 – Soil improvers and growing media – Sampling. Where testing or sampling is required that is not covered by these methods and sampling techniques, the competent body or bodies assessing the application (hereinafter referred to as the “competent body”) shall indicate which testing and/or sampling methods it considers acceptable.
Where appropriate, other test methods may be used if their equivalence is accepted by the competent body. Where no tests are mentioned, or are mentioned as being for use in verification or monitoring, competent bodies should rely as appropriate on declarations and documentation provided by the applicant and/or independent verifications.
The competent bodies are recommended to take into account the implementation of recognised environmental management schemes, such as EMAS or ISO 14001, when assessing applications and monitoring compliance with the criteria in this Annex. (Note: it is not required to implement such management schemes.)
These criteria aim in particular at promoting:
– the use and/or re-use of organic matter derived from the collection and/or processing of waste material and therefore contributing to a minimisation of solid waste at the final disposal (e.g. at landfill),
– the reduction of environmental damage or risks from heavy metals and other hazardous compounds in soil improvers and growing media.
The criteria are set at levels that promote the labelling of soil improvers and growing media that have a lower environmental impact during the whole life-cycle of the product.
ECOLOGICAL CRITERIA
1. Organic ingredients
(a) A product shall only be considered for the award of an eco-label if its organic matter content is derived from the processing and/or re-use of waste materials (as defined in Council Directive 75/442/EEC of 15 July 1975 on waste(1), as amended by Directive 91/156/EEC of 18 March 1991 amending Directive 75/442/EEC on waste(2), and in Annex I to the said Directive). Note: the term “organic” refers in the general sense to materials of, or formed from/by, living organisms.
(b) Products shall not contain sewage sludge.
The applicant shall provide the competent body with the detailed composition of the product, and a declaration of compliance with each of the above requirements.
2. Limitation of hazardous substances
(a) In the final product, the content of the following elements shall be lower than the values shown below, measured in terms of dry weight:
The applicant shall provide the competent body with the relevant test reports, and a declaration of compliance with this requirement.
(b) Products shall not contain bark which has been treated with pesticides.
The applicant shall provide the competent body with a declaration of compliance with this requirement.
3. Physical contaminants
In the final product (with mesh size > 2 mm), the content of glass, metal and plastic shall be lower than 0,5 % as measured in terms of dry weight.
The applicant shall provide the competent body with the relevant test reports, and a declaration of compliance with this requirement.
4. Nutrient loadings
(a) The concentration of nitrogen in the product shall not exceed 2 % total N (of dry weight) and inorganic N must not exceed 20 % total N (or organic N >= 80 %).
(b) When used at the rates of application as recommended in the information provided with the product, the product shall not exceed maximum nutrient loadings of:
– 17 g/m2 total nitrogen
– 10 g/m2 P2O5
– 20 g/m2 K2O
This requirement does not apply to products where less than 10 % (w/w) of the nutrient content is available for plant growth during the first season of application. Such products (for example many mulches) are defined as those having a C:N ratio greater than 30:1.
The applicant shall provide the competent body with the relevant test reports and documentation, and a declaration of compliance with these requirements.
5. Product performance
(a) Products shall be supplied in a solid form and contain not less than 25 % dry matter by weight and not less than 20 % organic matter by dry weight (measured by loss of ignition).
(b) Products shall not adversely affect plant emergence or subsequent growth.
(c) Products shall not give rise to offensive odours after being applied to the soil.
The applicant shall provide the competent body with a declaration of compliance with these requirements, together with related test reports and documentation.
6. Health and safety
The applicant shall provide the competent body with the relevant test reports and documentation, and a declaration of compliance with these requirements.
7. Viable seeds/propagules
In the final product, the content of weed seeds and the vegetative reproductive parts of aggressive weeds shall not exceed two units per litre.
The applicant shall provide the competent body with a declaration of compliance with these requirements, together with any related test reports and/or documentation.
8. Additional criteria specifically applicable to growing media
(a) The organic part of the product shall be composed exclusively of soil improvers that meet the requirements stated in the present Decision. Mineral coformulants such as sand, clay, etc. can be added in order to improve overall physical and chemical properties.
(b) Products shall not contain peat or any products derived from peat.
(c) The electrical conductivity of the products shall not exceed 1,5 dS/m.
9. Information provided with the product
The following information shall be provided with the product (whether the product is packaged or sold loose), either written on the packaging or on accompanying fact-sheets:
General information:
(a) the name and address of the body responsible for marketing;
(b) a descriptor identifying the product by type, including the wording “SOIL IMPROVER” or “GROWING MEDIA”;
(c) a batch identification code;

Pending: 32001D0634

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products(1), as last amended by Directive 97/79/EC(2), and in particular Article 11 thereof,Whereas:(1) A Commission expert has conducted an inspection visit to Guinea to verify the conditions under which fishery products are produced, stored and dispatched to the Community.(2) The provisions of legislation of Guinea on health inspection and monitoring of fishery products may be considered equivalent to those laid down in Directive 91/493/EEC.(3) In particular, the “Direction nationale des pêches maritimes (DNPM) of the Ministère de la pêche et de l’aquaculture” is capable of effectively verifying the application of the laws in force.(4) However the inspection visit to Guinea has revealed certain deficiencies in the hygienic conditions of the establishments processing and preparing fishery products. It has also revealed deficiencies in the sanitary control applied to the processing and preparation of the fishery products. Therefore, only the fishery products which have not undergone any preparation or processing operation other than chilling or freezing may be authorised for imports into the Community.(5) The modalities for obtaining the health certificate referred to in Article 11(4)(a) of Directive 91/493/EEC must include the definition of a model certificate, the minimum requirements regarding the language(s) in which it must be drafted and the status of the person empowered to sign it.(6) Pursuant to Article 11(4)(b) of Directive 91/493/EEC, a mark should be affixed to packages of fishery products giving the name of the non-member country and the approval/registration number of the establishment, factory vessel, cold store or freezer vessel of origin, except for certain frozen products.(7) Pursuant to Article 11(4)(c) of Directive 91/493/EEC a list of approved establishments, factory vessels, or cold stores must be drawn up, and a list of freezer vessels equipped in accordance with points 1 to 7 of Annex II to Council Directive 92/48/EEC(3) must also be drawn up. These lists must be drawn up on the basis of a communication from the DNPM to the Commission. It is therefore for the DNPM to ensure compliance with the provisions laid down to that end in Article 11(4) of Directive 91/493/EEC.(8) The DNPM has provided official assurances regarding compliance with the rules set out in Chapter V of the Annex to Directive 91/493/EEC with regard to the control of non-processed products, and regarding the fulfilment of hygienic requirements equivalent to those laid down by that Directive.(9) However, the inspection visit has revealed certain deficiencies in the procedure followed by the DNPM for the approval/suspension of establishments and vessels, therefore the modification of the list of establishments and vessels from which the imports are authorised, will require a new inspection visit on the spot by the Commission experts.(10) Taking into account the results of the inspection visit, the reduction in the frequency of physical checks, laid down by Commission Decision 94/360/EC of 20 May 1994 on the reduced frequency of physical checks of consignments of certain products to be implemented from non-member countries, under Council Directive 90/675/EEC(4), shall not be applied to fishery products imported from Guinea.(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,

Article 1
The “Direction nationale des pêches maritimes (DNPM) of the Ministère de la pêche et de l’aquaculture” shall be the competent authority in Guinea for verifying and certifying compliance of fishery products with the requirements of Directive 91/493/EEC.

Article 2
Fishery products originating in Guinea must meet the following conditions:
1. They shall not have undergone any preparation or processing operation other than chilling or freezing.
2. Each consignment must be accompanied by a numbered original health certificate, duly completed, signed, dated and comprising a single sheet in accordance with the model in Annex A hereto.
3. The products must come from approved establishments, factory vessels or cold stores or from registered freezer vessels listed in Annex B hereto.
4. Except in the case of frozen fishery products in bulk and intended for the manufacture of preserved foods, all packages must bear the word “GUINEA” and the approval/registration number of the establishment, factory vessel, cold store or freezer vessel of origin in indelible letters.

Article 3
1. Certificates as referred to in Article 2 point 1 must be drawn up in at least one official language of the Member State where the checks are carried out.
2. Certificates must bear the name, capacity and signature of the representative of the DNPM and the latter’s official stamp in a colour different from that of other endorsements.

Article 4
Member States, when importing fishery products from Guinea, shall not apply to these products the reduction in the frequency of physical checks provided by Decision 94/360/EC.

Article 6
This Decision shall come into effect 60 days after its publication in the Official Journal of the European Communities.

Article 7
This Decision is addressed to the Member States.
Done at Brussels, 16 August 2001.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 268, 24.9.1991, p. 15.
(2) OJ L 24, 30.1.1998, p. 31.
(3) OJ L 187, 7.7.1992, p. 41.
(4) OJ L 158, 25.6.1994, p. 41.

THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/493/EEC of 22 July 1991 laying down the health conditions for the production and the placing on the market of fishery products(1), as last amended by Directive 97/79/EC(2), and in particular Article 11 thereof,Whereas:(1) A Commission expert has conducted an inspection visit to Guinea to verify the conditions under which fishery products are produced, stored and dispatched to the Community.(2) The provisions of legislation of Guinea on health inspection and monitoring of fishery products may be considered equivalent to those laid down in Directive 91/493/EEC.(3) In particular, the “Direction nationale des pêches maritimes (DNPM) of the Ministère de la pêche et de l’aquaculture” is capable of effectively verifying the application of the laws in force.(4) However the inspection visit to Guinea has revealed certain deficiencies in the hygienic conditions of the establishments processing and preparing fishery products. It has also revealed deficiencies in the sanitary control applied to the processing and preparation of the fishery products. Therefore, only the fishery products which have not undergone any preparation or processing operation other than chilling or freezing may be authorised for imports into the Community.(5) The modalities for obtaining the health certificate referred to in Article 11(4)(a) of Directive 91/493/EEC must include the definition of a model certificate, the minimum requirements regarding the language(s) in which it must be drafted and the status of the person empowered to sign it.(6) Pursuant to Article 11(4)(b) of Directive 91/493/EEC, a mark should be affixed to packages of fishery products giving the name of the non-member country and the approval/registration number of the establishment, factory vessel, cold store or freezer vessel of origin, except for certain frozen products.(7) Pursuant to Article 11(4)(c) of Directive 91/493/EEC a list of approved establishments, factory vessels, or cold stores must be drawn up, and a list of freezer vessels equipped in accordance with points 1 to 7 of Annex II to Council Directive 92/48/EEC(3) must also be drawn up. These lists must be drawn up on the basis of a communication from the DNPM to the Commission. It is therefore for the DNPM to ensure compliance with the provisions laid down to that end in Article 11(4) of Directive 91/493/EEC.(8) The DNPM has provided official assurances regarding compliance with the rules set out in Chapter V of the Annex to Directive 91/493/EEC with regard to the control of non-processed products, and regarding the fulfilment of hygienic requirements equivalent to those laid down by that Directive.(9) However, the inspection visit has revealed certain deficiencies in the procedure followed by the DNPM for the approval/suspension of establishments and vessels, therefore the modification of the list of establishments and vessels from which the imports are authorised, will require a new inspection visit on the spot by the Commission experts.(10) Taking into account the results of the inspection visit, the reduction in the frequency of physical checks, laid down by Commission Decision 94/360/EC of 20 May 1994 on the reduced frequency of physical checks of consignments of certain products to be implemented from non-member countries, under Council Directive 90/675/EEC(4), shall not be applied to fishery products imported from Guinea.(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Veterinary Committee,
The “Direction nationale des pêches maritimes (DNPM) of the Ministère de la pêche et de l’aquaculture” shall be the competent authority in Guinea for verifying and certifying compliance of fishery products with the requirements of Directive 91/493/EEC.
Fishery products originating in Guinea must meet the following conditions:
1. They shall not have undergone any preparation or processing operation other than chilling or freezing.
2. Each consignment must be accompanied by a numbered original health certificate, duly completed, signed, dated and comprising a single sheet in accordance with the model in Annex A hereto.
3. The products must come from approved establishments, factory vessels or cold stores or from registered freezer vessels listed in Annex B hereto.
4. Except in the case of frozen fishery products in bulk and intended for the manufacture of preserved foods, all packages must bear the word “GUINEA” and the approval/registration number of the establishment, factory vessel, cold store or freezer vessel of origin in indelible letters.
1. Certificates as referred to in Article 2 point 1 must be drawn up in at least one official language of the Member State where the checks are carried out.
2. Certificates must bear the name, capacity and signature of the representative of the DNPM and the latter’s official stamp in a colour different from that of other endorsements.
Member States, when importing fishery products from Guinea, shall not apply to these products the reduction in the frequency of physical checks provided by Decision 94/360/EC.
This Decision shall come into effect 60 days after its publication in the Official Journal of the European Communities.
This Decision is addressed to the Member States.
Done at Brussels, 16 August 2001.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 268, 24.9.1991, p. 15.
(2) OJ L 24, 30.1.1998, p. 31.
(3) OJ L 187, 7.7.1992, p. 41.
(4) OJ L 158, 25.6.1994, p. 41.
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>PIC FILE= “L_2001221EN.005301.TIF”>
LIST OF ESTABLISHMENTS AND VESSELS
PP: Processing plant
ZV: Freezer vessel