Brussels, 4 February 2002
Common position adopted by the Council with a view to the adoption of a Directive of the European Parliament and of the Council amending for the seventh time Council Directive
76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. Draft statement of the Council's reasons. Brussels, 1 February 2002 (document 15073/01 ADD 1 2000/0077 (COD) ECO 382 CODEC 1332). Full text
.... III. Analysis of the Common Position
1. The Council has been examining the proposal since the middle of 2000. The Council's common position is generally consistent with the aims of the Commission's proposal, in particular as regards compliance with WTO commitments.
Nevertheless, the Council has agreed on a number of substantial changes to the Commission's proposal. The most important changes are as follows:
- provisions on a marketing ban on cosmetic products where the final product or its ingredients have been subject to animal testing have been reinstated, while making the implementation of the marketing ban dependent on the existence of alternative testing methods accepted within the framework of the OECD;
- the introduction of a final cut off date for the implementation of a testing ban on ingredients in the EU has not been included;
- as requested by the European Parliament, specific provisions on substances classified as carcinogenic, mutagenic or toxic for reproduction have been inserted;
- provisions on information to consumers have been strengthened also in line with requests from the European Parliament.
The Commission has accepted the common position agreed by the Council.
2. On 3 April 2001, the European Parliament adopted 31 amendments to the proposal. The Council incorporated, at least in essence, 10 of these amendments and part of 7 others.
3. The Council incorporated part of amendments 1 and 2 that suggest a reference to Council Directive 86/609/EEC on protection of animals used for experimental and other scientific purposes.
4. The Council welcomed amendments 4 and 5 which underline the need to give priority to the support of development of alternative testing methods in particular within the 6th Framework Research Programme.
5. The Council incorporated in general amendment 10 and part of amendment 14 relating to restrictions on substances classified as carcinogenic, mutagenic or toxic for reproduction.
6. The Council incorporated in essence amendments 11, 12 and 30 and part of amendments 23 and 32 which aim at improving labelling requirements in particular as concerns potential fragrance allergens and the minimum durability of the product. The Council incorporated part of amendments 7 and 47 relating to claims by enterprises that no animal testing has been carried out on cosmetic products or their ingredients by a provision stating that the Commission shall adopt guidelines concerning the use of such claims.
7. The Council incorporated part of amendment 14 and amendments 17 to 19 on the Commission's report to Council and the European Parliament while stating that the Commission should forward reports every third year instead of every year.
8. The Council incorporated amendment 26 concerning the reinforcement of the safety assessment of the finished product and in particular the requirement of specific safety assessments for cosmetic products intended exclusively for use on children under the age of three or in external intimate hygiene.
9. The Council considers that it is the prerogative of the Commission to propose an amendment of Directive 86/609/EEC as well as legislation concerning new products and therefore rejected part of amendment 1 and amendment 36 referring to Commission proposals on these subjects.
10. While the Council agrees with the aim of abolishing also animal testing on ingredients for cosmetic products as soon as possible, it considers that this objective should be pursued without compromising the health and safety of consumers. Given the current state of scientific knowledge and the experience gained in the research and development of alternative methods, the Council considers it impossible to predict when all necessary alternative methods, not entailing the use of animals, could be available. The Council therefore favours a stepwise approach linked to the availability of alternative methods, whilst supporting at the same time a reinforcement of the regulatory framework so as to ensure the mandatory use of these methods when they exist, including those which permit a reduction of the number of animals used or a diminution of their pain. However, the Council has underlined that an alternative method which entails the use of animals cannot be accepted when an equivalent method, which does not entail the use of animals, exists.
The Council has also considered that the scientific knowledge necessary for the development of additional alternative methods could only improve through the pooling and co-ordination of all resources available. The Council as a consequence rejected part of amendment 2 as well as amendments 3 and 15 relating to the introduction of a final cut off date for totally prohibiting animal testing on ingredients and a limitation of the concept of alternative testing methods to methods that do not entail the use of animals. As a consequence, part of amendment 15 regarding possible derogations from the testing ban was also rejected.
11. By linking the implementation of a marketing ban on cosmetics tested on animals to the existence of alternative testing methods accepted within the framework of the OECD, the Council has struck a balance between the aim of abolishing animal tests in the cosmetic sector and the need to comply with the Community's international obligations, especially in relation to the WTO. The Council therefore rejected part of amendments 14 and 37 relating to a final cut off date for the implementation of a total marketing ban and as a consequence also part of amendment 14 which provides for a possibility to derogate from the marketing ban.
12. By incorporating provisions on specific safety assessments for cosmetic products intended exclusively for use on children or in external intimate hygiene, the Council considers that it has taken due account of the particular risks potentially associated with such products and therefore rejected amendments 9 and 43.
13. The Council rejected amendments 13, 21 and 28 on information to be included in the inventory drawn up and published by the Commission due to concerns that such a provision could be in conflict with provisions on protection of data.
14. The Council considers that amendments 16 and 20 concerning, respectively, a reference to a prototype in relation to finished cosmetic products and the definition of cosmetic ingredients do not add to the clarity of the terms and therefore rejected the two amendments.
15. The Council rejected amendment concerning detailed information on any animal test performed in connection with development of the product and its ingredients as such a requirement would be impossible to enforce and would be in conflict with the Community's obligations in relation to the WTO.
16. Concerning labelling, the Council has for the sake of clarity for consumers opted for a single date on the durability of cosmetic products by extending the current requirement of a minimum durability date to all products and therefore rejected the part of amendment 32 that refers specifically to a maximum product life and period after opening. The Council rejected part of amendment 23, as the Council considers it necessary to exempt perfume and aromatic compositions from systematic inclusion in the list of ingredients when these substances have no allergenic potential. The Council rejected amendment 39 and part of amendment 37 which relate to an obligatory labelling of products where the final product or ingredients therein have been subject to animal testing, partly due to the rejection of the specific criteria on size of the labelling, and partly due to concerns as to whether an obligatory labelling would be in compliance with WTO rules. The Council agrees with the need to consult all interested parties in relation to the development of guidelines for the use of claims of non-animal tested products but does not consider it appropriate in this context to specify the modalities of such consultations and therefore rejected the part of amendments 7 and 47 relating to consultation of specific parties.
17. While the Council in principle can support an adaptation of Annex III, as proposed in amendment 49, it considers that this should be done in accordance with the procedure relating to adaptation to technical progress and therefore rejected amendment 49.
18. The Council in addition has made a number of linguistic changes to the Commission proposal.
As recommended by the European Parliament, the Council has incorporated provisions in order to improve the level of information to be made available to consumers in relation to the use of cosmetic products and to better guarantee that all risks associated with these products are properly assessed. Regarding the use of animal testing for cosmetic products, the Council has sought to strike a balance between the imperative requirement to ensure the protection of consumers, the need to offer optimal protection to animals used for experimental purposes and the necessity for the Community to respect its international obligations.
Whilst recognising animal welfare as a legitimate objective to be pursued under Community legislation, the Council could not endorse a solution which would have totally prohibited the performance of animal tests for cosmetic products after a fixed date, irrespective of the availability of adequate alternative methods. In its view, such an approach would have jeopardised consumer safety in disregard of the fundamental objectives to be pursued under the Cosmetics Directive and of the duty of the Community to secure a high level of protection to human health.
Given the need for additional scientific knowledge for the development of alternative methods, the Council considers that the most effective way to improve the protection of animals used for experimental purposes is to promote the development of alternative methods through co-ordination of all scientific resources available and to ensure that alternative methods are effectively used when they exist and are scientifically validated. The Council therefore welcomes the commitment of the Commission to review the current framework of Directive 86/609/EEC and to consider the availability of appropriate funding under the EC Research and Development Framework Programme for the research of alternative methods.
With regard to provisions for a ban on imported cosmetic products tested on animals, the Council considers it to be indispensable to implement such a ban gradually along with the availability of alternative testing methods agreed at international level in order to ensure compliance with WTO commitments.