Explanatory Memorandum to COM(2001)703 - Amendment of Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes - Main contents
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| dossier | COM(2001)703 - Amendment of Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the ... |
|---|---|
| source | COM(2001)703  |
| date | 28-11-2001 |
In 1986 the Council adopted Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. The Directive seeks to improve the controls on the use of laboratory animals, to set minimum standards for housing and care as well as to the training of personnel handling these animals and supervising the experiments. It also aims at reducing the numbers of animals used for experiments by encouraging the development and the validation of alternative methods to replace animal methods.
The Directive contains two Annexes; Annex 1 listing the species of animals covered by Article 21 of the Directive and Annex 2 containing the guidelines for the housing and care of laboratory animals. These Annexes are of a technical nature, and rely on scientific knowledge on the physiological and ethological needs of the animals, as well as on the influence of the environment on their well-being. The guidelines need periodic adaptation to the latest scientific and technical developments and results in the research within the fields covered.
The existing Regulatory Committees do not cover the area of the protection of animals used in experiments. Therefore it is necessary to establish a regulatory Committee that has the appropriate competence.
2. Developments at the Council of Europe
In 1998 the Community became a Party to the 31 March 1986 Council of Europe Convention ETS 123 for the protection of vertebrate animals used for experimental and other scientific purposes. The implementing tool for the Convention is Directive 86/609/EEC.
Appendix A of the Convention contains guidelines for the housing and care of laboratory animals. Appendix A of the Convention is transformed into Annex 2 of the Directive. Appendix B of the Convention contains statistical tables. However, at the time of concluding the Convention, the Community made a reservation in respect of Article 28 i of the Convention on the requirement to provide statistical. Therefore the Community is not bound by Appendix B.
The Council of Europe has opened for signature and ratification a 'Protocol of Amendment' to the Convention. This Protocol of Amendment will allow the Appendices of the Convention to be amended by a simplified procedure, instead of via a fully-fledged amendment to the Convention, necessitating ratification by all of its Parties. The Commission is proposing a Council Decision on the conclusion, on behalf of the European Community of the Protocol of Amendment to that effect.
Under the auspices of the Council of Europe, a Working Party is currently reviewing Appendix A of the Convention, which contains the guidelines on housing and care. This revision is scheduled to be finalised and ready for adoption in 2002. The Council of Europe intends to use the simplified procedure contained in the Protocol of Amendment for the first time to adopt these amendments to Appendix A.
3. Community participation in the Council of Europe
The Community has to ensure full and timely implementation of the Convention and the Protocol. Currently any changes to the Annexes can only be adopted by the co-decision procedure. The co-decision procedure will in most cases not meet the twelve-month period for entering into force of amendments of the Appendices as provided for in Article 2 i of the Protocol. Before the Community concludes the Protocol of Amendment, a corresponding implementing tool should exist at Community level. Consequently, Directive 86/609/EEC should be amended beforehand to include the Regulatory Committee Procedure (Council Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission).
The Regulatory Committee Procedure would provide for a simplified procedure, to ensure that the Annexes of the Directive are kept up-to-date with the latest available scientific knowledge and research on the welfare of laboratory animals, including amendments to the Appendix A of the Council of Europe Convention.
If the Protocol of Amendment is ratified by the Community, and should the Directive not provide for a simplified procedure as regards adaptation to technical progress by, in this case, a Regulatory Committee Procedure, the Community will risk to run into a situation whereby its implementing legislation (the Annexes to the Directive) would not be in line with the obligations resulting from the Protocol.
4. Further revision of the Directive
The Commission acknowledges the fact that Directive 86/609/EEC requires a full revision. Since the scientific basis of the Directive dates back at least 15 years, some provisions are out of date. Furthermore, the scope of the Council of Europe Convention goes beyond that of Directive 86/609/EEC and also covers animals used for the purposes of education and training. The Directive would need to be aligned accordingly. At the same time the Commission could fulfil its commitments to improve the controls and welfare of certain species such as non-human primates, and to provide an opportunity to revisit some of the definitions and existing provisions.
5. Two steps for the necessary amendments
To safeguard progress in the field of welfare of laboratory animals through the Council of Europe Convention, with a view to meet the international animal welfare standards without unnecessary delay, as well as to allow for an in-depth discussion of the further revision of the Directive, the amendments will be carried out in two phases.
The first amendment of the Directive will introduce the Regulatory Committee Procedure. Since this does not require scientific-technical discussions it can be adopted quite swiftly and will therefore not jeopardise the conclusion of the Protocol of Amendment.
The second amendment should provide stakeholders an opportunity for in-depth scientific-technical discussions thus contributing to a fully-fledged revision of the Directive.
6. Conclusion
*Since the nature of the Annexes to the Directive requires their regular revision in order to strive for the highest possible animal welfare standards in the Community;
*Since the welfare of laboratory animals is increasingly becoming a politically sensitive issue in the Community, especially in the light of the increase in the Commission's responsibilities towards animal protection imposed by the recent amendment of the Treaty on European Union, which includes a Protocol requiring the European Union and Member States to pay full regard to the welfare of animals when drawing up agriculture, transport, single market and research policies, and the recently adopted White Paper on the Strategy for a future Chemicals Policy in the EU;
*Since an implementing tool should exist in the Community legislation to allow the Community to adhere to the Protocol of Amendment
it is appropriate for the Council and the European Parliament to adopt the Proposal for a Directive presented here in order to amend Directive 86/609/EEC to include a Regulatory Committee Procedure for the purposes of updating the Annexes of the said Directive.