Explanatory Memorandum to COM(2001)704 - Conclusion of the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

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1. Background

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. A Declaration was entered in the Council Minutes stating that Member States who had not yet ratified or acceded to the Convention will take the necessary measures to allow the instruments of approval of the Community and its Members States to be deposited, as far as possible simultaneously, and by 1 January 2000 at the latest. However, five Member States have not yet completed the ratification or accession to the Convention. The implementing tool for the Convention is Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes.

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 data. Therefore the Community is not bound by Appendix B.

The guidelines for housing and care 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. To ensure that the guidelines reflect the latest scientific and technical developments and results in the research within the fields covered, these guidelines need to be revised periodically.

1.1. Protocol of Amendment

The Council of Europe has opened for signature, either subject to ratification, acceptance or approval or without reservation in this respect, a 'Protocol of Amendment' to the Convention. The Commission's proposal is for the Council to approve this Protocol on behalf of the Community and to authorise the designation of the person or persons empowered to sign the Protocol in order to express the consent of the Community to be bound by it. Since the Community has already deposited its instrument of approval of the Convention, it may sign the Protocol without reservation as to ratification, acceptance or approval, as provided for in Article 4 i (a) of the Protocol. A separate procedure for final conclusion by the Community of this Protocol at a later stage is therefore unnecessary and can be avoided. The opinion of the European Parliament on the present proposal must be obtained because it implies the final conclusion of the Protocol on behalf of the Community.

This Protocol of Amendment will allow the Appendices of the Convention to be amended via a simplified procedure, instead of via a fully-fledged amendment to the Convention, necessitating ratification by all of its Parties. At the time of negotiation of the Protocol, the Commission did not ask for a negotiating mandate from the Council, since the Community became Party to the Convention itself only six months after the negotiations of the Protocol of Amendment were rounded off.

The Protocol of Amendment has to be ratified by all Parties to the Convention in order for it to enter into force.

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.

1.2. Implementing tool

However, 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 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 Commission is proposing a Directive to amend Directive 86/609/EEC to that sole effect.

It has to be noted that, without such modification of the Directive, any change to the Annexes of the Directive (necessary every time the Appendix A to the Convention is modified via the simplified procedure of the Protocol) would require a long-lasting co-decision procedure. 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 data on the welfare of laboratory animals, including amendments to the Appendix A of the Council of Europe Convention.

2. Conclusion

*Given that the welfare of laboratory animals is becoming a matter of increasing concern within the Community, especially in the light of the increase in the Commission's responsibilities towards animal protection imposed by the 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;

*given that the current efforts made by the Council of Europe with regard to the revision of Appendix A are of great value to the Community;

*given that the collaboration in this highly technical field is of mutual benefit and avoids duplication of effort;

*and given that the Protocol of Amendment needs to be ratified by all the Parties to the Convention in order for it to enter into force and thus the Community should not be seen as an obstacle to progress in the animal welfare in the international arena,

it is appropriate for the Community to sign and thereby conclude the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes.

However, in order to encourage a timely ratification of the Protocol by other Parties to the Convention, and in particular by Member States of the Community, it is recommended that the Council decides that signature will only take place once those Member States who are also Parties to the Convention have ratified the Protocol of Amendment themselves.

While the decision to defer the signature by the Community will not delay the entry into force of the Protocol of Amendment, it will provide a strong signal requesting swift action by those Member States who are Parties to the Convention and have not yet ratified the Protocol.