Proposal for a COUNCIL DECISION concerning the conclusion of the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

(presented by the Commission)

EXPLANATORY MEMORANDUM

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(1) 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(1) (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.

2001/0278 (CNS)

Proposal for a COUNCIL DECISION concerning the conclusion of the Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95, in conjunction with Article 300 (2) and the first subparagraph of Article 300 (3), thereof,

Having regard to the proposal from the Commission [1],

[1] OJ C , , p. .

Having regard to the opinion of the European Parliament [2],

[2] OJ C , , p. .

Whereas:

(1) On 24 November 1986 the Council adopted 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 [3], setting out common rules incorporating the principles, objectives and main provisions of the European Convention of 18 March 1986 for the protection of vertebrate animals used for experimental and other scientific purposes (hereinafter referred to as "the Convention").

[3] OJ L358, 18.12.1986, p.1.

(2) On 23 March 1998 the Council adopted Decision 1999/575/EC concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes and made a Declaration that the European Community does not consider itself bound by the requirements to communicate statistical data laid down in Article 28(1) of the said Convention [4]. The Convention entered into force on 1 November 1998 in the territory of the Community;

[4] OJ L222, 24.08.1999, p. 29.

(3) The provisions contained in the Appendices to the Convention are of a technical nature and should reflect the latest scientific and technical developments and results in the research within the fields covered. It is therefore appropriate to revise these provisions periodically, through a simplified procedure;

(4) On 22 June 1998 a Protocol of Amendment setting out a simplified procedure to amend the Appendices to the Convention has been opened for signature by the Signatories to the Convention. This Protocol of Amendment should be approved,

HAS DECIDED AS FOLLOWS:

Article 1

The Protocol of Amendment to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes is hereby approved on behalf of the European Community.

The text of the Protocol of Amendment is attached to this Decision.

Article 2

The President of the Council is hereby authorised to designate the person or persons empowered to sign the Protocol of Amendment in accordance with Article 4(1)(a) thereof, in order to express the consent of the Community to be bound thereby.

Article 3

The signature by the Community shall only take place once those Member States who are also Parties to the European Convention referred to in Article 1 have completed procedures to ratify, accept, approve or accede to the Protocol of Amendment. Member States shall inform the Commission, not later than [date] that they have completed the necessary procedures.

Article 4

The reservation in respect of Article 28(1) of the said Convention made by the European Community as laid down in Annex B of Council Decision 1999/575/EC shall remain unaltered.

Article 5

This Decision shall be published in the Official Journal of the European Communities.

Done at Brussels,

For the Council

The President

ANNEX

Protocol of Amendment to the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes

Strasbourg, 22.VI.1998

The member States of the Council of Europe and the European Community, Signatories to this Protocol to the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes, opened for signature in Strasbourg, on 18 March 1986 (hereinafter referred to as "the Convention"),

Having regard to the Convention which includes general provisions designed to safeguard animals intended to be used for scientific purposes from suffering pain and distress, and to their resolve to limit the use of animals for experimental and other scientific purposes, with the aim of replacing such use whenever possible, in particular by seeking alternative measures and encouraging the use of these alternative measures;

Considering the technical nature of the provisions included in the Appendices to the Convention;

Acknowledging the need to ensure their consistency with the results of research in the fields covered,

Have agreed as follows:

Article 1

Article 30 of the Convention shall be amended as follows:

"1 The Parties shall, within five years from the entry into force of this Convention and every five years thereafter, or more frequently if a majority of the Parties should so request, hold multilateral consultations within the Council of Europe to examine the application of this Convention, and the advisability of revising it or extending any of its provisions.

2 These consultations shall take place at meetings convened by the Secretary General of the Council of Europe.

The Parties shall communicate the name of their representative to the Secretary General of the Council of Europe at least two months before meetings.

3 Subject to the provisions of this Convention, the Parties shall draw up the rules of procedure for the consultations."

Article 2

The Convention shall be supplemented by a new Part XI: "Amendments" including a new Article 31 as follows:

"1 Any amendment to Appendices A and B, proposed by a Party or the Committee of Ministers of the Council of Europe shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, to the European Community and to any non-member State which has acceded to, or has been invited to accede to the Convention in accordance with the provisions of Article 34.

2 Any amendments proposed in accordance with the provisions of the preceding paragraph shall be examined at a multilateral consultation not less than six months after the date of forwarding by the Secretary General where it may be adopted by a two-thirds majority of the Parties. The text adopted shall be forwarded to the Parties.

3 Twelve months after its adoption at a multilateral consultation, any amendment shall enter into force unless one third of the Parties have notified objections."

Article 3

Articles 31 to 37 of the Convention shall become Articles 32 to 38 of the Convention respectively.

Article 4

1 This Protocol shall be open for signature by the Signatories to the Convention, which may become Parties to this Protocol by:

(a) signature without reservation as to ratification, acceptance or approval; or

(b) signature subject to ratification, acceptance or approval, followed by ratification, acceptance or approval.

2 A Signatory of the Convention may not sign this Protocol without reservation as to ratification, acceptance or approval, or deposit an instrument of ratification, acceptance or approval, unless it has already deposited or simultaneously deposits an instrument of ratification, acceptance or approval of the Convention.

3 States which have acceded to the Convention may also accede to this Protocol.

4 The instruments of ratification, acceptance, approval or accession shall be deposited with the Secretary General of the Council of Europe.

Article 5

This Protocol shall enter into force on the thirtieth day after the date on which all the Parties to the Convention have become Parties to this Protocol in accordance with Article 4.

Article 6

The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, the other Parties to the Convention and the European Community of:

(a) any signature without reservation in respect of ratification, acceptance or approval;

(b) any signature with reservation in respect of ratification, acceptance or approval;

(c) any deposit of an instrument of ratification, acceptance, approval or accession;

(d) any date of entry into force of this Protocol in accordance with Article 5 thereof;

(e) any other act, notification or communication relating to this Protocol.

In witness thereof the undersigned, being duly authorised thereto, have signed this Protocol.

Done at Strasbourg, this 22nd day of June 1998, in English and in French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the other Parties to the Convention and to the European Community.