Proposal for a Council Regulation (EC) amending Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (96/C 381/07) (Text with EEA relevance) COM(96) 584 final - 96/0279(CNS)

(Submitted by the Commission on 20 November 1996) THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

Whereas, since Council Regulation (EEC) No 2377/90 (1) was adopted, the regulatory environment of veterinary medicinal products has been radically altered, in particular as a result of the entry into force of Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (2) and of Directive 93/40/EEC of 14 June 1993 amending Directives 81/851/EEC and 81/852/EEC on the approximation of the laws of the Member States relating to veterinary medicinal products (3);

Whereas the Committee for Veterinary Medicinal Products is henceforth responsible to the European Agency for the Evaluation of Medicinal Products and whereas it falls to this Agency, through this Committee, to issue an opinion on the maximum residue limits of veterinary medicinal products which are acceptable in foodstuffs of animal origin in accordance with Regulation (EEC) No 2377/90;

Whereas Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (4) establishes the fees payable to the Agency for examining applications for the establishment, amendment and extension of maximum residue limits;

Whereas it is necessary, consequently, to adapt Regulation (EEC) 2377/90 by conferring on the Agency the task of dealing with applications for the establishment, amendment and extension of maximum residue limits and by aligning the decision-making process with respect to the authorization and supervision of medicinal products for veterinary use with that introduced by Regulation (EEC) No 2309/93;

Whereas the Agreement on the application of sanitary and phytosanitary measures which emerged from the multilateral negotiations of the Uruguay Round, approved on behalf of the European Community by Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (5), creates transparency obligations as regards health measures; whereas Regulation (EEC) No 2377/90 must therefore be adapted in order to enable the Community to fulfil its obligations under this Agreement;

Whereas Directive 81/851/EEC (6) as amended by Directive 93/40/EEC prohibits from 1 January 1997 foodstuffs for human consumption being taken from animals used for clinical trials unless maximum residue limits have been established by the Community; whereas, Regulation (EEC) No 2377/90 has to be amended in order to allow the use of this procedure for substances undergoing clinical trials; for this purpose, the level of development of the substance concerned should be taken into account; the information and particulars to be included in an application for the establishment of a MRL within the meaning of Annex V of this Regulation should be reviewed;

Whereas it is necessary to maintain on the market substances the use of which was authorized on the date when Regulation (EEC) No 2377/90 entered into force and for which applications were submitted to the Commission or to the Agency before 1 January 1996, in order to make it possible to continue their scientific evaluation in the best possible conditions, given the resources available,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) 2377/90 is amended as follows:

1. The following Article is inserted:

'Article 4 (a)

A provisional maximum residue limit may be established for a pharmacologically active substance undergoing clinical trials, provided that there are no grounds for supposing that residues of the substance concerned at the level proposed present a health hazard to consumers. A suitable waiting period shall be fixed to guarantee that this provisional maximum residue limit is respected. This provisional maximum residue limit shall apply for a defined period of time, which shall not exceed two years.

The list of pharmacologically active substances used in the context of clinical trials for which provisional maximum residue limits have been established, together with their appropriate time periods, shall be contained in Annex III (a), which shall be adopted in accordance with the procedure laid down in Article 8. Except as provided for in Article 9, any amendments to Annex III (a) shall be adopted in accordance with the same procedure.`

2. Article 6 is replaced by the following text:

'Article 6

1. In order to obtain the inclusion in Annex I, II or III of a pharmacologically active substance which is intended for use in veterinary medicinal products for administration to food-producing animals, an application to establish a maximum residue limit shall be submitted to the European Agency for the Evaluation of Medicinal Products set up by Council Regulation (EEC) No 2309/93, hereinafter referred to as the "Agency".

This application shall contain the information and particulars referred to in Annex V and shall conform with the principles laid down in Directive 81/852/EEC. When a provisional maximum residue limit as referred to in Article 4 (a) of this Regulation has been established, only the data needed to complete Annex V have to be supplied.

2. In order to obtain the inclusion in Annex III (a) of a pharmacologically active substance administered to food-producing animals and used in the context of clinical trials, an application to establish a provisional maximum residue limit shall be submitted to the Agency. This application shall contain the information and particulars referred to in Annex V, which shall be amended to that end.

3. The application shall also be accompanied by the fee due to the Agency for examining the application fixed by Regulation (EC) No 297/95.` 3. Article 7 is replaced by the following text:

'Article 7

1. The Committee for Veterinary Medicinal Products referred to in Article 27 of Regulation (EEC) No 2309/93, hereinafter referred to as the "Committee", shall be responsible for formulating the Agency's opinion on the classification of substances in Annexes I, II, III, III (a) or IV of this Regulation.

2. Articles 52 and 53 of Regulation (EEC) No 2309/93 are applicable mutatis mutandis for the purposes of this Regulation.

3. The Agency shall ensure that the Committee's opinion is delivered within a period of 120 days following the reception of a valid application. If the information submitted by the applicant is not sufficient to enable such an opinion to be prepared, the Committee may ask the applicant to supply additional information within a specific time limit. The deadline for the opinion shall then be deferred until the additional information has been received.

4. The Agency shall forward the opinion to the applicant. Within 15 days of receipt of the opinion, the applicant may provide written notice to the Agency that he wishes to appeal. In that case he shall forward the detailed grounds for his appeal to the Agency within 60 days of receipt of the opinion. Within 60 days of the receipt of the grounds for appeal, the Committee shall consider whether its opinion should be revised and the reasons for the conclusion reached on the appeal shall be annexed to the report referred to in paragraph 7.

5. The Agency shall forward the definitive opinion of the Committee within 30 days of its adoption both to the Commission and to the applicant. The opinion shall be accompanied by a report describing the safety evaluation of the substance by the Committee and which shall give the grounds for its conclusions.

6. The Commission shall prepare draft measures taking account of Community legislation and shall start the procedure provided for in Article 8. The Committee referred to in Article 8 shall adapt its rules of procedure in order to take account of the tasks conferred upon it by this Regulation.` 4. In Article 8, paragraph 1 is replaced by the following text:

'1. Where the procedure laid down in this Article is to be followed, the Commission shall be assisted by the Standing Committee for Veterinary Medicinal Products.` 5. In Article 10, paragraph 1 is replaced by the following text:

'1. Where the procedure laid down in this Article is to be followed, the Commission shall be assisted by the Standing Committee for Veterinary Medicinal Products.` 6. Article 12 is replaced by the following text:

'Article 12

As soon as possible after the amendment of Annexes I, II, III, III (a) or IV, the Agency shall publish a summary of the assessment of the safety of the substances concerned that have been examined by the Committee. The Agency shall provide the competent authorities with appropriate methods of analysis for tracing residues. The confidential nature of any proprietary data shall be respected.`

7. In Article 13, the terms 'in Annex I or III` are replaced by 'in Annex I, III or III (a)`.

8. Article 14 is replaced by the following text:

'Article 14

With effect from 1 January 1997, the administration to food-producing animals of veterinary medicinal products containing pharmacologically active substances which are not mentioned in Annexes I, II or III shall be prohibited within the Community.

With regard to substances whose use was authorized in veterinary medicinal products before the date on which this Regulation entered into force and for which applications to establish maximum residue limits were submitted either to the Commission or to the Agency before 1 January 1996, the prohibition date indicated in the previous subparagraph shall be deferred to 1 January 1999. Within three months of the adoption of this Regulation, the Agency will publish a list of these substances.

As from 1 January 1997, the Member States shall not allow foodstuffs destined for human consumption to originate from animals that have been subjected to clinical trials unless the substance in question is mentioned in Annex III (a).`

Article 2

This Regulation shall enter into force on 1 January 1997.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

(1) OJ No L 224, 18. 8. 1990, p. 1.

(2) OJ No L 214, 24. 8. 1993, p. 1.

(3) OJ No L 214, 24. 8. 1993, p. 31.

(4) OJ No L 35, 15. 2. 1995, p. 1.

(5) OJ No L 336, 23. 12. 1994, p. 1.

(6) OJ No L 317, 6. 11. 1981, p. 1.