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

(1999/C 131/05)

COM(1999) 130 final. - 1999/0072(CNS)

(Submitted by the Commission on 18 March 1999)

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission,

Having regardt to the opinion of the European Parliament,

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

Whereas, since the adoption of Council Regulation (EEC) No 2377/90(1), as last amended by Commission Regulation (EC) 2728/98(2) the regulatory environment of veterinary medicinal products has been radically altered, in particular as a result of the entry into force of Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(3) and of the amendments made by Directive 93/40/EEC(4) to Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products(5) and to Council Directive 81/852/EEC of 28 Sepember 1981 on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols of the testing of veterinary medicinal products(6);

Whereas the Committee for Veterinary Medicinal Products is henceforth responsible to the European Agency for the Evaluation of Medicinal Products and it falls to that Agency, through that 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 Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products(7) as amended by Regulation (EC) No 2743/98(8) 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 amend Regulation (EEC) No 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 decisionmaking process with respect to the authorisation 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 Council Decision 94/800/EC of 22 December 1994 concerning the conclusion on behalf of the European Community, as regards matters within itscompetence, of the agreements reached in the Uruguay Round multilateral negotiations (1986 - 1994)(9), 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 that Agreement,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EEC) No 2377/90 is hereby amended as follows:

1. Articles 6 and 7 are replaced by the following:

"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.

2. The application shall aslo be accompanied by the fee payable to the Agency.

Article 7

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

2. Articles 52 and 53 of Regulation (EEC) No 2309/93 are applicable 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 tha 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 5.

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, 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 Standing Committee for Veterinary Medicinal Products 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."

2. Article 8(1) is replaced by the following:

"1. The words 'Committee for the Adaption to Technical Progress of the Directives on Veterinary Medicinal Products' are replaced by 'Standing Committee for Veterinary Medicinal Products'."

3. In Article 8(2) the words "Committee for the Adaption to Technical Progress of the Directives on Veterinary Medicinal Products" are replaced by "Standing Committee for Veterinary Medicinal Products".

4. In Article 9(2) the first sentence is replaced by the following:

"The Commission shall as soon as possible examine the grounds given by the Member State concerned and, after consulting the Committee for Veterinary Medicinal Products, it shall then deliver its opinion forthwith and take appropriate measures; the person responsible for marketing may be requested to provide the Committee with oral or written explanations".

5. In Article 10, the words "Committee for the Adaptation to Technical Progress of the Directives on Veterinary Medicinal Products" are replaced by "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 or IV, the Commission shall publish a summary of the assessment of the safety of the substances concerned that have been examined by the Committe for Veterinary Medicinal Products. The confidential nature of any proprietary data shall be respected. The Agency shall provide the competent authorities and the Commission with appropriate methods of analysis for tracing residues."

Article 2

This Regulation shall enter into force on ... 1999.

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

(1) OJ L 224, 18.8.1990, p. 1.

(2) OJ L 343, 18.12.1998, p. 8.

(3) OJ L 214, 24.8.1993, p. 1.

(4) OJ L 317, 6.11.1981, p. 16.

(5) OJ L 214, 24.8.1993, p. 31.

(6) OJ L 317, 6.11.1981, p. 1.

(7) OJ L 35, 15.2.1995, p. 1.

(8) OJ L 345, 19.12.1998, p. 3.

(9) OJ L 336, 23.12.1994, p. 1.