EN Official Journal of the European Communities L 35/1

COMMISSION REGULATION (EC) No 211/97

of 4 February 1997

amending Annex II of Council 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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1), as last amended by Commission Regulation (EC) No 17/97 (2) and in particular Articles 6, 7 and 8 thereof,

Whereas, in accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals;

Whereas maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs;

Whereas, in establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue);

Whereas, for the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney, whereas, however, the liver and kidney are frequently removed from carcasses moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues;

Whereas Somatosalm should be inserted into Annex II to Regulation (EEC) No 2377/90;

Whereas a period of 60 days should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/EEC (3), as last amended by Directive 93/40/EEC (4) to take account of the provisions of this Regulation;

Whereas, in accordance with the procedure laid down in Article 8 of Regulation (EEC) No 2377/90, the draft of the measures to be adopted was submitted to the Community for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector; whereas the Committee was not able to deliver an opinion; whereas the Commission therefore proposed the measures to be adopted to the Council;

Whereas the Council did not act or vote against the proposed measures by a simple majority in the three-month period allowed; whereas it is therefore incumbent upon the Commission to adopt the measures,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the sixtieth day following its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 4 February 1997. For the Commission Martin BANGEMANN Member of the Commission

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

(2) OJ No L 5, 9. 1. 1997, p. 12.

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

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