Commission Regulation (EC) No 1323/2007 of 12 November 2007 amending Annex I to 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, as regards firocoxib Text with EEA relevance

• Published date: 13 November 2007
• Subject Matter: Veterinary legislation
• Official Gazette Publication: Official Journal of the European Union, L 294, 13 November 2007

13.11.2007 EN Official Journal of the European Union L 294/11

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COMMISSION REGULATION (EC) No 1323/2007

of 12 November 2007

amending Annex I to 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, as regards firocoxib

(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), and in particular Article 2 thereof,

Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

Whereas:

(1) All pharmacologically active substances used in the Community in veterinary medicinal products intended for food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.

(2) The substance firocoxib is included in Annex III to Regulation (EEC) No 2377/90 for Equidae for muscle, fat, liver and kidney. These provisional maximum residue limits (hereinafter MRLs) expired on 1 July 2007. Additional data were provided and assessed leading the Committee for Medicinal Products for Veterinary Use (hereinafter CVMP) to recommend that MRLs for Firocoxib should be set as definitive and consequently included in Annex I to Regulation (EEC) No 2377/90 for Equidae for muscle, fat, liver and kidney.

(3) The CVMP’s recommendation is based on a provisional estimation of the substance and its residues that can be ingested daily over a lifetime without any appreciable health risk to exposed individuals (hereinafter ‘ADI’). The established temporary Acceptable Daily Intake (ADI) has been determined by applying a different methodology to the usual approach used for establishing ADI of veterinary medicine. However a higher safety factor has been applied to compensate for this use in order to ensure that there are no grounds for supposing that the residues of Firocoxib at the level proposed for use present a hazard for the health of the consumer.

(4) It is therefore proposed to include Firocoxib in Annex I of Regulation (EEC) No 2377/90 accordingly.

(5)

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