Commission Regulation (EC) No 1729/2006 of 23 November 2006 amending Annexes I and III 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 and triclabendazole (Text with EEA relevance)
Commission Regulation (EC) No 1729/2006of 23 November 2006amending Annexes I and III 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 and triclabendazole(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 originOJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1451/2006 (OJ L 271, 30.9.2006, p. 37)., and in particular Article 2 and the third paragraph of Article 4 thereof,Having regard to the opinions 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)Following examination of an application for the establishment of maximum residue limits for firocoxib in Equidae and in order to allow for the completion of minor scientific validation of studies, it is considered appropriate to include firocoxib in Annex III to Regulation (EEC) No 2377/90 for Equidae species.(3)The substance triclabendazole is included in Annex I to Regulation (EEC) No 2377/90 for bovine and ovine for muscle, kidney and liver, excluding animals producing milk for human consumption. Following examination of an application for the modification of those maximum residue limits, it is considered appropriate to include triclabendazole in that Annex for all ruminants for muscle, fat, liver and kidney, excluding animals producing milk for human consumption amending the maximum residue limits values.(4)Regulation (EEC) No 2377/90 should therefore be amended accordingly.(5)An adequate period should be allowed before the applicability of this Regulation in order to enable Member States to make any necessary adjustment in the light of this Regulation to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal productsOJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58)..(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,HAS ADOPTED THIS REGULATION:
Article 1Annexes I and III to Regulation (EEC) No 2377/90 are amended in accordance with the Annex to this Regulation.
Article 2This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.It shall apply from 21 January 2007.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 23 November 2006.For the CommissionGünter VerheugenVice-PresidentANNEXA.The following substance is inserted in Annex I to Regulation (EEC) No 2377/90:2.Antiparasitic agents2.1.Agents acting against endoparasites2.1.3.Benzimidazoles and pro-benzimidazoles
Not for use in animals producing milk for human consumption."
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissues
"TriclabendazoleSum of extractable residues that may be oxidised to ketotriclabendazoleAll ruminants225 μg/kgMuscle
100 μg/kgFat
250 μg/kgLiver
150 μg/kgKidney
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Not for use in animals producing milk for human consumption."B.The following substance is inserted in Annex III to Regulation (EEC) No 2377/90:5.Anti-inflammatory agents5.1.Non-steroidal anti-inflammatory agents5.1.4.Sulfonated phenyl lactones
Provisional MRLs expire on 1 July 2007."
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissues
"FirocoxibFirocoxibEquidae10 μg/kgMuscle
15 μg/kgFat
60 μg/kgLiver
10 μg/kgKidney
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Provisional MRLs expire on 1 July 2007."