Commission Regulation (EC) No 1055/2006 of 12 July 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 flubendazole and lasalocid (Text with EEA relevance)
Commission Regulation (EC) No 1055/2006of 12 July 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 flubendazole and lasalocid(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 205/2006 (OJ L 34, 7.2.2006, p. 21)., 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)The substance flubendazole is currently included in Annex I to Regulation (EEC) No 2377/90 for chicken, turkey, game birds and porcine for muscle, skin and fat, liver and kidney as well as for chicken from which eggs are produced for human consumption. The entry for flubendazole in that Annex should be extended to all poultry species for muscle, skin and fat, liver, kidney and eggs.(3)The substance lasalocid is currently included in Annex I to Regulation (EEC) No 2377/90 for poultry for muscle, skin and fat, liver and kidney, excluding animals from which eggs are produced for human consumption. The substance lasalocid should be included in Annex III to that Regulation for poultry from which eggs are produced for human consumption, awaiting validation of analytical methods. Consequently the current provision, excluding animals from which eggs are produced for human consumption, should be deleted from the entry of lasalocid in Annex I to Regulation (EEC) No 2377/90.(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 adjustment which may be necessary 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). to take account of the provisions of this Regulation.(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 11 September 2006.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 12 July 2006.For the CommissionGünter VerheugenVice-PresidentANNEXA.The following substances are inserted in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maximum residue limits have been fixed):2.Antiparasitic agents2.1.Agents acting against endoparasites2.1.3.Benzimidazoles and pro-benzimidazoles
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissues
"FlubendazoleSum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4fluorophenyl) methanonePoultry, porcine50 μg/kgMuscle
50 μg/kgSkin + fat
400 μg/kgLiver
300 μg/kgKidney
FlubendazoleFlubendazolePoultry400 μg/kgEggs"
2.4.Agents acting against protozoa2.4.4.Ionophores
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissues
"LasalocidLasalocid APoultry20 μg/kgMuscle
100 μg/kgSkin + fat
100 μg/kgLiver
50 μg/kgKidney"
B.The following substance is inserted in Annex III to Regulation (EEC) No 2377/90 (List of pharmacologically active substances used in veterinary medicinal products for which provisional maximum residue limits have been fixed):2.Antiparasitic agents2.4.Agents acting against protozoa2.4.5.Ionophores
Provisional MRLs expire on 1 January 2008."
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissues
"LasalocidLasalocid APoultry150 μg/kgEggs
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Provisional MRLs expire on 1 January 2008."