Commission Regulation (EC) No 712/2005 of 11 May 2005 amending Annexes I and II 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 lasalocid and ammonium and sodium salts of bituminosulfonates (Text with EEA relevance)
Commission Regulation (EC) No 712/2005of 11 May 2005amending Annexes I and II 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 lasalocid and ammonium and sodium salts of bituminosulfonates(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 75/2005 (OJ L 15, 19.1.2005, p. 3)., and in particular Articles 2 and 3 and the third subparagraph 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 which are used within the Community in veterinary medicinal products intended for administration to food-producing animals should be evaluated in accordance with Regulation (EEC) No 2377/90.(2)The substance lasalocid should be included in Annex I for poultry excluding animals from which eggs are produced for human consumption.(3)The substances ammonium and sodium salts of bituminosulfonates have been included in Annex II for all mammalian food producing species excluding animals from which milk is produced for human consumption. The entry for those substances should be extended to cover dairy cattle.(4)Regulation (EEC) No 2377/90 should 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 THE FOLLOWING REGULATION:
Article 1Annexes I and II 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 July 2005.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 11 May 2005.For the CommissionGünter VerheugenVice-PresidentANNEXA.The following substance(s) is(are) inserted in Annex I to Regulation (EEC) No 2377/902.Antiparasitic agents2.4.Agents acting against protozoa2.4.4.Ionophores
Not for use in animals from which eggs are produced for human consumption."
Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissues
"LasalocidLasalocid APoultry20 μg/kgMuscle
100 μg/kgSkin + fat
100 μg/kgLiver
50 μg/kgKidney
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Not for use in animals from which eggs are produced for human consumption."
B.The following substance(s) is(are) inserted in Annex II to Regulation (EEC) No 2377/902.Organic compounds
For topical use only."
Pharmacologically active substance(s)Animal species
"Bituminosulfonates, ammonium and sodium saltsAll mammalian food producing species
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For topical use only."