Commission Regulation (EC) No 1353/2007 of 20 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 Monensin, Lasalocid and Tylvalosin (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2007/1353@2007-11-20/en
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, 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) An application for establishing maximum residue limits for Monensin, an antibiotic and anticoccidial belonging to the group of ionophores, has been submitted to the European Medicines Agency. On the basis of the recommendation of the Committee for Medicinal Products for Veterinary Use, this substance should be added in Annex I to Regulation (EEC) No 2377/90 for bovine species (muscle, fat, liver, kidney and milk).
(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 and in Annex III to Regulation (EEC) No 2377/90 for poultry from which eggs are produced for human consumption, awaiting validation of analytical method. Those scientific studies have been now completed and the analytical method has been validated by the Committee for Medicinal Products for Veterinary Use. Lasalocid belongs to the group of antibiotic ionophores having anticoccidial properties. Consequently, Lasalocid should be added in Annex I to Regulation (EEC) No 2377/90 for poultry from which eggs are produced for human consumption, under the new point 1.2.16, while the Lasalocid entry under point 2.4.4 of Annex I to Regulation (EEC) No 2377/90 should be deleted.
(4) The substance Acetylisovaleryltylosin, an antibiotic belonging to the group of macrolides is currently included in Annex I to Regulation (EEC) No 2377/90 for porcine and poultry species. A change to the International Non-proprietary Name (INN) of this active substance has been notified to the European Medicines Agency. The substance’s name Acetylisovaleryltylosin should be replaced by the new INN, Tylvalosin.
(5) Regulation (EEC) No 2377/90 should therefore be amended accordingly.
(6) 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 products to take account of the provisions of this Regulation.
(7) 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 1
Annex I to Regulation (EEC) No 2377/90 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union. It shall apply from 20 January 2008.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 November 2007. For the Commission Günter Verheugen Vice-President
ANNEX
ANNEX
Annex I to Regulation (EEC) No 2377/90 is amended as follows:
(1) in point 1.2.4, the entry for Acetylisovaleryltylosin is replaced by the following:
1.2.4. Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Tylvalosin Sum of tylvalosin and 3-O-acetyltylosin Porcine 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney Poultry 50 μg/kg Fat 50 μg/kg Liver
(2) the following point 1.2.16 is added:
1.2.16. Ionophores Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Monensin Monensin A Bovine 2 μg/kg Muscle 10 μg/kg Fat 30 μg/kg Liver 2 μg/kg Kidney 2 μg/kg Milk Lasalocid Lasalocid A Poultry 20 μg/kg Muscle 100 μg/kg Fat 100 μg/kg Liver 50 μg/kg Kidney 150 μg/kg Eggs
(3) in point 2.4.4, the entry for Lasalocid is deleted.