Commission Regulation (EC) No 1148/2005

of 15 July 2005

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 penethamate

(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 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) Penethamate has been included in Annex I to Regulation (EEC) No 2377/90 for bovine and porcine for muscle, fat, liver and kidney and for milk but only for bovine. That entry should be extended to all mammalian food-producing species.

(3) Regulation (EEC) No 2377/90 should be amended accordingly.

(4) 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 marketing authorisations 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 [2].

(5) 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 are 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 14 September 2005.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 July 2005.

For the Commission

Günter Verheugen

Vice-President

[1] OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 869/2005 (OJ L 145, 9.6.2005, p. 19).

[2] OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58).

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ANNEX

The following substance is inserted in Annex I to Regulation (EEC) No 2377/90:

1. Anti-infectious agents

1.2. Antibiotics

1.2.1. Penicillins

Pharmacologically active substance(s) | Marker residue | Animal species | MRLs | Target tissues |

"Penethamate | Benzylpenicillin | All mammalian-food producing species | 50 μg/kg | Muscle |

50 μg/kg | Fat |

50 μg/kg | Liver |

50 μg/kg | Kidney |

4 μg/kg | Milk" |

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