20070917

Commission Regulation (EC) No 1064/2007

of 17 September 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 Avilamycin

(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 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 Avilamycin, an antibiotic belonging to the group of orthosomycins, 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 porcine species (muscle, skin plus fat, liver and kidney), rabbit (muscle, fat, liver and kidney) and poultry (muscle, skin plus fat, liver and kidney) provided that, for the latter, the substance Avilamycin is not used in poultry species from which eggs are produced for human consumption.

(3) Regulation (EEC) No 2377/90 should therefore 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 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 [2] to take account of the provisions of this Regulation.

(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 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union. It shall apply from 18 November 2007.

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

Done at Brussels, 17 September 2007.

For the Commission

G眉nter Verheugen

Vice-President

[1] OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 703/2007 (OJ L 161, 22.6.2007, p. 28).

[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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20070917

ANNEX

The following substance is added in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maximum residue limits have been fixed):

1. Anti-infectious agents

1.2. Antibiotics

1.2.15. Orthosomycins

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

Avilamycin | Dichloroisoeverninic acid | Porcine | 50 渭g/kg | Muscle |

100 渭g/kg | Fat [1] |

300 渭g/kg | Liver |

200 渭g/kg | Kidney |

Rabbit | 50 渭g/kg | Muscle |

100 渭g/kg | Fat |

300 渭g/kg | Liver |

200 渭g/kg | Kidney |

Poultry [2] | 50 渭g/kg | Muscle |

100 渭g/kg | Fat [3] |

300 渭g/kg | Liver |

200 渭g/kg | Kidney |

[1] For porcine and poultry species, this MRL relates to skin and fat in natural proportions.

[2] Not for use in animals from which eggs are produced for human consumption.

[3] For porcine and poultry species, this MRL relates to skin and fat in natural proportions.

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