Commission Regulation (EC) No 287/2007 of 16 March 2007 amending Annex 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 Ginseng, standardised extracts and preparations thereof (Text with EEA relevance )

of 16 March 2007

amending Annex 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 Ginseng, standardised extracts and preparations thereof

(Text with EEA relevance)

Preamble

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 3 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 Ginseng is included in Annex II to Regulation (EEC) No 2377/90 in the category of substances used in homeopathic veterinary medicinal products, for all food-producing species, for use only in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture, and dilutions thereof. Following the examination of an application, it is considered appropriate to include a new entry in Annex II, in the category of substances of vegetable origin, for Ginseng, standardised extracts and preparations thereof, for all food-producing species.

(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 II 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 16 May 2007.

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 16 March 2007. 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 1831/2006 ( OJ L 354, 14.12.2006, p. 5 ).

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 ).

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

6. Substances of vegetable origin

Pharmacologically active substance(s) Animal species ‘ Ginseng , standardised extracts and preparations thereof All food-producing species’

Footnotes

1. . Regulation as last amended by Commission Regulation (EC) No 1831/2006 (). ↩ ↩²

2. . Directive as last amended by Directive 2004/28/EC (). ↩ ↩²