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)

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)

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 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 products ² 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 1

Annexes I and II 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 11 July 2005.

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 11 May 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 75/2005 ( OJ L 15, 19.1.2005, p. 3 ).

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 ).

A. The following substance(s) is(are) inserted in Annex I to Regulation (EEC) No 2377/90

2. Antiparasitic agents

2.4. Agents acting against protozoa

2.4.4. Ionophores

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues ‘Lasalocid Lasalocid A Poultry ¹ 20 μg/kg Muscle 100 μg/kg Skin + fat 100 μg/kg Liver 50 μg/kg Kidney

B. The following substance(s) is(are) inserted in Annex II to Regulation (EEC) No 2377/90

2. Organic compounds

Pharmacologically active substance(s) Animal species ‘Bituminosulfonates, ammonium and sodium salts All mammalian food producing species ²

¹ Not for use in animals from which eggs are produced for human consumption.’

² For topical use only.’

Footnotes

1. Not for use in animals from which eggs are produced for human consumption.’ ↩ ↩² ↩³ ↩⁴

2. For topical use only.’ ↩ ↩² ↩³ ↩⁴