Commission Regulation (EC) No 1055/2006 of 12 July 2006 amending Annexes I and III 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 flubendazole and lasalocid (Text with EEA relevance)

of 12 July 2006

amending Annexes I and III 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 flubendazole and lasalocid

(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 2 and the third paragraph 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 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 flubendazole is currently included in Annex I to Regulation (EEC) No 2377/90 for chicken, turkey, game birds and porcine for muscle, skin and fat, liver and kidney as well as for chicken from which eggs are produced for human consumption. The entry for flubendazole in that Annex should be extended to all poultry species for muscle, skin and fat, liver, kidney and eggs.

(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, excluding animals from which eggs are produced for human consumption. The substance lasalocid should be included in Annex III to that Regulation for poultry from which eggs are produced for human consumption, awaiting validation of analytical methods. Consequently the current provision, excluding animals from which eggs are produced for human consumption, should be deleted from the entry of lasalocid in Annex I to Regulation (EEC) No 2377/90.

(4) Regulation (EEC) No 2377/90 should therefore 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 THIS REGULATION:

Article 1

Annexes I and III 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 September 2006.

Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 12 July 2006. 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 205/2006 ( OJ L 34, 7.2.2006, p. 21 ).

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 substances are inserted in Annex I to Regulation (EEC) No 2377/90 (List of pharmacologically active substances for which maximum residue limits have been fixed):

2. Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.3. Benzimidazoles and pro-benzimidazoles

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues ‘ Flubendazole Sum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4fluorophenyl) methanone Poultry, porcine 50 μg/kg Muscle 50 μg/kg Skin + fat 400 μg/kg Liver 300 μg/kg Kidney Flubendazole Flubendazole Poultry 400 μg/kg Eggs’

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 20 μg/kg Muscle 100 μg/kg Skin + fat 100 μg/kg Liver 50 μg/kg Kidney’

B. The following substance is inserted in Annex III to Regulation (EEC) No 2377/90 (List of pharmacologically active substances used in veterinary medicinal products for which provisional maximum residue limits have been fixed):

2. Antiparasitic agents

2.4. Agents acting against protozoa

2.4.5. Ionophores

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues ‘ Lasalocid Lasalocid A Poultry 150 μg/kg Eggs ¹

¹ Provisional MRLs expire on 1 January 2008.’

Footnotes

1. Provisional MRLs expire on 1 January 2008.’ ↩ ↩² ↩³ ↩⁴

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