Commission Regulation (EC) No 1356/2005 of 18 August 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 oxolinic acid and morantel (Text with EEA relevance)

EU Regulation No 1356/2005 · Adopted 18 August 2005 · Extends to United Kingdom

Commission Regulation (EC) No 1356/2005

of 18 August 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 oxolinic acid and morantel

(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^f1, 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)

Oxolinic acid has been included in Annex I to Regulation (EEC) No 2377/90 for chicken and porcine for muscle, skin and fat, liver and kidney, for muscle and skin in natural proportions for fin fish and excluding animals from which eggs are produced for human consumption. The entry should be extended to all food-producing species excluding animals from which milk or eggs are produced for human consumption, for fin fish, this entry relates only to ‘muscle and skin in natural proportions’ and for porcine and poultry species the maximum residue limit concerning fat relates to ‘skin and fat in natural proportions’.

(3)

Morantel has been included in Annex I to Regulation (EEC) No 2377/90 for bovine and ovine for muscle, fat, liver, kidney and milk. That entry should be extended to all ruminants.

(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 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^f2.

(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:

Annotations to the whole text

Footnotes

f1: OJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1299/2005 (OJ L 206, 9.8.2005, p. 4).
f2: 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).

1Article 1
2Article 2
Signature
Annex
The following substances are inserted in Annex I (List of pharmacologically active substances for which maximum residue limits have been fixed)
Anti-infectious agents
Antibiotics
1.2.3Quinolones
Antiparasitic agents
Agents acting against endoparasites
2.1.7Tetrahydropyrimides

For the Commission

Günter Verheugen

Vicepresident

1.2.3Quinolones

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
Not for use in animals from which milk or eggs are produced for human consumption; MRLs for fat, liver and kidney do not apply to fin fish
For fin fish this MRL relates to ‘muscle and skin in natural proportions’;
For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’.
Oxolinic acid	Oxolinic acid	All food-producing species^f1	100 μg/kg	Muscle^f2
			50 μg/kg	Fat^f3
			150 μg/kg	Liver
			150 μg/kg	Kidney

2.1.7Tetrahydropyrimides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
Morantel	Sum of residues which may be hydrolysed to N-methyl-1,3-propanediamine and expressed as morantel equivalents	All ruminants	100 μg/kg	Muscle
			100 μg/kg	Fat
			800 μg/kg	Liver
			200 μg/kg	Kidney
			50 μg/kg	Milk

Annotations to the whole text

Footnotes

Contents

1

2

Signature

1.2.3Quinolones

2.1.7Tetrahydropyrimides