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Commission Regulation (EC) No 1646/2004 of 20 September 2004 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(Text with EEA relevance)

Commission Regulation (EC) No 1646/2004of 20 September 2004amending 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(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 originOJ L 224, 18.8.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1101/2004 (OJ L 211, 12.6.2004, p. 3)., and in particular Articles 6, 7 and 8 thereof;Whereas:(1)In accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals.(2)Maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs.(3)In establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue).(4)In view of the reduced availability of veterinary medicinal products for certain food-producing speciesAvailability of veterinary medicinal products Communication from the Commission to the Council and the European Parliament COM(2000) 806 final., maximum residue limits may be established by methods of extrapolation from maximum residue limits set for other species on a strictly scientific basis.(5)For the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney. However, the liver and kidney are frequently removed from carcasses moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues.(6)In the case of veterinary medicinal products intended for use in laying birds, lactating animals or honey bees, maximum residue limits must also be established for eggs, milk or honey.(7)Albendazole, Febantel, Fenbendazole, Oxfendazole, Thiabendazole, Oxyclozanide, Amitraz, Cypermethrin, Deltamethrin and Dexamethasone should be inserted into Annex I to Regulation (EEC) No 2377/90;(8)An adequate period should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorisations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Directive 2001/82/ECOJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58). of the European Parliament and of the Council to take account of the provisions of this Regulation.(9)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 1Annex I to Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex hereto.

Article 2This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.It shall apply from the sixtieth day following its publication.

This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 20 September 2004.For the CommissionOlli RehnMember of the CommissionANNEXThe following substance(s) is(are) inserted in Annex I:2.Antiparasitic agents2.1.Agents acting against endoparasites2.1.3.Benzimidazoles and pro-benzimidazoles

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
"Albendazole	Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	All ruminants	100 μg/kg	Muscle
			100 μg/kg	Fat
			1000 μg/kg	Liver
			500 μg/kg	Kidney
			100 μg/kg	Milk
Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
			10 μg/kg	Milk
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
			10 μg/kg	Milk
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
			10 μg/kg	Milk
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Caprine	100 μg/kg	Muscle
			100 μg/kg	Fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
			100 μg/kg	Milk"

2.1.4.Phenol derivatives including salicylanides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
"Oxyclozanide	Oxyclozanide	All ruminants	20 μg/kg	Muscle
			20 μg/kg	Fat
			500 μg/kg	Liver
			100 μg/kg	Kidney
			10 μg/kg	Milk"

2.2.Agents acting against ectoparasites2.2.2.Formamidines

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
"Amitraz	Sum of amitraz and all metabolites containing the 2,4-dimethylaniline moiety, expressed as amitraz	Caprine	200 μg/kg	Fat
			100 μg/kg	Liver
			200 μg/kg	Kidney
			10 μg/kg	Milk"

2.2.3.Pyrethroids

Further provisions in Commission Directive 98/82/EC are to be observed (OJ L290, 29.10.1998, p. 25)."

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
"Cypermethrin	Cypermethrin (sum of isomers)	All ruminants	20 μg/kg	Muscle
			200 μg/kg	Fat
			20 μg/kg	Liver
			20 μg/kg	Kidney
			20 μg/kg	Milk
Deltamethrin	Deltamethrin	All ruminants	10 μg/kg	Muscle
			50 μg/kg	Fat
			10 μg/kg	Liver
			10 μg/kg	Kidney
			20 μg/kg	Milk

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Further provisions in Commission Directive 98/82/EC are to be observed (OJ L290, 29.10.1998, p. 25)."5.Corticoids5.1.Glucocorticoids

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
"Dexamethasone	Dexamethasone	Caprine	0,75 μg/kg	Muscle
			2 μg/kg	Liver
			0,75 μg/kg	Kidney
			0,3 μg/kg	Milk"