Legalize / European Union / Regulation

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)

Type Regulation

Publication 2004-09-21

Last updated 2004-09-24

State Repealed

Department European Commission

Source EUR-Lex

articles 2

Reform history JSON API

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)

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 ([^E0001]), 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 species ([^E0002]), 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/EC ([^E0003]) 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 1

Annex I to Regulation (EEC) No 2377/90 is hereby amended as set out in the Annex hereto.

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 the sixtieth day following its publication.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX

The following substance(s) is(are) inserted in Annex I:

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
‘Albendazole	Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	All ruminants	100 μg/kg	Muscle
‘Albendazole	Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	All ruminants	100 μg/kg	Fat
‘Albendazole	Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	All ruminants	1 000 μg/kg	Liver
‘Albendazole	Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	All ruminants	500 μg/kg	Kidney
‘Albendazole	Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	All ruminants	100 μg/kg	Milk
Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Muscle
Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Fat
Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	500 μg/kg	Liver
Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Kidney
Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	10 μg/kg	Milk
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Muscle
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Fat
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	500 μg/kg	Liver
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Kidney
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	10 μg/kg	Milk
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Muscle
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Fat
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	500 μg/kg	Liver
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	50 μg/kg	Kidney
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	All ruminants	10 μg/kg	Milk
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Caprine	100 μg/kg	Muscle
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Caprine	100 μg/kg	Fat
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Caprine	100 μg/kg	Liver
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Caprine	100 μg/kg	Kidney
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Caprine	100 μg/kg	Milk’

2.1.1.Salicylanilides

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

2.2.Agents acting against ectoparasites

2.2.2.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
‘Amitraz	Sum of amitraz and all metabolites containing the 2,4-dimethylaniline moiety, expressed as amitraz	Caprine	100 μg/kg	Liver
‘Amitraz	Sum of amitraz and all metabolites containing the 2,4-dimethylaniline moiety, expressed as amitraz	Caprine	200 μg/kg	Kidney
‘Amitraz	Sum of amitraz and all metabolites containing the 2,4-dimethylaniline moiety, expressed as amitraz	Caprine	10 μg/kg	Milk’

2.2.3.Pyrethroids

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
‘Cypermethrin	Cypermethrin (sum of isomers)	All ruminants	20 μg/kg	Muscle
‘Cypermethrin	Cypermethrin (sum of isomers)	All ruminants	200 μg/kg	Fat
‘Cypermethrin	Cypermethrin (sum of isomers)	All ruminants	20 μg/kg	Liver
‘Cypermethrin	Cypermethrin (sum of isomers)	All ruminants	20 μg/kg	Kidney
‘Cypermethrin	Cypermethrin (sum of isomers)	All ruminants	20 μg/kg	Milk [^E0004]
Deltamethrin	Deltamethrin	All ruminants	10 μg/kg	Muscle
Deltamethrin	Deltamethrin	All ruminants	50 μg/kg	Fat
Deltamethrin	Deltamethrin	All ruminants	10 μg/kg	Liver
Deltamethrin	Deltamethrin	All ruminants	10 μg/kg	Kidney
Deltamethrin	Deltamethrin	All ruminants	20 μg/kg	Milk

[^E0004]: (¹)Further provisions in Commission Directive 98/82/EC are to be observed (OJ L290, 29.10.1998, p. 25).’

5.Corticoids

5.1.Glucocorticoids

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

[^E0001]: OJ 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).

[^E0002]: Availability of veterinary medicinal products Communication from the Commission to the Council and the European Parliament COM(2000) 806 final.

[^E0003]: 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).

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.