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Document 02002R1181-20020705

Consolidated text: Commission Regulation (EC) No 1181/2002 of 1 July 2002 amending Annex I of 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)

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ELI: http://data.europa.eu/eli/reg/2002/1181/2002-07-05

Date of document:: 05/07/2002
Date of effect:: 05/07/2002

Author:: European Commission
Form:: Consolidated text
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Consolidated TEXT: 32002R1181 — EN — 05.07.2002

2002R1181 — EN — 05.07.2002 — 000.002

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►B

COMMISSION REGULATION (EC) No 1181/2002

of 1 July 2002

amending Annex I of 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)

(OJ L 172, 2.7.2002, p.13)

Corrected by:

►C1	Corrigendum, OJ L 251, 19.9.2002, p. 20 (1181/02)
C2	Corrigendum, OJ L 045, 19.2.2003, p. 27 (1181/02)
►C3	Corrigendum, OJ L 062, 6.3.2003, p. 27 (1181/02)

▼B

COMMISSION REGULATION (EC) No 1181/2002

of 1 July 2002

(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 ( 1 ), as last amended by Commission Regulation (EC) No 869/2002 ( 2 ) 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 ( 3 ), 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)	Trimethoprim, Neomycin (including framycetin), Paromomycin, Spectinomycin, Colistin, Danofloxacin, Difloxacin, Enrofloxacin, Flumequine, Erythromycin, Tilmicosin, Tylosin, Florfenicol, Lincomycin and Oxyclozanide 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 ( 4 ) 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 of 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 Communities.

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

Annex I to Regulation (EEC No 2377/90 is amended as follows:

1. Anti-infectious agents

1.1. Chemotherapeutics

1.1.2. Diamino pyrimidine derivatives

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Trimethoprim	Trimethoprim	All food producing species except equidae	50 μg/kg	Fat (1)	Not for use in animals from which eggs are produced for human consumption
			50 μg/kg	Muscle (2)
			50 μg/kg	Liver
			50 μg/kg	Kidney
			50 μg/kg	Milk
		Equidae	100 μg/kg	Muscle
			100 μg/kg	Fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
(1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

1.2. Antibiotics

1.2.3. Quinolones

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Danofloxacin	Danofloxacin	►C1 All food producing species except bovine, ovine, caprine, porcine and poultry ◄	100 μg/kg	Muscle (2)
			50 μg/kg	Fat (1)
			200 μg/kg	Liver
			200 μg/kg	Kidney
		Bovine, ovine, caprine	200 μg/kg	Muscle
			100 μg/kg	Fat
			400 μg/kg	Liver
			400 μg/kg	Kidney
			30 μg/kg	Milk
		Poultry	200 μg/kg	Muscle	Not for use in animals from which eggs are produced for human consumption
			100 μg/kg	Skin and fat
			400 μg/kg	Liver
			400 μg/kg	Kidney
Difloxacin	Difloxacin	All food producing species except bovine, ovine, caprine and poultry	300 μg/kg	Muscle (2)
			100 μg/kg	Fat
			800 μg/kg	Liver
			600 μg/kg	Kidney
		Bovine, ovine, caprine	400 μg/kg	Muscle	Not for use in animals from which milk is produced for human consumption
			100 μg/kg	Fat
			1 400 μg/kg	Liver
			800 μg/kg	Kidney
		Porcine	400 μg/kg	Muscle
			100 μg/kg	Skin and fat
			800 μg/kg	Liver
			800 μg/kg	Kidney
		Poultry	300 μg/kg	Muscle	Not for use in animals from which eggs are produced for human consumption
			400 μg/kg	Skin and fat
			1 900 μg/kg	Liver
			600 μg/kg	Kidney
Enrofloxacin	Sum of enrofloxacin and ciprofloxacin	All food producing species except bovine, ovine, caprine, porcine, rabbits and poultry	100 μg/kg	Muscle (2)
			100 μg/kg	Fat
			200 μg/kg	Liver
			200 μg/kg	Kidney
		Bovine, ovine, caprine	100 μg/kg	Muscle
			100 μg/kg	Fat
			300 μg/kg	Liver
			200 μg/kg	Kidney
			100 μg/kg	Milk
		Porcine, rabbits	100 μg/kg	Muscle
			100 μg/kg	Fat (1)
			200 μg/kg	Liver
			300 μg/kg	Kidney
		Poultry	100 μg/kg	Muscle	Not for use in animals from which eggs are produced for human consumption
			100 μg/kg	Skin and fat
			200 μg/kg	Liver
			300 μg/kg	Kidney
Flumequine	Flumequine	All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish	200 μg/kg	Muscle
			250 μg/kg	Fat
			500 μg/kg	Liver
			1 000 μg/kg	Kidney
		Bovine, porcine, ovine, caprine	200 μg/kg	Muscle
			300 μg/kg	Fat (1)
			500 μg/kg	Liver
			1 500 μg/kg	Kidney
			50 μg/kg	Milk
		Poultry	400 μg/kg	Muscle	Not for use in animals from which eggs are produced for human consumption
			250 μg/kg	Skin and fat
			800 μg/kg	Liver
			1 000 μg/kg	Kidney
		Fin fish	600 μg/kg	Muscle and skin in natural proportion
(1) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘. (2) ‘For porcine species this MRL relates to “‘skin and fat in natural proportions”‘.’

1.2.4. Macrolides

‘Pharmacologically active substanceactiva	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Erythromycin	erythromicyin A	All food producing species	200 μg/kg	Muscle (1)
			200 μg/kg	Fat (2)
			200 μg/kg	Liver
			200 μg/kg	Kidney
			40 μg/kg	Milk
			150 μg/kg	Eggs
Tilmicosin	Tilmicosin	All food producing species except poultry	50 μg/kg	Muscle (1)
			50 μg/kg	Fat (2)
			1 000 μg/kg	Liver
			1 000 μg/kg	Kidney
			50 μg/kg	Milk
		Poultry	75 μg/kg	Muscle	Not for use in animals from which eggs are produced for human consumption
			75 μg/kg	Sin and fat
			1 000 μg/kg	Liver
			250 μg/kg	Kidney
Tylosin	Tylosin A	All food producing species	100 μg/kg	Fat (3)
			100 μg/kg	Muscle (1)
			100 μg/kg	Liver
			100 μg/kg	Kidney
			50 μg/kg	Milk
			200 μg/kg	Eggs
(1) ‘For fin fish this MRL relates to a “‘muscle and skin in natural proportions”‘. (2) ‘For procine species this MRL relates to “‘skin and fat in natural proportions”‘. (3) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘.’

1.2.5. Florfenicol and related compounds

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Florfenicol	Sum of florfenicol and its metabolites measured as florfenicol-amine	All food producing species except bovine, ovine, caprine, porcine, poultry and fin fish	100 μg/kg	Muscle
			200 μg/kg	Fat
			2 000 μg/kg	Liver
			300 μg/kg	Kidney
		Bovine, ovine, caprine	200 μg/kg	Muscle	Not for use in animals from which milk is produced for human consumption
			►C3 3 000 μg/kg ◄	►C3 Liver ◄
			300 μg/kg	Kidney
		Porcine	300 μg/kg	Muscle
			500 μg/kg	Skin and fat
			2 000 μg/kg	Liver
			500 μg/kg	Kidney
		Poultry	100 μg/kg	Muscle	Not for use in animals from which eggs are produced for human consumption
			200 μg/kg	Skin and fat
			2 500 μg/kg	Liver
			750 μg/kg	Kidney
		Fin fish	1 000 μg/kg	Muscle and skin in natural proportions’

1.2.9. Lincosamides

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Lincomycin	Lincomicyn	All food producing species	50 μg/kg	Fat (1)
			100 μg/kg	Muscle (2)
			500 μg/kg	Liver
			1 500 μg/kg	Kidney
			150 μg/kg	Milk
			50 μg/kg	Eggs
(1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

1.2.10. Aminoglycosides

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Neomycin (including framycetin)	Neomycin B	All food producing species	500 μg/kg	Fat (1)
			500 μg/kg	Muscle (2)
			500 μg/kg	Liver
			5 000 μg/kg	Kidney
			1 500 μg/kg	Milk
			500 μg/kg	Eggs
Paromomycin	Paromomycin	All food producing species	500 μg/kg	Muscle (2)	Not for use in animals from which milk or eggs are produced for human consumption
			1 500 μg/kg	Liver
			1 500 μg/kg	Kidney
Spectinomycin	Spectinomycin	All food producing species except ovine	500 μg/kg	Fat (1)	Not for use in animals from which eggs are produced for human consumption
			300 μg/kg	Muscle (2)
			1 000 μg/kg	Liver
			5 000 μg/kg	Kidney
			200 μg/kg	Milk
		Ovine	300 μg/kg	Muscle
			500 μg/kg	Fat
			2 000 μg/kg	Liver
			5 000 μg/kg	Kidney
			200 μg/kg	Milk
(1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

1.2.14. Polymyxins

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Colistin	Colistin	All food producing species	150 μg/kg	Fat (1)
			150 μg/kg	Muscle (2)
			150 μg/kg	Liver
			200 μg/kg	Kidney
			50 μg/kg	Milk
			300 μg/kg	Eggs
(1) ‘For porcine and poultry species this MRL relates to “‘skin and fat in natural proportions”‘. (2) ‘For fin fish this MRL relates to “‘muscle and skin in natural proportions”‘.’

2. Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.4. Phenol derivatives including salicylanides

‘Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
Oxyclozanide	Oxyclozanide	Bovine	20 μg/kg	Muscle
			20 μg/kg	Fat
			500 μg/kg	Liver
			100 μg/kg	Kidney
			10 μg/kg	Milk
		Ovine	20 μg/kg	Muscle	Not for use in animals from which milk is produced for human consumption
			20 μg/kg	Fat
			500 μg/kg	Liver
			100 μg/kg	Kidney’

( 1 ) OJ L 224, 18.8.1990, p. 1.

( 2 ) OJ L 137, 25.5.2002, p. 10.

( 3 ) Availability of veterinary medical products Communication from the Commission to the Council and the European Parliament COM(2000) 806 final.

( 4 ) OJ L 311, 28.11.2001, p. 1.

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