Commission Regulation (EC) No 2701/94Show full title

Commission Regulation (EC) No 2701/94

of 7 November 1994

amending Annexes I, II, III and IV 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(1), as last amended by Commission Regulation (EC) No 1430/94(2), and in particular Articles 6, 7 and 8 thereof,

Whereas, since the adoption of the Regulation, the Annexes have been amended a number of times; whereas, by reason of their number, their complexity and their dispersal among various Official Journals of the European Communities, the texts are difficult to use and thus lack the clarity which should be an essential feature of all legislation; whereas, they should therefore be consolidated; whereas on the same occasion the name or chemical description of some compounds should be rectified or made more precise and certain material errors should be corrected;

Whereas the measures provided for in this Regulation are in accordance with the opinion of the Committee for the adaptation to technical progress of directives on the removal of technical barriers to trade in the veterinary medicinal products sector,

HAS ADOPTED THIS REGULATION:

Article 1 U.K.

Annexes I, II, III and IV to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto.

Article 2 U.K.

This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities.

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

Done at Brussels, 7 November 1994.

For the Commission

Martin Bangemann

Member of the Commission

ANNEX U.K.

“ANNEX I List of pharmacologically active substances for which maximum residue limits have been fixed

1.

Anti-infectious agents

1.1.

Chemotherapeutics

1.1.1.

Sulfonamides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
All substances belonging to the sulfonamide group	Parent drug	All food producing species	100 μg/kg	Muscle, liver, kidney, fat	The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg

1.2.

Antibiotics

1.2.1.

Penicillins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.2.1.1. Benzylpenicillin	Benzylpenicillin	All food producing species	50 μg/kg	Muscle, liver, kidney, fat
			4 μg/kg	Milk
1.2.1.2. Ampicillin	Ampicillin	All food producing species	50 μg/kg	Muscle, liver, kidney, fat
			4 μg/kg	Milk
1.2.1.3. Amoxicillin	Amoxicillin	All food producing species	50 μg/kg	Muscle, liver, kidney, fat
			4 μg/kg	Milk
1.2.1.4. Oxacillin	Oxacillin	All food producing species	300 μg/kg	Muscle, liver, kidney, fat
			30 μg/kg	Milk
1.2.1.5. Cloxacillin	Cloxacillin	All food producing species	300 μg/kg	Muscle, liver, kidney, fat
			30 μg/kg	Milk
1.2.1.6. Dicloxacillin	Dicloxacillin	All food producing species	300 μg/kg	Muscle, liver, kidney, fat
			30 μg/kg	Milk

1.2.2.

Cephalosporins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.2.2.1. Cefquinome	Cefquinome	Bovine	200 μg/kg	Kidney
			100 μg/kg	Liver
			50 μg/kg	Muscle
			50 μg/kg	Fat

1.2.3.

Quinolones

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.2.3.1. Enrofloxacin	Sum of enrofloxacin and ciprofloxacin	Bovine, porcine, poultry	30 μg/kg	Muscle, liver, kidney

1.2.4.

Macrolides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.2.4.1. Tilmicosin	Tilmicosin	Bovine	1 000 μg/kg	Liver, kidney
			50 μg/kg	Muscle, fat

2.

Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.1.

Avermectins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
2.1.1.1. Ivermectin	22,23- Dihydroavermectin B1a	Bovine	100 μg/kg	Liver
		40 μg/kg	Fat
		Porcine	15 μg/kg	Liver
		Ovine	20 μg/kg	Fat
Equidae
2.1.1.2. Abamectin	Avermectin B1a	Bovine	20 μg/kg	Liver
			10 μg/kg	Fat
2.1.1.3. Doramectin	Doramectin	Bovine	15 μg/kg	Liver
			25 μg/kg	Fat

2.1.2

Salicylanilides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
2.1.2.1. Closantel	Closantel	Bovine	1 000 μg/kg	Muscle, liver
			3 000 μg/kg	Kidney, fat
		Ovine	1 500 μg/kg	Muscle, liver
			5 000 μg/kg	Kidney, fat
			2 000 μg/kg

ANNEX II List of substances not subject to maximum residue limits

1.

Inorganic chemicals

Pharmacologically active substance(s)	Animal species	Other provisions
1.1. Hydrogen peroxide	Fish
1.2. Sulphur	Bovine
	Porcine
	Ovine
	Caprine
	Equidae
1.3. Iodine and iodine inorganic compounds including: Sodium and potassium — iodide Sodium and potassium — iodate Iodophors including polyvinylpyrrolidone — iodine	All food producing species
1.4. Sodium chlorite	Bovine	For tropical use only

2.

Organic compounds

Pharmacologically active substance(s)	Animal species	Others provisions
2.1. Etiproston tromethamine	Bovine
	Porcine
2.2. Ketanserin tartrate	Equidae
2.3. Fertirelin acetate	Bovine
2.4. Human menopausal urinary gonadotrophin	Bovine
2.5. Lactic acid	All food producing species
2.6. Melatonin	Ovine
	Caprine
2.7. Iodine organic compounds Iodoform	All food producing species
2.8. Acetyl cysteine	All food producing species

ANNEX III List of pharmacologically active substances used in veterinary medicinal products for which provisional maximum residue limits have been fixed

1.

Anti-infectious agents

1.1.

Chemotherapeutics

1.1.1.

Sulfonamides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
All substances belonging to the sulfonamide group	Parent drug	Bovine, ovine, caprine	100 μg/kg	Milk	Provisional MRL expires on 1. 1. 1996. The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg

1.1.2.

Diamino pyrimidine derivates

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.1.2.1. Trimethoprim	Trimethoprim	All food producing species	50 μg/kg	Muscle, liver, kidney, fat, milk	Provisional MRL expires on 1. 1. 1996

1.1.3.

Nitrofurans

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.1.3.1. Furazolidone	All residues with intact 5-nitro structure	All food producing species	5 μg/kg	Muscle, liver, kidney, fat	Provisional MRL expires on 1. 7. 1995

1.1.4.

Nitroimidazoles

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.1.4.1. Dimetridazole	All residues with intact nitroimidazole structure	All food producing species	10 μg/kg	Muscle, liver, kidney, fat	Provisional MRL expires on 1. 1. 1995

1.2.

Antibiotics

1.2.1.

Tetracyclines

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
All substances belonging to the tetracycline group	Parent drug	All food producing species	600 μg/kg	Kidney	Provisional MRLs expire on 1. 1. 1996. The combined total residues of all substances within the tetracycline group should not exceed the limits indicated
			300 μg/kg	Liver
			200 μg/kg	Eggs
			100 μg/kg	Muscle
			100 μg/kg	Milk

1.2.2.

Macrolides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
1.2.2.1. Spiramycin	Spiramycin	Bovine, porcine	300 μg/kg	Liver,	Provisional MRLs expire on 1. 7. 1995. The MRLs for liver, kidney and muscle apply to both the bovine and porcine species
			200 μg/kg	Kidney,
			50 μg/kg	Muscle
		Bovine	150 μg/kg	Milk
1.2.2.2.	Tylosin	Bovine	100 μg/kg	Muscle, liver, kidney	Provisional MRLs expire on 1. 7. 1995
		Porcine
		Poultry
		Bovine	50 μg/kg	Milk

1.2.3.

Thiamphenicol and related compounds

Pharmacologically active substance(s)	Market residue	Animal species	MRLs	Target tissues	Other provisions
1.2.3.1. Thiamphenicol	Thiamphenicol	Bovine Poultry	40 μg/kg	Muscle, liver, kidney, fat	Provisional MRL expires on 1. 1. 1996

2.

Antiparasitic agents

2.1.

Agents acting against endo-parasites

2.1.1.

Benzimidazoles and pro-benzimidazoles

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
2.1.1.1. Febantel	Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole	All food producing species	1 000 μg/kg	Liver	Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole
			10 μg/kg	Muscle, kidney, fat
	10 μg/kg	Milk
2.1.1.2. Fenbendazole	Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole	All food producing species	1 000 μg/kg	Liver	Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole
			10 μg/kg	Muscle, kidney, fat
			10 μg/kg	Milk
2.1.1.3. Oxfendazole	Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole	All food producing species	1 000 μg/kg	Liver	Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole
			10 μg/kg	Muscle, kidney, fat
			10 μg/kg	Milk
2.1.1.4. Albendazole	Sum of albendazole and metabolites which are measured as 2-amino-benzimidazole sulphone	Bovine	100 μg/kg	Muscle, fat, milk,	Provisional MRLs expire on 1. 1. 1996
		Ovine	500 μg/kg	Kidney
			1 000 μg/kg	Liver
2.1.1.5. Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Bovine	100 μg/kg	Muscle, liver, kidney, fat, milk	Provisional MRLs expire on 1. 1. 1996
		Ovine
		Caprine
2.1.1.6. Triclabendazole	Sum of extractable residues that may be oxidized to ketotriclabendazole	Bovine	150 μg/kg	Muscle, liver, kidney	Provisional MRLs expire on 1. 7. 1995
		Ovine	50 μg/kg	Fat
2.1.1.7. Flubendazole	Flubendazole	Poultry	500 μg/kg	Liver,	Provisional MRLs expire on 1. 1. 1996
		Game birds	200 μg/kg	Muscle,
			400 μg/kg	Eggs
		Porcine	10 μg/kg	Muscle, liver, kidney, fat
2.1.1.8. Oxibendazole	Oxibendazole	Bovine Ovine	100 μg/kg	Muscle, liver, kidney, fat	Provisional MRLs expire on 1. 1. 1996
			50 μg/kg	Milk
		Porcine Equidae	100 μg/kg	Muscle, liver, kidney, fat

2.1.2.

Tetra-hydro-imidazoles (imidazolthiazoles)

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
2.1.2.1. Levamisole	Levamisole	All food producing species	10 μg/kg	Musle, liver, kidney, fat, milk	Provisional MRL expires on 1. 1. 1995

2.2.

Agents acting against ectoparasites

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
2.2.1. Amitraz	Sum of amitraz and metabolites which are measured as 2,4-dimethylaniline	Porcine	50 μg/kg	Muscle	Provisional MRLs expire on 1. 7. 1996.
		200 μg/kg	Kidney, liver

3.

Agents acting on the nervous system

3.1.

Agents acting on the central nervous system

3.1.1.

Butyrophenone tranquilizers

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
3.1.1.1. Azaperone	Azaperol	All food producing species	100 μg/kg	Kidney	Provisional MRLs expire on 1. 1. 1996
			50 μg/kg1	Liver, muscle, fat

3.2.

Agents acting on the autonomic nervous system

3.2.1.

Anti-adrenergics

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
3.2.1.1. Carazolol	Carazolol	All food producing species	30 μg/kg	Liver	Provisional MRLs expire on 1. 7. 1995
			5 μg/kg	Kidney, muscle, fat

ANNEX IV List of pharmacologically active substances for which no maximum levels can be fixed

1.

Nitrofurans, except furazolidone (see Annex III)

2.

Ronidazole

3.

Dapsone

4.

Chloramphenicol”

(1)

OJ No L 224, 18. 8. 1990, p. 1.

(2)

OJ No L 156, 23. 6. 1994, p. 6.