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)
2701/94 • 31994R2701
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8.11.1994
EN
Official Journal of the European Communities
L 287/7
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
Annexes I, II, III and IV to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto.
Article 2
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
(1) OJ No L 224, 18. 8. 1990, p. 1.
(2) OJ No L 156, 23. 6. 1994, p. 6.
ANNEX
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