8.11.1994
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EN
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Official Journal of the European Communities
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L 287/7
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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.
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Anti-infectious agents
1.1.
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Chemotherapeutics
1.1.1.
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Sulfonamides
Pharmacologically active substance(s)
|
Marker residue
|
Animal species
|
MRLs
|
Target tissues
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Other provisions
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All substances belonging to the sulfonamide group
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Parent drug
|
All food producing species
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100 μg/kg
|
Muscle, liver, kidney, fat
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The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg
|
|
|
1.2.
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Antibiotics
1.2.1.
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Penicillins
Pharmacologically active substance(s)
|
Marker residue
|
Animal species
|
MRLs
|
Target tissues
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Other provisions
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1.2.1.1.
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Benzylpenicillin
|
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Benzylpenicillin
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All food producing species
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50 μg/kg
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Muscle, liver, kidney, fat
|
|
4 μg/kg
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Milk
|
|
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Ampicillin
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All food producing species
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50 μg/kg
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Muscle, liver, kidney, fat
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4 μg/kg
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Milk
|
|
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Amoxicillin
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All food producing species
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50 μg/kg
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Muscle, liver, kidney, fat
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4 μg/kg
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Milk
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|
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Oxacillin
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All food producing species
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300 μg/kg
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Muscle, liver, kidney, fat
|
|
30 μg/kg
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Milk
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|
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Cloxacillin
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All food producing species
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300 μg/kg
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Muscle, liver, kidney, fat
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30 μg/kg
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Milk
|
|
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Dicloxacillin
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All food producing species
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300 μg/kg
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Muscle, liver, kidney, fat
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30 μg/kg
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Milk
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|
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1.2.2.
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Cephalosporins
Pharmacologically active substance(s)
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Marker residue
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Animal species
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MRLs
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Target tissues
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Other provisions
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Cefquinome
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Bovine
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200 μg/kg
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Kidney
|
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100 μg/kg
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Liver
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50 μg/kg
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Muscle
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50 μg/kg
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Fat
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1.2.3.
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Quinolones
Pharmacologically active substance(s)
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Marker residue
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Animal species
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MRLs
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Target tissues
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Other provisions
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Sum of enrofloxacin and ciprofloxacin
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Bovine, porcine, poultry
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30 μg/kg
|
Muscle, liver, kidney
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|
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1.2.4.
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Macrolides
Pharmacologically active substance(s)
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Marker residue
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Animal species
|
MRLs
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Target tissues
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Other provisions
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1.2.4.1. Tilmicosin
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Tilmicosin
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Bovine
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1 000 μg/kg
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Liver, kidney
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|
50 μg/kg
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Muscle, fat
|
|
|
|
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2.
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Antiparasitic agents
2.1.
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Agents acting against endoparasites
2.1.1.
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Avermectins
Pharmacologically active substance(s)
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Marker residue
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Animal species
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MRLs
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Target tissues
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Other provisions
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22,23- Dihydroavermectin B1a
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Bovine
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100 μg/kg
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Liver
|
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40 μg/kg
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Fat
|
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Porcine
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15 μg/kg
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Liver
|
|
Ovine
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20 μg/kg
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Fat
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Equidae
|
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Avermectin B1a
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Bovine
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20 μg/kg
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Liver
|
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10 μg/kg
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Fat
|
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Doramectin
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Bovine
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15 μg/kg
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Liver
|
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25 μg/kg
|
Fat
|
|
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2.1.2
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Salicylanilides
Pharmacologically active substance(s)
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Marker residue
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Animal species
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MRLs
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Target tissues
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Other provisions
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Closantel
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Bovine
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1 000 μg/kg
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Muscle, liver
|
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3 000 μg/kg
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Kidney, fat
|
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Ovine
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1 500 μg/kg
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Muscle, liver
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5 000 μg/kg
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Kidney, fat
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2 000 μg/kg
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|
|
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ANNEX II
List of substances not subject to maximum residue limits
1.
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Inorganic chemicals
Pharmacologically active substance(s)
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Animal species
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Other provisions
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Fish
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|
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Bovine
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Porcine
|
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Ovine
|
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Caprine
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Equidae
|
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1.3.
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Iodine and iodine inorganic compounds including:
—
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Sodium and potassium — iodide
|
—
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Sodium and potassium — iodate
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—
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Iodophors including polyvinylpyrrolidone — iodine
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|
|
All food producing species
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|
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Bovine
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For tropical use only
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2.
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Organic compounds
Pharmacologically active substance(s)
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Animal species
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Others provisions
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2.1.
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Etiproston tromethamine
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Bovine
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Porcine
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|
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Equidae
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Bovine
|
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2.4.
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Human menopausal urinary gonadotrophin
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Bovine
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|
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All food producing species
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Ovine
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Caprine
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2.7.
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Iodine organic compounds
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All food producing species
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All food producing species
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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
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100 μg/kg
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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.
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Diamino pyrimidine derivates
Pharmacologically active substance(s)
|
Marker residue
|
Animal species
|
MRLs
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Target tissues
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Other provisions
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|
Trimethoprim
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All food producing species
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50 μg/kg
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Muscle, liver, kidney, fat, milk
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Provisional MRL expires on 1. 1. 1996
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1.1.3.
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Nitrofurans
Pharmacologically active substance(s)
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Marker residue
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Animal species
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MRLs
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Target tissues
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Other provisions
|
|
All residues with intact 5-nitro structure
|
All food producing species
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5 μg/kg
|
Muscle, liver, kidney, fat
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Provisional MRL expires on 1. 7. 1995
|
|
1.1.4.
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Nitroimidazoles
Pharmacologically active substance(s)
|
Marker residue
|
Animal species
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MRLs
|
Target tissues
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Other provisions
|
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All residues with intact nitroimidazole structure
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All food producing species
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10 μg/kg
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Muscle, liver, kidney, fat
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Provisional MRL expires on 1. 1. 1995
|
|
|
1.2.
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Antibiotics
1.2.1.
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Tetracyclines
Pharmacologically active substance(s)
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Marker residue
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Animal species
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MRLs
|
Target tissues
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Other provisions
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All substances belonging to the tetracycline group
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Parent drug
|
All food producing species
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600 μg/kg
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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
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Eggs
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100 μg/kg
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Muscle
|
100 μg/kg
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Milk
|
|
1.2.2.
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Macrolides
Pharmacologically active substance(s)
|
Marker residue
|
Animal species
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MRLs
|
Target tissues
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Other provisions
|
|
Spiramycin
|
Bovine, porcine
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300 μg/kg
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Liver,
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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
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Kidney,
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50 μg/kg
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Muscle
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Bovine
|
150 μg/kg
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Milk
|
1.2.2.2.
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Tylosin
|
Bovine
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100 μg/kg
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Muscle, liver, kidney
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Provisional MRLs expire on 1. 7. 1995
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Porcine
|
|
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Poultry
|
|
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Bovine
|
50 μg/kg
|
Milk
|
|
1.2.3.
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Thiamphenicol and related compounds
Pharmacologically active substance(s)
|
Market residue
|
Animal species
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MRLs
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Target tissues
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Other provisions
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Sum of thiabendazole and 5-hydroxythiabendazole
|
Bovine
|
100 μg/kg
|
Muscle, liver, kidney, fat, milk
|
Provisional MRLs expire on 1. 1. 1996
|
Ovine
|
|
Caprine
|
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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)
|
’