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

"" ID="1">All substances belonging to the sulfonamide group> ID="2">Parent drug> ID="3">All food producing species> ID="4">100 mg/kg> ID="5">Muscle, liver, kidney, fat> ID="6">The combined total residues of all substances within the sulfonamide group should not exceed 100 mg/kg">

1.2. Antibiotics

1.2.1. Penicillins

"" ID="1">1.2.1.1. Benzylpenicillin> ID="2">Benzylpenicillin> ID="3">All food producing species> ID="4">50 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="4">4 mg/kg> ID="5">Milk"> ID="1">1.2.1.2. Ampicillin> ID="2">Ampicillin> ID="3">All food producing species> ID="4">50 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="4">4 mg/kg> ID="5">Milk"> ID="1">1.2.1.3. Amoxicillin> ID="2">Amoxicillin> ID="3">All food producing species> ID="4">50 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="4">4 mg/kg> ID="5">Milk"> ID="1">1.2.1.4. Oxacillin> ID="2">Oxacillin> ID="3">All food producing species> ID="4">300 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="4">30 mg/kg> ID="5">Milk"> ID="1">1.2.1.5. Cloxacillin> ID="2">Cloxacillin> ID="3">All food producing species> ID="4">300 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="4">30 mg/kg> ID="5">Milk"> ID="1">1.2.1.6. Dicloxacillin> ID="2">Dicloxacillin> ID="3">All food producing species> ID="4">300 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="4">30 mg/kg> ID="5">Milk">

1.2.2. Cephalosporins

"" ID="1">1.2.2.1. Cefquinome> ID="2">Cefquinome> ID="3">Bovine> ID="4">200 mg/kg> ID="5">Kidney"> ID="4">100 mg/kg> ID="5">Liver"> ID="4">50 mg/kg> ID="5">Muscle"> ID="4">50 mg/kg> ID="5">Fat">

1.2.3. Quinolones

"" ID="1">1.2.3.1. Enrofloxacin> ID="2">Sum of enrofloxacin and ciprofloxacin> ID="3">Bovine, porcine, poultry> ID="4">30 mg/kg> ID="5">Muscle, liver, kidney">

1.2.4. Macrolides

"" ID="1">1.2.4.1. Tilmicosin> ID="2">Tilmicosin> ID="3">Bovine> ID="4">1 000 mg/kg> ID="5">Liver, kidney"> ID="4">50 mg/kg> ID="5">Muscle, fat">

2. Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.1. Avermectins

"" ID="1">2.1.1.1. Ivermectin> ID="2">22,23-Dihydroavermectin B1a> ID="3">Bovine> ID="4">100 mg/kg> ID="5">Liver"> ID="4">40 mg/kg> ID="5">Fat"> ID="3">Porcine> ID="4">15 mg/kg> ID="5">Liver"> ID="3">Ovine> ID="4">20 mg/kg> ID="5">Fat"> ID="3">Equidae"> ID="1">2.1.1.2. Abamectin> ID="2">Avermectin B1a> ID="3">Bovine> ID="4">20 mg/kg> ID="5">Liver"> ID="4">10 mg/kg> ID="5">Fat"> ID="1">2.1.1.3. Doramectin> ID="2">Doramectin> ID="3">Bovine> ID="4">15 mg/kg> ID="5">Liver"> ID="4">25 mg/kg> ID="5">Fat">

2.1.2 Salicylanilides

"" ID="1">2.1.2.1. Closantel> ID="2">Closantel> ID="3">Bovine> ID="4">1 000 mg/kg> ID="5">Muscle, liver"> ID="4">3 000 mg/kg> ID="5">Kidney, fat"> ID="3">Ovine> ID="4">1 500 mg/kg> ID="5">Muscle, liver"> ID="4">5 000 mg/kg> ID="5">Kidney, fat"> ID="4">2 000 mg/kg">

ANNEX II

List of substances not subject to maximum residue limits 1. Inorganic chemicals "" ID="1">1.1. Hydrogen peroxide> ID="2">Fish"> ID="1">1.2. Sulphur> ID="2">Bovine"> ID="2">Porcine"> ID="2">Ovine"> ID="2">Caprine"> ID="2">Equidae"> ID="1">1.3. Iodine and iodine inorganic compounds including:> ID="2">All food producing species"> ID="1">- Sodium and potassium - iodide"> ID="1">- Sodium and potassium - iodate"> ID="1">- Iodophors including polyvinylpyrrolidone - iodine"> ID="1">1.4. Sodium chlorite> ID="2">Bovine> ID="3">For tropical use only">

2. Organic compounds

"" ID="1">2.1. Etiproston tromethamine> ID="2">Bovine"> ID="2">Porcine"> ID="1">2.2. Ketanserin tartrate> ID="2">Equidae"> ID="1">2.3. Fertirelin acetate> ID="2">Bovine"> ID="1">2.4. Human menopausal urinary gonadotrophin> ID="2">Bovine"> ID="1">2.5. Lactic acid> ID="2">All food producing species"> ID="1">2.6. Melatonin> ID="2">Ovine"> ID="2">Caprine"> ID="1">2.7. Iodine organic compounds> ID="2">All food producing species"> ID="1">- Iodoform"> ID="1">2.8. Acetyl cysteine> ID="2">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

"" ID="1">All substances belonging to the sulfonamide group> ID="2">Parent drug> ID="3">Bovine, ovine, caprine> ID="4">100 mg/kg> ID="5">Milk> ID="6">Provisional MRL expires on 1. 1. 1996. The combined total residues of all substances within the sulfonamide group should not exceed 100 mg/kg">

1.1.2. Diamino pyrimidine derivates

"" ID="1">1.1.2.1. Trimethoprim> ID="2">Trimethoprim> ID="3">All food producing species> ID="4">50 mg/kg> ID="5">Muscle, liver, kidney, fat, milk> ID="6">Provisional MRL expires on 1. 1. 1996">

1.1.3. Nitrofurans

"" ID="1">1.1.3.1. Furazolidone> ID="2">All residues with intact 5-nitro structure> ID="3">All food producing species> ID="4">5 mg/kg> ID="5">Muscle, liver, kidney, fat> ID="6">Provisional MRL expires on 1. 7. 1995">

1.1.4. Nitroimidazoles

"" ID="1">1.1.4.1. Dimetridazole> ID="2">All residues with intact nitroimidazole structure> ID="3">All food producing species> ID="4">10 mg/kg> ID="5">Muscle, liver, kidney, fat> ID="6">Provisional MRL expires on 1. 1. 1995">

1.2. Antibiotics

1.2.1. Tetracyclines

"" ID="1">All substances belonging to the tetracycline group> ID="2">Parent drug> ID="3">All food producing species> ID="4">600 mg/kg> ID="5">Kidney> ID="6">Provisional MRLs expire on 1. 1. 1996. The combined total residues of all substances within the tetracycline group should not exceed the limits indicated"> ID="4">300 mg/kg> ID="5">Liver"> ID="4">200 mg/kg> ID="5">Eggs"> ID="4">100 mg/kg> ID="5">Muscle"> ID="4">100 mg/kg> ID="5">Milk">

1.2.2. Macrolides

"" ID="1">1.2.2.1. Spiramycin> ID="2">Spiramycin> ID="3">Bovine, porcine> ID="4">300 mg/kg> ID="5">Liver,> ID="6">Provisional MRLs expire on 1. 7. 1995. The MRLs for liver, kidney and muscle apply to both the bovine and porcine species"> ID="4">200 mg/kg> ID="5">Kidney,"> ID="4">50 mg/kg> ID="5">Muscle"> ID="3">Bovine> ID="4">150 mg/kg> ID="5">Milk"> ID="1">1.2.2.2. > ID="2">Tylosin> ID="3">Bovine> ID="4">100 mg/kg> ID="5">Muscle, liver, kidney> ID="6">Provisional MRLs expire on 1. 7. 1995"> ID="3">Porcine"> ID="3">Poultry"> ID="3">Bovine> ID="4">50 mg/kg> ID="5">Milk">

1.2.3. Thiamphenicol and related compounds

"" ID="1">1.2.3.1. Thiamphenicol> ID="2">Thiamphenicol> ID="3">Bovine> ID="4">40 mg/kg> ID="5">Muscle, liver, kidney, fat> ID="6">Provisional MRL expires on 1. 1. 1996"> ID="3">Poultry">

2. Antiparasitic agents

2.1. Agents acting against endo-parasites

2.1.1. Benzimidazoles and pro-benzimidazoles

"" ID="1">2.1.1.1. Febantel> ID="2">Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole> ID="3">All food producing species> ID="4">1 000 mg/kg> ID="5">Liver> ID="6">Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole"> ID="4">10 mg/kg> ID="5">Muscle, kidney, fat"> ID="4">10 mg/kg> ID="5">Milk"> ID="1">2.1.1.2. Fenbendazole> ID="2">Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole> ID="3">All food producing species> ID="4">1 000 mg/kg> ID="5">Liver> ID="6">Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole"> ID="4">10 mg/kg> ID="5">Muscle, kidney, fat"> ID="4">10 mg/kg> ID="5">Milk"> ID="1">2.1.1.3. Oxfendazole> ID="2">Combined residues of oxfendazole, oxfendazole sulfone and fenbendazole> ID="3">All food producing species> ID="4">1 000 mg/kg> ID="5">Liver> ID="6">Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole"> ID="4">10 mg/kg> ID="5">Muscle, kidney, fat"> ID="4">10 mg/kg> ID="5">Milk"> ID="1">2.1.1.4. Albendazole> ID="2">Sum of albendazole and metabolites which are measured as 2-amino-benzimidazole sulphone> ID="3">Bovine> ID="4">100 mg/kg> ID="5">Muscle, fat, milk,> ID="6">Provisional MRLs expire on 1. 1. 1996"> ID="3">Ovine> ID="4">500 mg/kg> ID="5">Kidney"> ID="4">1 000 mg/kg> ID="5">Liver"> ID="1">2.1.1.5. Thiabendazole> ID="2">Sum of thiabendazole and 5-hydroxythiabendazole> ID="3">Bovine> ID="4">100 mg/kg> ID="5">Muscle, liver, kidney, fat, milk> ID="6">Provisional MRLs expire on 1. 1. 1996"> ID="3">Ovine"> ID="3">Caprine"> ID="1">2.1.1.6. Triclabendazole> ID="2">Sum of extractable residues that may be oxidized to ketotriclabendazole> ID="3">Bovine> ID="4">150 mg/kg> ID="5">Muscle, liver, kidney> ID="6">Provisional MRLs expire on 1. 7. 1995"> ID="3">Ovine> ID="4">50 mg/kg> ID="5">Fat"> ID="1">2.1.1.7. Flubendazole> ID="2">Flubendazole> ID="3">Poultry> ID="4">500 mg/kg> ID="5">Liver,> ID="6">Provisional MRLs expire on 1. 1. 1996"> ID="3">Game birds> ID="4">200 mg/kg> ID="5">Muscle,"> ID="4">400 mg/kg> ID="5">Eggs"> ID="3">Porcine> ID="4">10 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="1">2.1.1.8. Oxibendazole> ID="2">Oxibendazole> ID="3">Bovine> ID="4">100 mg/kg> ID="5">Muscle, liver, kidney, fat> ID="6">Provisional MRLs expire on 1. 1. 1996"> ID="3">Ovine"> ID="4">50 mg/kg> ID="5">Milk"> ID="3">Porcine> ID="4">100 mg/kg> ID="5">Muscle, liver, kidney, fat"> ID="3">Equidae">

2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles)

"" ID="1">2.1.2.1. Levamisole> ID="2">Levamisole> ID="3">All food producing species> ID="4">10 mg/kg> ID="5">Musle, liver, kidney, fat, milk> ID="6">Provisional MRL expires on 1. 1. 1995">

2.2. Agents acting against ectoparasites

"" ID="1">2.2.1. Amitraz> ID="2">Sum of amitraz and metabolites which are measured as 2,4-dimethylaniline> ID="3">Porcine> ID="4">50 mg/kg> ID="5">Muscle> ID="6">Provisional MRLs expire on 1. 7. 1996."> ID="4">200 mg/kg> ID="5">Kidney, liver">

3. Agents acting on the nervous system

3.1. Agents acting on the central nervous system

3.1.1. Butyrophenone tranquilizers

"" ID="1">3.1.1.1. Azaperone> ID="2">Azaperol> ID="3">All food producing species> ID="4">100 mg/kg> ID="5">Kidney> ID="6">Provisional MRLs expire on 1. 1. 1996"> ID="4">50 mg/kg> ID="5">Liver, muscle, fat">

3.2. Agents acting on the autonomic nervous system

3.2.1. Anti-adrenergics

"" ID="1">3.2.1.1. Carazolol> ID="2">Carazolol> ID="3">All food producing species> ID="4">30 mg/kg> ID="5">Liver> ID="6">Provisional MRLs expire on 1. 7. 1995"> ID="4">5 mg/kg> ID="5">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'