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Commission Regulation (EEC) No 675/92 of 18 March 1992 amending Annexes I and III 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 Official Journal L 073 , 19/03/1992 P. 0008 - 0014 Finnish special edition: Chapter 3 Volume 41 P. 0108 Swedish special edition: Chapter 3 Volume 41 P. 0108

COMMISSION REGULATION (EEC) No 675/92 of 18 March 1992 amending Annexes I and III 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 THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic 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), and in particular Articles 7 and 8 thereof; Whereas 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; Whereas 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; Whereas, 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); Whereas, for the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissue of liver or kidney; whereas, however, the liver and kidney are frequently removed from carcases moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues; Whereas, 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; Whereas the sulfonamide group of substances (in respect of residues in meat), ivermectin, benzylpenicillin, ampicillin, amoxicillin, oxacillin, cloxacillin and dicloxacillin should be inserted into Annex I to Regulation (EEC) No 2377/90; Whereas dimetridazole, ronidazole, chloramphenicol, azaperone and carazolol, the nitrofurans group, trimethoprim, dapsone, compounds belonging to the tetracyclines group, spiramycin, febantel, fenbendazole, oxfendazole, levamisol and sulfonamide group (in respect of residues in milk) should be inserted into Annex III to Regulation (EEC) No 2377/90; whereas it is necessary to define the duration of the provisional maximum residue limits; Whereas a period of 60 days 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 authorizations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/CEE (2) to take account of the provisions of this Regulation; Whereas the measures provided for in this Regulation are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector, HAS ADOPTED THIS REGULATION: Article 1 Annexes I and III of 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 60 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, 18 March 1992. For the Commission Martin BANGEMANN Vice-President (1) OJ No L 224, 18. 8. 1990, p. 1. (2) OJ No L 317, 6. 11. 1981, p. 1. ANNEX A. Annex I is hereby replaced by the following: '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 mg/kg Muscle, liver, kidney, fat The combined total residues of all substances within the sulfonamide group should not excced 100 mg/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 Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat 4 mg/kg milk 1.2.1.2. Ampicillin Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat 4 mg/kg milk 1.2.1.3. Amoxicillin Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat 4 mg/kg milk 1.2.1.4. Oxacillin Parent drug All food producing species 300 mg/kg Muscle, liver, kidney, fat 30 mg/kg milk 1.2.1.5. Cloxacillin Parent drug All food producing species 300 mg/kg Muscle, liver, kidney, fat 30 mg/kg milk 1.2.1.6. Dicloxacillin Parent drug All food producing species 300 mg/kg Muscle, liver, kidney, fat 30 mg/kg milk 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 H2B1a metabolite Bovine, ovine, porcine, equine 15 mg/kg 20 mg/kg Liver fat The MRLs for liver and fat apply to all four species mentioned' B. Annex III is hereby replaced by the following: '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 Cattle, sheep, goats 100 mg/kg milk Provisional MRL expires on 1 January 1994. The combined total residues of all substances within the sulfonamide group should not exceed 100 mg/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 Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat milk Provisional MRL expires on 1 January 1996 1.1.3. Nitrofurans Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions All substances belonging to the nitrofuran group All residues with intact 5-nitro structure All food producing species 5 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 July 1993 The combined total residues of all substances within this group should not exceed 5 mg/kg 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 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994 1.1.4.2. Ronidazole All residues with intact nitroimidazole structure All food producing species 2 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994 1.1.n. Other chemotherapeutics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 1.1.n.1. Dapsone Parent drug All food producing species 25 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994 25 mg/kg milk 1.2. Antibiotics 1.2.2. 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 mg/kg 300 mg/kg 200 mg/kg 100 mg/kg 100 mg/kg Kidney, liver eggs, muscle, milk Provisional MRLs expires on 1 January 1994. The combined total residues of all substances within the tetracycline group should not exceed the limits indicated 1.2.3. Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 1.2.3.1. Spiramycin Parent drug Bovine, porcine 300 mg/kg 200 mg/kg 50 mg/kg Liver kidney muscle Provisional MRLs expire on 1 July 1995 bovine 150 mg/kg milk The MRLs for liver, kidney and muscle apply to both the bovine and porcine species 1.2.4. Chloramphenicol and related compounds Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 1.2.4.1. Chloramphenicol Parent drug All food producing species 10 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on July 1994 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 2.1.1.2. Fenbendazole 2.1.1.3. Oxfendazole combined residues of oxfendazole, oxfendazole sulfone and fenbendazole All food producing species 1 000 mg/kg 10 mg/kg 10 mg/kg Liver muscle, kidney, fat milk Provisional MRLs expire on 1 July 1995 The MRLs cover all residues of febantel, fenbendazole and oxfendazole 2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles) Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 2.1.2.1. Levamisol Parent drug All food producing species 10 mg/kg Muscle, liver, kidney, fat, milk Provisional MRL expires on 1 January 1995 3. Agents acting on the nervous system 3.1. Agents acting on the central nervous system 3.1.1. Butyrofenone tranquillizers Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 3.1.1.1. Azaperone Azaperol All food producing species 100 mg/kg 50 mg/kg kidney liver, muscle, fat Provisional MRLs expire on 1 January 1996 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 Parent drug All food producing species 30 mg/kg 5 mg/kg Liver, kidney muscle, fat Provisional MRLs expire on 1 July 1995'

COMMISSION REGULATION (EEC) No 675/92 of 18 March 1992 amending Annexes I and III 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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic 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), and in particular Articles 7 and 8 thereof;

Whereas 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;

Whereas 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;

Whereas, 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);

Whereas, for the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissue of liver or kidney; whereas, however, the liver and kidney are frequently removed from carcases moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues;

Whereas, 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;

Whereas the sulfonamide group of substances (in respect of residues in meat), ivermectin, benzylpenicillin, ampicillin, amoxicillin, oxacillin, cloxacillin and dicloxacillin should be inserted into Annex I to Regulation (EEC) No 2377/90;

Whereas dimetridazole, ronidazole, chloramphenicol, azaperone and carazolol, the nitrofurans group, trimethoprim, dapsone, compounds belonging to the tetracyclines group, spiramycin, febantel, fenbendazole, oxfendazole, levamisol and sulfonamide group (in respect of residues in milk) should be inserted into Annex III to Regulation (EEC) No 2377/90; whereas it is necessary to define the duration of the provisional maximum residue limits;

Whereas a period of 60 days 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 authorizations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/CEE (2) to take account of the provisions of this Regulation;

Whereas the measures provided for in this Regulation are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector,

HAS ADOPTED THIS REGULATION:

Article 1

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

This Regulation shall enter into force on the 60 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, 18 March 1992. For the Commission

Martin BANGEMANN

Vice-President

(1) OJ No L 224, 18. 8. 1990, p. 1. (2) OJ No L 317, 6. 11. 1981, p. 1.

ANNEX

A. Annex I is hereby replaced by the following:

'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 mg/kg Muscle, liver, kidney, fat The combined total residues of all substances within the sulfonamide group should not excced 100 mg/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 Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat 4 mg/kg milk 1.2.1.2. Ampicillin Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat 4 mg/kg milk 1.2.1.3. Amoxicillin Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat 4 mg/kg milk 1.2.1.4. Oxacillin Parent drug All food producing species 300 mg/kg Muscle, liver, kidney, fat 30 mg/kg milk 1.2.1.5. Cloxacillin Parent drug All food producing species 300 mg/kg Muscle, liver, kidney, fat 30 mg/kg milk 1.2.1.6. Dicloxacillin Parent drug All food producing species 300 mg/kg Muscle, liver, kidney, fat 30 mg/kg milk

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 H2B1a metabolite Bovine, ovine, porcine, equine 15 mg/kg

20 mg/kg Liver fat The MRLs for liver and fat apply to all four species mentioned'

B. Annex III is hereby replaced by the following:

'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 Cattle, sheep, goats 100 mg/kg milk Provisional MRL expires on 1 January 1994.

The combined total residues of all substances within the sulfonamide group should not exceed 100 mg/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 Parent drug All food producing species 50 mg/kg Muscle, liver, kidney, fat milk Provisional MRL expires on 1 January 1996

1.1.3. Nitrofurans

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions All substances belonging to the nitrofuran group All residues with intact 5-nitro structure All food producing species 5 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 July 1993

The combined total residues of all substances within this group should not exceed 5 mg/kg

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 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994 1.1.4.2. Ronidazole All residues with intact nitroimidazole structure All food producing species 2 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994

1.1.n. Other chemotherapeutics

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 1.1.n.1. Dapsone Parent drug All food producing species 25 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on 1 January 1994 25 mg/kg milk

1.2. Antibiotics

1.2.2. 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 mg/kg

300 mg/kg

200 mg/kg

100 mg/kg

100 mg/kg Kidney,

liver

eggs,

muscle,

milk Provisional MRLs expires on 1 January 1994. The combined total residues of all substances within the tetracycline group should not exceed the limits indicated

1.2.3. Macrolides

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 1.2.3.1. Spiramycin Parent drug Bovine, porcine 300 mg/kg

200 mg/kg

50 mg/kg Liver

kidney

muscle Provisional MRLs expire on 1 July 1995 bovine 150 mg/kg milk The MRLs for liver, kidney and muscle apply to both the bovine and porcine species

1.2.4. Chloramphenicol and related compounds

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 1.2.4.1. Chloramphenicol Parent drug All food producing species 10 mg/kg Muscle, liver, kidney, fat Provisional MRL expires on July 1994

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

2.1.1.2. Fenbendazole

2.1.1.3. Oxfendazole combined residues of oxfendazole, oxfendazole sulfone and fenbendazole All food producing species 1 000 mg/kg

10 mg/kg

10 mg/kg Liver

muscle, kidney, fat

milk Provisional MRLs expire on 1 July 1995

The MRLs cover all residues of febantel, fenbendazole and oxfendazole

2.1.2. Tetra-hydro-imidazoles (imidazolthiazoles)

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 2.1.2.1. Levamisol Parent drug All food producing species 10 mg/kg Muscle, liver, kidney, fat, milk Provisional MRL expires on 1 January 1995

3. Agents acting on the nervous system

3.1. Agents acting on the central nervous system

3.1.1. Butyrofenone tranquillizers

Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 3.1.1.1. Azaperone Azaperol All food producing species 100 mg/kg

50 mg/kg kidney

liver, muscle, fat Provisional MRLs expire on 1 January 1996

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 Parent drug All food producing species 30 mg/kg

5 mg/kg Liver, kidney

muscle, fat Provisional MRLs expire on 1 July 1995'