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 origin1, as last amended by Commission Regulation (EC) No 1430/942, 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

ANNEX

ANNEX IList of pharmacologically active substances for which maximum residue limits have been fixed

  1. 1.

    Anti-infectious agents

    1. 1.1.

      Chemotherapeutics

      1. 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

    2. 1.2.

      Antibiotics

      1. 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

      2. 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

      3. 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

      4. 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. 2.

    Antiparasitic agents

    1. 2.1.

      Agents acting against endoparasites

      1. 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. 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 IIList of substances not subject to maximum residue limits

  1. 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. 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 IIIList of pharmacologically active substances used in veterinary medicinal products for which provisional maximum residue limits have been fixed

  1. 1.

    Anti-infectious agents

    1. 1.1.

      Chemotherapeutics

      1. 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

      2. 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

      3. 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

      4. 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

    2. 1.2.

      Antibiotics

      1. 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

      2. 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

      3. 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. 2.

    Antiparasitic agents

    1. 2.1.

      Agents acting against endo-parasites

      1. 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. 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. 2.2.

      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. 3.

    Agents acting on the nervous system

    1. 3.1.

      Agents acting on the central nervous system

      1. 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

    2. 3.2.

      Agents acting on the autonomic nervous system

      1. 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 IVList of pharmacologically active substances for which no maximum levels can be fixed

  1. 1.

    Nitrofurans, except furazolidone (see Annex III)

  2. 2.

    Ronidazole

  3. 3.

    Dapsone

  4. 4.

    Chloramphenicol