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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)

EU Regulation No 2701/1994 · Adopted 7 November 1994 · Extends to United Kingdom

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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 originf1, as last amended by Commission Regulation (EC) No 1430/94f2, 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:

Annotations to the whole text

Footnotes

f1

OJ No L 224, 18. 8. 1990, p. 1.

f2

OJ No L 156, 23. 6. 1994, p. 6.

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex Annex

1

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

2

This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities.

Signature

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 I

List 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 residueAnimal speciesMRLsTarget tissuesOther provisions
        All substances belonging to the sulfonamide groupParent drugAll food producing species100 μg/kgMuscle, liver, kidney, fatThe 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 residueAnimal speciesMRLsTarget tissuesOther provisions

        1.2.1.1.

        Benzylpenicillin

        BenzylpenicillinAll food producing species50 μg/kgMuscle, liver, kidney, fat
        4 μg/kgMilk

        1.2.1.2.

        Ampicillin

        AmpicillinAll food producing species50 μg/kgMuscle, liver, kidney, fat
        4 μg/kgMilk

        1.2.1.3.

        Amoxicillin

        AmoxicillinAll food producing species50 μg/kgMuscle, liver, kidney, fat
        4 μg/kgMilk

        1.2.1.4.

        Oxacillin

        OxacillinAll food producing species300 μg/kgMuscle, liver, kidney, fat
        30 μg/kgMilk

        1.2.1.5.

        Cloxacillin

        CloxacillinAll food producing species300 μg/kgMuscle, liver, kidney, fat
        30 μg/kgMilk

        1.2.1.6.

        Dicloxacillin

        DicloxacillinAll food producing species300 μg/kgMuscle, liver, kidney, fat
        30 μg/kgMilk
      2. 1.2.2.

        Cephalosporins

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        1.2.2.1.

        Cefquinome

        CefquinomeBovine200 μg/kgKidney
        100 μg/kgLiver
        50 μg/kgMuscle
        50 μg/kgFat
      3. 1.2.3.

        Quinolones

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        1.2.3.1.

        Enrofloxacin

        Sum of enrofloxacin and ciprofloxacinBovine, porcine, poultry30 μg/kgMuscle, liver, kidney
      4. 1.2.4.

        Macrolides

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
        1.2.4.1. TilmicosinTilmicosinBovine1 000 μg/kgLiver, kidney
        50 μg/kgMuscle, fat
  2. 2..

    Antiparasitic agents

    1. 2.1.

      Agents acting against endoparasites

      1. 2.1.1.

        Avermectins

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        2.1.1.1.

        Ivermectin

        22,23- Dihydroavermectin B1aBovine100 μg/kgLiver
        40 μg/kgFat
        Porcine15 μg/kgLiver
        Ovine20 μg/kgFat
        Equidae

        2.1.1.2.

        Abamectin

        Avermectin B1aBovine20 μg/kgLiver
        10 μg/kgFat

        2.1.1.3.

        Doramectin

        DoramectinBovine15 μg/kgLiver
        25 μg/kgFat
      2. 2.1.2

        Salicylanilides

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        2.1.2.1.

        Closantel

        ClosantelBovine1 000 μg/kgMuscle, liver
        3 000 μg/kgKidney, fat
        Ovine1 500 μg/kgMuscle, liver
        5 000 μg/kgKidney, fat
        2 000 μg/kg

ANNEX II

List of substances not subject to maximum residue limits

  1. 1..

    Inorganic chemicals

    Pharmacologically active substance(s)Animal speciesOther 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

    BovineFor tropical use only
  2. 2..

    Organic compounds

    Pharmacologically active substance(s)Animal speciesOthers 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. 1..

    Anti-infectious agents

    1. 1.1.

      Chemotherapeutics

      1. 1.1.1.

        Sulfonamides

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
        All substances belonging to the sulfonamide groupParent drugBovine, ovine, caprine100 μg/kgMilk

        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 residueAnimal speciesMRLsTarget tissuesOther provisions

        1.1.2.1.

        Trimethoprim

        TrimethoprimAll food producing species50 μg/kgMuscle, liver, kidney, fat, milkProvisional MRL expires on 1. 1. 1996
      3. 1.1.3.

        Nitrofurans

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        1.1.3.1.

        Furazolidone

        All residues with intact 5-nitro structureAll food producing species5 μg/kgMuscle, liver, kidney, fatProvisional MRL expires on 1. 7. 1995
      4. 1.1.4.

        Nitroimidazoles

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        1.1.4.1.

        Dimetridazole

        All residues with intact nitroimidazole structureAll food producing species10 μg/kgMuscle, liver, kidney, fatProvisional MRL expires on 1. 1. 1995
    2. 1.2.

      Antibiotics

      1. 1.2.1.

        Tetracyclines

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
        All substances belonging to the tetracycline groupParent drugAll food producing species600 μg/kgKidneyProvisional 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/kgLiver
        200 μg/kgEggs
        100 μg/kgMuscle
        100 μg/kgMilk
      2. 1.2.2.

        Macrolides

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        1.2.2.1.

        Spiramycin

        SpiramycinBovine, porcine300 μg/kgLiver,Provisional MRLs expire on 1. 7. 1995. The MRLs for liver, kidney and muscle apply to both the bovine and porcine species
        200 μg/kgKidney,
        50 μg/kgMuscle
        Bovine150 μg/kgMilk
        1.2.2.2.TylosinBovine100 μg/kgMuscle, liver, kidneyProvisional MRLs expire on 1. 7. 1995
        Porcine
        Poultry
        Bovine50 μg/kgMilk
      3. 1.2.3.

        Thiamphenicol and related compounds

        Pharmacologically active substance(s)Market residueAnimal speciesMRLsTarget tissuesOther provisions

        1.2.3.1.

        Thiamphenicol

        Thiamphenicol

        Bovine

        Poultry

        40 μg/kgMuscle, liver, kidney, fatProvisional 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 residueAnimal speciesMRLsTarget tissuesOther provisions

        2.1.1.1.

        Febantel

        Combined residues of oxfendazole, oxfendazole sulfone and fenbendazoleAll food producing species1 000 μg/kgLiverProvisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole
        10 μg/kgMuscle, kidney, fat
        10 μg/kgMilk

        2.1.1.2.

        Fenbendazole

        Combined residues of oxfendazole, oxfendazole sulfone and fenbendazoleAll food producing species1 000 μg/kgLiverProvisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole
        10 μg/kgMuscle, kidney, fat
        10 μg/kgMilk

        2.1.1.3.

        Oxfendazole

        Combined residues of oxfendazole, oxfendazole sulfone and fenbendazoleAll food producing species1 000 μg/kgLiver

        Provisional MRLs expire on 1. 7. 1995. The MRLs cover all residues of febantel, fenbendazole and oxfendazole

        10 μg/kgMuscle, kidney, fat
        10 μg/kgMilk

        2.1.1.4.

        Albendazole

        Sum of albendazole and metabolites which are measured as 2-amino-benzimidazole sulphoneBovine100 μg/kgMuscle, fat, milk,Provisional MRLs expire on 1. 1. 1996
        Ovine500 μg/kgKidney
        1 000 μg/kgLiver

        2.1.1.5.

        Thiabendazole

        Sum of thiabendazole and 5-hydroxythiabendazoleBovine100 μg/kgMuscle, liver, kidney, fat, milkProvisional MRLs expire on 1. 1. 1996
        Ovine
        Caprine

        2.1.1.6.

        Triclabendazole

        Sum of extractable residues that may be oxidized to ketotriclabendazoleBovine150 μg/kgMuscle, liver, kidneyProvisional MRLs expire on 1. 7. 1995
        Ovine50 μg/kgFat

        2.1.1.7.

        Flubendazole

        FlubendazolePoultry500 μg/kgLiver,Provisional MRLs expire on 1. 1. 1996
        Game birds200 μg/kgMuscle,
        400 μg/kgEggs
        Porcine10 μg/kgMuscle, liver, kidney, fat

        2.1.1.8.

        Oxibendazole

        Oxibendazole

        Bovine

        Ovine

        100 μg/kgMuscle, liver, kidney, fatProvisional MRLs expire on 1. 1. 1996
        50 μg/kgMilk

        Porcine

        Equidae

        100 μg/kgMuscle, liver, kidney, fat
      2. 2.1.2.

        Tetra-hydro-imidazoles (imidazolthiazoles)

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        2.1.2.1.

        Levamisole

        LevamisoleAll food producing species10 μg/kgMusle, liver, kidney, fat, milkProvisional MRL expires on 1. 1. 1995
    2. 2.2.

      Agents acting against ectoparasites

      Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

      2.2.1.

      Amitraz

      Sum of amitraz and metabolites which are measured as 2,4-dimethylanilinePorcine50 μg/kgMuscleProvisional MRLs expire on 1. 7. 1996.
      200 μg/kgKidney, 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 residueAnimal speciesMRLsTarget tissuesOther provisions

        3.1.1.1.

        Azaperone

        AzaperolAll food producing species100 μg/kgKidneyProvisional MRLs expire on 1. 1. 1996
        50 μg/kg1Liver, muscle, fat
    2. 3.2.

      Agents acting on the autonomic nervous system

      1. 3.2.1.

        Anti-adrenergics

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions

        3.2.1.1.

        Carazolol

        CarazololAll food producing species30 μg/kgLiverProvisional MRLs expire on 1. 7. 1995
        5 μg/kgKidney, muscle, fat

ANNEX IV

List 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