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Commission Regulation (EC) No 1570/98 of 17 July 1998 amending Annexes I to 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 1570/1998 · Adopted 17 July 1998 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Commission Regulation (EC) No 1570/98

of 17 July 1998

amending Annexes I to 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 1569/98f2, 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, 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 Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 224, 18. 8. 1990, p. 1.

f2

See page 7 of this Official Journal.

Contents

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

1

Annexes I to 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, 17 July 1998.

For the Commission

Martin Bangemann

Member of the Commission

  1. A..

    Annex I to Regulation (EEC) No 2377/90 is amended as follows:

    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/kgMuscleThe combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg’
          100 μg/kgFat
          100 μg/kgLiver
          100 μg/kgKidney
          Bovine, ovine, caprine100 μg/kgMilk
        2. 1.1.2.

          Diamino pyrimidine derivates

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘BaquiloprimBaquiloprimBovine10 μg/kgFat
          300 μg/kgLiver
          150 μg/kgKidney
          30 μg/kgMilk
          Porcine40 μg/kgSkin + fat
          50 μg/kgLiver
          50 μg/kgKidney
          TrimethoprimTrimethoprimBovine50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
          50 μg/kgMilk
          Porcine50 μg/kgMuscle
          50 μg/kgSkin + fat
          50 μg/kgLiver
          50 μg/kgKidney
          Equidae100 μg/kgMuscle
          100 μg/kgFat
          100 μg/kgLiver
          100 μg/kgKidney
          Poultry not for use in animals from which eggs are produced for human consumption50 μg/kgMuscle
          50 μg/kgSkin + fat
          50 μg/kgLiver
          50 μg/kgKidney
          Fin fish50 μg/kgMuscle and skin in natural proportions’
      2. 1.2.

        Antibiotics

        1. 1.2.1.

          Penicillins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘AmoxicyllinAmoxicyllinAll food producing species50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
          4 μg/kgMilk
          AmpicillinAmpicillinAll food producing species50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
          4 μg/kgMilk
          BenzylpenicillinBenzylpenicillinAll food producing species50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
          4 μg/kgMilk
          CloxacillinCloxacillinAll food producing species300 μg/kgMuscle
          300 μg/kgFat
          300 μg/kgLiver
          300 μg/kgKidney
          30 μg/kgMilk
          OxacillinOxacillinAll food producing species300 μg/kgMuscle
          300 μg/kgFat
          300 μg/kgLiver
          300 μg/kgKidney
          30 μg/kgMilk
          PenethamateBenzylpenicillinBovine50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
          4 μg/kgMilk’
        2. 1.2.2.

          Cephalosporins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘CefazolinCefazolinBovine, ovine, caprine50 μg/kgMilk
          CefquinomeCefquinomeBovine50 μg/kgMuscle
          50 μg/kgFat
          100 μg/kgLiver
          200 μg/kgKidney
          20 μg/kgMilk’
        3. 1.2.3.

          Quinolones

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘DanofloxacineDanofloxacineBovine (not for use in animals from which milk is produced for human consumption)200 μg/kgMuscle
          100 μg/kgFat
          400 μg/kgLiver
          400 μg/kgKidney
          Chicken (not for use in animals from which eggs are produced for human consumption)200 μg/kgMuscle
          100 μg/kgSkin + fat
          400 μg/kgLiver
          400 μg/kgKidney
          DifloxacinDifloxacinChicken, turkey300 μg/kgMuscle
          400 μg/kgSkin + fat
          1 900 μg/kgLiver
          600 μg/kgKidney
          EnrofloxacinSum of enrofloxacin and ciprofloxacinBovine, porcine, poultry30 μg/kgMuscle
          30 μg/kgLiver
          30 μg/kgKidney
          SarafloxacinSarafloxacinChicken10 μg/kgSkin + fat
          100 μg/kgLiver’
        4. 1.2.4.

          Macrolides

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘SpiramycinSum of spiramycin and neospiramycinBovine200 μg/kgMuscle
          300 μg/kgFat
          300 μg/kgLiver
          300 μg/kgKidley
          200 μg/kgMilk
          Chicken200 μg/kgMuscle
          300 μg/kgSkin + fat
          400 μg/kgLiver
          TilmicosinTilmicosinBovine, ovine, porcine1 000 μg/kgLiver
          1 000 μg/kgKidney
          Ovine50 μg/kgMilk
          TylosinTylosin ABovine100 μg/kgMuscle
          100 μg/kgFat
          100 μg/kgLiver
          100 μg/kgKidney
          50 μg/kgMilk
          Porcine100 μg/kgMuscle
          100 μg/kgSkin + fat
          100 μg/kgLiver
          100 μg/kgKidney
          Poultry (not for use in hens producing eggs for human consumption)100 μg/kgMuscle
          100 μg/kgSkin + fat
          100 μg/kgLiver
          100 μg/kgKidney’
        5. 1.2.5.

          Florfenicol and related compounds

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘FlorfenicolSum of florfenicol and its metabolites measured as florfenicol-amineBovine200 μg/kgMuscle
          3 000 μg/kgLiver
          300 μg/kgKidney’
        6. 1.2.6.

          Tetracyclines

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘ChlortetracyclineSum of parent drug and its 4-epimerAll food producing species100 μg/kgMuscle
          300 μg/kgLiver
          600 μg/kgKidney
          100 μg/kgMilk
          200 μg/kgEggs
          DoxycyclineDoxycyclineBovine100 μg/kgMuscle
          300 μg/kgLiver
          600 μg/kgKidney
          Porcine, poultry100 μg/kgMuscle
          300 μg/kgSkin + fat
          300 μg/kgLiver
          600 μg/kgKidney
          OxytetracyclineSum of parent drug and its 4-epimerAll food producing species100 μg/kgMuscle
          300 μg/kgLiver
          600 μg/kgKidney
          100 μg/kgMilk
          200 μg/kgEggs
          TetracyclineSum of parent drug and its 4-epimerAll food producing species100 μg/kgMuscle
          300 μg/kgLiver
          600 μg/kgKidney
          100 μg/kgMilk
          200 μg/kgEggs’
        7. 1.2.7.

          Thiamphenicol and related compounds

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘ThiamphenicolThiamphenicolBovine50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
          50 μg/kgMilk
          Chicken (not for use in animals from which eggs are produced for human consumption)50 μg/kgMuscle
          50 μg/kgSkin + fat
          50 μg/kgLiver
          50 μg/kgKidney’
    2. 2..

      Antiparasitic agents

      1. 2.1.

        Agents acting against endoparasites

        1. 2.1.1.

          Salicylanilides

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘ClosantelClosantelBovine1 000 μg/kgMuscle
          3 000 μg/kgFat
          1 000 μg/kgLiver
          3 000 μg/kgKidney
          Ovine1 500 μg/kgMuscle
          2 000 μg/kgFat
          1 500 μg/kgLiver
          5 000 μg/kgKidney’
        2. 2.1.2.

          Tatra-hydro-imidazoles (imidazolthiazoles)

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘LevamisoleLevamisoleBovine, ovine, porcine, poultry10 μg/kgMuscle
          10 μg/kgFat
          100 μg/kgLiver
          10 μg/kgKidney’
        3. 2.1.3.

          Benzimidazoles and pro-benzimidazoles

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘FebantelSum of extractable residues which may be oxidised to oxfendazole sulphoneBovine, ovine10 μg/kgMilk
          Bovine, ovine, porcine, equidae50 μg/kgMuscle
          50 μg/kgFat
          500 μg/kgLiver
          50 μg/kgKidney
          FenbendazoleSum of extractable residues which may be oxidised to oxfendazole sulphoneBovine, ovine10 μg/kgMilk
          Bovine, ovine, porcine, equidae50 μg/kgMuscle
          50 μg/kgFat
          500 μg/kgLiver
          50 μg/kgKidney
          FlubendazoleSum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4-flurorophenyl)methanonePorcine, chicken, game birds50 μg/kgMuscle
          50 μg/kgSkin + fat
          400 μg/kgLiver
          300 μg/kgKidney
          FlubendazoleChicken400 μg/kgEggs
          OxfendazoleSum of extractable residues which may be oxidised to oxfendazole sulphoneBovine, ovine10 μg/kgMilk
          Bovine, ovine, porcine, equidae50 μg/kgMuscle
          50 μg/kgFat
          500 μg/kgLiver
          50 μg/kgKidney
          OxibendazoleOxibendazolePorcine100 μg/kgMuscle
          500 μg/kgSkin + fat
          200 μg/kgLiver
          100 μg/kgKidney
          ThiabendazoleSum of thiabendazole and 5-hydroxythiabendazoleBovine100 μg/kgMuscle
          100 μg/kgFat
          100 μg/kgLiver
          100 μg/kgKidney
          100 μg/kgMilk
          TriclabendazoleSum of extractable residues that may be oxidised to ketotriclaben-dazoleBovine, ovine100 μg/kgMuscleNot for use in animals from which milk is produced for human consumption’
          100 μg/kgLiver
          100 μg/kgKidney
      2. 2.2.

        Agents acting against ectoparasites

        1. 2.2.1.

          Organophosphates

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘DiazinonDiazinonBovine, ovine, caprine20 μg/kgMilk
          Bovine, porcine, ovine, caprine20 μg/kgMuscle
          700 μg/kgFat
          20 μg/kgLiver
          20 μg/kgKidney’
        2. 2.2.2.

          Formamidines

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘AmitrazSum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitrazPorcine400 μg/kgSkin + fat
          200 μg/kgLiver
          200 μg/kgKidney’
      3. 2.3.

        Agents acting against endo- and ectoparasites

        1. 2.3.1.

          Avermectins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘AbamectinAvermectin BlaBovine10 μg/kgFat
          20 μg/kgLiver
          DoramectinDoramectinBovine10 μg/kgMuscleNot for use in ovines from which milk is produced for human consumption’
          150 μg/kgFat
          100 μg/kgLiver
          30 μg/kgKidney
          Porcine, ovine20 μg/kgMuscle
          100 μg/kgFat
          50 μg/kgLiver
          30 μg/kgKidney
          EprinomectinEprinomectin BlaBovine30 μg/kgMuscle
          30 μg/kgFat
          600 μg/kgLiver
          100 μg/kgKidney
          30 μg/kgMilk
          Ivermectin22,23-Dihydro-aver-mectin BlaBovine40 μg/kgFat
          100 μg/kgLiver
          Porcine, ovine, equidae20 μg/kgFat
          15 μg/kgLiver
          MoxidectinMoxidectinBovine, ovine50 μg/kgMuscle
          500 μg/kgFat
          100 μg/kgLiver
          50 μg/kgKidney
    3. 3..

      Agents acting on the nervous system

      1. 3.2.

        Agents acting on the autonomic nervous system

        1. 3.2.1.

          Anti-adrenergics

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘CarazololCarazololPorcine5 μg/kgMuscle
          5 μg/kgSkin + fat
          25 μg/kgLiver
          25 μg/kgKidney’
    4. 4..

      Anti-infammatory agents

      1. 4.1.

        Nonsteroidal anti-infammatory agents

        1. 4.1.1.

          Arylpropionic acid derivative

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘VedaprofenVedaprofenEquidae50 μg/kgMuscle
          20 μg/kgFat
          100 μg/kgLiver
          1 000 μg/kgKidney’
        2. 4.1.2.

          Fenamate group derivates

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘Tolfenamic acidTolfenamic acidBovine50 μg/kgMuscle
          400 μg/kgLiver
          100 μg/kgKidney
          50 μg/kgMilk
          Porcine50 μg/kgMuscle
          400 μg/kgLiver
          100 μg/kgKidney’
    5. 5..

      Corticoides

      1. 5.1.

        Glucocorticoides

        Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
        ‘DexamethasoneDexamethasoneBovine03 μg/kgMilk
        Bovine, porcine, equidae0,75 μg/kgMuscle
        2 μg/kgLiver
        0,75 μg/kgKidney’
  2. B..

    Annexe II to Regulation (EEC) No 2377/90 is amended as follows:

    1. 1..

      Inorganic chemicals

      Pharmacologically active substance(s)Animal speciesOther provisions
      ‘Bismuth subcarbonateAll food producing speciesFor oral use only
      Bismuth subgallateAll food producing speciesFor oral use only
      Bismuth subnitrateAll food producing speciesFor oral use only
      Bismuth subsalicylateAll food producing speciesFor oral use only
      Boric acid and boratesAll food producing species
      Bromide, Sodium saltAll mammalian food producing speciesFor topical use only

      Calcium acetate

      All food producing species

      Calcium benzoate

      Calcium carbonate

      Calcium chloride

      Calcium gluconate

      Calcium hydroxide

      Calcium hypophosphite

      Calcium malate

      Calcium oxide

      Calcium phosphate

      Calcium polyphosphates

      Calcium propionate

      Calcium silicate

      Calcium stearate

      Calcium sulphate
      Hydrochloric acidAll food producing speciesFor use as excipient
      Hydrogen peroxideAll food producing species

      Iodine and iodine inorganic compounds including:

      • All food producing species

      • Sodium and potassium-iodide

      • Sodium and potassium-iodide

      Iodophors including polyvinylpyrrolidone-iodine

      Magnesium

      All food producing species

      Magnesium sulphate

      Magnesium hydroxide

      Magnesium stearate

      Magnesium glutamate

      Magnesium orotate

      Magnesium aluminium silicate

      Magnesium oxide

      Magnesium carbonate

      Magnesium phosphate

      Magnesium glycerophosphate

      Magnesium asparate

      Magnesium citrate

      Magnesium acetate

      Magnesium trisilicate
      Potassium DL-aspartateAll food producing species
      Potassium glucuronateAll food producing species
      Potassium glycerophosphateAll food producing species
      Potassium nitrateAll food producing species
      Potassium selenateAll food producing species
      Sodium chloriteBovineFor topical use only
      Sodium dichloroisocyanurateBovine, ovine, caprineFor topical use only’
      Sodium selenateAll food producing species
      Sodium seleniteAll food producing species
      SulphurBovine, porcine, ovine, caprine, equidae

      Zinc acetate

      All food producing species

      Zinc chloride

      Zinc gluconate

      Zinc oleate

      Zinc stearate
    2. 2..

      Organic compounds

      Pharmacologically active substance(s)Animal speciesOther provisions
      ‘17B-OestradiolAll mammalian food producing speciesFor therapeutic and zootechnical uses only
      Acetyl cysteineAll food producing species
      AlfaprostolBovine, porcine, equidae
      BenzylalcoholAll food producing speciesFor use as excipient
      BetaineAll food producing species
      BrotizolamBovineFor therapeutic uses only
      BuserelinAll food producing species
      Butyl 4-hydroxybenzoateAll food producing species
      CaffeineAll food producing species
      CarbetocinAll mammalian food producing species
      Cefazolin

      Bovine

      Ovine, caprine

      For intramammary use (except if the udder may be used as food for human consumption)
      CetrimideAll food producing species
      ChlorhexidineAll food producing speciesFor topical use only
      ChlorocresolAll food producing species
      CloprostenolBovine, porcine, equidae
      D-phe 6-luteinizing-hormone-releasing-hormoneAll food producing species
      DembrexineEquidae
      DetomidineBovine, equidaeFor therapeutic uses only
      DiclazurilOvineFor oral use in lambs only
      DicloxacillinAll food producing species
      Diethyl phtalateAll food producing species
      Dimethyl phtalateAll food producing species
      Dinoprost tromethamineAll mammalian food producing species
      Etamiphylline camsylateAll food producing species
      EthanolAll food producing speciesFor use as excipient
      Ethyl lactateAll food producing species
      Etiproston tromethamineBovine, porcine
      Fertirelin acetateBovine
      Folic acidAll food producing species
      Glycerol formalAll food producing species
      Gonadotrophin releasing hormoneAll food producing species
      HeptaminolAll food producing species
      HesperidinEquidae
      Hesperidin methyl chalconeEquidae
      Human chorion gonadotrophin (HCG)All food producing species
      Human menopausal urinary gonadotrophinBovine

      Iodine organic compounds:

      • Iodoform

      All food producing species
      IsobutaneAll food producing species
      IsofluraneEquidaeFor use as anaesthetic only
      IsoxsuprineBovine, equidaeFor therapeutic use only in accordance with Council Directive 96/22/EEC (OJ L 125, 23.5.1996, p. 3)
      Ketanserin tartrateEquidae
      Ketoprofen

      Bovine, equidae

      Porcine

      L-tartaric acid and its mono- and di- basic salt of sodium, potassium and calciumAll food producing speciesFor use as excipient
      Lactic acidAll food producing species
      Lecirelin
      Lini oleumAll food producing species
      LobelineAll food producing species
      LuprostiolAll mammalian species
      Malic acidAll food producing speciesFor use as excipient
      Medroxyprogesterone acetateOvineFor intravaginal use for zootechnical purposes only
      MelatoninOvine, caprine
      MenbutoneBovine, ovine, caprine, porcine, equidae
      MentholAll food producing species
      Mineral hydrocarbons, low to high viscosity including micro-cristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compoundsAll food producing speciesExcludes aromatic and unsaturated compounds
      N-butaneAll food producing species
      N-butanolAll food producing speciesFor use as excipient
      NeostigmineAll food producing species
      OxytocinAll mammalian food producing species
      PancreatinAll mammalian food producing speciesFor topical use only
      PapainAll food producing species
      PapaverineBovineNew-born calves only
      Peracetic acidAll food producing species
      PhenolAll food producing species
      PhloroglucinolAll food producing species
      PolicresuleneAll food producing speciesFor topical use only
      Polysulphated glycosaminoglycanEquidae
      PraziquantelOvineFor non-lactating sheep only
      Pregnant mare serum gonadotrophinAll food producing species
      PropaneAll food producing species
      Propylene glycolAll food producing species
      QuatresinAll food producing speciesFor use as preservative only at concentrations of up to 0,5 %
      Quillaia saponinsAll food producing species
      R-clopostenolBovine, porcine, equidae
      RifaximinBovineFor intramammary use - except if the udder may be used as food for human consumption - and intra-uterine use only
      RomifidineEquidaeFor therapeutic uses only
      Sodium benzyl 4-hydroxybenzoateAll food producing species
      Sodium butyl 4-hydroxybenzoateAll food producing species
      SomatosalmSalmon
      Tau fluvalinateHoney bees
      TheobromineAll food producing species
      TheophyllineAll food producing species
      ThiomersalAll food producing speciesFor use only as preservatives in multi-dose vaccines at a concentration not exceeding 0,02 %
      ThymolAll food producing species
      TimerfonateAll food producing speciesFor use only as preservatives in multi-dose vaccines at a concentration not exceeding 0,02 %’
      TrimethylphloroglucinolAll food producing species
    3. 3..

      Substances generally recognised as safe

      Pharmacologically active substance(s)Animal speciesOther provisions
      ‘Absinthium extractAll food producing species
      AcetylmethionineAll food producing species
      Aluminium hydroxideAll food producing species
      Aluminium monostearateAll food producing species
      Ammonium sulfateAll food producing species
      Benzoyl benzoateAll food producing species
      Benzyl p-hydroxybenzoateAll food producing species
      Calcium borogluconateAll food producing species
      Calcium citrateAll food producing species
      CamphorAll food producing speciesExternal use only’
      Cardamon extractAll food producing species
      Diethyl sebacateAll food producing species
      DimethiconeAll food producing species
      Dimethyl acetamideAll food producing species
      Dimethyl sulphoxideAll food producing species
      EpinephrineAll food producing species
      Ethyl oleateAll food producing species
      Ethylenediaminetetraacetic acid and saltsAll food producing species
      EucalyptolAll food producing species
      Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)All food producing species
      FormaldehydeAll food producing species
      Formic acidAll food producing species
      GlutaraldehydeAll food producing species
      GuaiacolAll food producing species
      Heparin and its saltsAll food producing species
      Human chorionic gonadotropin (natural HCG and its synthetic analogues)All food producing species
      Iron ammonium citrateAll food producing species
      Iron dextranAll food producing species
      Iron glucoheptonateAll food producing species
      IsopropanolAll food producing species
      Luteinising hormone (natural LH from all species and their synthetic analogues)All food producing species
      LanolinAll food producing species
      Magnesium chlorideAll food producing species
      Magnesium gluconateAll food producing species
      Magnesium hypophosphiteAll food producing species
      MannitolAll food producing species
      MethylbenzoateAll food producing species
      MonothioglycerolAll food producing species
      MontanideAll food producing species
      MyglyolAll food producing species
      OrgoteinAll food producing species
      PoloxaleneAll food producing species
      PoloxamerAll food producing species
      Polyethylene glycols (molecular weight ranging from 200 to 10 000)All food producing species
      Polysorbate 80All food producing species
      SerotoninAll food producing species
      Sodium chlorideAll food producing species
      Sodium cromoglycateAll food producing species
      Sodium dioctylsulphosuccinateAll food producing species
      Sodium formaldehydesulphoxylateAll food producing species
      Sodium lauryl sulphateAll food producing species
      Sodium pyrosulphiteAll food producing species
      Sodium stearateAll food producing species
      Sodium thiosulphateAll food producing species
      TragacanthAll food producing species
      UreaAll food producing species
      Zinc oxideAll food producing species
      Zinc sulphateAll food producing species
    4. 4..

      Substances used in homeopathic veterinary medicinal products

      Pharmacologically active substance(s)Animal speciesOther provisions
      ‘All substances used in homeopathic veterinary medicinal products provided that their concentration in the product does not exceed one part per 10 000All food producing species’
    5. 5..

      Substances used as food additives in foodstuffs for human consumption

      Pharmacologically active substance(s)Animal speciesOther provisions
      ‘Substances with an E numberAll food producing speciesOnly substances approved as additives in foodstuffs for human consumption, with the exception of preservatives listed in Part C of Annex III to European Parliament and Council Directive 95/2/EC (OJ L 61, 18. 3. 1995, p. 1.)’
  3. C..

    Annex III to Regulation (EEC) No 2377/90 is amended as follows:

    1. 1..

      Anti-infectious agents

      1. 1.1.

        Chemotherapeutics

        1. 1.1.2.

          Benzenesulphonamides

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘ClorsulonClorsulonBovine50 μg/kgMuscleProvisional MRLs expire on 1 January 2000’
          150 μg/kgLiver
          400 μg/kgKidney
      2. 1.2.

        Antibiotics

        1. 1.2.1.

          Beta-lactamase inhibitors

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘Clavulanic acidClavulanic acidBovine, ovine200 μg/kgMilkProvisional MRLs expire on 1 July 1999’
          Bovine, ovine, porcine200 μg/kgMuscle
          200 μg/kgFat
          200 μg/kgLiver
          200 μg/kgKidney
        2. 1.2.2.

          Macrolides

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘ErythromycinErythromycinBovine, ovine40 μg/kgMilkProvisional MRLs expire on 1 June 2000; MRLs apply to all microbiological active residues expressed as erythromycin equivalent
          Bovine, ovine, porcine, poultry400 μg/kgMuscle
          400 μg/kgFat
          400 μg/kgLiver
          400 μg/kgKidney
          Poultry200 μg/kgEggs
          JosamycinJosamycinChicken200 μg/kgMuscleProvisional MRLs expire on 1 July 2000’
          200 μg/kgFat
          200 μg/kgLiver
          400 μg/kgKidney
          200 μg/kgEggs
        3. 1.2.4.

          Cephalosporins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘CeftiofurSum of all residues retaining the betalactam structure expressed as desfuroylceftiofurBovine200 μg/kgMuscleProvisional MRLs expire on 1 January 1999
          600 μg/kgFat
          2 000 μg/kgLiver
          2 000 μg/kgKidney
          100 μg/kgMilk
          Porcine500 μg/kgMuscle
          600 μg/kgFat
          3 000 μg/kgLiver
          4 000 μg/kgKidney
          CephapirinSum of cephapirin and desacetylcephapirinBovine50 μg/kg50 μg/kgMuscle
          FatProvisional MRLs expire on 1 January 1999’
          50 μg/kgLiver
          100 μg/kgKidney
          10 μg/kgMilk
        4. 1.2.5.

          Aminoglycosides

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘AminosidineAminosidineBovine, porcine, rabbits, chicken500 μg/kgMuscleProvisional MRLs expire on 1 July 2000
          1 500 μg/kgLiver
          1 500 μg/kgkidney
          ApramycinApramycinBovine (for use in non-lactating cattle only)1 000 μg/kgMuscleProvisional MRLs expire on 1 July 1999
          1 000 μg/kgLiver
          10 000 μg/kgLiver
          20 000 μg/kgKidney
          Porcine1 000 μg/kgMuscle
          1 000 μg/kgSkin and fat
          1 000 μg/kgLiver
          5 000 μg/kgKidney
          DihydrostreptomycinDihydrostreptomycinBovine, ovine200 μg/kgMilkProvisional MRLs expire on 1 June 2000
          Bovine, ovine, porcine, poultry500 μg/kgMuscle
          500 μg/kgFat
          500 μg/kgLiver
          1 000 μg/kgKidney
          GentamicinGentamicinBovine100 μg/kgMilkProvisional MRLs expire on 1 June 2000
          Bovine, porcine100 μg/kgMuscle
          100 μg/kgFat
          200 μg/kgLiver
          1 000 μg/kgKidney
          Neomycin (includingNeomycinBovine, ovine, caprine500 μg/kgMilkProvisional MRLs expire on 1 June 2000 framycetin)
          Bovine, ovine, caprine, porcine, chicken,500 μg/kgMuscle turkey, duck
          500 μg/kgFat
          500 μg/kgLiver
          5 000 μg/kgKidney
          Chicken500 μg/kgEggs
          SpectinomycinSpectinomycinBovine200 μg/kgMilkProvisional MRLs expire on 1 July 1998
          Bovine, porcine, poultry300 μg/kgMuscle
          500 μg/kgFat
          2 000 μg/kgLiver
          5 000 μg/kgKidney
          StreptomycinStreptomycinBovine, ovine200 μg/kgMilkProvisional MRLs expire on 1 June 2000’
          Bovine, ovine, porcine, poultry500 μg/kgMuscle
          500 μg/kgFat
          500 μg/kgLiver
          1 000 μg/kgKidney
        5. 1.2.6.

          Quinolones

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘DecoquinateDecoquinateBovine, ovine500 μg/kgMuscleProvisional MRLs expire on 1 July 2000
          500 μg/kgFat
          500 μg/kgLiver
          500 μg/kgKidney
          FlumequineFlumequineBovine, ovine, porcine, chicken50 μg/kgMuscleProvisional MRLs expire on 1 January 2000
          FlumequineFlumequineBovine, ovine, porcine, chicken50 μg/kgFat or skin + fatProvisional MRLs expire on 1 January 2000
          100 μg/kgLiver
          300 μg/kgKidney
          Salmonidae150 μg/kg
          MarbofloxacinMarbofloxacinBovine150 μg/kgMuscleProvisional MRLs expire on 1 July 2000
          50 μg/kgFat
          150 μg/kgLiver
          150 μg/kgKidney
          75 μg/kgMilk
          Porcine150 μg/kgMuscle
          50 μg/kgSkin + fat
          150 μg/kgLiver
          150 μg/kgKidney
          SarafloxacinSarafloxacinSalmonidae30 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1 July 1998’
        6. 1.2.9.

          Polymyxins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘ColistinColistinBovine, ovine50 μg/kgMilkProvisional MRLs expire on 1 July 2000’
          Bovine, ovine, porcine, chicken, rabbits150 μg/kgMuscle
          150 μg/kgFat
          150 μg/kgLiver
          200 μg/kgKidney
          Chicken300 μg/kgEggs
        7. 1.2.10.

          Penicillins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘NafcillinNafcillinBovine30 μg/kgMuscle

          Provisional MRLs expire on 1 January 1999

          For intramammary use only

          30 μg/kgFat
          30 μg/kgLiver
          30 μg/kgKidney
          30 μg/kgMilk
          PenethamateBenzylpenicillinOvine150 μg/kgMuscleProvisional MRLs expire on 1 January 2000’
          150 μg/kgFat
          150 μg/kgLiver
          150 μg/kgKidney
          4 μg/kgMilk
          Porcine50 μg/kgMuscle
          50 μg/kgFat
          50 μg/kgLiver
          50 μg/kgKidney
        8. 1.2.11.

          Florfenicol and related compounds

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘FlorfenicolSum of florfenicol and its metabolites measured as florfenicol-amineFish1 000 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1 July 2001’
    2. 2..

      Antiparasitic agents

      1. 2.1.

        Agents acting against endoparasites

        1. 2.1.2.

          Benzimidazoles and pro-benzimidazoles

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘Albendazole sulphoxideSum of albendazole, albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazoleBovine, ovine100 μg/kgMilkProvisional MRLs expire on 1 January 2000
          Bovine, ovine, pheasant100 μg/kgMuscle
          100 μg/kgFat
          1 000 μg/kgLiver
          500 μg/kgKidney
          NetobiminSum of netobimin and albendazole and metabolites of albendazole measured as 2-amino-benzimidazole sulphoneBovine, ovine, caprine100 μg/kgMuscleProvisional MRLs expire on 31 July 1999’
          100 μg/kgFat
          1 000 μg/kgLiver
          500 μg/kgKidney
          100 μg/kgMilk
      2. 2.2.

        Agents acting against ectoparasites

        1. 2.2.1.

          Formamidines

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘AmitrazSum of amitraz and metabolites which are measured as 2,4-dime-thylanilineBovine200 μg/kgFatProvisional MRLs expire on 1 July 1998
          200 μg/kgLiver
          200 μg/kgKidney
          10 μg/kgMilk
          Ovine400 μg/kgFat
          200 μg/kgLiver
          200 μg/kgKidney
          Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitrazBees200 μg/kgHoneyProvisional MRLs expire on 1 July 1999’
        2. 2.2.2.

          Iminophenyl thiazolidine derivative

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘CymiazoleCymiazoleBees1 000 μg/kgHoneyProvisional MRLs expire on 1 July 1999’
        3. 2.2.4.

          Organophosphates

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘AzamethiphosAzamethiphosSalmonidae100 μg/kgMuscle and skin in natural proportionsProvisional MRLs expire on 1 June 1999’
        4. 2.2.5.

          Acyl urea derivates

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘TeflubenzuronTeflubenzuronSalmonidae500 μg/kgMuscle And skin in natural proportionsProvisional MRLs expire on 1 July 1999’
      3. 2.3.

        Agents acting against endo- and ectoparasites

        1. 2.3.1.

          Avermectins

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘Ivermectin22,23-Dihydro-aver-mectin BlaDeer, including reindeer20 μg/kgMuscleProvisional MRLs expire on 1 January 1999
          100 μg/kgFat
          50 μg/kgLiver
          20 μg/kgKidney
          MoxidectinMoxidectinEquidae50 μg/kgMuscleProvisional MRLs expire on 1 January 2000’
          500 μg/kgFat
          100 μg/kgLiver
          50 μg/kgKidney
    3. 3..

      Agents acting on the nervous system

      1. 3.2.

        Agents acting on the autonomic nervous system

        1. 3.2.1.

          62 sympathomimetic agents

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘Clenbuterol hydrochlorideClenbuterolBovine (indication: solely for tocolysis in parturient cows)0,1 μg/kgMuscleProvisional MRLs expire on 1 July 2000’
          0,5 μg/kgLiver
          0,5 μg/kgKidney
          0,05 μg/kgMilk
          Equidae (indications: locolysis and the treatment of respiratory ailments)0,1 μg/kgMuscle
          0,5 μg/kgLiver
          0,5 μg/kgKidney
    4. 5..

      Anti-inflammatory agents

      1. 5.1.

        Non-steroidal anti-inflammatory agents

        1. 5.1.1.

          Arylpropionic acid derivative

          Pharmacologically active substance(s)Marker residueAnimal speciesMRLsTarget tissuesOther provisions
          ‘CarprofenCarprofenBovine500 μg/kgMuscleProvisional MRLs expire on 1 January 2000’
          500 μg/kgFat
          1 000 μg/kgLiver
          1 000 μg/kgKidney
          Equidae50 μg/kgMuscle
          100 μg/kgFat
          1 000 μg/kgLiver
          1 000 μg/kgKidney
  4. D..

    Annex IV to Regulation (EEC) No 2377/90 is amended as follows:

    Pharmacologically active substance(s)
    ‘Chloramphenicol
    Chloroform
    Chlorpromazine
    Colchicine
    Dapsone
    Dimetridazole
    Furazolidone
    Metronidazole
    Nitrofurans
    Ronidazole’