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Document 31998R1570

    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)

    OJ L 205, 22.7.1998, p. 10–39 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

    This document has been published in a special edition(s) (CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO)

    Legal status of the document No longer in force, Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470

    ELI: http://data.europa.eu/eli/reg/1998/1570/oj

    22.7.1998   

    EN

    Official Journal of the European Communities

    L 205/10


    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 origin (1), as last amended by Commission Regulation (EC) No 1569/98 (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, 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:

    Article 1

    Annexes I to 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, 17 July 1998.

    For the Commission

    Martin BANGEMANN

    Member of the Commission


    (1)  OJ L 224, 18. 8. 1990, p. 1.

    (2)  See page 7 of this Official Journal.


    ANNEX

    A.

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

    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 μg/kg

    Muscle

    The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg’

    100 μg/kg

    Fat

    100 μg/kg

    Liver

    100 μg/kg

    Kidney

    Bovine, ovine, caprine

    100 μg/kg

    Milk

    1.1.2.

    Diamino pyrimidine derivates

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Baquiloprim

    Baquiloprim

    Bovine

    10 μg/kg

    Fat

     

    300 μg/kg

    Liver

    150 μg/kg

    Kidney

    30 μg/kg

    Milk

    Porcine

    40 μg/kg

    Skin + fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    Trimethoprim

    Trimethoprim

    Bovine

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    50 μg/kg

    Milk

    Porcine

    50 μg/kg

    Muscle

    50 μg/kg

    Skin + fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    Equidae

    100 μg/kg

    Muscle

    100 μg/kg

    Fat

    100 μg/kg

    Liver

    100 μg/kg

    Kidney

    Poultry not for use in animals from which eggs are produced for human consumption

    50 μg/kg

    Muscle

    50 μg/kg

    Skin + fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    Fin fish

    50 μg/kg

    Muscle and skin in natural proportions’

    1.2.

    Antibiotics

    1.2.1.

    Penicillins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Amoxicyllin

    Amoxicyllin

    All food producing species

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    4 μg/kg

    Milk

    Ampicillin

    Ampicillin

    All food producing species

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    4 μg/kg

    Milk

    Benzylpenicillin

    Benzylpenicillin

    All food producing species

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    4 μg/kg

    Milk

    Cloxacillin

    Cloxacillin

    All food producing species

    300 μg/kg

    Muscle

     

    300 μg/kg

    Fat

    300 μg/kg

    Liver

    300 μg/kg

    Kidney

    30 μg/kg

    Milk

    Oxacillin

    Oxacillin

    All food producing species

    300 μg/kg

    Muscle

     

    300 μg/kg

    Fat

    300 μg/kg

    Liver

    300 μg/kg

    Kidney

    30 μg/kg

    Milk

    Penethamate

    Benzylpenicillin

    Bovine

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    4 μg/kg

    Milk’

    1.2.2.

    Cephalosporins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Cefazolin

    Cefazolin

    Bovine, ovine, caprine

    50 μg/kg

    Milk

     

    Cefquinome

    Cefquinome

    Bovine

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    100 μg/kg

    Liver

    200 μg/kg

    Kidney

    20 μg/kg

    Milk’

    1.2.3.

    Quinolones

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Danofloxacine

    Danofloxacine

    Bovine (not for use in animals from which milk is produced for human consumption)

    200 μg/kg

    Muscle

     

    100 μg/kg

    Fat

    400 μg/kg

    Liver

    400 μg/kg

    Kidney

    Chicken (not for use in animals from which eggs are produced for human consumption)

    200 μg/kg

    Muscle

    100 μg/kg

    Skin + fat

    400 μg/kg

    Liver

    400 μg/kg

    Kidney

    Difloxacin

    Difloxacin

    Chicken, turkey

    300 μg/kg

    Muscle

     

    400 μg/kg

    Skin + fat

    1 900 μg/kg

    Liver

    600 μg/kg

    Kidney

    Enrofloxacin

    Sum of enrofloxacin and ciprofloxacin

    Bovine, porcine, poultry

    30 μg/kg

    Muscle

     

    30 μg/kg

    Liver

    30 μg/kg

    Kidney

    Sarafloxacin

    Sarafloxacin

    Chicken

    10 μg/kg

    Skin + fat

     

    100 μg/kg

    Liver’

    1.2.4.

    Macrolides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Spiramycin

    Sum of spiramycin and neospiramycin

    Bovine

    200 μg/kg

    Muscle

     

    300 μg/kg

    Fat

    300 μg/kg

    Liver

    300 μg/kg

    Kidley

    200 μg/kg

    Milk

    Chicken

    200 μg/kg

    Muscle

    300 μg/kg

    Skin + fat

    400 μg/kg

    Liver

    Tilmicosin

    Tilmicosin

    Bovine, ovine, porcine

    1 000 μg/kg

    Liver

     

    1 000 μg/kg

    Kidney

    Ovine

    50 μg/kg

    Milk

    Tylosin

    Tylosin A

    Bovine

    100 μg/kg

    Muscle

     

    100 μg/kg

    Fat

    100 μg/kg

    Liver

    100 μg/kg

    Kidney

    50 μg/kg

    Milk

    Porcine

    100 μg/kg

    Muscle

    100 μg/kg

    Skin + fat

    100 μg/kg

    Liver

    100 μg/kg

    Kidney

    Poultry (not for use in hens producing eggs for human consumption)

    100 μg/kg

    Muscle

    100 μg/kg

    Skin + fat

    100 μg/kg

    Liver

     

    100 μg/kg

    Kidney’

    1.2.5.

    Florfenicol and related compounds

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Florfenicol

    Sum of florfenicol and its metabolites measured as florfenicol-amine

    Bovine

    200 μg/kg

    Muscle

     

    3 000 μg/kg

    Liver

    300 μg/kg

    Kidney’

    1.2.6.

    Tetracyclines

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Chlortetracycline

    Sum of parent drug and its 4-epimer

    All food producing species

    100 μg/kg

    Muscle

     

    300 μg/kg

    Liver

    600 μg/kg

    Kidney

    100 μg/kg

    Milk

    200 μg/kg

    Eggs

    Doxycycline

    Doxycycline

    Bovine

    100 μg/kg

    Muscle

     

    300 μg/kg

    Liver

    600 μg/kg

    Kidney

    Porcine, poultry

    100 μg/kg

    Muscle

    300 μg/kg

    Skin + fat

    300 μg/kg

    Liver

    600 μg/kg

    Kidney

    Oxytetracycline

    Sum of parent drug and its 4-epimer

    All food producing species

    100 μg/kg

    Muscle

     

    300 μg/kg

    Liver

    600 μg/kg

    Kidney

    100 μg/kg

    Milk

    200 μg/kg

    Eggs

    Tetracycline

    Sum of parent drug and its 4-epimer

    All food producing species

    100 μg/kg

    Muscle

     

    300 μg/kg

    Liver

    600 μg/kg

    Kidney

    100 μg/kg

    Milk

    200 μg/kg

    Eggs’

    1.2.7.

    Thiamphenicol and related compounds

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Thiamphenicol

    Thiamphenicol

    Bovine

    50 μg/kg

    Muscle

     

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    50 μg/kg

    Milk

    Chicken (not for use in animals from which eggs are produced for human consumption)

    50 μg/kg

    Muscle

    50 μg/kg

    Skin + fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney’

    2.

    Antiparasitic agents

    2.1.

    Agents acting against endoparasites

    2.1.1.

    Salicylanilides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Closantel

    Closantel

    Bovine

    1 000 μg/kg

    Muscle

     

    3 000 μg/kg

    Fat

    1 000 μg/kg

    Liver

    3 000 μg/kg

    Kidney

    Ovine

    1 500 μg/kg

    Muscle

    2 000 μg/kg

    Fat

    1 500 μg/kg

    Liver

    5 000 μg/kg

    Kidney’

    2.1.2.

    Tatra-hydro-imidazoles (imidazolthiazoles)

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Levamisole

    Levamisole

    Bovine, ovine, porcine, poultry

    10 μg/kg

    Muscle

     

    10 μg/kg

    Fat

    100 μg/kg

    Liver

    10 μg/kg

    Kidney’

    2.1.3.

    Benzimidazoles and pro-benzimidazoles

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Febantel

    Sum of extractable residues which may be oxidised to oxfendazole sulphone

    Bovine, ovine

    10 μg/kg

    Milk

     

    Bovine, ovine, porcine, equidae

    50 μg/kg

    Muscle

    50 μg/kg

    Fat

    500 μg/kg

    Liver

    50 μg/kg

    Kidney

    Fenbendazole

    Sum of extractable residues which may be oxidised to oxfendazole sulphone

    Bovine, ovine

    10 μg/kg

    Milk

     

    Bovine, ovine, porcine, equidae

    50 μg/kg

    Muscle

    50 μg/kg

    Fat

    500 μg/kg

    Liver

    50 μg/kg

    Kidney

    Flubendazole

    Sum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4-flurorophenyl)methanone

    Porcine, chicken, game birds

    50 μg/kg

    Muscle

     

    50 μg/kg

    Skin + fat

    400 μg/kg

    Liver

    300 μg/kg

    Kidney

    Flubendazole

    Chicken

    400 μg/kg

    Eggs

    Oxfendazole

    Sum of extractable residues which may be oxidised to oxfendazole sulphone

    Bovine, ovine

    10 μg/kg

    Milk

     

    Bovine, ovine, porcine, equidae

    50 μg/kg

    Muscle

    50 μg/kg

    Fat

    500 μg/kg

    Liver

    50 μg/kg

    Kidney

    Oxibendazole

    Oxibendazole

    Porcine

    100 μg/kg

    Muscle

     

    500 μg/kg

    Skin + fat

    200 μg/kg

    Liver

    100 μg/kg

    Kidney

    Thiabendazole

    Sum of thiabendazole and 5-hydroxythiabendazole

    Bovine

    100 μg/kg

    Muscle

     

    100 μg/kg

    Fat

    100 μg/kg

    Liver

    100 μg/kg

    Kidney

    100 μg/kg

    Milk

    Triclabendazole

    Sum of extractable residues that may be oxidised to ketotriclaben-dazole

    Bovine, ovine

    100 μg/kg

    Muscle

    Not for use in animals from which milk is produced for human consumption’

    100 μg/kg

    Liver

    100 μg/kg

    Kidney

    2.2.

    Agents acting against ectoparasites

    2.2.1.

    Organophosphates

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Diazinon

    Diazinon

    Bovine, ovine, caprine

    20 μg/kg

    Milk

     

    Bovine, porcine, ovine, caprine

    20 μg/kg

    Muscle

    700 μg/kg

    Fat

    20 μg/kg

    Liver

    20 μg/kg

    Kidney’

    2.2.2.

    Formamidines

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Amitraz

    Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitraz

    Porcine

    400 μg/kg

    Skin + fat

     

    200 μg/kg

    Liver

    200 μg/kg

    Kidney’

    2.3.

    Agents acting against endo- and ectoparasites

    2.3.1.

    Avermectins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Abamectin

    Avermectin Bla

    Bovine

    10 μg/kg

    Fat

     

    20 μg/kg

    Liver

    Doramectin

    Doramectin

    Bovine

    10 μg/kg

    Muscle

    Not for use in ovines from which milk is produced for human consumption’

    150 μg/kg

    Fat

    100 μg/kg

    Liver

    30 μg/kg

    Kidney

    Porcine, ovine

    20 μg/kg

    Muscle

    100 μg/kg

    Fat

    50 μg/kg

    Liver

    30 μg/kg

    Kidney

    Eprinomectin

    Eprinomectin Bla

    Bovine

    30 μg/kg

    Muscle

     

    30 μg/kg

    Fat

    600 μg/kg

    Liver

    100 μg/kg

    Kidney

    30 μg/kg

    Milk

    Ivermectin

    22,23-Dihydro-aver-mectin Bla

    Bovine

    40 μg/kg

    Fat

     

    100 μg/kg

    Liver

    Porcine, ovine, equidae

    20 μg/kg

    Fat

    15 μg/kg

    Liver

    Moxidectin

    Moxidectin

    Bovine, ovine

    50 μg/kg

    Muscle

     

    500 μg/kg

    Fat

    100 μg/kg

    Liver

    50 μg/kg

    Kidney

    3.

    Agents acting on the nervous system

    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

    ‘Carazolol

    Carazolol

    Porcine

    5 μg/kg

    Muscle

     

    5 μg/kg

    Skin + fat

    25 μg/kg

    Liver

    25 μg/kg

    Kidney’

    4.

    Anti-infammatory agents

    4.1.

    Nonsteroidal anti-infammatory agents

    4.1.1.

    Arylpropionic acid derivative

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Vedaprofen

    Vedaprofen

    Equidae

    50 μg/kg

    Muscle

     

    20 μg/kg

    Fat

    100 μg/kg

    Liver

    1 000 μg/kg

    Kidney’

    4.1.2.

    Fenamate group derivates

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Tolfenamic acid

    Tolfenamic acid

    Bovine

    50 μg/kg

    Muscle

     

    400 μg/kg

    Liver

    100 μg/kg

    Kidney

    50 μg/kg

    Milk

    Porcine

    50 μg/kg

    Muscle

    400 μg/kg

    Liver

    100 μg/kg

    Kidney’

    5.

    Corticoides

    5.1.

    Glucocorticoides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Dexamethasone

    Dexamethasone

    Bovine

    03 μg/kg

    Milk

     

    Bovine, porcine, equidae

    0,75 μg/kg

    Muscle

    2 μg/kg

    Liver

    0,75 μg/kg

    Kidney’

    B.

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

    1.

    Inorganic chemicals

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    ‘Bismuth subcarbonate

    All food producing species

    For oral use only

    Bismuth subgallate

    All food producing species

    For oral use only

    Bismuth subnitrate

    All food producing species

    For oral use only

    Bismuth subsalicylate

    All food producing species

    For oral use only

    Boric acid and borates

    All food producing species

     

    Bromide, Sodium salt

    All mammalian food producing species

    For 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 acid

    All food producing species

    For use as excipient

    Hydrogen peroxide

    All 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-aspartate

    All food producing species

     

    Potassium glucuronate

    All food producing species

     

    Potassium glycerophosphate

    All food producing species

     

    Potassium nitrate

    All food producing species

     

    Potassium selenate

    All food producing species

     

    Sodium chlorite

    Bovine

    For topical use only

    Sodium dichloroisocyanurate

    Bovine, ovine, caprine

    For topical use only’

    Sodium selenate

    All food producing species

     

    Sodium selenite

    All food producing species

     

    Sulphur

    Bovine, porcine, ovine, caprine, equidae

     

    Zinc acetate

    All food producing species

    Zinc chloride

    Zinc gluconate

    Zinc oleate

    Zinc stearate

     

    2.

    Organic compounds

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    ‘17B-Oestradiol

    All mammalian food producing species

    For therapeutic and zootechnical uses only

    Acetyl cysteine

    All food producing species

     

    Alfaprostol

    Bovine, porcine, equidae

     

    Benzylalcohol

    All food producing species

    For use as excipient

    Betaine

    All food producing species

     

    Brotizolam

    Bovine

    For therapeutic uses only

    Buserelin

    All food producing species

     

    Butyl 4-hydroxybenzoate

    All food producing species

     

    Caffeine

    All food producing species

     

    Carbetocin

    All mammalian food producing species

     

    Cefazolin

    Bovine

    Ovine, caprine

    For intramammary use (except if the udder may be used as food for human consumption)

    Cetrimide

    All food producing species

     

    Chlorhexidine

    All food producing species

    For topical use only

    Chlorocresol

    All food producing species

     

    Cloprostenol

    Bovine, porcine, equidae

     

    D-phe 6-luteinizing-hormone-releasing-hormone

    All food producing species

     

    Dembrexine

    Equidae

     

    Detomidine

    Bovine, equidae

    For therapeutic uses only

    Diclazuril

    Ovine

    For oral use in lambs only

    Dicloxacillin

    All food producing species

     

    Diethyl phtalate

    All food producing species

     

    Dimethyl phtalate

    All food producing species

     

    Dinoprost tromethamine

    All mammalian food producing species

     

    Etamiphylline camsylate

    All food producing species

     

    Ethanol

    All food producing species

    For use as excipient

    Ethyl lactate

    All food producing species

     

    Etiproston tromethamine

    Bovine, porcine

     

    Fertirelin acetate

    Bovine

     

    Folic acid

    All food producing species

     

    Glycerol formal

    All food producing species

     

    Gonadotrophin releasing hormone

    All food producing species

     

    Heptaminol

    All food producing species

     

    Hesperidin

    Equidae

     

    Hesperidin methyl chalcone

    Equidae

     

    Human chorion gonadotrophin (HCG)

    All food producing species

     

    Human menopausal urinary gonadotrophin

    Bovine

     

    Iodine organic compounds:

    Iodoform

    All food producing species

     

    Isobutane

    All food producing species

     

    Isoflurane

    Equidae

    For use as anaesthetic only

    Isoxsuprine

    Bovine, equidae

    For therapeutic use only in accordance with Council Directive 96/22/EEC (OJ L 125, 23.5.1996, p. 3)

    Ketanserin tartrate

    Equidae

     

    Ketoprofen

    Bovine, equidae

    Porcine

     

    L-tartaric acid and its mono- and di- basic salt of sodium, potassium and calcium

    All food producing species

    For use as excipient

    Lactic acid

    All food producing species

     

    Lecirelin

     

     

    Lini oleum

    All food producing species

     

    Lobeline

    All food producing species

     

    Luprostiol

    All mammalian species

     

    Malic acid

    All food producing species

    For use as excipient

    Medroxyprogesterone acetate

    Ovine

    For intravaginal use for zootechnical purposes only

    Melatonin

    Ovine, caprine

     

    Menbutone

    Bovine, ovine, caprine, porcine, equidae

     

    Menthol

    All food producing species

     

    Mineral hydrocarbons, low to high viscosity including micro-cristalline waxes, approximately C10-C60; aliphatic, branched aliphatic and alicyclic compounds

    All food producing species

    Excludes aromatic and unsaturated compounds

    N-butane

    All food producing species

     

    N-butanol

    All food producing species

    For use as excipient

    Neostigmine

    All food producing species

     

    Oxytocin

    All mammalian food producing species

     

    Pancreatin

    All mammalian food producing species

    For topical use only

    Papain

    All food producing species

     

    Papaverine

    Bovine

    New-born calves only

    Peracetic acid

    All food producing species

     

    Phenol

    All food producing species

     

    Phloroglucinol

    All food producing species

     

    Policresulene

    All food producing species

    For topical use only

    Polysulphated glycosaminoglycan

    Equidae

     

    Praziquantel

    Ovine

    For non-lactating sheep only

    Pregnant mare serum gonadotrophin

    All food producing species

     

    Propane

    All food producing species

     

    Propylene glycol

    All food producing species

     

    Quatresin

    All food producing species

    For use as preservative only at concentrations of up to 0,5 %

    Quillaia saponins

    All food producing species

     

    R-clopostenol

    Bovine, porcine, equidae

     

    Rifaximin

    Bovine

    For intramammary use - except if the udder may be used as food for human consumption - and intra-uterine use only

    Romifidine

    Equidae

    For therapeutic uses only

    Sodium benzyl 4-hydroxybenzoate

    All food producing species

     

    Sodium butyl 4-hydroxybenzoate

    All food producing species

     

    Somatosalm

    Salmon

     

    Tau fluvalinate

    Honey bees

     

    Theobromine

    All food producing species

     

    Theophylline

    All food producing species

     

    Thiomersal

    All food producing species

    For use only as preservatives in multi-dose vaccines at a concentration not exceeding 0,02 %

    Thymol

    All food producing species

     

    Timerfonate

    All food producing species

    For use only as preservatives in multi-dose vaccines at a concentration not exceeding 0,02 %’

    Trimethylphloroglucinol

    All food producing species

     

    3.

    Substances generally recognised as safe

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    ‘Absinthium extract

    All food producing species

     

    Acetylmethionine

    All food producing species

     

    Aluminium hydroxide

    All food producing species

     

    Aluminium monostearate

    All food producing species

     

    Ammonium sulfate

    All food producing species

     

    Benzoyl benzoate

    All food producing species

     

    Benzyl p-hydroxybenzoate

    All food producing species

     

    Calcium borogluconate

    All food producing species

     

    Calcium citrate

    All food producing species

     

    Camphor

    All food producing species

    External use only’

    Cardamon extract

    All food producing species

     

    Diethyl sebacate

    All food producing species

     

    Dimethicone

    All food producing species

     

    Dimethyl acetamide

    All food producing species

     

    Dimethyl sulphoxide

    All food producing species

     

    Epinephrine

    All food producing species

     

    Ethyl oleate

    All food producing species

     

    Ethylenediaminetetraacetic acid and salts

    All food producing species

     

    Eucalyptol

    All food producing species

     

    Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)

    All food producing species

     

    Formaldehyde

    All food producing species

     

    Formic acid

    All food producing species

     

    Glutaraldehyde

    All food producing species

     

    Guaiacol

    All food producing species

     

    Heparin and its salts

    All food producing species

     

    Human chorionic gonadotropin (natural HCG and its synthetic analogues)

    All food producing species

     

    Iron ammonium citrate

    All food producing species

     

    Iron dextran

    All food producing species

     

    Iron glucoheptonate

    All food producing species

     

    Isopropanol

    All food producing species

     

    Luteinising hormone (natural LH from all species and their synthetic analogues)

    All food producing species

     

    Lanolin

    All food producing species

     

    Magnesium chloride

    All food producing species

     

    Magnesium gluconate

    All food producing species

     

    Magnesium hypophosphite

    All food producing species

     

    Mannitol

    All food producing species

     

    Methylbenzoate

    All food producing species

     

    Monothioglycerol

    All food producing species

     

    Montanide

    All food producing species

     

    Myglyol

    All food producing species

     

    Orgotein

    All food producing species

     

    Poloxalene

    All food producing species

     

    Poloxamer

    All food producing species

     

    Polyethylene glycols (molecular weight ranging from 200 to 10 000)

    All food producing species

     

    Polysorbate 80

    All food producing species

     

    Serotonin

    All food producing species

     

    Sodium chloride

    All food producing species

     

    Sodium cromoglycate

    All food producing species

     

    Sodium dioctylsulphosuccinate

    All food producing species

     

    Sodium formaldehydesulphoxylate

    All food producing species

     

    Sodium lauryl sulphate

    All food producing species

     

    Sodium pyrosulphite

    All food producing species

     

    Sodium stearate

    All food producing species

     

    Sodium thiosulphate

    All food producing species

     

    Tragacanth

    All food producing species

     

    Urea

    All food producing species

     

    Zinc oxide

    All food producing species

     

    Zinc sulphate

    All food producing species

     

    4.

    Substances used in homeopathic veterinary medicinal products

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    ‘All substances used in homeopathic veterinary medicinal products provided that their concentration in the product does not exceed one part per 10 000

    All food producing species’

     

    5.

    Substances used as food additives in foodstuffs for human consumption

    Pharmacologically active substance(s)

    Animal species

    Other provisions

    ‘Substances with an E number

    All food producing species

    Only 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.)’

    C.

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

    1.

    Anti-infectious agents

    1.1.

    Chemotherapeutics

    1.1.2.

    Benzenesulphonamides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Clorsulon

    Clorsulon

    Bovine

    50 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 2000’

    150 μg/kg

    Liver

    400 μg/kg

    Kidney

    1.2.

    Antibiotics

    1.2.1.

    Beta-lactamase inhibitors

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Clavulanic acid

    Clavulanic acid

    Bovine, ovine

    200 μg/kg

    Milk

    Provisional MRLs expire on 1 July 1999’

    Bovine, ovine, porcine

    200 μg/kg

    Muscle

    200 μg/kg

    Fat

    200 μg/kg

    Liver

    200 μg/kg

    Kidney

    1.2.2.

    Macrolides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Erythromycin

    Erythromycin

    Bovine, ovine

    40 μg/kg

    Milk

    Provisional MRLs expire on 1 June 2000; MRLs apply to all microbiological active residues expressed as erythromycin equivalent

    Bovine, ovine, porcine, poultry

    400 μg/kg

    Muscle

    400 μg/kg

    Fat

    400 μg/kg

    Liver

    400 μg/kg

    Kidney

    Poultry

    200 μg/kg

    Eggs

    Josamycin

    Josamycin

    Chicken

    200 μg/kg

    Muscle

    Provisional MRLs expire on 1 July 2000’

    200 μg/kg

    Fat

    200 μg/kg

    Liver

    400 μg/kg

    Kidney

    200 μg/kg

    Eggs

    1.2.4.

    Cephalosporins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Ceftiofur

    Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur

    Bovine

    200 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 1999

    600 μg/kg

    Fat

    2 000 μg/kg

    Liver

    2 000 μg/kg

    Kidney

    100 μg/kg

    Milk

    Porcine

    500 μg/kg

    Muscle

    600 μg/kg

    Fat

    3 000 μg/kg

    Liver

    4 000 μg/kg

    Kidney

    Cephapirin

    Sum of cephapirin and desacetylcephapirin

    Bovine

    50 μg/kg

    50 μg/kg

    Muscle

    Fat

    Provisional MRLs expire on 1 January 1999’

    50 μg/kg

    Liver

    100 μg/kg

    Kidney

    10 μg/kg

    Milk

    1.2.5.

    Aminoglycosides

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Aminosidine

    Aminosidine

    Bovine, porcine, rabbits, chicken

    500 μg/kg

    Muscle

    Provisional MRLs expire on 1 July 2000

    1 500 μg/kg

    Liver

    1 500 μg/kg

    kidney

    Apramycin

    Apramycin

    Bovine (for use in non-lactating cattle only)

    1 000 μg/kg

    Muscle

    Provisional MRLs expire on 1 July 1999

    1 000 μg/kg

    Liver

    10 000 μg/kg

    Liver

    20 000 μg/kg

    Kidney

    Porcine

    1 000 μg/kg

    Muscle

    1 000 μg/kg

    Skin and fat

    1 000 μg/kg

    Liver

    5 000 μg/kg

    Kidney

    Dihydrostreptomycin

    Dihydrostreptomycin

    Bovine, ovine

    200 μg/kg

    Milk

    Provisional MRLs expire on 1 June 2000

    Bovine, ovine, porcine, poultry

    500 μg/kg

    Muscle

    500 μg/kg

    Fat

    500 μg/kg

    Liver

    1 000 μg/kg

    Kidney

    Gentamicin

    Gentamicin

    Bovine

    100 μg/kg

    Milk

    Provisional MRLs expire on 1 June 2000

    Bovine, porcine

    100 μg/kg

    Muscle

    100 μg/kg

    Fat

    200 μg/kg

    Liver

    1 000 μg/kg

    Kidney

    Neomycin (including

    Neomycin

    Bovine, ovine, caprine

    500 μg/kg

    Milk

    Provisional MRLs expire on 1 June 2000 framycetin)

    Bovine, ovine, caprine, porcine, chicken,

    500 μg/kg

    Muscle turkey, duck

    500 μg/kg

    Fat

    500 μg/kg

    Liver

    5 000 μg/kg

    Kidney

    Chicken

    500 μg/kg

    Eggs

    Spectinomycin

    Spectinomycin

    Bovine

    200 μg/kg

    Milk

    Provisional MRLs expire on 1 July 1998

    Bovine, porcine, poultry

    300 μg/kg

    Muscle

    500 μg/kg

    Fat

    2 000 μg/kg

    Liver

    5 000 μg/kg

    Kidney

    Streptomycin

    Streptomycin

    Bovine, ovine

    200 μg/kg

    Milk

    Provisional MRLs expire on 1 June 2000’

    Bovine, ovine, porcine, poultry

    500 μg/kg

    Muscle

    500 μg/kg

    Fat

    500 μg/kg

    Liver

    1 000 μg/kg

    Kidney

    1.2.6.

    Quinolones

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Decoquinate

    Decoquinate

    Bovine, ovine

    500 μg/kg

    Muscle

    Provisional MRLs expire on 1 July 2000

    500 μg/kg

    Fat

    500 μg/kg

    Liver

    500 μg/kg

    Kidney

    Flumequine

    Flumequine

    Bovine, ovine, porcine, chicken

    50 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 2000

    Flumequine

    Flumequine

    Bovine, ovine, porcine, chicken

    50 μg/kg

    Fat or skin + fat

    Provisional MRLs expire on 1 January 2000

    100 μg/kg

    Liver

    300 μg/kg

    Kidney

    Salmonidae

    150 μg/kg

     

    Marbofloxacin

    Marbofloxacin

    Bovine

    150 μg/kg

    Muscle

    Provisional MRLs expire on 1 July 2000

    50 μg/kg

    Fat

    150 μg/kg

    Liver

    150 μg/kg

    Kidney

    75 μg/kg

    Milk

    Porcine

    150 μg/kg

    Muscle

    50 μg/kg

    Skin + fat

    150 μg/kg

    Liver

    150 μg/kg

    Kidney

    Sarafloxacin

    Sarafloxacin

    Salmonidae

    30 μg/kg

    Muscle and skin in natural proportions

    Provisional MRLs expire on 1 July 1998’

    1.2.9.

    Polymyxins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Colistin

    Colistin

    Bovine, ovine

    50 μg/kg

    Milk

    Provisional MRLs expire on 1 July 2000’

    Bovine, ovine, porcine, chicken, rabbits

    150 μg/kg

    Muscle

    150 μg/kg

    Fat

    150 μg/kg

    Liver

    200 μg/kg

    Kidney

    Chicken

    300 μg/kg

    Eggs

    1.2.10.

    Penicillins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Nafcillin

    Nafcillin

    Bovine

    30 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 1999

    For intramammary use only

    30 μg/kg

    Fat

    30 μg/kg

    Liver

    30 μg/kg

    Kidney

    30 μg/kg

    Milk

    Penethamate

    Benzylpenicillin

    Ovine

    150 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 2000’

    150 μg/kg

    Fat

    150 μg/kg

    Liver

    150 μg/kg

    Kidney

    4 μg/kg

    Milk

    Porcine

    50 μg/kg

    Muscle

    50 μg/kg

    Fat

    50 μg/kg

    Liver

    50 μg/kg

    Kidney

    1.2.11.

    Florfenicol and related compounds

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Florfenicol

    Sum of florfenicol and its metabolites measured as florfenicol-amine

    Fish

    1 000 μg/kg

    Muscle and skin in natural proportions

    Provisional MRLs expire on 1 July 2001’

    2.

    Antiparasitic agents

    2.1.

    Agents acting against endoparasites

    2.1.2.

    Benzimidazoles and pro-benzimidazoles

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Albendazole sulphoxide

    Sum of albendazole, albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole

    Bovine, ovine

    100 μg/kg

    Milk

    Provisional MRLs expire on 1 January 2000

    Bovine, ovine, pheasant

    100 μg/kg

    Muscle

    100 μg/kg

    Fat

    1 000 μg/kg

    Liver

    500 μg/kg

    Kidney

    Netobimin

    Sum of netobimin and albendazole and metabolites of albendazole measured as 2-amino-benzimidazole sulphone

    Bovine, ovine, caprine

    100 μg/kg

    Muscle

    Provisional MRLs expire on 31 July 1999’

    100 μg/kg

    Fat

    1 000 μg/kg

    Liver

    500 μg/kg

    Kidney

    100 μg/kg

    Milk

    2.2.

    Agents acting against ectoparasites

    2.2.1.

    Formamidines

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Amitraz

    Sum of amitraz and metabolites which are measured as 2,4-dime-thylaniline

    Bovine

    200 μg/kg

    Fat

    Provisional MRLs expire on 1 July 1998

    200 μg/kg

    Liver

    200 μg/kg

    Kidney

    10 μg/kg

    Milk

    Ovine

    400 μg/kg

    Fat

    200 μg/kg

    Liver

    200 μg/kg

    Kidney

    Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitraz

    Bees

    200 μg/kg

    Honey

    Provisional MRLs expire on 1 July 1999’

    2.2.2.

    Iminophenyl thiazolidine derivative

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Cymiazole

    Cymiazole

    Bees

    1 000 μg/kg

    Honey

    Provisional MRLs expire on 1 July 1999’

    2.2.4.

    Organophosphates

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Azamethiphos

    Azamethiphos

    Salmonidae

    100 μg/kg

    Muscle and skin in natural proportions

    Provisional MRLs expire on 1 June 1999’

    2.2.5.

    Acyl urea derivates

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Teflubenzuron

    Teflubenzuron

    Salmonidae

    500 μg/kg

    Muscle And skin in natural proportions

    Provisional MRLs expire on 1 July 1999’

    2.3.

    Agents acting against endo- and ectoparasites

    2.3.1.

    Avermectins

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Ivermectin

    22,23-Dihydro-aver-mectin Bla

    Deer, including reindeer

    20 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 1999

    100 μg/kg

    Fat

    50 μg/kg

    Liver

    20 μg/kg

    Kidney

    Moxidectin

    Moxidectin

    Equidae

    50 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 2000’

    500 μg/kg

    Fat

    100 μg/kg

    Liver

    50 μg/kg

    Kidney

    3.

    Agents acting on the nervous system

    3.2.

    Agents acting on the autonomic nervous system

    3.2.1.

    62 sympathomimetic agents

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Clenbuterol hydrochloride

    Clenbuterol

    Bovine (indication: solely for tocolysis in parturient cows)

    0,1 μg/kg

    Muscle

    Provisional MRLs expire on 1 July 2000’

    0,5 μg/kg

    Liver

    0,5 μg/kg

    Kidney

    0,05 μg/kg

    Milk

    Equidae (indications: locolysis and the treatment of respiratory ailments)

    0,1 μg/kg

    Muscle

    0,5 μg/kg

    Liver

    0,5 μg/kg

    Kidney

    5.

    Anti-inflammatory agents

    5.1.

    Non-steroidal anti-inflammatory agents

    5.1.1.

    Arylpropionic acid derivative

    Pharmacologically active substance(s)

    Marker residue

    Animal species

    MRLs

    Target tissues

    Other provisions

    ‘Carprofen

    Carprofen

    Bovine

    500 μg/kg

    Muscle

    Provisional MRLs expire on 1 January 2000’

    500 μg/kg

    Fat

    1 000 μg/kg

    Liver

    1 000 μg/kg

    Kidney

    Equidae

    50 μg/kg

    Muscle

    100 μg/kg

    Fat

    1 000 μg/kg

    Liver

    1 000 μg/kg

    Kidney

    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’


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