# Commission Regulation (EC) No 508/1999 of 4 March 1999 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 EU Regulation No 508/1999 · adopted 4 March 1999 Commission Regulation (EC) No 508/1999 of 4 March 1999 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 ## Introductory text Commission Regulation (EC) No 508/1999 of 4 March 1999 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 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, as last amended by Commission Regulation (EC) No 2728/98, and in particular Articles 6, 7 and 8 thereof, Whereas, since the adoption of Regulation (EEC) No 2377/90, the Annexes have been amended a number of times; whereas, since the texts are numerous, complex and dispersed among various Official Journals, they are difficult to use and thus lack the clarity which should be an essential feature of all legislation; whereas, certain of those Annexes 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: ## 1 Annexes I to IV to Regulation (EEC) No 2377/90 are hereby replaced by the texts set out in the Annex to this Regulation. ## 2 This Regulation shall enter into force on the 60th day following that of 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. ## Annex I: LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH MAXIMUM RESIDUE LIMITS HAVE BEEN FIXED ## 1 Anti-infectious agents ## 1.1 Chemotheurapeutics ## 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 derivatives 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 and 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 and 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 50 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 50 μg/kg Skin and 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 Dicloxacillin Dicloxacillin 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 Danofloxacin Danofloxacin Bovine 200 μg/kg Muscle Not for use in animals from which milk is produced for human consumption 100 μg/kg Fat 400 μg/kg Liver 400 μg/kg Kidney Chicken 200 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 100 μg/kg Skin and fat 400 μg/kg Liver 400 μg/kg Kidney Difloxacin Difloxacin Chicken, turkey 300 μg/kg Muscle 400 μg/kg Skin and fat 1 900 μg/kg Liver 600 μg/kg Kidney Enrofloxacin Sum of enrofloxacin and ciprofloxacin Bovine 100 μg/kg Muscle 100 μg/kg Fat 300 μg/kg Liver 200 μg/kg Kidney 100 μg/kg Milk Rabbits 100 μg/kg Muscle 100 μg/kg Fat 200 μg/kg Liver 300 μg/kg Kidney Porcine 100 μg/kg Muscle 100 μg/kg Skin and fat 200 μg/kg Liver 300 μg/kg Kidney Poultry 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 100 μg/kg Skin and fat 200 μg/kg Liver 300 μg/kg Kidney Sarafloxacin Sarafloxacin Chicken 10 μg/kg Skin and fat 100 μg/kg Liver Salmonidae 30 μg/kg Muscle and skin in natural proportions ## 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 Kidney 200 μg/kg Milk Chicken 200 μg/kg Muscle 300 μg/kg Skin and fat 400 μg/kg Liver Tilmicosin Tilmicosin Bovine, ovine, porcine 50 μg/kg Muscle 50 μg/kg Fat 1 000 μg/kg Liver 1 000 μg/kg Kidney Ovine 50 μg/kg Milk Chicken 75 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 75 μg/kg Skin and fat 1 000 μg/kg Liver 250 μg/kg Kidney 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 and fat 100 μg/kg Liver 100 μg/kg Kidney Poultry 100 μg/kg Muscle Not for use in hens producing eggs for human consumption 100 μg/kg Skin and 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 Thiamphenicol Thiamphenicol Bovine 50 μg/kg Muscle 50 μg/kg Fat 50 μg/kg Liver 50 μg/kg Kidney 50 μg/kg Milk Chicken 50 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 50 μg/kg Skin and fat 50 μg/kg Liver 50 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 Not for use in animals from which milk is produced for human consumption 300 μg/kg Liver 600 μg/kg Kidney Porcine 100 μg/kg Muscle 300 μg/kg Skin and fat 300 μg/kg Liver 600 μg/kg Kidney Poultry 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 300 μg/kg Skin and 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 Naphtalene-ringed ansamycin Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Rifaximin Rifaximin Bovine 60 μg/kg Milk ## 1.2.8 Pleuromutilines Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Valnemulin Valnemulin Porcine 50 μg/kg Muscle 500 μg/kg Liver 100 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 Albendazole Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole Bovine, ovine 100 μg/kg Muscle 100 μg/kg Fat 1 000 μg/kg Liver 500 μg/kg Kidney 100 μg/kg Milk Febantel Sum of extractable residues which may be oxidised to oxfendazole 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, equide 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) (4fluorophenyl) methanone Porcine, chicken, game birds 50 μg/kg Muscle 50 μg/kg Skin and 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 and 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 ketotriclabendazole 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 moiety, expressed as amitraz Bovine 200 μg/kg Fat 200 μg/kg Liver 200 μg/kg Kidney 10 μg/kg Milk Ovine 400 μg/kg Fat 100 μg/kg Liver 200 μg/kg Kidney 10 μg/kg Milk Porcine 400 μg/kg Skin and fat 200 μg/kg Liver 200 μg/kg Kidney ## 2.2.3 Pyrethroids Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Flumethrin Flumethrin (sum of trans-Z isomers) Bovine 10 μg/kg Muscle 150 μg/kg Fat 20 μg/kg Liver 10 μg/kg Kidney 30 μg/kg Milk ## 2.3 Agents acting against endo- and ectoparasites ## 2.3.1 Avermectins Phramacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Abamectin Avermectin B1a Bovine 10 μg/kg Fat 20 μg/kg Liver Doramectin Doramectin Bovine 10 μg/kg Muscle Not for use in bovine 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 Not for use in ovine from which milk is produced for human consumption 100 μg/kg Fat 50 μg/kg Liver 30 μg/kg Kidney Eprinomectin Eprinomectin B1a 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-avermectin B1a Bovine 40 μg/kg Fat 100 μg/kg Liver Porcine, ovine, equidae 20 μg/kg Fat 15 μg/kg Liver Deer, including reindeer 20 μg/kg Muscle 100 μg/kg Fat 50 μg/kg Liver 20 μg/kg Kidney Moxidectin Moxidectin Bovine, ovine 50 μg/kg Muscle 500 μg/kg Fat 100 μg/kg Liver 50 μg/kg Kidney ## 2.4 Agents acting against protozoa ## 2.4.1 Triazinetrione derivative Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Toltrazuril Toltrazuril sulfone Chicken 100 μg/kg Muscle Not for use in animals from which eggs are produced for human consumption 200 μg/kg Skin and fat 600 μg/kg Liver 400 μg/kg Kidney Turkey 100 μg/kg Muscle 200 μg/kg Skin and fat 600 μg/kg Liver 400 μg/kg Kidney ## 3 Agents acting on the nervous system ## 3.1 Agents acting on the central nervous system ## 3.1.1 Butyrophenone tranquillisers Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Azaperone Sum of azaperone and azaperol Porcine 100 μg/kg Muscle 100 μg/kg Skin and fat 100 μg/kg Liver 100 μg/kg Kidney ## 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 and fat 25 μg/kg Liver 25 μg/kg Kidney ## 4 Anti-inflammatory agents ## 4.1 Nonsteroidal anti-inflammatory 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 derivatives 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 0,3 μg/kg Milk Bovine, porcine, equidae 0,75 μg/kg Muscle 2 μg/kg Liver 0,75 μg/kg Kidney ## Annex II: LIST OF SUBSTANCES NOT SUBJECT TO MAXIMUM RESIDUE LIMITS ## 1 Inorganic chemicals Pharmacologically active substance(s) Animal species Other provisions Aluminium distearate All food-producing species Aluminium hydroxide acetate All food-producing species Aluminium phosphate All food-producing species Aluminium tristearate All food-producing species Ammonium chloride All food-producing species 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 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 All food-producing species Calcium glucoheptonate All food-producing species Calcium glucono glucoheptonate All food-producing species Calcium gluconolactate All food-producing species Calcium glutamate All food-producing species Cobalt carbonate All food-producing species Cobalt dichloride All food-producing species Cobalt gluconate All food-producing species Cobalt oxide All food-producing species Cobalt sulphate All food-producing species Cobalt trioxide All food-producing species Copper chloride All food-producing species Copper gluconate All food-producing species Copper heptanoate All food-producing species Copper methionate All food-producing species Copper oxide All food-producing species Copper sulphate All food-producing species Dicopper oxide All food-producing species Hydrochloric acid All food-producing species For use as excipient Hydrogen peroxide All food-producing species Iodine and iodine inorganic compounds including: Sodium and potassium-iodide Sodium and potassium-iodate Iodophors including polyvinylpyrrolidone-iodine All food-producing species Iron dichloride All food-producing species Iron sulphate All food-producing species Magnesium Magnesium sulphate Magnesium hydroxide Magnesium stearate Magnesium glutamate Magnesium orotate Magnesium aluminium silicate Magnesium oxide Magnesium carbonate Magnesium phosphate Magnesium glycerophosphate Magnesium aspartate Magnesium citrate Magnesium acetate Magnesium trisilicate All food-producing species Nickel gluconate All food-producing species Nickel sulphate All food-producing species 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 hypophosphite All food-producing species Sodium selenate All food-producing species Sodium selenite All food-producing species Sulphur Bovine, porcine, ovine, caprine, equidae Zinc acetate Zinc chloride Zinc gluconate Zinc oleate Zinc stearate All food-producing species ## 2 Organic compounds Pharmacologically active substance(s) Animal species Other provisions 17β-Oestradiol All mammalian food-producing species For therapeutic and zootechnical uses only 2-Aminoethanol All food-producing species 2-Aminoethyl dihydrogenphosphate All food-producing species 2-Pyrrolidone All food-producing species At parenteral doses up to 40 mg/kg bw 8-Hydroxyquinoline All mammalian food-producing species For topical use in newborn animals only Acetyl cysteine All food-producing species Alfacalcidol Bovine For parturient cows only Alfaprostol Rabbits Bovine, porcine, equidae Bacitracin Bovine For intramammary use in lactating cows only and for all tissues except milk Benzalkonium chloride All food-producing species For use as an excipient at concentrations up to 0,05 % only Benzocaine All food-producing species For use as local anaesthetic only Benzylalcohol All food-producing species For use as excipient Betaine All food-producing species Bronopol Salmonidae For use only on farmed fertilised eggs Brotizolam Bovine For therapeutic uses only Buserelin All food-producing species Butorphanol tartrate Equidae For intravenous administration only Butyl 4-hydroxybenzoate All food-producing species Butylscopolaminium bromide 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 Cetostearyl alcohol All food-producing species Cetrimide All food-producing species Chlorhexidine All food-producing species For topical use only Chlorocresol All food-producing species Clazuril Pigeon Cloprostenol Bovine, porcine, equidae Coco alkyl dimethyl betaines All food-producing species For use as excipient Corticotropin All food-producing species D-Phe 6 -luteinising-hormone releasing hormone All food-producing species Dembrexine Equidae Denaverine hydrochloride Bovine Detomidine Bovine, equidae For therapeutic uses only Diclazuril Ovine For oral use in lambs only Diethyl phtalate All food-producing species Diethylene glycol monoethyl ether Bovine, porcine Dimanganese trioxide All food-producing species For oral use only Dimethyl phtalate All food-producing species Dinoprost All mammalian food-producing species Dinoprost tromethamine All mammalian food-producing species Diprophylline All 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 Flumethrin Bees (honey) 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 Hexetidine Equidae For topical use only Human chorion gonadotrophin All food-producing species Human menopausal urinary gonadotrophin Bovine Hydrocortisone All food-producing species For topical use only 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) Ketamine All food-producing species Ketanserin tartrate Equidae Ketoprofen Bovine, porcine, equidae 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 Bovine, equidae, rabbits Lobeline All food-producing species Luprostiol All mammalian species Malic acid All food-producing species For use as excipient Manganese carbonate All food-producing species For oral use only Manganese chloride All food-producing species For oral use only Manganese gluconate All food-producing species For oral use only Manganese glycerophosphate All food-producing species For oral use only Manganese oxide All food-producing species For oral use only Manganese pidolate All food-producing species For oral use only Manganese ribonucleate All food-producing species For oral use only Manganese sulphate All food-producing species For oral use only Mecillinam Bovine For intrauterine use only Medroxyprogesterone acetate Ovine For intravaginal use for zootechnical purposes only Melatonin Ovine, caprine Menadione All food-producing species Menbutone Bovine, ovine, caprine, porcine, equidae Menthol All food-producing species Methyl nicotinate Bovine, equidae For topical use only Mineral hydrocarbons, low to high viscosity including microcristalline 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 Natamycin Bovine, equidae For topical use only Neostigmine All food-producing species Nicoboxil Equidae For topical use only Nonivamide Equidae For topical use only Oleyloleate All food-producing species For topical use only Oxytocin All mammalian food-producing species Pancreatin All mammalian food-producing species For topical use only Papain All food-producing species Papaverine Bovine Newborn calves only Peracetic acid All food-producing species Phenol All food-producing species Phloroglucinol All food-producing species Phytomenadione All food-producing species Policresulen All food-producing species For topical use only Polyethylene glycol 15 hydroxystearate All food-producing species For use as excipient Polyethylene glycol 7 glyceryl cocoate All food-producing species For topical use only Polyethylene glycol stearates with 8-40 oxyethylene units All food-producing species For use as excipient Polysulphated glycosaminoglycan Equidae Praziquantel Ovine Equidae For use in non-lactating sheep only Pregnant mare serum gonadotrophin All food-producing species Prethcamide (crotethamide and cropropamide) All mammalian food-producing species Procaine 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 % R-Cloprostenol Bovine, porcine, equidae Rifaximin All mammalian food-producing species Bovine For topical use only For intramammary use, except if the udder may be used as food for human consumption, and intrauterine use only Romifidine Equidae For therapeutic uses only Sodium 2-methyl-2-phenoxy-propanoate Bovine, porcine, caprine, equidae Sodium benzyl 4-hydroxybenzoate All food-producing species Sodium butyl 4-hydroxybenzoate All food-producing species Sodium cetostearyl sulphate All food-producing species For topical use only Somatosalm Salmon Tanninum All food-producing species Tau fluvalinate Terpin hydrate Bovine, porcine, ovine, caprine Tetracaine All food-producing species For use as anaesthetic only Theobromine All food-producing species Theophylline All food-producing species Thiomersal All food-producing species For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 % Thymol All food-producing species Timerfonate All food-producing species For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 % Trimethylphloroglucinol All food-producing species Vitamin D All food-producing species Wool alcohols All food-producing species For topical use only ## 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 Benzyl 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 Lanolin All food-producing species Luteinising hormone (natural LH from all species and their synthetic analogues) 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 ten thousand 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). ## 6 Substances of vegetable origin Pharmacologically active substance(s) Animal species Other provisions Angelicae radix aetheroleum All food-producing species Anisi aetheroleum All food-producing species Balsamum peruvianum All food-producing species For topical use only Carvi aetheroleum All food-producing species Caryophylli aetheroleum All food-producing species Chrysanthemi cinerariifolii flos All food-producing species For topical use only Cinnamomi cassiae aetheroleum All food-producing species Cinnamomi ceylanici aetheroleum All food-producing species Citri aetheroleum All food-producing species Citronellae aetheroleum All food-producing species Coriandri aetheroleum All food-producing species Echinacea purpurea All food-producing species For topical use only Eucalypti aetheroleum All food-producing species Foeniculi aetheroleum All food-producing species Hamamelis virginiana All food-producing species For topical use only Hyperici oleum All food-producing species For topical use only Lespedeza capitata All food-producing species Lini oleum All food-producing species Majoranae herba All food-producing species Matricariae flos All food-producing species Medicago sativa extractum All food-producing species For topical use only Melissae folium All food-producing species Menthae piperitae aetheroleum All food-producing species Millefolii herba All food-producing species Myristicae aetheroleum All food-producing species For use in newborn animals only Oxidation products of Terebinthinae oleum Bovine, porcine, ovine, caprine Pyrethrum extract All food-producing species For topical use only Quercus cortex All food-producing species Quillaia saponins All food-producing species Ricini oleum All food-producing species For use as excipient Rosmarini aetheroleum All food-producing species Rosmarini folium All food-producing species Salviae folium All food-producing species Sambuci flos All food-producing species Sinapis nigrae semen All food-producing species Terebinthinae aetheroleum rectificatum All food-producing species For topical use only Terebinthinae laricina All food-producing species For topical use only Thymi aetheroleum All food-producing species Tiliae flos All food-producing species Urticae herba 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 Anti-infectious agents ## 1.1 Chemotheurapeutics ## 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 MRLs apply to all microbiological active residues expressed as erythromycin equivalent Bovine, ovine 40 μg/kg Milk Provisional MRLs expire on 1 June 2000 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 ## 1.2.5 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 1 000 μg/kg Muscle Provisional MRLs expire on 1 July 1999 For use in non-lactating cattle only 1 000 μg/kg Fat 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 framycetin) Neomycin Bovine, ovine, caprine 500 μg/kg Milk Provisional MRLs expire on 1 June 2000 Bovine, ovine, caprine, porcine, chicken, turkey, duck 500 μg/kg Muscle 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 2000 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 Enrofloxacin Sum of enrofloxacin and ciprofloxacin Ovine 100 μg/kg Muscle Provisional MRLs expire on 1 July 1999 100 μg/kg Fat 300 μg/kg Liver 200 μg/kg Kidney Flumequine Flumequine Bovine, ovine, porcine, chicken 50 μg/kg Muscle Provisional MRLs expire on 1 January 2000 50 μg/kg Fat or skin and fat 100 μg/kg Liver 300 μg/kg Kidney Salmonidae 150 μg/kg Muscle and skin 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 and fat 150 μg/kg Liver 150 μg/kg Kidney ## 1.2.9 Polymyxins Phamarcologically 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 Penethamate Benzylpenicillin Ovine 50 μg/kg Muscle Provisional MRLs expire on 1 January 2000 50 μg/kg Fat 50 μg/kg Liver 50 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 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 ## 2.2.3 Pyretrin and pyrethroids Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Cyfluthrin Cyfluthrin Bovine 10 μg/kg Muscle Provisional MRLs expire on 1 January 2001 50 μg/kg Fat 10 μg/kg Liver 10 μg/kg Kidney 20 μg/kg Milk Further provisions in Council Directive 94/29/EC are to be observed (OJ L 189, 23.7.1994, p. 67) ## 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 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 β 2 sympathomimetic agents Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Clenbuterol hydrochloride Clenbuterol Bovine 0,1 μg/kg Muscle Provisional MRLs expire on 1 July 2000 Indication: solely for tocolysis in parturient cows 0,5 μg/kg Liver 0,5 μg/kg Kidney 0,05 μg/kg Milk Equidae 0,1 μg/kg Muscle Indications: tocolysis and the treatment of respiratory ailments 0,5 μg/kg Liver 0,5 μg/kg Kidney ## 5 Anti-inflammatory agents ## 5.1 Nonsteroidal 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 ## 5.1.2 Enolic acid derivates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Meloxicam Meloxicam Bovine 25 μg/kg Muscle Provisional MRLs expire on 1 January 2000 60 μg/kg Liver 35 μg/kg Kidney ## Annex IV LIST OF PHARMACOLOGICALLY ACTIVE SUBSTANCES FOR WHICH NO MAXIMUM LEVELS CAN BE FIXED Pharmacologically active substance(s) Aristolochia spp. and preparations thereof Chloramphenicol Chloroform Chlorpromazine Colchicine Dapsone Dimetridazole Metronidazole Nitrofurans (including furazolidone) Ronidazole --- Source: https://www.legislation.gov.uk/eur/1999/508 (the official version) Page: https://openlegislation.uk/eu-regulation-1999-508 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.