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
Corrected by
  • Corrigendum to Commission Regulation (EC) No 508/1999 of 4 March 1999 amending Annexes I to IV of 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, 399R0508R(01), April 30, 2008
  • Corrigendum to Commission Regulation (EC) No 508/1999 of 4 March 1999 amending Annexes I to IV of 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, 399R0508R(02), November 19, 2009
Commission Regulation (EC) No 508/1999of 4 March 1999amending 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 originOJ L 224, 18. 8. 1990, p. 1., as last amended by Commission Regulation (EC) No 2728/98OJ L 343, 18. 12. 1998, p. 8., 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:
Article 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.
Article 2 This Regulation shall enter into force on the 60th day following that of 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. 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
1900 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
1000 μg/kg Liver
1000 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
1000 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
3000 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 1000 μg/kg Muscle
3000 μg/kg Fat
1000 μg/kg Liver
3000 μg/kg Kidney
Ovine 1500 μg/kg Muscle
2000 μg/kg Fat
1500 μg/kg Liver
5000 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
1000 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
1000 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 acetateCalcium benzoateCalcium carbonateCalcium chlorideCalcium gluconateCalcium hydroxideCalcium hypophosphiteCalcium malateCalcium oxideCalcium phosphateCalcium polyphosphatesCalcium propionateCalcium silicateCalcium stearateCalcium 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
MagnesiumMagnesium sulphateMagnesium hydroxideMagnesium stearateMagnesium glutamateMagnesium orotateMagnesium aluminium silicateMagnesium oxideMagnesium carbonateMagnesium phosphateMagnesium glycerophosphateMagnesium aspartateMagnesium citrateMagnesium acetateMagnesium 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 acetateZinc chlorideZinc gluconateZinc oleateZinc 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 RabbitsBovine, 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 BovineOvine, 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 OvineEquidae 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 speciesBovine For topical use onlyFor 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 10000) 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 speciesFor 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
1500 μg/kg Liver
1500 μg/kg Kidney
Apramycin Apramycin Bovine 1000 μg/kg Muscle Provisional MRLs expire on 1 July 1999
For use in non-lactating cattle only 1000 μg/kg Fat
10000 μg/kg Liver
20000 μg/kg Kidney
Porcine 1000 μg/kg Muscle
1000 μg/kg Skin and fat
1000 μg/kg Liver
5000 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
1000 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
1000 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
5000 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
2000 μg/kg Liver
5000 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
1000 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 1000 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
1000 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
1000 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 1000 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
1000 μg/kg Liver
1000 μg/kg Kidney
Equidae 50 μg/kg Muscle
100 μg/kg Fat
1000 μg/kg Liver
1000 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