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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

Type Regulation

Publication 1999-03-09

Last updated 1999-05-08

State Repealed

Department European Commission

Source EUR-Lex

articles 2

Reform history JSON API

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 ([^E0001]), as last amended by Commission Regulation (EC) No 2728/98 ([^E0002]), 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
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
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
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
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
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
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
Valnemulin	Valnemulin	Porcine	50 μg/kg	Muscle
			500 μg/kg	Liver
			100 μg/kg	Kidney

1. Antiparasitic agents

2.1. Agents acting against endoparasites

2.1.1. Salicylanilides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
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
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
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
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
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

1. 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
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
Carazolol	Carazolol	Porcine	5 μg/kg	Muscle
			5 μg/kg	Skin and fat
			25 μg/kg	Liver
			25 μg/kg	Kidney

1. 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
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
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

1. Corticoides

5.1. Glucocorticoides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
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

1. 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

1. 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

1. 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

1. 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).

1. 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

1. 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

1. 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

1. 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

[^E0001]: OJ L 224, 18. 8. 1990, p. 1.

[^E0002]: OJ L 343, 18. 12. 1998, p. 8.

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