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Document 31998R1570

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Commission Regulation (EC) No 1570/98 of 17 July 1998 amending Annexes I to IV to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (Text with EEA relevance)

OJ L 205, 22.7.1998, p. 10–39 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 03 Volume 023 P. 244 - 273
Special edition in Estonian: Chapter 03 Volume 023 P. 244 - 273
Special edition in Latvian: Chapter 03 Volume 023 P. 244 - 273
Special edition in Lithuanian: Chapter 03 Volume 023 P. 244 - 273
Special edition in Hungarian Chapter 03 Volume 023 P. 244 - 273
Special edition in Maltese: Chapter 03 Volume 023 P. 244 - 273
Special edition in Polish: Chapter 03 Volume 023 P. 244 - 273
Special edition in Slovak: Chapter 03 Volume 023 P. 244 - 273
Special edition in Slovene: Chapter 03 Volume 023 P. 244 - 273
Special edition in Bulgarian: Chapter 03 Volume 025 P. 6 - 35
Special edition in Romanian: Chapter 03 Volume 025 P. 6 - 35

Legal status of the document No longer in force, Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470

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

Date of document:: 17/07/1998
Date of effect:: 20/09/1998; Entry into force Date pub. + 60 See Art 2
Date of end of validity:: 05/07/2009; Implicitly repealed by 32009R0470

Author:: European Commission
Form:: Regulation
Additional information:: Extended to the EEA by 22000D1123(04), EEA relevance
Authentic language:: Spanish, Danish, German, Greek, English, French, Italian, Dutch, Portuguese, Finnish, Swedish, Icelandic, Norwegian

Treaty:

Treaty establishing the European Community

Legal basis:

31990R2377 - A06 31990R2377 - A07 31990R2377 - A08

Link

Select all documents mentioning this document

Modifies:

Relation	Act	Comment	Subdivision concerned	From
Modifies	31990R2377	Completion	annex 4	20/09/1998
Modifies	31990R2377	Completion	annex 1	20/09/1998
Modifies	31990R2377	Completion	annex 3	20/09/1998
Modifies	31990R2377	Completion	annex 2	20/09/1998

Modified by:

Relation	Act	Comment	Subdivision concerned	From	To
Corrected by	31998R1570R(01)
Implicitly repealed by	32009R0470			06/07/2009

Link

EUROVOC descriptor:

Subject matter:

Veterinary legislation

Directory code:

03.50.30.00 Agriculture / Approximation of laws and health measures / Animal health and zootechnics

HTML

PDF

Official Journal

22.7.1998

Official Journal of the European Communities

L 205/10

COMMISSION REGULATION (EC) No 1570/98

of 17 July 1998

amending Annexes I to IV to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (1), as last amended by Commission Regulation (EC) No 1569/98 (2), and in particular Articles 6, 7 and 8 thereof,

Whereas, since the adoption of the Regulation, the Annexes have been amended a number of times; whereas, by reason of their number, their complexity and their dispersal among various Official Journals, the texts are difficult to use and thus lack the clarity which should be an essential feature of all legislation; whereas, they should therefore be consolidated; whereas on the same occasion the name or chemical description of some compounds should be rectified or made more precise and certain material errors should be corrected;

Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I to IV to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on the 60th day following its publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 17 July 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

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

(2) See page 7 of this Official Journal.

ANNEX

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

Anti-infectious agents

1.1.

Chemotherapeutics

1.1.1.

Sulfonamides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘All substances belonging to the sulfonamide group	Parent drug	All food producing species	100 μg/kg	Muscle	The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg’
			100 μg/kg	Fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
		Bovine, ovine, caprine	100 μg/kg	Milk

1.1.2.

Diamino pyrimidine derivates

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Baquiloprim	Baquiloprim	Bovine	10 μg/kg	Fat
			300 μg/kg	Liver
			150 μg/kg	Kidney
			30 μg/kg	Milk
		Porcine	40 μg/kg	Skin + fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
Trimethoprim	Trimethoprim	Bovine	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
			50 μg/kg	Milk
		Porcine	50 μg/kg	Muscle
			50 μg/kg	Skin + fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
		Equidae	100 μg/kg	Muscle
			100 μg/kg	Fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
		Poultry not for use in animals from which eggs are produced for human consumption	50 μg/kg	Muscle
			50 μg/kg	Skin + fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
		Fin fish	50 μg/kg	Muscle and skin in natural proportions’

1.2.

Antibiotics

1.2.1.

Penicillins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Amoxicyllin	Amoxicyllin	All food producing species	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
			4 μg/kg	Milk
Ampicillin	Ampicillin	All food producing species	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
			4 μg/kg	Milk
Benzylpenicillin	Benzylpenicillin	All food producing species	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
			4 μg/kg	Milk
Cloxacillin	Cloxacillin	All food producing species	300 μg/kg	Muscle
			300 μg/kg	Fat
			300 μg/kg	Liver
			300 μg/kg	Kidney
			30 μg/kg	Milk
Oxacillin	Oxacillin	All food producing species	300 μg/kg	Muscle
			300 μg/kg	Fat
			300 μg/kg	Liver
			300 μg/kg	Kidney
			30 μg/kg	Milk
Penethamate	Benzylpenicillin	Bovine	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
			4 μg/kg	Milk’

1.2.2.

Cephalosporins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Cefazolin	Cefazolin	Bovine, ovine, caprine	50 μg/kg	Milk
Cefquinome	Cefquinome	Bovine	50 μg/kg	Muscle
			50 μg/kg	Fat
			100 μg/kg	Liver
			200 μg/kg	Kidney
			20 μg/kg	Milk’

1.2.3.

Quinolones

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Danofloxacine	Danofloxacine	Bovine (not for use in animals from which milk is produced for human consumption)	200 μg/kg	Muscle
			100 μg/kg	Fat
			400 μg/kg	Liver
			400 μg/kg	Kidney
		Chicken (not for use in animals from which eggs are produced for human consumption)	200 μg/kg	Muscle
			100 μg/kg	Skin + fat
			400 μg/kg	Liver
			400 μg/kg	Kidney
Difloxacin	Difloxacin	Chicken, turkey	300 μg/kg	Muscle
			400 μg/kg	Skin + fat
			1 900 μg/kg	Liver
			600 μg/kg	Kidney
Enrofloxacin	Sum of enrofloxacin and ciprofloxacin	Bovine, porcine, poultry	30 μg/kg	Muscle
			30 μg/kg	Liver
			30 μg/kg	Kidney
Sarafloxacin	Sarafloxacin	Chicken	10 μg/kg	Skin + fat
Sarafloxacin	Sarafloxacin	Chicken	100 μg/kg	Liver’

1.2.4.

Macrolides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Spiramycin	Sum of spiramycin and neospiramycin	Bovine	200 μg/kg	Muscle
			300 μg/kg	Fat
			300 μg/kg	Liver
			300 μg/kg	Kidley
			200 μg/kg	Milk
		Chicken	200 μg/kg	Muscle
			300 μg/kg	Skin + fat
			400 μg/kg	Liver
Tilmicosin	Tilmicosin	Bovine, ovine, porcine	1 000 μg/kg	Liver
		Bovine, ovine, porcine	1 000 μg/kg	Kidney
		Ovine	50 μg/kg	Milk
Tylosin	Tylosin A	Bovine	100 μg/kg	Muscle
			100 μg/kg	Fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
			50 μg/kg	Milk
		Porcine	100 μg/kg	Muscle
			100 μg/kg	Skin + fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
		Poultry (not for use in hens producing eggs for human consumption)	100 μg/kg	Muscle
			100 μg/kg	Skin + fat
			100 μg/kg	Liver
			100 μg/kg	Kidney’

1.2.5.

Florfenicol and related compounds

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Florfenicol	Sum of florfenicol and its metabolites measured as florfenicol-amine	Bovine	200 μg/kg	Muscle
			3 000 μg/kg	Liver
			300 μg/kg	Kidney’

1.2.6.

Tetracyclines

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Chlortetracycline	Sum of parent drug and its 4-epimer	All food producing species	100 μg/kg	Muscle
			300 μg/kg	Liver
			600 μg/kg	Kidney
			100 μg/kg	Milk
			200 μg/kg	Eggs
Doxycycline	Doxycycline	Bovine	100 μg/kg	Muscle
			300 μg/kg	Liver
			600 μg/kg	Kidney
		Porcine, poultry	100 μg/kg	Muscle
			300 μg/kg	Skin + fat
			300 μg/kg	Liver
			600 μg/kg	Kidney
Oxytetracycline	Sum of parent drug and its 4-epimer	All food producing species	100 μg/kg	Muscle
			300 μg/kg	Liver
			600 μg/kg	Kidney
			100 μg/kg	Milk
			200 μg/kg	Eggs
Tetracycline	Sum of parent drug and its 4-epimer	All food producing species	100 μg/kg	Muscle
			300 μg/kg	Liver
			600 μg/kg	Kidney
			100 μg/kg	Milk
			200 μg/kg	Eggs’

1.2.7.

Thiamphenicol and related compounds

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Thiamphenicol	Thiamphenicol	Bovine	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney
			50 μg/kg	Milk
		Chicken (not for use in animals from which eggs are produced for human consumption)	50 μg/kg	Muscle
			50 μg/kg	Skin + fat
			50 μg/kg	Liver
			50 μg/kg	Kidney’

Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.1.

Salicylanilides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Closantel	Closantel	Bovine	1 000 μg/kg	Muscle
			3 000 μg/kg	Fat
			1 000 μg/kg	Liver
			3 000 μg/kg	Kidney
		Ovine	1 500 μg/kg	Muscle
			2 000 μg/kg	Fat
			1 500 μg/kg	Liver
			5 000 μg/kg	Kidney’

2.1.2.

Tatra-hydro-imidazoles (imidazolthiazoles)

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Levamisole	Levamisole	Bovine, ovine, porcine, poultry	10 μg/kg	Muscle
			10 μg/kg	Fat
			100 μg/kg	Liver
			10 μg/kg	Kidney’

2.1.3.

Benzimidazoles and pro-benzimidazoles

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Febantel	Sum of extractable residues which may be oxidised to oxfendazole sulphone	Bovine, ovine	10 μg/kg	Milk
		Bovine, ovine, porcine, equidae	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
Fenbendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	Bovine, ovine	10 μg/kg	Milk
		Bovine, ovine, porcine, equidae	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
Flubendazole	Sum of flubendazole and (2-amino 1H-benzimidazol-5-yl) (4-flurorophenyl)methanone	Porcine, chicken, game birds	50 μg/kg	Muscle
			50 μg/kg	Skin + fat
			400 μg/kg	Liver
			300 μg/kg	Kidney
	Flubendazole	Chicken	400 μg/kg	Eggs
Oxfendazole	Sum of extractable residues which may be oxidised to oxfendazole sulphone	Bovine, ovine	10 μg/kg	Milk
		Bovine, ovine, porcine, equidae	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
Oxibendazole	Oxibendazole	Porcine	100 μg/kg	Muscle
			500 μg/kg	Skin + fat
			200 μg/kg	Liver
			100 μg/kg	Kidney
Thiabendazole	Sum of thiabendazole and 5-hydroxythiabendazole	Bovine	100 μg/kg	Muscle
			100 μg/kg	Fat
			100 μg/kg	Liver
			100 μg/kg	Kidney
			100 μg/kg	Milk
Triclabendazole	Sum of extractable residues that may be oxidised to ketotriclaben-dazole	Bovine, ovine	100 μg/kg	Muscle	Not for use in animals from which milk is produced for human consumption’
			100 μg/kg	Liver
			100 μg/kg	Kidney

2.2.

Agents acting against ectoparasites

2.2.1.

Organophosphates

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Diazinon	Diazinon	Bovine, ovine, caprine	20 μg/kg	Milk
		Bovine, porcine, ovine, caprine	20 μg/kg	Muscle
			700 μg/kg	Fat
			20 μg/kg	Liver
			20 μg/kg	Kidney’

2.2.2.

Formamidines

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Amitraz	Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitraz	Porcine	400 μg/kg	Skin + fat
			200 μg/kg	Liver
			200 μg/kg	Kidney’

2.3.

Agents acting against endo- and ectoparasites

2.3.1.

Avermectins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Abamectin	Avermectin Bla	Bovine	10 μg/kg	Fat
‘Abamectin	Avermectin Bla	Bovine	20 μg/kg	Liver
Doramectin	Doramectin	Bovine	10 μg/kg	Muscle	Not for use in ovines from which milk is produced for human consumption’
			150 μg/kg	Fat
			100 μg/kg	Liver
			30 μg/kg	Kidney
		Porcine, ovine	20 μg/kg	Muscle
			100 μg/kg	Fat
			50 μg/kg	Liver
			30 μg/kg	Kidney
Eprinomectin	Eprinomectin Bla	Bovine	30 μg/kg	Muscle
			30 μg/kg	Fat
			600 μg/kg	Liver
			100 μg/kg	Kidney
			30 μg/kg	Milk
Ivermectin	22,23-Dihydro-aver-mectin Bla	Bovine	40 μg/kg	Fat
		Bovine	100 μg/kg	Liver
		Porcine, ovine, equidae	20 μg/kg	Fat
		Porcine, ovine, equidae	15 μg/kg	Liver
Moxidectin	Moxidectin	Bovine, ovine	50 μg/kg	Muscle
			500 μg/kg	Fat
			100 μg/kg	Liver
			50 μg/kg	Kidney

Agents acting on the nervous system

3.2.

Agents acting on the autonomic nervous system

3.2.1.

Anti-adrenergics

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Carazolol	Carazolol	Porcine	5 μg/kg	Muscle
			5 μg/kg	Skin + fat
			25 μg/kg	Liver
			25 μg/kg	Kidney’

Anti-infammatory agents

4.1.

Nonsteroidal anti-infammatory agents

4.1.1.

Arylpropionic acid derivative

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Vedaprofen	Vedaprofen	Equidae	50 μg/kg	Muscle
			20 μg/kg	Fat
			100 μg/kg	Liver
			1 000 μg/kg	Kidney’

4.1.2.

Fenamate group derivates

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Tolfenamic acid	Tolfenamic acid	Bovine	50 μg/kg	Muscle
			400 μg/kg	Liver
			100 μg/kg	Kidney
			50 μg/kg	Milk
		Porcine	50 μg/kg	Muscle
			400 μg/kg	Liver
			100 μg/kg	Kidney’

Corticoides

5.1.

Glucocorticoides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Dexamethasone	Dexamethasone	Bovine	03 μg/kg	Milk
		Bovine, porcine, equidae	0,75 μg/kg	Muscle
			2 μg/kg	Liver
			0,75 μg/kg	Kidney’

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

Inorganic chemicals

Pharmacologically active substance(s)

Animal species

Other provisions

‘Bismuth subcarbonate

All food producing species

For oral use only

Bismuth subgallate

All food producing species

For oral use only

Bismuth subnitrate

All food producing species

For oral use only

Bismuth subsalicylate

All food producing species

For oral use only

Boric acid and borates

All food producing species

Bromide, Sodium salt

All mammalian food producing species

For topical use only

Calcium acetate

All food producing species

Calcium benzoate

Calcium carbonate

Calcium chloride

Calcium gluconate

Calcium hydroxide

Calcium hypophosphite

Calcium malate

Calcium oxide

Calcium phosphate

Calcium polyphosphates

Calcium propionate

Calcium silicate

Calcium stearate

Calcium sulphate

Hydrochloric acid

All food producing species

For use as excipient

Hydrogen peroxide

All food producing species

Iodine and iodine inorganic compounds including:

—	All food producing species

—	Sodium and potassium-iodide

—	Sodium and potassium-iodide

Iodophors including polyvinylpyrrolidone-iodine

Magnesium

All food producing species

Magnesium sulphate

Magnesium hydroxide

Magnesium stearate

Magnesium glutamate

Magnesium orotate

Magnesium aluminium silicate

Magnesium oxide

Magnesium carbonate

Magnesium phosphate

Magnesium glycerophosphate

Magnesium asparate

Magnesium citrate

Magnesium acetate

Magnesium trisilicate

Potassium DL-aspartate

All food producing species

Potassium glucuronate

All food producing species

Potassium glycerophosphate

All food producing species

Potassium nitrate

All food producing species

Potassium selenate

All food producing species

Sodium chlorite

Bovine

For topical use only

Sodium dichloroisocyanurate

Bovine, ovine, caprine

For topical use only’

Sodium selenate

All food producing species

Sodium selenite

All food producing species

Sulphur

Bovine, porcine, ovine, caprine, equidae

Zinc acetate

All food producing species

Zinc chloride

Zinc gluconate

Zinc oleate

Zinc stearate

Organic compounds

Pharmacologically active substance(s)

Animal species

Other provisions

‘17B-Oestradiol

All mammalian food producing species

For therapeutic and zootechnical uses only

Acetyl cysteine

All food producing species

Alfaprostol

Bovine, porcine, equidae

Benzylalcohol

All food producing species

For use as excipient

Betaine

All food producing species

Brotizolam

Bovine

For therapeutic uses only

Buserelin

All food producing species

Butyl 4-hydroxybenzoate

All food producing species

Caffeine

All food producing species

Carbetocin

All mammalian food producing species

Cefazolin

Bovine

Ovine, caprine

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

Cetrimide

All food producing species

Chlorhexidine

All food producing species

For topical use only

Chlorocresol

All food producing species

Cloprostenol

Bovine, porcine, equidae

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

All food producing species

Dembrexine

Equidae

Detomidine

Bovine, equidae

For therapeutic uses only

Diclazuril

Ovine

For oral use in lambs only

Dicloxacillin

All food producing species

Diethyl phtalate

All food producing species

Dimethyl phtalate

All food producing species

Dinoprost tromethamine

All mammalian food producing species

Etamiphylline camsylate

All food producing species

Ethanol

All food producing species

For use as excipient

Ethyl lactate

All food producing species

Etiproston tromethamine

Bovine, porcine

Fertirelin acetate

Bovine

Folic acid

All food producing species

Glycerol formal

All food producing species

Gonadotrophin releasing hormone

All food producing species

Heptaminol

All food producing species

Hesperidin

Equidae

Hesperidin methyl chalcone

Equidae

Human chorion gonadotrophin (HCG)

All food producing species

Human menopausal urinary gonadotrophin

Bovine

Iodine organic compounds:

—

Iodoform

All food producing species

Isobutane

All food producing species

Isoflurane

Equidae

For use as anaesthetic only

Isoxsuprine

Bovine, equidae

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

Ketanserin tartrate

Equidae

Ketoprofen

Bovine, equidae

Porcine

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

All food producing species

For use as excipient

Lactic acid

All food producing species

Lecirelin

Lini oleum

All food producing species

Lobeline

All food producing species

Luprostiol

All mammalian species

Malic acid

All food producing species

For use as excipient

Medroxyprogesterone acetate

Ovine

For intravaginal use for zootechnical purposes only

Melatonin

Ovine, caprine

Menbutone

Bovine, ovine, caprine, porcine, equidae

Menthol

All food producing species

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

All food producing species

Excludes aromatic and unsaturated compounds

N-butane

All food producing species

N-butanol

All food producing species

For use as excipient

Neostigmine

All food producing species

Oxytocin

All mammalian food producing species

Pancreatin

All mammalian food producing species

For topical use only

Papain

All food producing species

Papaverine

Bovine

New-born calves only

Peracetic acid

All food producing species

Phenol

All food producing species

Phloroglucinol

All food producing species

Policresulene

All food producing species

For topical use only

Polysulphated glycosaminoglycan

Equidae

Praziquantel

Ovine

For non-lactating sheep only

Pregnant mare serum gonadotrophin

All food producing species

Propane

All food producing species

Propylene glycol

All food producing species

Quatresin

All food producing species

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

Quillaia saponins

All food producing species

R-clopostenol

Bovine, porcine, equidae

Rifaximin

Bovine

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

Romifidine

Equidae

For therapeutic uses only

Sodium benzyl 4-hydroxybenzoate

All food producing species

Sodium butyl 4-hydroxybenzoate

All food producing species

Somatosalm

Salmon

Tau fluvalinate

Honey bees

Theobromine

All food producing species

Theophylline

All food producing species

Thiomersal

All food producing species

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

Thymol

All food producing species

Timerfonate

All food producing species

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

Trimethylphloroglucinol

All food producing species

Substances generally recognised as safe

Pharmacologically active substance(s)	Animal species	Other provisions
‘Absinthium extract	All food producing species
Acetylmethionine	All food producing species
Aluminium hydroxide	All food producing species
Aluminium monostearate	All food producing species
Ammonium sulfate	All food producing species
Benzoyl benzoate	All food producing species
Benzyl p-hydroxybenzoate	All food producing species
Calcium borogluconate	All food producing species
Calcium citrate	All food producing species
Camphor	All food producing species	External use only’
Cardamon extract	All food producing species
Diethyl sebacate	All food producing species
Dimethicone	All food producing species
Dimethyl acetamide	All food producing species
Dimethyl sulphoxide	All food producing species
Epinephrine	All food producing species
Ethyl oleate	All food producing species
Ethylenediaminetetraacetic acid and salts	All food producing species
Eucalyptol	All food producing species
Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)	All food producing species
Formaldehyde	All food producing species
Formic acid	All food producing species
Glutaraldehyde	All food producing species
Guaiacol	All food producing species
Heparin and its salts	All food producing species
Human chorionic gonadotropin (natural HCG and its synthetic analogues)	All food producing species
Iron ammonium citrate	All food producing species
Iron dextran	All food producing species
Iron glucoheptonate	All food producing species
Isopropanol	All food producing species
Luteinising hormone (natural LH from all species and their synthetic analogues)	All food producing species
Lanolin	All food producing species
Magnesium chloride	All food producing species
Magnesium gluconate	All food producing species
Magnesium hypophosphite	All food producing species
Mannitol	All food producing species
Methylbenzoate	All food producing species
Monothioglycerol	All food producing species
Montanide	All food producing species
Myglyol	All food producing species
Orgotein	All food producing species
Poloxalene	All food producing species
Poloxamer	All food producing species
Polyethylene glycols (molecular weight ranging from 200 to 10 000)	All food producing species
Polysorbate 80	All food producing species
Serotonin	All food producing species
Sodium chloride	All food producing species
Sodium cromoglycate	All food producing species
Sodium dioctylsulphosuccinate	All food producing species
Sodium formaldehydesulphoxylate	All food producing species
Sodium lauryl sulphate	All food producing species
Sodium pyrosulphite	All food producing species
Sodium stearate	All food producing species
Sodium thiosulphate	All food producing species
Tragacanth	All food producing species
Urea	All food producing species
Zinc oxide	All food producing species
Zinc sulphate	All food producing species

Substances used in homeopathic veterinary medicinal products

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

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.)’

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

Anti-infectious agents

1.1.

Chemotherapeutics

1.1.2.

Benzenesulphonamides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Clorsulon	Clorsulon	Bovine	50 μg/kg	Muscle	Provisional MRLs expire on 1 January 2000’
			150 μg/kg	Liver
			400 μg/kg	Kidney

1.2.

Antibiotics

1.2.1.

Beta-lactamase inhibitors

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Clavulanic acid	Clavulanic acid	Bovine, ovine	200 μg/kg	Milk	Provisional MRLs expire on 1 July 1999’
		Bovine, ovine, porcine	200 μg/kg	Muscle
			200 μg/kg	Fat
			200 μg/kg	Liver
			200 μg/kg	Kidney

1.2.2.

Macrolides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Erythromycin	Erythromycin	Bovine, ovine	40 μg/kg	Milk	Provisional MRLs expire on 1 June 2000; MRLs apply to all microbiological active residues expressed as erythromycin equivalent
		Bovine, ovine, porcine, poultry	400 μg/kg	Muscle
			400 μg/kg	Fat
			400 μg/kg	Liver
			400 μg/kg	Kidney
		Poultry	200 μg/kg	Eggs
Josamycin	Josamycin	Chicken	200 μg/kg	Muscle	Provisional MRLs expire on 1 July 2000’
			200 μg/kg	Fat
			200 μg/kg	Liver
			400 μg/kg	Kidney
			200 μg/kg	Eggs

1.2.4.

Cephalosporins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Ceftiofur	Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur	Bovine	200 μg/kg	Muscle	Provisional MRLs expire on 1 January 1999
			600 μg/kg	Fat
			2 000 μg/kg	Liver
			2 000 μg/kg	Kidney
			100 μg/kg	Milk
		Porcine	500 μg/kg	Muscle
			600 μg/kg	Fat
			3 000 μg/kg	Liver
			4 000 μg/kg	Kidney
Cephapirin	Sum of cephapirin and desacetylcephapirin	Bovine	50 μg/kg	50 μg/kg	Muscle
			Fat	Provisional MRLs expire on 1 January 1999’
			50 μg/kg	Liver
			100 μg/kg	Kidney
			10 μg/kg	Milk

1.2.5.

Aminoglycosides

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Aminosidine	Aminosidine	Bovine, porcine, rabbits, chicken	500 μg/kg	Muscle	Provisional MRLs expire on 1 July 2000
			1 500 μg/kg	Liver
			1 500 μg/kg	kidney
Apramycin	Apramycin	Bovine (for use in non-lactating cattle only)	1 000 μg/kg	Muscle	Provisional MRLs expire on 1 July 1999
			1 000 μg/kg	Liver
			10 000 μg/kg	Liver
			20 000 μg/kg	Kidney
		Porcine	1 000 μg/kg	Muscle
			1 000 μg/kg	Skin and fat
			1 000 μg/kg	Liver
			5 000 μg/kg	Kidney
Dihydrostreptomycin	Dihydrostreptomycin	Bovine, ovine	200 μg/kg	Milk	Provisional MRLs expire on 1 June 2000
		Bovine, ovine, porcine, poultry	500 μg/kg	Muscle
			500 μg/kg	Fat
			500 μg/kg	Liver
			1 000 μg/kg	Kidney
Gentamicin	Gentamicin	Bovine	100 μg/kg	Milk	Provisional MRLs expire on 1 June 2000
		Bovine, porcine	100 μg/kg	Muscle
			100 μg/kg	Fat
			200 μg/kg	Liver
			1 000 μg/kg	Kidney
Neomycin (including	Neomycin	Bovine, ovine, caprine	500 μg/kg	Milk	Provisional MRLs expire on 1 June 2000 framycetin)
		Bovine, ovine, caprine, porcine, chicken,	500 μg/kg	Muscle turkey, duck
			500 μg/kg	Fat
			500 μg/kg	Liver
			5 000 μg/kg	Kidney
		Chicken	500 μg/kg	Eggs
Spectinomycin	Spectinomycin	Bovine	200 μg/kg	Milk	Provisional MRLs expire on 1 July 1998
		Bovine, porcine, poultry	300 μg/kg	Muscle
			500 μg/kg	Fat
			2 000 μg/kg	Liver
			5 000 μg/kg	Kidney
Streptomycin	Streptomycin	Bovine, ovine	200 μg/kg	Milk	Provisional MRLs expire on 1 June 2000’
		Bovine, ovine, porcine, poultry	500 μg/kg	Muscle
			500 μg/kg	Fat
			500 μg/kg	Liver
			1 000 μg/kg	Kidney

1.2.6.

Quinolones

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Decoquinate	Decoquinate	Bovine, ovine	500 μg/kg	Muscle	Provisional MRLs expire on 1 July 2000
			500 μg/kg	Fat
			500 μg/kg	Liver
			500 μg/kg	Kidney
Flumequine	Flumequine	Bovine, ovine, porcine, chicken	50 μg/kg	Muscle	Provisional MRLs expire on 1 January 2000
Flumequine	Flumequine	Bovine, ovine, porcine, chicken	50 μg/kg	Fat or skin + fat	Provisional MRLs expire on 1 January 2000
			100 μg/kg	Liver
			300 μg/kg	Kidney
		Salmonidae	150 μg/kg
Marbofloxacin	Marbofloxacin	Bovine	150 μg/kg	Muscle	Provisional MRLs expire on 1 July 2000
			50 μg/kg	Fat
			150 μg/kg	Liver
			150 μg/kg	Kidney
			75 μg/kg	Milk
		Porcine	150 μg/kg	Muscle
			50 μg/kg	Skin + fat
			150 μg/kg	Liver
			150 μg/kg	Kidney
Sarafloxacin	Sarafloxacin	Salmonidae	30 μg/kg	Muscle and skin in natural proportions	Provisional MRLs expire on 1 July 1998’

1.2.9.

Polymyxins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Colistin	Colistin	Bovine, ovine	50 μg/kg	Milk	Provisional MRLs expire on 1 July 2000’
		Bovine, ovine, porcine, chicken, rabbits	150 μg/kg	Muscle
			150 μg/kg	Fat
			150 μg/kg	Liver
			200 μg/kg	Kidney
		Chicken	300 μg/kg	Eggs

1.2.10.

Penicillins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Nafcillin	Nafcillin	Bovine	30 μg/kg	Muscle	Provisional MRLs expire on 1 January 1999 For intramammary use only
			30 μg/kg	Fat
			30 μg/kg	Liver
			30 μg/kg	Kidney
			30 μg/kg	Milk
Penethamate	Benzylpenicillin	Ovine	150 μg/kg	Muscle	Provisional MRLs expire on 1 January 2000’
			150 μg/kg	Fat
			150 μg/kg	Liver
			150 μg/kg	Kidney
			4 μg/kg	Milk
		Porcine	50 μg/kg	Muscle
			50 μg/kg	Fat
			50 μg/kg	Liver
			50 μg/kg	Kidney

1.2.11.

Florfenicol and related compounds

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Florfenicol	Sum of florfenicol and its metabolites measured as florfenicol-amine	Fish	1 000 μg/kg	Muscle and skin in natural proportions	Provisional MRLs expire on 1 July 2001’

Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.2.

Benzimidazoles and pro-benzimidazoles

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Albendazole sulphoxide	Sum of albendazole, albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole	Bovine, ovine	100 μg/kg	Milk	Provisional MRLs expire on 1 January 2000
		Bovine, ovine, pheasant	100 μg/kg	Muscle
			100 μg/kg	Fat
			1 000 μg/kg	Liver
			500 μg/kg	Kidney
Netobimin	Sum of netobimin and albendazole and metabolites of albendazole measured as 2-amino-benzimidazole sulphone	Bovine, ovine, caprine	100 μg/kg	Muscle	Provisional MRLs expire on 31 July 1999’
			100 μg/kg	Fat
			1 000 μg/kg	Liver
			500 μg/kg	Kidney
			100 μg/kg	Milk

2.2.

Agents acting against ectoparasites

2.2.1.

Formamidines

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Amitraz	Sum of amitraz and metabolites which are measured as 2,4-dime-thylaniline	Bovine	200 μg/kg	Fat	Provisional MRLs expire on 1 July 1998
			200 μg/kg	Liver
			200 μg/kg	Kidney
			10 μg/kg	Milk
		Ovine	400 μg/kg	Fat
			200 μg/kg	Liver
			200 μg/kg	Kidney
	Sum of amitraz and all metabolites containing the 2,4-DMA moeity, expressed as amitraz	Bees	200 μg/kg	Honey	Provisional MRLs expire on 1 July 1999’

2.2.2.

Iminophenyl thiazolidine derivative

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Cymiazole	Cymiazole	Bees	1 000 μg/kg	Honey	Provisional MRLs expire on 1 July 1999’

2.2.4.

Organophosphates

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Azamethiphos	Azamethiphos	Salmonidae	100 μg/kg	Muscle and skin in natural proportions	Provisional MRLs expire on 1 June 1999’

2.2.5.

Acyl urea derivates

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Teflubenzuron	Teflubenzuron	Salmonidae	500 μg/kg	Muscle And skin in natural proportions	Provisional MRLs expire on 1 July 1999’

2.3.

Agents acting against endo- and ectoparasites

2.3.1.

Avermectins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Ivermectin	22,23-Dihydro-aver-mectin Bla	Deer, including reindeer	20 μg/kg	Muscle	Provisional MRLs expire on 1 January 1999
			100 μg/kg	Fat
			50 μg/kg	Liver
			20 μg/kg	Kidney
Moxidectin	Moxidectin	Equidae	50 μg/kg	Muscle	Provisional MRLs expire on 1 January 2000’
			500 μg/kg	Fat
			100 μg/kg	Liver
			50 μg/kg	Kidney

Agents acting on the nervous system

3.2.

Agents acting on the autonomic nervous system

3.2.1.

62 sympathomimetic agents

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Clenbuterol hydrochloride	Clenbuterol	Bovine (indication: solely for tocolysis in parturient cows)	0,1 μg/kg	Muscle	Provisional MRLs expire on 1 July 2000’
			0,5 μg/kg	Liver
			0,5 μg/kg	Kidney
			0,05 μg/kg	Milk
		Equidae (indications: locolysis and the treatment of respiratory ailments)	0,1 μg/kg	Muscle
			0,5 μg/kg	Liver
			0,5 μg/kg	Kidney

Anti-inflammatory agents

5.1.

Non-steroidal anti-inflammatory agents

5.1.1.

Arylpropionic acid derivative

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues	Other provisions
‘Carprofen	Carprofen	Bovine	500 μg/kg	Muscle	Provisional MRLs expire on 1 January 2000’
			500 μg/kg	Fat
			1 000 μg/kg	Liver
			1 000 μg/kg	Kidney
		Equidae	50 μg/kg	Muscle
			100 μg/kg	Fat
			1 000 μg/kg	Liver
			1 000 μg/kg	Kidney