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Commission Regulation (EC) No 1837/97 of 24 September 1997 amending Annexes I, II and III 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)

Commission Regulation (EC) No 1837/97of 24 September 1997amending Annexes I, II and III 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 originOJ L 224, 18. 8. 1990, p. 1., as last amended by Commission Regulation (EC) No 749/97OJ L 110, 26. 4. 1997, p. 24., and in particular Articles 6, 7 and 8 thereof,Whereas, in accordance with Regulation (EEC) No 2377/90, maximum residue limits must be established progressively for all pharmacologically active substances which are used within the Community in veterinary medicinal products intended for administration to food-producing animals;Whereas maximum residue limits should be established only after the examination within the Committee for Veterinary Medicinal Products of all the relevant information concerning the safety of residues of the substance concerned for the consumer of foodstuffs of animal origin and the impact of residues on the industrial processing of foodstuffs;Whereas, in establishing maximum residue limits for residues of veterinary medicinal products in foodstuffs of animal origin, it is necessary to specify the animal species in which residues may be present, the levels which may be present in each of the relevant meat tissues obtained from the treated animal (target tissue) and the nature of the residue which is relevant for the monitoring of residues (marker residue);Whereas, for the control of residues, as provided for in appropriate Community legislation, maximum residue limits should usually be established for the target tissues of liver or kidney; whereas, however, the liver and kidney are frequently removed from carcasses moving in international trade, and maximum residue limits should therefore also always be established for muscle or fat tissues;Whereas, in the case of veterinary medicinal products intended for use in laying birds, lactating animals or honey bees, maximum residue limits must also be established for eggs, milk or honey;Whereas, febentel, fenbendazole, oxfendazole and dexamethasone should be inserted into Annex I to Regulation (EEC) No 2377/90;Whereas bromide, sodium salt should be inserted into Annex II to Regulation (EEC) No 2377/90;Whereas, in order to allow for the completion of scientific studies, ceftiofur, danofloxacin and netobimin should be inserted into Annex III to Regulation (EEC) No 2377/90;Whereas a period of 60 days should be allowed before the entry into force of this Regulation in order to allow Member States to make any adjustment which may be necessary to the authorizations to place the veterinary medicinal products concerned on the market which have been granted in accordance with Council Directive 81/851/EECOJ L 317, 6. 11. 1981, p. 1., as last amended by Directive 93/40/EECOJ L 214, 24. 8. 1993, p. 31., to take account of the provisions of this Regulation;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 1Annexes I, II and III to Regulation (EEC) No 2377/90 are hereby amended as set out in the Annex hereto.

Article 2This 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, 24 September 1997.For the CommissionMartin BangemannMember of the CommissionANNEXThe Annexes to Regulation (EEC) No 2377/90 are hereby amended as follows:A.Annex I is amended as follows:2.Antiparasitic agents2.1.Agents acting against endoparasites2.1.3.Benzimidazoles and pro-benzoimidazoles

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues
"2.1.3.1.Febantel	Sum of extractable residues which may be oxidized to oxfendazole sulphone	Bovine, ovine, porcine, equidae	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
		Bovine, ovine	10 μg/kg	Milk
2.1.3.2.Fenbendazole	Sum of extractable residues which may be oxidized to oxfendazole sulphone	Bovine, ovine, porcine, equidae	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
		Bovine, ovine	10 μg/kg	Milk
2.1.3.3.Oxfendazole	Sum of extractable residues which may be oxidized to oxfendazole sulphone	Bovine, ovine, porcine, equidae	50 μg/kg	Muscle
			50 μg/kg	Fat
			500 μg/kg	Liver
			50 μg/kg	Kidney
		Bovine, ovine	10 μg/kg	Milk"

5.Corticoids5.1.Glucocorticoids

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues
"5.1.1.Dexamethasone	Dexamethasone	Bovine, porcine, equidae	0,75 μg/kg	Muscle
			2,0 μg/kg	Liver
			0,75 μg/kg	Kidney
		Bovine	0,3 μg/kg	Milk"

B.Annex II is amended as follows:1.Inorganic compounds

Pharmacologically active substance(s)	Animal species	Other provisions
"1.29.Bromide, sodium salt	All food producing mammals	For topical use only"

C.Annex III is amended as follows:1.Anti-infectious agents1.2.Antibiotics1.2.4.Cephalosporins

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
"1.2.4.1.Ceftiofur	Sum of all residues retaining the betalactam structure expressed as desfuroylceftiofur	Bovine	2000 μg/kg	Liver, kidney	200 μg/kg
			Muscle	600 μg/kg
			Fat	100 μg/kg
			Milk	Provisional MRLs expire on 1. 1. 1999"
		Porcine	4000 μg/kg	Kidney
			3000 μg/kg	Liver
			500 μg/kg	Muscle
			600 μg/kg	Fat

1.2.6.Quinolones

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
"1.2.6.1.Danofloxacin	Danofloxacin	Bovine	900 μg/kg	Liver	500 μg/kg
			Kidney	300 μg/kg
			Muscle	200 μg/kg
			Fat	Provisional MRLs expire on 1. 1. 1999"
		Chicken	1200 μg/kg	Liver, kidney
			600 μg/kg	Skin + fat
			300 μg/kg	Muscle

2.Antiparasitic agents2.1.Agents acting against endo-parasites2.1.1.Benzimidazoles and pro-benzoimidazoles

Pharmacologically active substance	Marker residue	Animal species	MRLs	Target tissues	Other provisions
"2.1.1.9.Netobimin	Sum of netobimin and albendazole and metabolites of albendazole measured as 2-amino-benzimidazole sulphone	Bovine, ovine, caprine	100 μg/kg	Muscle, fat	Provisional MRLs expire on 31. 7. 1999"
			1000 μg/kg	Liver
			500 μg/kg	Kidney
			100 μg/kg	Milk