Eurlexa

English
- Sign in
- Register

Commission Regulation (EC) No 2728/98 of 17 December 1998 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 2728/98of 17 December 1998amending 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 2692/98OJ L 338, 15. 12. 1998, p. 5., 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 carcases 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 enrofloxacin and ivermectin should be inserted into Annex I to Regulation (EEC) No 2377/90;Whereas hyperici oleum, eucalypti aetheroleum, sodium 2-methyl-2-phenoxy-propanoate, nonivamide, nicoboxil, methyl nicotinate, mecillinam, 8-hydroxyquinoline and diethylene glycol monoethyl ether should be inserted into Annex II to Regulation (EEC) No 2377/90;Whereas, in order to allow for the completion of scientific studies, the duration of the validity of the provisional maximum residue limits previously defined in Annex III to Regulation (EEC) No 2377/90 should be extended for enrofloxacin;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 authorisations 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, 17 December 1998.For the CommissionMartin BangemannMember of the CommissionANNEXA.Annex I to Regulation (EEC) No 2377/90 is amended as follows:1.Anti-infectious agents1.2.Antibiotics1.2.3.Quinolones

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
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 + 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 + fat
			200 μg/kg	Liver
			300 μg /kg	Kidney

2.Antiparasitic agents2.3.Agents acting against endo- and ectoparasites2.3.1.Avermectins

Pharmacologically active substance(s)	Marker residue	Animal species	MRLs	Target tissues
Ivermectin	22,23-Dihydro-aver-mectin B1a	Deer, including reindeer	20 μg/kg	Muscle
			100 μg/kg	Fat
			50 μg/kg	Liver
			20 μg/kg	Kidney

B.Annex II to Regulation (EEC) No 2377/90 is amended as follows:2.Organic compounds

Pharmacologically active substance(s)	Animal species	Other provisions
8-Hydroxyquinoline	All mammalian food producing species	For topical use in new-born animals only
Diethylene glycol monoethyl ether	Bovine, porcine
Mecillinam	Bovine	For intra-uterine use only
Methyl nicotinate	Bovine, equidae	For topical use only
Nicoboxil	Equidae	For topical use only
Nonivamide	Equidae	For topical use only
Sodium 2-methyl-2-phenoxy-propanoate	Bovine, porcine, caprine, equidae

6.Substances of vegetable origin

Pharmacologically active substance(s)	Animal species	Other provisions
Eucalypti aetheroleum	All food producing species
Hyperici oleum	All food producing species	For topical use only

C.Annex III to Regulation (EEC) No 2377/90 is amended as follows:1.Anti-infectious agents1.2.Antibiotics1.2.06.Quinolones

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