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Commission Regulation (EC) No 1958/98 of 15 September 1998 amending Annexes I, II and III 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 (Text with EEA relevance)

Commission Regulation (EC) no 1958/98of 15 September 1998amending Annexes I, II and III 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(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 1570/98OJ L 205, 22. 7. 1998, p. 10. 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 azaperone should be inserted into Annex I to Regulation (EEC) No 2377/90;Whereas urticae herba, tiliae flos, sambuci flos, salviae folium, rosmarini folium, quercus cortex, millefolii herba, melissae folium, matricariae flos and butylscopo-laminium bromide should be inserted into Annex II to Regulation (EEC) No 2377/90;Whereas, in order to allow for the completion of scientific studies, cyfluthrin 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 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 of 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, 15 September 1998.For the CommissionMartin BangemannMember of the CommissionANNEXA.Annex I to Regulation (EEC) No 2377/90 is amended as follows:3.Agents acting on the nervous system3.1.Agents acting on the central nervous system3.1.1.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"

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

Pharmacologically active substance(s)	Animal species	Other provisions
"Butylscopolaminium bromide	All food producing species
Matricariae flos	All food producing species
Melissae folium	All food producing species
Millefolii herba	All food producing species
Quercus cortex	All food producing species
Rosmarini folium	All food producing species
Salviae folium	All food producing species
Sambuci flos	All food producing species
Tiliae flos	All food producing species
Urticae herba	All food producing species"

C.Annex III to Regulation (EEC) No 2377/90 is amended as follows:2.Antiparastitic agents2.2.Agents acting against ectoparasites2.2.3.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 1.1. 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"