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Document 31997R0017

Commission Regulation (EC) No 17/97 of 8 January 1997 amending Annexes I, II, III and IV 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

SL L 5, 9.1.1997, p. 12–16 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)

Ovaj dokument objavljen je u određenim posebnim izdanjima (CS, ET, LV, LT, HU, MT, PL, SK, SL, BG, RO)

Legal status of the document No longer in force, Date of end of validity: 05/07/2009; Implicitno stavljeno izvan snage 32009R0470

ELI: http://data.europa.eu/eli/reg/1997/17/oj

9.1.1997   

EN

Official Journal of the European Communities

L 5/12


COMMISSION REGULATION (EC) No 17/97

of 8 January 1997

amending Annexes I, II, III and IV 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

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 2034/96 (2) 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, eprinomectin should be inserted into Annex I to Regulation (EEC) No 2377/90;

Whereas zinc acetate, zinc chloride, zinc gluconate, zinc oleate, zinc stearate, chlorhexidine, glycerol formal, hesperidin, hesperidin methyl chalcone, menbutone and quatresin should be inserted into Annex II to Regulation (EEC) No 2377/90;

Whereas, in order to allow for the completion of scientific studies, flumequine, doxycycline and albendazole sulfoxide should be inserted into Annex III to Regulation (EEC) No 2377/90;

Whereas it appears that maximum residue limits cannot be established for chlorpromazine because residues, at whatever limit, in foodstuffs of animal origin constitute a hazard to the health of the consumer, whereas chlorpromazine should therefore be inserted into Annex IV 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/EEC (3), as last amended by Directive 93/40/EEC (4) 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 1

Annexes I, II, III and IV of 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 sixtieth 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, 8 January 1997.

For the Commission

Martin BANGEMANN

Member of the Commission


(1)  OJ No L 224, 18. 8. 1990, p. 1.

(2)  OJ No L 272, 25. 10. 1996, p. 2.

(3)  OJ No L 317, 6. 11. 1981, p. 1.

(4)  OJ No L 214, 24. 8. 1993, p. 31.


ANNEX

Regulation (EEC) No 2377/90 is modified as follows:

A.

Annex I is modified as follows:

2.

Anti-parasitic agents

2.3.

Agents acting against endo- and ectoparasites

2.3.1.

Avermectins

Pharmacologically active substance

Marker residue

Animal Species

MRLs

Target tissues

Other provisions

‘2.3.1.4.

Eprinomectin

Eprinomectin B1a

Bovine

30 μg/kg

Muscle

 

30 μg/kg

Fat

600 μg/kg

Liver

100 μg/kg

Kidney

30 μg/kg

Milk’

B.

Annex II is modified as follows:

1.

Inorganic chemicals

Pharmacologically active substance(s)

Animal Species

Other provisions

‘1.24.

Zinc acetate

All food producing species

 

1.25.

Zinc chloride

All food producing species

 

1.26.

Zinc gluconate

All food producing species

 

1.27.

Zinc oleate

All food producing species

 

1.28.

Zinc stearate

All food producing species’

 

2.

Organic compounds

Pharmacologically active substance(s)

Animal Species

Other provisions

‘2.69.

Chlorhexidine

All food producing species

For topical use only

2.70.

Glycerol formal

All food producing species

 

2.71.

Hesperidin

Equidae

 

2.72.

Hesperidin methyl chalcone

Equidae

 

2.73.

Menbutone

Bovine, ovine, caprine, porcine, equidae

 

2.74.

Quatresin

All food producing species

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

C.

Annex III is modified as follows:

1.

Anti-infectious agents

1.2.

Antibiotics

1.2.6.

Quinolones

Pharmacologically active substance

Marker residue

Animal Species

MRLs

Target tissues

Other provisions

‘1.2.6.4.

Flumequine

Flumequine

Bovine, ovine, porcine, chicken

50 μg/kg

Muscle, fat or fat/skin

Provisional MRLs expire on 1.1.2000’

100 μg/kg

Liver

300 μg/kg

Kidney

Salmonidae

150 μg/kg

Muscle/skin

1.2.8.

Tetracyclines

Pharmacologically active substance

Marker residue

Animal Species

MRLs

Target tissues

Other provisions

‘1.2.8.1.

Doxycycline

Sum of parent drug and its 4-epimer

Porcine, poultry

600 μg/kg

Kidney

Provisional MRLs expire on 1.1.1998’

300 μg/kg

Liver, skin/fat

100 μg/kg

Muscle

Bovine

600 μg/kg

Kidney

300 μg/kg

Liver

100 μg/kg

Muscle

2.

Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.1.

Benzimidazoles and pro-benzimidazoles

Pharmacologically active substance

Marker residue

Animal Species

MRLs

Target tissues

Other provisions

‘2.1.1.10.

Albendazole sulphoxide

Sum of albendazole, albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole

Bovine, ovine, pheasant

1 000 μg/kg

Liver

Provisional MRLs expire on 1.1.1998’

500 μg/kg

Kidney

100 μg/kg

Muscle, fat

Bovine, ovine

100 μg/kg

Milk

D.

Annex IV is modified as follows:

List of pharmacologically active substances for which no maximum levels can be fixed:

‘8.

Chlorpromazine’


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