Commission Regulation (EC) No 2796/95 of 4 December 1995 amending Annex II 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)
Date: 1995-12-04
Institutions: European Commission
Subjects: animal product, food inspection, health control, veterinary drug, waste








L_1995290EN.01000101.xml










5.12.1995   


EN


Official Journal of the European Communities


L 290/1





COMMISSION REGULATION (EC) No 2796/95
of 4 December 1995
amending Annex II 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 origin (1), as last amended by Commission Regulation (EC) No 1798/95 (2), and in particular Articles 7 and 8 thereof,
Whereas, in accordance with Regulation (EEC) No 2377/90, the 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, a number of pharmacologically active substances are generally recognized as safe; whereas these substances should be inserted into Annex II of Regulation (EEC) No 2377/90;
Whereas, substances used in homeopathic veterinary medicinal products shall be inserted into Annex II of Regulation (EEC) No 2377/90 provided that their concentration does not exceed one part per 10 000;
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/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 Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Veterinary Medicinal Products Sector,
HAS ADOPTED THIS REGULATION:
Article 1
Annex II of Regulation (EEC) No 2377/90 is 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, 4 December 1995.


For the Commission

Martin BANGEMANN

Member of the Commission





(1)  OJ No L 224, 18. 8. 1990, p. 1.

(2)  OJ No L 174, 27. 7. 1995, p. 20.

(3)  OJ No L 317, 6. 11. 1981, p. 1.

(4)  OJ No L 214, 24. 8. 1993, p. 31.


ANNEX
Annex II is modified as follows







‘3.


Substances generally recognized as safe







Pharmacologically active substances


Animal species


Other provisions










3.1.


Absinthium extract






All food producing species


 










3.2.


Acetylmethionine






All food producing species


 










3.3.


Aluminium hydroxide






All food producing species


 










3.4.


Aluminium monostearate






All food producing species


 










3.5.


Ammonium sulfate






All food producing species


 










3.6.


Benzoyl benzoate






All food producing species


 










3.7.


Benzyl p-hydroxybenzoate






All food producing species


 










3.8.


Calcium borogluconate






All food producing species


 










3.9.


Calcium citrate






All food producing species


 










3.10.


Camphor






All food producing species


External use only










3.11.


Cardamon extract






All food producing species


 










3.12.


Diethyl sebacate






All food producing species


 










3.13.


Dimethicone






All food producing species


 










3.14.


Dimethyl acetamide






All food producing species


 










3.15.


Dimethyl sulphoxide






All food producing species


 










3.16.


Ethylenediaminetetraacetic acid and salts






All food producing species


 










3.l7.


Eucalyptol






All food producing species


 










3.18.


Epinephrine






All food producing species


 










3.19.


Ethyl oleate






All food producing species


 










3.20.


Formaldehyde






All food producing species


 










3.21.


Formic acid






All food producing species


 










3.22.


Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)






All food producing species


 










3.23.


Glutaraldehyde






All food producing species


 










3.24.


Guaiacol






All food producing species


 










3.25.


Heparin and its salts






All food producing species


 










3.26.


Human chorionic gonadotropin (natural HCG and its synthetic analogues)






All food producing species


 










3.27.


Iron ammonium citrate






All food producing species


 










3.28.


Iron dextran






All food producing species


 










3.29.


Iron glucoheptonate






All food producing species


 










3.30.


Isopropanol






All food producing species


 










3.31.


Lanolin






All food producing species


 










3.32.


Luteinizing hormone (natural LH from all species and their synthetic analogues)






All food producing species


 










3.33.


Magnesium chloride






All food producing species


 










3.34.


Magnesium gluconate






All food producing species


 










3.35.


Magnesium hypophosphite






All food producing species


 










3.36.


Mannitol






All food producing species


 










3.37.


Montanide






All food producing species


 










3.38.


Methylbenzoate






All food producing species


 










3.39.


Monothioglycerol






All food producing species


 










3.40.


Myglyol






All food producing species


 










3.41.


Orgotein






All food producing species


 










3.42.


Poloxalene






All food producing species


 










3.43.


Poloxamer






All food producing species


 










3.44.


Polyethylene glycol 200






All food producing species


 










3.45.


Polyethylene glycol 400






All food producing species


 










3.46.


Polyethylene glycol 600






All food producing species


 










3.47.


Polyethylene glycol 3500






All food producing species


 










3.48.


Polysorbate 80






All food producing species


 










3.49.


Serotonin






All food producing species


 










3.50.


Sodium chloride






All food producing species


 










3.51.


Sodium cromoglycate






All food producing species


 










3.52.


Sodium dioctylsulphosuccinate






All food producing species


 










3.53.


Sodium formaldehydesulphoxylate






All food producing species


 










3.54.


Sodium lauryl sulphate






All food producing species


 










3.55.


Sodium pyrosulphite






All food producing species


 










3.56.


Sodium stearate






All food producing species


 










3.57.


Sodium thiosulphate






All food producing species


 










3.58.


Tragacanth






All food producing species


 










3.59.


Urea






All food producing species


 










3.60.


Zinc sulphate






All food producing species


 










3.61.


Zinc oxide






All food producing species


 














4.


Substances used in homeopathic veterinary medicinal products







Pharmacologically active substance(s)


Animal species


Other provisions










4.1.


Any substance used in veterinary homeopathic medicinal products provided that its concentration in the product does not exceed one part per 10 000






All food producing species ’