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)
2796/95 • 31995R2796
Legal Acts - Regulations
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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 ’