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Document 31995R2796

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)

OJ L 290, 5.12.1995, p. 1–4 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 03 Volume 018 P. 295 - 298
Special edition in Estonian: Chapter 03 Volume 018 P. 295 - 298
Special edition in Latvian: Chapter 03 Volume 018 P. 295 - 298
Special edition in Lithuanian: Chapter 03 Volume 018 P. 295 - 298
Special edition in Hungarian Chapter 03 Volume 018 P. 295 - 298
Special edition in Maltese: Chapter 03 Volume 018 P. 295 - 298
Special edition in Polish: Chapter 03 Volume 018 P. 295 - 298
Special edition in Slovak: Chapter 03 Volume 018 P. 295 - 298
Special edition in Slovene: Chapter 03 Volume 018 P. 295 - 298
Special edition in Bulgarian: Chapter 03 Volume 018 P. 49 - 52
Special edition in Romanian: Chapter 03 Volume 018 P. 49 - 52

No longer in force, Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470

ELI: http://data.europa.eu/eli/reg/1995/2796/oj

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 ’

 


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