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Document 31995R1442

Title and reference
Commission Regulation (EC) No 1442/95 of 26 June 1995 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
  • No longer in force, Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470
OJ L 143, 27.6.1995, p. 26–30 (ES, DA, DE, EL, EN, FR, IT, NL, PT, FI, SV)
Special edition in Czech: Chapter 03 Volume 017 P. 409 - 413
Special edition in Estonian: Chapter 03 Volume 017 P. 409 - 413
Special edition in Latvian: Chapter 03 Volume 017 P. 409 - 413
Special edition in Lithuanian: Chapter 03 Volume 017 P. 409 - 413
Special edition in Hungarian Chapter 03 Volume 017 P. 409 - 413
Special edition in Maltese: Chapter 03 Volume 017 P. 409 - 413
Special edition in Polish: Chapter 03 Volume 017 P. 409 - 413
Special edition in Slovak: Chapter 03 Volume 017 P. 409 - 413
Special edition in Slovene: Chapter 03 Volume 017 P. 409 - 413
Special edition in Bulgarian: Chapter 03 Volume 017 P. 74 - 78
Special edition in Romanian: Chapter 03 Volume 017 P. 74 - 78

ELI: http://data.europa.eu/eli/reg/1995/1442/oj
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Authentic language
  • Authentic language: Spanish, Danish, German, Greek, English, French, Italian, Dutch, Portuguese, Icelandic, Norwegian
Dates
  • Date of document: 26/06/1995
  • Date of effect: 26/08/1995; Entry into force Date pub. + 60 See Art 2
  • Date of end of validity: 05/07/2009; Implicitly repealed by 32009R0470
Miscellaneous information
  • Author: European Commission
  • Form: Regulation
  • Additional information: Extended to the EEA by 21997D0904(01) EEA relevance
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Text

27.6.1995   

EN

Official Journal of the European Communities

L 143/26


COMMISSION REGULATION (EC) No 1442/95

of 26 June 1995

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

(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 1441/95 (2), and in particular Article 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 carazolol, diazinon and spiramycin (applicable to the species cattle and chicken) should be inserted into Annex I to Regulation (EEC) No 2377/90;

Whereas lecirelin, sodium dichloroisocyanurate, dinoprost tromethamine, hydrochloric acid, malic acid, 1-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium, benzylalcohol, ethanol, n-butanol should be inserted into Annex II to Regulation (EEC) No 2377/90;

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

Whereas, in order to allow for the completion of scientific studies, the duration of the validity of the provisional maximum residue limits previously defined in Annex III of Regulation (EEC) No 2377/90 should be extended for tylosin and spiramycin (applicable to the species pigs);

Whereas it appears that maximum residue limits cannot be established for furazolidone because residues, at whatever limit, in foodstuffs of animal origin constitute a hazard to the health of the consumer; whereas furazolidone 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 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

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, 26 June 1995.

For the Commission

Martin BANGEMANN

Member of the Commission


(1)  OJ No L 224, 18. 8. 1990, p. 1.

(2)  See page 22 of this Official Journal.

(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 amended as follows:

A.

Annex I is modified as follows:

1.

Anti-infectious agents

1.2.

Antibiotics

1.2.4.

Macrolides

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘1.2.4.3.

Spiramycin

Sum of spiramycin and neospiramycin

Bovine

300 μg/kg

Liver, kidney, fat

 

200 μg/kg

Muscle

200 μg/kg

Milk

Chicken

400 μg/kg

Liver

300 μg/kg

Fat + skin

200 μg/kg

Muscle’

2.

Antiparasitic agents

2.2.

Agents acting against ectoparasites

2.2.3.

Organophosphates

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘2.2.3.1.

Diazinon

Diazinon

Bovine, ovine, caprine,

700 μg/kg

porcine

 

Fat

20 μg/kg

Kidney, liver, muscle

Bovine, ovine, caprine

20 μg/kg

Milk’

3.

Agents acting on the nervous system

3.2.

Agents acting on the autonomic nervous system

3.2.1.

Anti-adrenergics

Pharmacologically active substance(s)

Marker residue

Animal species

MRLs

Target tissues

Other provisions

‘3.2.1.1.

Carazolol

Carazolol

Porcine

25 μg/kg

Liver, kidney

 

5 μg/kg

Muscle, fat, + skin’

B.

In Annex II the following headings are added:

1.

Inorganic chemicals

Pharmacologically Active Substance(s)

Animal Species

Other provisions

‘1.6.

Hydrochloric acid

All food producing species

For use as excipient

1.7.

Sodium dichloroisocyanurate

Bovine, ovine, caprine

For topical use only’

2.

Organic chemicals

Pharmacologically Active Substance(s)

Animal Species

Other provisions

‘2.20.

Lecirelin

Bovine, equidae, rabbit

 

2.21.

Dinoprost tromethamine

All mammalian species

 

2.22.

Malic acid

All food producing species

For use as excipient

2.23.

L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium

Al food producing species

For use as excipient

2.24.

Benzylalcohol

All food producing species

For use as excipient

2.25.

Ethanol

All food producing species

For use as excipient

2.26.

N-butanol

All food producing species

For use as excipient’

C.

Annex III is modified as follows:

1.

Anti-infectious agents

1.2.

Antibiotics

1.2.2.

Macrolides

Pharmacologically Active substance(s)

Marker Residue

Animal Species

MRLs

Target Tissues

Other provisions

‘1.2.2.1.

Spiramycin

Spiramycin

Porcine

600 μg/kg

Liver

Provisional MRLs expire on 1 July 1997

MRLs apply to all microbiological active residues expressed as Spiramycin-equivalent

300 μg/kg

Kidney, muscle

200 μg/kg

Fat

1.2.2.2.

Tylosin

Tylosin

Bovine, Porcine, Poultry

100 μg/kg

Muscle, liver, kidney

Provisional MRLs expire on 1 July 1997

Bovine

50 μg/kg

Milk

1.2.2.3.

Erythromycin

Erythromycin

Bovine, ovine, porcine, poultry

400 μg/kg

Liver, kidney, muscle, fat

Provisional MRLs expire on 1 June 2000

MRLs apply to all microbiological active residues expressed as Erythromycin-equivalent’

Bovine, ovine

40 μg/kg

Milk

Poultry

200 μg/kg

Eggs

1.2.4.

Quinolones

Pharmacologically Active substance(s)

Marker Residue

Animal Species

MRLs

Target Tissues

Other provisions

‘1.2.4.1.

Danofloxacin

Danofloxacin

Bovine

900 μg/kg

Liver

Provisional MRLs expire on 1 July 1997’

500 μg/kg

Kidney

300 μg/kg

Muscle

200 μg/kg

Fat

Chicken

1 200 μg/kg

Liver, kidney

600 μg/kg

Fat + skin

300 μg/kg

Muscle

D.

Annex IV is modified as follows:

List of pharmacologically active substances for which no maximum residue limits can be fixed

‘5.

Furazolidon’


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