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
1442/95 • 31995R1442
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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
Loading citations...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’