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)
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Address https://gelex.eu/eli/EU/regulation/1995/1442@1995-06-26/en
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, as last amended by Commission Regulation (EC) No 1441/95, 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, as last amended by Directive 93/40/EEC 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
ANNEX
(1241243) Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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 (12) Antibiotics (1) Anti-infectious agents (2232231) Organophosphates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Diazinon Diazinon Bovine, ovine, caprine, 700 μg/kg porcine Fat 20 μg/kg Kidney, liver, muscle Bovine, ovine, caprine 20 μg/kg Milk (22) Agents acting against ectoparasites (2) Antiparasitic agents (3213211) Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Carazolol Carazolol Porcine 25 μg/kg Liver, kidney 5 μg/kg Muscle, fat, + skin (32) Agents acting on the autonomic nervous system (3) Agents acting on the nervous system (a) Annex I is modified as follows: (11617) Inorganic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Hydrochloric acid All food producing species For use as excipient Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only (2220221222223224225226) Organic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Lecirelin Bovine, equidae, rabbit Dinoprost tromethamine All mammalian species Malic acid All food producing species For use as excipient L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium Al food producing species For use as excipient Benzylalcohol All food producing species For use as excipient Ethanol All food producing species For use as excipient N-butanol All food producing species For use as excipient (b) In Annex II the following headings are added: (122122112221223) Macrolides Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 Tylosin Tylosin Bovine, Porcine, Poultry 100 μg/kg Muscle, liver, kidney Provisional MRLs expire on 1 July 1997 Bovine 50 μg/kg Milk 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 (1241241) Quinolones Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 1200 μg/kg Liver, kidney 600 μg/kg Fat + skin 300 μg/kg Muscle (12) Antibiotics (1) Anti-infectious agents (c) Annex III is modified as follows: (d5) Annex IV is modified as follows: List of pharmacologically active substances for which no maximum residue limits can be fixed Furazolidon Anx. annex. Regulation (EEC) No 2377/90 is amended as follows:
ANNEX
Regulation (EEC) No 2377/90 is amended as follows: (1241243) Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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 (12) Antibiotics (1) Anti-infectious agents (2232231) Organophosphates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Diazinon Diazinon Bovine, ovine, caprine, 700 μg/kg porcine Fat 20 μg/kg Kidney, liver, muscle Bovine, ovine, caprine 20 μg/kg Milk (22) Agents acting against ectoparasites (2) Antiparasitic agents (3213211) Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Carazolol Carazolol Porcine 25 μg/kg Liver, kidney 5 μg/kg Muscle, fat, + skin (32) Agents acting on the autonomic nervous system (3) Agents acting on the nervous system (a) Annex I is modified as follows: (11617) Inorganic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Hydrochloric acid All food producing species For use as excipient Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only (2220221222223224225226) Organic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Lecirelin Bovine, equidae, rabbit Dinoprost tromethamine All mammalian species Malic acid All food producing species For use as excipient L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium Al food producing species For use as excipient Benzylalcohol All food producing species For use as excipient Ethanol All food producing species For use as excipient N-butanol All food producing species For use as excipient (b) In Annex II the following headings are added: (122122112221223) Macrolides Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 Tylosin Tylosin Bovine, Porcine, Poultry 100 μg/kg Muscle, liver, kidney Provisional MRLs expire on 1 July 1997 Bovine 50 μg/kg Milk 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 (1241241) Quinolones Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 1200 μg/kg Liver, kidney 600 μg/kg Fat + skin 300 μg/kg Muscle (12) Antibiotics (1) Anti-infectious agents (c) Annex III is modified as follows: (d5) Annex IV is modified as follows: List of pharmacologically active substances for which no maximum residue limits can be fixed Furazolidon
A.
Annex I is modified as follows: (1241243) Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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 (12) Antibiotics (1) Anti-infectious agents (2232231) Organophosphates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Diazinon Diazinon Bovine, ovine, caprine, 700 μg/kg porcine Fat 20 μg/kg Kidney, liver, muscle Bovine, ovine, caprine 20 μg/kg Milk (22) Agents acting against ectoparasites (2) Antiparasitic agents (3213211) Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Carazolol Carazolol Porcine 25 μg/kg Liver, kidney 5 μg/kg Muscle, fat, + skin (32) Agents acting on the autonomic nervous system (3) Agents acting on the nervous system
1. Anti-infectious agents (1241243) Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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 (12) Antibiotics
1.
1.2. Antibiotics (1241243) Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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
1.2.
1.2.4.1.2.4.3.
Macrolides Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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 (2232231) Organophosphates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Diazinon Diazinon Bovine, ovine, caprine, 700 μg/kg porcine Fat 20 μg/kg Kidney, liver, muscle Bovine, ovine, caprine 20 μg/kg Milk (22) Agents acting against ectoparasites
2.
2.2. Agents acting against ectoparasites (2232231) Organophosphates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Diazinon Diazinon Bovine, ovine, caprine, 700 μg/kg porcine Fat 20 μg/kg Kidney, liver, muscle Bovine, ovine, caprine 20 μg/kg Milk
2.2.
2.2.3.2.2.3.1.
Organophosphates Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions 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 (3213211) Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Carazolol Carazolol Porcine 25 μg/kg Liver, kidney 5 μg/kg Muscle, fat, + skin (32) Agents acting on the autonomic nervous system
3.
3.2. Agents acting on the autonomic nervous system (3213211) Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Carazolol Carazolol Porcine 25 μg/kg Liver, kidney 5 μg/kg Muscle, fat, + skin
3.2.
3.2.1.3.2.1.1.
Anti-adrenergics Pharmacologically active substance(s) Marker residue Animal species MRLs Target tissues Other provisions Carazolol Carazolol Porcine 25 μg/kg Liver, kidney 5 μg/kg Muscle, fat, + skin
B.
In Annex II the following headings are added: (11617) Inorganic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Hydrochloric acid All food producing species For use as excipient Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only (2220221222223224225226) Organic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Lecirelin Bovine, equidae, rabbit Dinoprost tromethamine All mammalian species Malic acid All food producing species For use as excipient L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium Al food producing species For use as excipient Benzylalcohol All food producing species For use as excipient Ethanol All food producing species For use as excipient N-butanol All food producing species For use as excipient
1.1.6.1.7. Inorganic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Hydrochloric acid All food producing species For use as excipient Sodium dichloroisocyanurate Bovine, ovine, caprine For topical use only
2.2.20.2.21.2.22.2.23.2.24.2.25.2.26.
Organic chemicals Pharmacologically Active Substance(s) Animal Species Other provisions Lecirelin Bovine, equidae, rabbit Dinoprost tromethamine All mammalian species Malic acid All food producing species For use as excipient L-tartaric acid and its mono- and di-basic salt of sodium, potassium and calcium Al food producing species For use as excipient Benzylalcohol All food producing species For use as excipient Ethanol All food producing species For use as excipient N-butanol All food producing species For use as excipient
C.
Annex III is modified as follows: (122122112221223) Macrolides Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 Tylosin Tylosin Bovine, Porcine, Poultry 100 μg/kg Muscle, liver, kidney Provisional MRLs expire on 1 July 1997 Bovine 50 μg/kg Milk 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 (1241241) Quinolones Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 1200 μg/kg Liver, kidney 600 μg/kg Fat + skin 300 μg/kg Muscle (12) Antibiotics (1) Anti-infectious agents
1. Anti-infectious agents (122122112221223) Macrolides Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 Tylosin Tylosin Bovine, Porcine, Poultry 100 μg/kg Muscle, liver, kidney Provisional MRLs expire on 1 July 1997 Bovine 50 μg/kg Milk 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 (1241241) Quinolones Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 1200 μg/kg Liver, kidney 600 μg/kg Fat + skin 300 μg/kg Muscle (12) Antibiotics
1.
1.2. Antibiotics (122122112221223) Macrolides Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 Tylosin Tylosin Bovine, Porcine, Poultry 100 μg/kg Muscle, liver, kidney Provisional MRLs expire on 1 July 1997 Bovine 50 μg/kg Milk 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 (1241241) Quinolones Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 1200 μg/kg Liver, kidney 600 μg/kg Fat + skin 300 μg/kg Muscle
1.2.
1.2.2.1.2.2.1.1.2.2.2.1.2.2.3.
Macrolides Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 Tylosin Tylosin Bovine, Porcine, Poultry 100 μg/kg Muscle, liver, kidney Provisional MRLs expire on 1 July 1997 Bovine 50 μg/kg Milk 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
1.2.4.1.2.4.1.
Quinolones Pharmacologically Active substance(s) Marker Residue Animal Species MRLs Target Tissues Other provisions 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 1200 μg/kg Liver, kidney 600 μg/kg Fat + skin 300 μg/kg Muscle
D.5. Annex IV is modified as follows: List of pharmacologically active substances for which no maximum residue limits can be fixed Furazolidon
Versions
Cited by
- Commission Regulation (EC) no 1798/95 of 25 July 1995 amending Annex IV to 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 Regulation · Grade B
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 medecinal products in foodstuffs of animal origin, as last amended by Commission Regulation (EC) No 1442/95, and in particular Articles 7 and 8 thereof,