Special edition in Croatian: Chapter 03 Volume 032 P. 275 - 346
of 22 December 2009
on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council
(
1
)
, and in particular Article 27(1) thereof,
Whereas:
In order to protect public health, pharmacologically active substances, on the basis of the scientific assessment of the safety of those substances, were classified in four Annexes 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
(
2
)
. Annex I contained substances for which a maximum residue limit was established, Annex II contained substances for which it was not necessary to establish a maximum residue limit, Annex III contained substances for which a provisional maximum residue limit was established and Annex IV contained substances for which a maximum residue limit could not be established because residues of those substances, at whatever limit, constitute a hazard to human health.
For reasons of simplification, it is necessary to incorporate those pharmacologically active substances and their classification regarding maximum residue limits in a Commission Regulation. As this classification follows the classification system foreseen in Regulation (EC) No 470/2009, the classification should also be taken account of with regard to the possibility to administer those pharmacologically active substances to food-producing animals.
For reasons of ease of use, all pharmacologically active substances should be listed in one Annex in alphabetical order. For reasons of clarity, two separate tables should be established: one for allowed substances, listed in Annexes I, II and III of Regulation (EEC) No 2377/90, and one for prohibited substances, listed on Annex IV to that Regulation.
Article 1
Pharmacologically active substances and their classification regarding maximum residue limits are set out in the Annex.
Article 2
This Regulation shall enter into force on the 20th day following its publication in the
Official Journal of the European Union
.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 December 2009.
For the Commission
José Manuel BARROSO
The President
ANNEX
Pharmacologically active substances and their classification regarding maximum residue limits (MRL)
Table 1
Allowed substances
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per ten only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
Sum of albendazole sulphoxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole
All ruminants
100 μg/kg
100 μg/kg
1 000 μg/kg
500 μg/kg
100 μg/kg
Muscle
Liver
Kidney
NO ENTRY
Antiparasitic agents/Agents against endoparasites
Sum of albendazole oxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole
Bovine, ovine
100 μg/kg
100 μg/kg
1 000 μg/kg
500 μg/kg
100 μg/kg
Muscle
Liver
Kidney
NO ENTRY
Antiparasitic agents/Agents against endoparasites
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For oral use only. Not for use in animals from which milk is produced for human consumption.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only. For oral use only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.
NO ENTRY
For porcine and poultry species this MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per hundred only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for liver and kidney do not apply to fin fish.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
For poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For oral use only.
Not for use in animals from which milk is produced for human consumption
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
Not for use in animals from which milk is produced for human consumption.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which milk is produced for human consumption.
Antiparasitic agents/Agents acting against endo- and ectoparasites
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
For topical use only.
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding in the products not exceeding one part per ten only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
Not for animals from which milk is produced for human consumption.
Not for animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
Follicle stimulating hormone (natural FSH from all species and their synthetic analogues)
NOT APPLICABLE
All food producing species
No MRL required
NOT APPLICABLE
NO ENTRY
NO ENTRY
Food additives (substances with a valid E number approved as additives in foodstuffs for human consumption)
NOT APPLICABLE
All food producing species
No MRL required
NOT APPLICABLE
Only substances approved as additives in foodstuffs for human consumption, with the exception of preservatives listed in part C of Annex III to European Parliament and Council Directive 95/2/EC.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per ten only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which milk is produced for human consumption.
Antiparasitic agents/Agents acting against endo- and ectoparasites
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.
NO ENTRY
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which milk or eggs are produced for human consumption.
Antiparasitic agents/Agents against endoparasites
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
Sum of mebendazole methyl (5-(1-hydroxy, 1-phenyl) methyl-1H-benzimidazol-2-yl) carbamate and (2-amino-1H-benzimidazol-5-yl) phenylmethanone, expressed as mebendazole equivalents
Ovine, caprine,
Equidae
60 μg/kg
60 μg/kg
400 μg/kg
60 μg/kg
Muscle
Liver
Kidney
Not for use in animals from which milk is produced for human consumption.
Antiparasitic agents/Agents against endoparasites
Mineral hydrocarbons, low to high viscosity including micorcristalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds
NOT APPLICABLE
All food producing species
No MRL required
NOT APPLICABLE
Excludes aromatic and unsaturated compounds.
NO ENTRY
Sum of residues which may be hydrolysed to N-methyl-1,3-propanediamine and expressed as morantel equivalents
All ruminants
100 μg/kg
100 μg/kg
800 μg/kg
200 μg/kg
50 μg/kg
Muscle
Liver
Kidney
NO ENTRY
Antiparasitic agents/Agents against endoparasites
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Anti-infectious agents/Antibiotics
Sum of albendazole oxide, albendazole sulphone, and albendazole 2-amino sulphone, expressed as albendazole
Bovine, ovine
100 μg/kg
100 μg/kg
1 000 μg/kg
500 μg/kg
100 μg/kg
Muscle
Liver
Kidney
For oral use only.
Antiparasitic agents/Agents against endoparasites
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which milk or eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for liver and kidney do not apply to fin fish.
Not for use in animals from which milk or eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.
NO ENTRY
Only for intravaginal therapeutic or zootechnical use and in accordance with the provisions of Directive 96/22/EC.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations in the products not exceeding one part per thousand only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.
Not for use in animals from which milk is produced for human consumption.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
All substances used in homeopathic veterinary medicinal products provided that their concentration in the product does not exceed one part per ten thousand.
NO ENTRY
The combined total residues of all substances within the sulfonamide group should not exceed 100 μg/kg.
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Chemotheurapeutics/
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for liver and kidney do not apply to fin fish.
Anti-infectious agents/Antibiotics
For fin fish the muscle MRL relates to ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.
NO ENTRY
For fin fish the muscle MRL relates to a ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/Antibiotics
For use only as preservatives in multidose vaccines at a concentration not exceeding 0,02 %.
NO ENTRY
For porcine species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which milk is produced for human consumption.
Not for use in animals from which eggs are produced for human consumption.
Antiparasitic agents/Agents acting against protozoa
For fin fish the muscle MRL relates to a ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Not for use in animals from which eggs are produced for human consumption.
Anti-infectious agents/
Chemotheurapeutics
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10,13-tetra-hydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethy-lamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopent-decan-15-one expressed as tulathromycin equivalents
Bovine
100 μg/kg
3 000 μg/kg
3 000 μg/kg
Liver
Kidney
Not for use in animals from which milk is produced for human consumption.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
For fin fish the muscle MRL relates to a ‘muscle and skin in natural proportions’.
MRLs for fat, liver and kidney do not apply to fin fish.
For porcine and poultry species the fat MRL relates to ‘skin and fat in natural proportions’.
Anti-infectious agents/Antibiotics
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per hundred only.
For oral use only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias, at concentrations in the products not exceeding one part per thousand only.
NO ENTRY
For use in homeopathic veterinary medicinal products prepared according to homeopathic pharmacopoeias at concentrations corresponding to the mother tincture and dilutions thereof only.
NO ENTRY
