Commission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs (Text with EEA relevance)

Type Regulation
Publication 2008-10-04
Last updated 2019-02-19
State In force
Department European Commission
Source EUR-Lex
articles 2
Reform history JSON API

Article 1

The preparation belonging to the group ‘Coccidiostats and other medicinal substances’, as specified in the Annex, is authorised for use for ten years as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following that of 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.

ANNEX

Registration number of additive Name and registration number of person responsible for putting additive into circulation Additive (Trade name) Composition, chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
Registration number of additive Name and registration number of person responsible for putting additive into circulation Additive (Trade name) Composition, chemical formula, description Species or category of animal Maximum age mg of active substance/kg of complete feedingstuff mg of active substance/kg of complete feedingstuff Other provisions End of period of authorisation Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
Registration number of additive Name and registration number of person responsible for putting additive into circulation Additive (Trade name) Composition, chemical formula, description Species or category of animal Maximum age Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances
E 771 Elanco GmbH Diclazuril 0,5 g/100 g (Clinacox 0,5 % Premix) Additive composition: Diclazuril: 0,5 g/100 g Soybean meal: 99,25 g/100 g Polyvidone K 30: 0,2 g/100 g Sodium hydroxide: 0,0538 g/100 g Active substance: Diclazuril C17H9Cl3N4O2, (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl) phenyl]acetonitrile, CAS number: 101831-37-2 Related impurities: Degradation compound (R064318): < 0,2 % Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): < 0,5 % individually Total impurities: < 1,5 % Rabbits — 1 1 Other provisions End of period of authorisation Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin Use prohibited at least one day before slaughter. 24 October 2018 2 500  μg diclazuril/kg of wet liver 1 000  μg diclazuril/kg of wet kidney 150 μg diclazuril/kg of wet muscle 300 μg diclazuril/kg of wet fat

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