LegalizeCommission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs (Text with EEA relevance)
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feedingstuff | ||||||||||
| 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 | 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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