
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.Done at Brussels, 3 October 2008.
For the Commission
Androulla VASSILIOU
Member of the Commission
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 Janssen Pharmaceutica nv 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 gActive 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: 101831-37-2Related 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 g diclazuril/kg of wet liver1 000 g diclazuril/kg of wet kidney150 g diclazuril/kg of wet muscle300 g diclazuril/kg of wet fat