
Article 1 
In Annex I to Regulation (EC) No 2430/1999 the line for E 771 is replaced by the text in Annex I to this Regulation.
Article 2 
Annex III to Regulation (EC) No 418/2001 is replaced by the text in Annex II to this Regulation.
Article 3 
The Annex to Regulation (EC) No 162/2003 is replaced by the text in Annex III to this Regulation.
Article 4 
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, 6 October 2008.
For the Commission
Androulla VASSILIOU
Member of the Commission
ANNEX I


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 Diclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % 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
 Diclazuril: 0,2 g/100 g
 Soybean meal: 39,7 g/100 g
 Polyvidone K 30: 0,08 g/100 g
 Sodium hydroxide: 0,0215 g/100 g
 Wheat middling: 60 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 % Chickens for fattening — 1 1 — 30.9.2009 1 500 μg diclazuril/kg of wet liver1 000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat’

ANNEX II


ANNEX III 
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 Diclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % 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
 Diclazuril: 0,2 g/100 g
 Soybean meal: 39,7 g/100 g
 Polyvidone K 30: 0,08 g/100 g
 Sodium hydroxide: 0,0215 g/100 g
 Wheat middling: 60 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 % Turkeys for fattening 12 weeks 1 1 — 28.2.2011 1 500 μg diclazuril/kg of wet liver1 000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat

ANNEX III


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 Diclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % 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
 Diclazuril: 0,2 g/100 g
 Soybean meal: 39,7 g/100 g
 Polyvidone K 30: 0,08 g/100 g
 Sodium hydroxide: 0,0215 g/100 g
 Wheat middling: 60 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 % Chickens reared for laying 16 weeks 1 1 — 20.1.2013 1 500 μg diclazuril/kg of wet liver1 000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat
