
Article 1 
The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition subject to the conditions laid down in that 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, 23 February 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX

Identification number of the additive Name of the holder of authorisation Additive(Trade name) Composition, chemical formula, description, analytical method 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 with a moisture content of 12 %
Coccidiostats and histomonostats
5 1 771 Janssen Pharmaceutica N.V. Diclazuril 0,5 g/100 g(Clinacox 0,5 %) 
 Additive composition
Diclazuril: 0,50 g/100 g.
Protein-poor soybean meal:
99,25 g/100 g
Polyvidone K 30: 0,20 g/100 g
Sodium hydroxide: 0,05 g/100 g
 Characterisation of the active substance
Diclazuril, C17H9Cl3N4O2,
(±)-4-chlorophenyl[2,6-dichloro4-
(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): ≤ 0,1 %
Other related impurities (T001434, R066891, R068610, R070156, R070016):
≤ 0,5 % individually
Total impurities: ≤ 1,5 %
 Analytical method
 For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Regulation (EC) No 152/2009)
 For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two product ions Guinea fowls — 1 1 
1. The additive shall be incorporated in compound feed in form of a premixture.

2. Diclazuril shall not be mixed with other coccidiostats.

3. For safety: breathing protection, glasses and gloves shall be used during handling.

4. The holder of the authorisation shall carry out a post-market monitoring programme on the resistance to bacteria and Eimeria spp.
 16 March 2021 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
