
Article 1 
The preparation specified in the Annex belonging to the additive category ‘coccidiostats and histomonostas’, 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 twentieth 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, 20 August 2015.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Identification number of the additive Name of the holder of authorisation Additive 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 feeding stuff with a moisture content of 12 %
Coccidiostats and histomonostats
51775 Huvepharma NV Diclazuril 0,5 g/100 g (Coxiril) 
Preparation of:


 Diclazuril: 5 g/kg.
 Starch: 15 g/kg.
 Wheat meal: 700 g/kg.
 Calcium carbonate: 280 g/kg.

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.

Impurity D: ≤ 0,1 %.

Any other single impurity: ≤ 0,5 %.

Total impurities: ≤ 1,5 %.

For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Commission Regulation (EC) No 152/2009).
 Rabbits — 1 1 
1. The additive shall be incorporated in compound feed in the 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. Use prohibited at least two days before slaughter.

5. A post market monitoring programme concerning the resistance to Eimeria spp. shall be carried out by the holder of authorisation during the latter part of the period of the authorisation.
 10 September 2025 Commission Regulation (EU) No 37/2010
(— 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 skin/fat.)



