Commission Implementing Regulation (EU) 2015/46 of 14 January 2015 concerning the authorisation of diclazuril as a feed additive for chickens for fattening, for turkeys for fattening and for guinea fowl for fattening and breeding (holder of authorisation Huvepharma NV) (Text with EEA relevance) (c. 46)

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ANNEXU.K.

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
^a European Pharmacopoeia monograph 1718 (Diclazuril for Veterinary use).
^b Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
^c Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).
^d Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg of active substance/kg of complete feedingstuff with a moisture content of 12 %		Other provisions	End of period of authorisation
Coccidiostats and histomonostats
51775	Huvepharma NV.	Diclazuril 0,5 g/100 g (Coxiril)	Additive composition Diclazuril: 5 g/kg. Starch: 15 g/kg. Wheat meal: 700 g/kg. Calcium carbonate: 280 g/kg. Characterisation of the 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. Impurity D^a: ≤ 0,1 %. Any other single impurity: ≤ 0,5 %. Total impurities: ≤ 1,5 %. Analytical method ^b For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Regulation (EC) No 152/2009)^c.	Chickens for fattening Turkeys for fattening Guinea fowl for fattening and for breeding	—	0,8	1,2	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. A post-market monitoring programme concerning the resistance to bacteria and Eimeria spp. shall be carried out by the holder of authorisation.	4 February 2025	Regulation (EU) No 37/2010^d 1 500μg diclazuril/kg of wet liver; 1 000 μg diclazuril/kg of wet kidney; 500 μg diclazuril/kg of wet muscle; 500 μg diclazuril/kg of wet skin/fat.