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

Authorisation

Article 1

Diclazuril, CAS number 101831-37-2, 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 .

ANNEXSupplementary provisions

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 feedingstuff with a moisture content of 12 % 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, C 17 H 9 Cl 3 N 4 O 2 , (±)-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  ( 1 ) : ≤ 0,1 %. Any other single impurity: ≤ 0,5 %. Total impurities: ≤ 1,5 %. Analytical method  ( 2 ) For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Regulation (EC) No 152/2009)  ( 3 ) . 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  ( 4 ) — 1 500 μg 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. ( 1 )   European Pharmacopoeia monograph 1718 (Diclazuril for Veterinary use). ( 2 )   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 ( 3 )   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 ). ( 4 )   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 ).