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
Modified by
  • Commission Implementing Regulation (EU) 2023/2733of 7 December 2023concerning the authorisation of a preparation of diclazuril (Coxiril) as a feed additive for chickens reared for laying and pheasants (holder of authorisation: Huvepharma NV) and correcting Implementing Regulation (EU) 2015/46(Text with EEA relevance), 32023R2733, December 8, 2023
Commission Implementing Regulation (EU) 2015/46of 14 January 2015concerning 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)
Article 1AuthorisationDiclazuril, 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 2This 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.ANNEX
European Pharmacopoeia monograph 1718 (Diclazuril for Veterinary use).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-reportsCommission 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).Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).Coccidiostats and histomonostats
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
51775Huvepharma NV.Diclazuril 0,5 g/100 g (Coxiril)Additive compositionDiclazuril: 5 g/kg.Starch: 15 g/kg.Wheat meal: 700 g/kg.Calcium carbonate: 280 g/kg.Characterisation of the active substanceDiclazuril, 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 %.Analytical methodFor determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Regulation (EC) No 152/2009).Chickens for fatteningTurkeys for fatteningGuinea fowl for fattening and for breeding—0,81,21.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 2025Regulation (EU) No 37/20101500μg diclazuril/kg of wet liver;1000 μg diclazuril/kg of wet kidney;500 μg diclazuril/kg of wet muscle;500 μg diclazuril/kg of wet skin/fat.
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