Commission Implementing Regulation (EU) 2023/2733 of 7 December 2023 concerning 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

Authorisation

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.

Correction of Implementing Regulation (EU) 2015/46

Article 2

In the Annex to Implementing Regulation (EU) 2015/46, the text in the column ‘Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin’ is replaced by the following: ‘Regulation (EU) No 37/2010  ( *1 ) .

Entry into force

Article 3

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 % Category: coccidiostats and histomonostats 51775 Huvepharma NV Diclazuril 0,5 g/100 g (Coxiril) Additive composition: Preparation of 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 — CAS number: 101831-37-2 — (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro–3,5 -dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile — Produced by chemical synthesis. — Impurity D  ( 1 ) : ≤ 0,1 %. Any other single impurity: ≤ 0,5 %. Total impurities: ≤ 1,5 %. Analytical method  ( 2 ) : For determination of diclazuril in feed additive and premixtures: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Commission Regulation (EC) No 152/2009  ( 3 ) ). For the determination of diclazuril in compound feed: — reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Regulation (EC) No 152/2009), or — high performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299. Chickens reared for laying 12 weeks 0,8 1,2 1. In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. 2. The additive shall be incorporated in compound feed in the form of a premixture. 3. Diclazuril shall not be mixed with other coccidiostats. 4. A post-market monitoring program on the resistance of Eimeria spp. to diclazuril shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008  ( 4 ) . 28 December 2033 Regulation (EU) No 37/2010 Pheasants — 1,0 1,2 ( 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://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en ( 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 (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives ( OJ L 133, 22.5.2008, p. 1 ).