Commission Implementing Regulation (EU) 2026/2086 of 18 September 2026 concerning the renewal of the authorisation of a preparation of diclazuril (Clinacox 0,5 %) as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation: Elanco GmbH), and repealing Regulation (EU) No 1118/2010 and Implementing Regulation (EU) No 667/2013

Renewal of authorisation

Article 1

The authorisation of the preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’ is renewed subject to the conditions laid down in that Annex.

Repeal

Article 2

Regulation (EU) No 1118/2010 and Implementing Regulation (EU) No 667/2013 are repealed.

Transitional measures

Article 3

1.   The preparation, as authorised by Regulation (EU) No 1118/2010 and Implementing Regulation (EU) No 667/2013 and premixtures containing that additive, which are produced and labelled before 11 April 2027 in accordance with the rules applicable before 11 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. 2.   Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 11 October 2027 in accordance with the rules applicable before 11 October 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.

Entry into force

Article 4

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 Name of the additive (trade name) 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 feed with a moisture content of 12 % Category: coccidiostats and histomonostats 51771 Elanco GmbH Diclazuril 0,5 g/100 g (Clinacox 0,5 %) Additive composition Preparation of — Diclazuril: 5 g/kg — Polyvidone K30: 2 g/kg — Sodium hydroxide: 0,5 g/kg — Soybean meal q.s. Solid form. Characterisation of the active substance Diclazuril: (±)-2,6 -dichloro-α-(4-chlorophenyl)-4-(4,5-dihydro-3,5-dioxo-1,2,4-triazin-11-2(3H)-yl)benzeneacetonitrile; C 17 H 9 Cl 3 N 4 O 2 . CAS number: 101831-37-2. Related impurities: Impurities D and H: ≤ 0,1 % individually; Impurities A, C, E and F: ≤ 0,5 % individually; Total impurities A to I  ( 1 ) : ≤ 1,5 %. Produced by chemical synthesis. Analytical methods  ( 2 ) For the determination of diclazuril in the feed additive: High Performance Liquid Chromatography coupled with photometric detection (HPLC-UV). For the determination of diclazuril in premixtures: — High Performance Liquid Chromatography coupled with photometric detection (HPLC-UV) –Regulation (EC) No 152/2009  ( 3 ) . For the determination of diclazuril in compound feed: — High Performance Liquid Chromatography coupled with photometric detection (HPLC-UV) – Regulation (EC) No 152/2009 or — High Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299. Chickens for fattening — 1 1 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. The additive shall not be used simultaneously with other coccidiostats. 4. A post-market monitoring programme 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 ) . 5. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment. 11 October 2036 Commission Regulation (EU) No 37/2010  ( 5 ) Chickens reared for laying 16 weeks 1 1 ( 1 )   As listed in the European Pharmacopoeia (Ph. Eur. 11.1.2023). ( 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 , ELI: http://data.europa.eu/eli/reg/2009/152/oj ). ( 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 , ELI: http://data.europa.eu/eli/reg/2008/429/oj ). ( 5 )   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 , ELI: http://data.europa.eu/eli/reg/2010/37(1)/oj ).