Commission Implementing Regulation (EU) 2026/2061 of 17 September 2026 concerning the authorisation of a preparation of narasin and diclazuril (Interban) as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation: Elanco GmbH)

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.

Entry into force

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 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 51778 Elanco GmbH Narasin 100 mg/g and diclazuril 2 mg/g (Interban) Additive composition Preparation of — narasin: 90,0-110,0 g/kg — diclazuril: 1,8-2,2 g/kg — food-grade mineral oil — rice hulls qs 1 kg. Solid form. Characterisation of the active substances Narasin granulated containing: — Narasin: ≥ 100 mg/g, including: — narasin A: (2 R )-2-{(2 R ,3 S ,5 S ,6 R )-6-[(2 S ,3 S ,4 S ,6 R )-6-{(2 S ,5 S ,7 R ,9 S ,10 S ,12 R ,15 R )-2-[(2 R ,5 R ,6 S )-5-ethyl-5-hydroxy-6-methyltetrahydro-2 H -pyran-2-yl]-15-hydroxy-2,10,12-trimethyl-1,6,8-trioxadispiro[4.1.5 7 .3 5 ]pentadec-13-en-9-yl}-3-hydroxy-4-methyl-5-oxooctan-2-yl]-3,5-dimethyltetrahydro-2 H -pyran-2-yl}butanoic acid; C43H 72 O 11 ; CAS number: 55134-13-9: ≥ 85 %; — narasin B, D and I. — Fermentation mass. — Dipotassium phosphate. — Clays (> 99,9 % montmorillonite and < 0,1 % attapulgite). Produced by fermentation with Streptomyces spp. NRRL B-67771. 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. Total impurities A to I  ( 1 ) : ≤ 1,5 %. Produced by chemical synthesis. Analytical methods  ( 2 ) For the determination of narasin in the feed additive: High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis). For the determination of narasin in premixtures: High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183. For the determination of narasin in compound feed: — High Performance Liquid Chromatography using post-column derivatisation coupled with photometric detection (HPLC-PCD-UV-Vis) – EN ISO 14183 or — High Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299. 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) – Commission 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. For the determination of narasin in tissues: High Performance Liquid Chromatography coupled with tandem mass spectrometry – AOAC 2011.24. Chickens for fattening Chickens reared for laying — 50 (narasin) 1 (diclazuril) 50 (narasin) 1 (diclazuril) 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. Indicate in the directions for use of the additive, premixtures and related feed: ‘Dangerous for equines, turkeys and rabbits. This feed contains an ionophore: simultaneous use with certain medicinal substances, including tiamulin, is contra-indicated.’ 5. A post-market monitoring programme on the resistance of Eimeria spp. to narasin and diclazuril shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008  ( 4 ) . 6. 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. 8 October 2036 50 μg narasin/kg of all wet tissues Diclazuril: Commission Regulation (EU) No 37/2010  ( 5 ) ( 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 ).