Commission Implementing Regulation (EU) 2026/1860 of 29 July 2026 concerning the authorisation of a preparation of narasin (Monteban G100) as a feed additive for chickens for fattening (holder of authorisation: Elanco GmbH) and repealing Regulation (EC) No 1464/2004
Data as of 2026-08-20 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Authorisation
The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition for chickens for fattening, subject to the conditions laid down in that Annex.
Repeal
Regulation (EC) No 1464/2004 is repealed.
Transitional measures
1. The additive, as authorised by Regulation (EC) No 1464/2004 and premixtures containing that additive, which are produced and labelled before 19 February 2027 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the existing stocks are exhausted. 2. Compound feed and feed materials containing the feed additive referred to in paragraph 1, which are produced and labelled before 19 August 2027 in accordance with the rules applicable before 19 August 2026 may continue to be placed on the market and used until the stocks concerned are exhausted.
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
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 51765 Elanco GmbH Narasin 100 g/kg (Monteban G100) Additive composition Preparation of — narasin: 95,0-107,5 g/kg — food grade mineral oil: 10-25 g/kg — rice hulls qs 1 kg. Solid form. Characterisation of the active substance Narasin granulated containing: — Narasin: ≥ 100 g/kg, 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: ≥ 90 %, — narasin B, D and I, — Fermentation mass: 28 %, — Dipotassium hydrogen phosphate: 6 %, — Montmorillonite clay: 53 %. Produced by fermentation with Streptomyces spp. NRRL B-67771. Analytical methods ( 1 ) 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 the 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 narasin in tissues: High Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS). Chickens for fattening — 60 70 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 shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008 ( 2 ) . 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. 19 August 2036 50 μg narasin/kg of all wet tissues ( 1 ) 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 . ( 2 ) 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 ).
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