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THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 9(2) thereof,Whereas:
(1)Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.
(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of narasin and diclazuril (Interban). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3)The application concerns the authorisation of a preparation of narasin and diclazuril as a feed additive for chickens for fattening and chickens reared for laying, requesting that additive to be classified in the category ‘coccidiostats and histomonostats’.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinion of 6 February 2026note that the preparation of narasin and diclazuril is safe for the target species, as well as for consumers and the environment, when used at the proposed level of 50 mg narasin and 1 mg diclazuril/kg complete feed. It also concluded that the maximum residue limits currently in force for narasin and diclazuril are protective for the consumer at 0-day withdrawal. The Authority concluded that the preparation of narasin and diclazuril is not irritant to the skin, but should be considered a skin and respiratory sensitiser, inhalation and dermal exposure being considered a risk for the user, while it could not conclude on the eye irritation potential due to the lack of data. The Authority further concluded that the preparation of narasin and diclazuril is efficacious controlling coccidiosis in chickens for fattening when used at the proposed used level of 50 mg narasin and 1 mg diclazuril/kg complete feed and extended that conclusion to chickens reared for laying. It considered that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. In addition, the Authority highlighted the danger of the additive for equine species, turkeys and rabbits, as well as the fact that simultaneous use with certain medicinal substances can be contraindicated.
(5)In view of the above, the Commission considers that the preparation of narasin and diclazuril satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation should be authorised. It is appropriate to provide for post-market monitoring of the resistance of Eimeria spp. to narasin and diclazuril. It is appropriate to provide for indicating in the directions for use that the additive is dangerous for certain species and that its simultaneous use with certain medicinal substances can be contraindicated. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.
(6)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Authorisation#
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.
Article 2Entry 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.
| 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 compositionPreparation ofnarasin: 90,0-110,0 g/kgdiclazuril: 1,8-2,2 g/kgfood-grade mineral oilrice hulls qs 1 kg.Solid form.Characterisation of the active substancesNarasin granulated containing:Narasin: ≥ 100 mg/g, including:narasin A: (2R)-2-{(2R,3S,5S,6R)-6-[(2S,3S,4S,6R)-6-{(2S,5S,7R,9S,10S,12R,15R)-2-[(2R,5R,6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran-2-yl]-15-hydroxy-2,10,12-trimethyl-1,6,8-trioxadispiro[4.1.57.35]pentadec-13-en-9-yl}-3-hydroxy-4-methyl-5-oxooctan-2-yl]-3,5-dimethyltetrahydro-2H-pyran-2-yl}butanoic acid; C43H72O11; 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; C17H9Cl3N4O2.CAS number: 101831-37-2.Total impurities A to Inote: ≤ 1,5 %.Produced by chemical synthesis.Analytical methodsnoteFor 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 orHigh 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 152/2009note.For the determination of diclazuril in compound feed:High Performance Liquid Chromatography coupled with photometric detection (HPLC-UV) – Regulation (EC) No 152/2009 orHigh 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 fatteningChickens 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 429/2008.6. 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 tissuesDiclazuril: Commission Regulation (EU) No 37/2010note |
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