Contents
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 and renewing such an authorisation.
(2)A preparation of diclazuril (Clinacox 0,5 %) (‘the preparation’) was authorised for a period of 10 years as a feed additive for chickens for fattening by Commission Regulation (EU) No 1118/2010note and for chickens reared for laying by Commission Implementing Regulation (EU) No 667/2013note.
(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of the preparation as a feed additive for chickens for fattening and chickens reared for laying. The application requested that additive to be classified in the category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.
(4)The European Food Safety Authority (‘the Authority’) concluded in its opinions of 27 June 2024note and 28 January 2026note that the applicant has provided evidence that the preparation remains safe for the target species, as well as for the consumers and the environment at a maximum use level of 1 mg diclazuril/kg complete feed. It also concluded that the preparation is irritant to skin, eyes and the respiratory tract but is not a skin sensitiser. The Authority further concluded that the preparation at a concentration of 1 mg diclazuril/kg complete feed has the potential to control coccidiosis in chickens for fattening and extended that conclusion to chickens reared for laying. It considered that there is a need for specific requirements of post-market monitoring, recommending that the development of resistance to diclazuril of field Eimeria spp. strains isolated from chickens be monitored.
(5)The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the method of analysis of the preparation as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005note, an evaluation report of the Reference Laboratory is therefore not required.
(6)In view of the above, the Commission considers that the preparation satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of that additive should be renewed. 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.
(7)As a consequence of the renewal of the authorisation of the preparation as a feed additive, Regulation (EU) No 1118/2010 and Implementing Regulation (EU) No 667/2013 should be repealed.
(8)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.
(9)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 1Renewal of authorisation#
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.
Article 2Repeal#
Regulation (EU) No 1118/2010 and Implementing Regulation (EU) No 667/2013 are repealed.
Article 3Transitional measures#
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.
Article 4Entry 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 | ||||||||||
| 51771 | Elanco GmbH | Diclazuril 0,5 g/100 g(Clinacox 0,5 %) | Additive compositionPreparation ofDiclazuril: 5 g/kgPolyvidone K30: 2 g/kgSodium hydroxide: 0,5 g/kgSoybean meal q.s.Solid form.Characterisation of the active substanceDiclazuril: (±)-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.Related impurities:Impurities D and H: ≤ 0,1 % individually;Impurities A, C, E and F: ≤ 0,5 % individually;Total impurities A to Inote: ≤ 1,5 %.Produced by chemical synthesis.Analytical methodsnoteFor 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.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. | 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 429/2008.5. 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 37/2010note |
| Chickens reared for laying | 16 weeks | 1 | 1 |
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.