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.
Commission Regulation (EU) No 1118/2010 of 2 December 2010 concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999 Text with EEA relevance
Commission Regulation (EU) No 1118/2010 of 2 December 2010 concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999 Text with EEA relevance
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
In Annex I to Regulation (EC) No 2430/1999, the entry under the registration number of additive E 771, concerning diclazuril for chickens for fattening, is deleted.
Article 3
Premixtures and compound feed containing diclazuril labelled in accordance with Directive 70/524/EEC may continue to be placed on the market and used until stocks are exhausted.
Article 4
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX Identification number of the additive Name of the holder of authorisation 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 feedingstuff with a moisture content of 12 % Coccidiostats and histomonostats 5 1 771 Janssen Pharmaceutica NV Diclazuril 0,5 g/ 100 g (Clinacox 0,5 %) Additive composition Diclazuril: 0,50 g/100 g. Protein-poor soybean meal: 99,25 g/100 g Polyvidone K 30: 0,20 g/100 g Sodium hydroxide: 0,05 g/100 g Characterisation of the active substance Diclazuril, C 17 H 9 Cl 3 N 4 O 2 , (±)-4-chlorophenyl[2,6-dichloro4- (2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, CAS number: 101831-37-2 Related impurities: Degradation compound (R064318): ≤ 0,1 % Other related impurities (T001434, R066891, R068610, R070156, R070016): ≤ 0,5 % individually Total impurities: ≤ 1,5 % Analytical method ( 1 ) For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Regulation (EC) No 152/2009) For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two product ions. Chickens for fattening — 1 1 1. The additive shall be incorporated in compound feed in form of a premixture. 2. Diclazuril shall not be mixed with other coccidiostats. 3. For safety: breathing protection, glasses and gloves shall be used during handling. 4. A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation. 23 December 2020 1 500 μg diclazuril/kg of wet liver 1 000 μg diclazuril/kg of wet kidney 500 μg diclazuril/kg of wet muscle 500 μg diclazuril/kg of wet skin/fat ( 1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives
Other acts of the same type
Commission Implementing Regulation (EU) 2020/779 of 12 June 2020 amending Implementing Regulation (EU) 2019/250 as regards the dates of application following the extension of the transposition deadline of Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance)Commission Implementing Regulation (EU) 2020/781 of 12 June 2020 amending Implementing Regulation (EU) 2018/545 as regards the dates of application and certain transitional provisions following the extension of the transposition deadline of Directive (EU) 2016/797 of the European Parliament and of the Council (Text with EEA relevance)Commission Delegated Regulation (EU) 2020/782 of 12 June 2020 amending Delegated Regulations (EU) 2018/761 and (EU) 2018/762 as regards their dates of application following the extension of the transposition deadline of Directive (EU) 2016/798 of the European Parliament and of the Council (Text with EEA relevance)Commission Regulation (EU) 2020/771 of 11 June 2020 amending Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of Annatto, Bixin, Norbixin (E 160b) (Text with EEA relevance)Commission Regulation (EU) 2020/772 of 11 June 2020 amending Annexes I, VII and VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards eradication measures for transmissible spongiform encephalopathies in goats and endangered breeds (Text with EEA relevance)Commission Regulation (EU) 2020/764 of 10 June 2020 correcting the Swedish language version of Regulation (EU) No 68/2013 on the Catalogue of feed materials (Text with EEA relevance)Commission Regulation (EU) 2020/762 of 9 June 2020 amending Regulation (EU) No 142/2011 as regards microbiological standards for raw petfood, requirements concerning approved establishments, technical parameters applicable to the alternative method Brookes’ gasification process and hydrolysis of rendered fats, and exports of processed manure, certain blood, blood products and intermediate products (Text with EEA relevance)Commission Regulation (EU) 2020/763 of 9 June 2020 amending the Annex to Regulation (EU) No 231/2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards specifications for tricalcium phosphate (E 341 (iii)) (Text with EEA relevance)Commission Regulation (EU) 2020/785 of 9 June 2020 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chromafenozide, fluometuron, pencycuron, sedaxane, tau-fluvalinate and triazoxide in or on certain products (Text with EEA relevance)Commission Regulation (EU) 2020/856 of 9 June 2020 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyantraniliprole, cyazofamid, cyprodinil, fenpyroximate, fludioxonil, fluxapyroxad, imazalil, isofetamid, kresoxim-methyl, lufenuron, mandipropamid, propamocarb, pyraclostrobin, pyriofenone, pyriproxyfen and spinetoram in or on certain products (Text with EEA relevance)Commission Delegated Regulation (EU) 2020/1203 of 9 June 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the entry for perfluorooctane sulfonic acid and its derivatives (PFOS) (Text with EEA relevance)Commission Delegated Regulation (EU) 2020/1204 of 9 June 2020 amending Annex I to Regulation (EU) 2019/1021 of the European Parliament and of the Council as regards the listing of dicofol (Text with EEA relevance)
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