Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003 Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2019/138of 29 January 2019amending Regulations (EC) No 1356/2004, (EC) No 1464/2004, (EC) No 786/2007, (EC) No 971/2008, (EU) No 1118/2010, (EU) No 169/2011 and Implementing Regulations (EU) No 888/2011 and (EU) No 667/2013 as regards the name of the holder of the authorisation for feed additives(Text with EEA relevance), 32019R0138, January 30, 2019
Commission Implementing Regulation (EU) No 667/2013of 12 July 2013concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Elanco GmbH) and repealing Regulation (EC) No 162/2003(Text with EEA relevance)
Article 1The 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Article 2Regulation (EC) No 162/2003 is repealed.
Article 3The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 2 February 2014 in accordance with the rules applicable before 2 August 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxOJ L 54, 26.2.2009, p. 1.OJ L 15, 20.1.2010, p. 1.Coccidiostats and histomonostats
Identification number of the additiveName of the holder of authorisationAdditive(Trade name)Composition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
51771Elanco GmbHDiclazuril 0,5 g/100 g(Clinacox 0,5 %)Additive compositionDiclazuril: 0,50 g/100 gProtein-poor soybean meal: 99,25 g/100 gPolyvidone K 30: 0,20 g/100 gSodium hydroxide: 0,05 g/100 gCharacterisation of the active substanceDiclazuril, C17H9Cl3N4O2, (±)-4-chlorophenyl[2,6-dichloro-4- (2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,CAS number: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,1 %Other related impurities (T001434, R066891, R068610, R070156, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Analytical methodFor determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Commission 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 diagnostic product ions.Chickens reared for laying16 weeks111.The additive shall be incorporated in compound feed in the 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 programme concerning the resistance to bacteria and Eimeria spp. shall be carried out by the holder of authorisation.2 August 2023Commission Regulation (EU) No 37/2010
Article 1The 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 2Regulation (EC) No 162/2003 is repealed.
Article 3The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 2 February 2014 in accordance with the rules applicable before 2 August 2013 may continue to be placed on the market and used until the existing stocks are exhausted.
Article 4This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX
Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspxOJ L 54, 26.2.2009, p. 1.OJ L 15, 20.1.2010, p. 1.Coccidiostats and histomonostats
Identification number of the additiveName of the holder of authorisationAdditive(Trade name)Composition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
51771Elanco GmbHDiclazuril 0,5 g/100 g(Clinacox 0,5 %)Additive compositionDiclazuril: 0,50 g/100 gProtein-poor soybean meal: 99,25 g/100 gPolyvidone K 30: 0,20 g/100 gSodium hydroxide: 0,05 g/100 gCharacterisation of the active substanceDiclazuril, C17H9Cl3N4O2, (±)-4-chlorophenyl[2,6-dichloro-4- (2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,CAS number: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,1 %Other related impurities (T001434, R066891, R068610, R070156, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Analytical methodFor determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Commission 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 diagnostic product ions.Chickens reared for laying16 weeks111.The additive shall be incorporated in compound feed in the 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 programme concerning the resistance to bacteria and Eimeria spp. shall be carried out by the holder of authorisation.2 August 2023Commission Regulation (EU) No 37/2010