Commission Implementing Regulation (EU) No 888/2011 of 5 September 2011 concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999 Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) No 160/2013of 21 February 2013amending Regulations (EC) No 162/2003, (EC) No 971/2008, (EU) No 1118/2010 and (EU) No 169/2011 and Implementing Regulation (EU) No 888/2011 as regards the name of the holder of the authorisation of diclazuril in animal feed(Text with EEA relevance), 32013R0160, February 22, 2013
  • 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 888/2011of 5 September 2011concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999(Text with EEA relevance)
Article 1The preparation specified in 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 2The entry in Annex II to Regulation (EC) No 2430/1999 concerning the diclazuril for turkeys, identified with registration number 27, is deleted.
Article 3Premixtures and compound feed labelled in accordance with Directive 70/524/EEC and containing diclazuril, as authorised by Regulation (EC) No 2430/1999 for use on turkeys up to 12 weeks, 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 20th day following 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.aspxCoccidiostats 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 %
5 1 771Elanco GmbHDiclazuril 0,5 g/ 100 g(Clinacox 0,5 %)Additive composition:Diclazuril: 0,50 g/100 g.Protein-poor soybean meal: 99,25 g/100 gPolyvidone K 30: 0,20 g/100 gSodium hydroxide: 0,05 g/100 gCharacterisation of the active substance:Diclazuril, 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 method:For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (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.Turkeys for fattening—111.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 program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation.26 September 20211500 μg diclazuril/kg of wet liver1000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat
Article 1The preparation specified in 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 2The entry in Annex II to Regulation (EC) No 2430/1999 concerning the diclazuril for turkeys, identified with registration number 27, is deleted.
Article 3Premixtures and compound feed labelled in accordance with Directive 70/524/EEC and containing diclazuril, as authorised by Regulation (EC) No 2430/1999 for use on turkeys up to 12 weeks, 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 20th day following 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.aspxCoccidiostats 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 %
5 1 771Elanco GmbHDiclazuril 0,5 g/ 100 g(Clinacox 0,5 %)Additive composition:Diclazuril: 0,50 g/100 g.Protein-poor soybean meal: 99,25 g/100 gPolyvidone K 30: 0,20 g/100 gSodium hydroxide: 0,05 g/100 gCharacterisation of the active substance:Diclazuril, 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 method:For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (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.Turkeys for fattening—111.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 program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation.26 September 20211500 μg diclazuril/kg of wet liver1000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat