law://eu/reg/2011/888@2026-11-13| 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 % | ||||||||||
| 5 1 771 | Elanco GmbH | 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 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 | — | 1 | 1 | 1.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 2021 | 1500 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 |
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