LegalizeCommission Regulation (EU) No 169/2011 of 23 February 2011 concerning the authorisation of diclazuril as a feed additive for guinea fowls (holder of authorisation Janssen Pharmaceutica N.V.) Text with EEA relevance
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.
Article 2
This 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
| 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 | 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 g Polyvidone K 30: 0,20 g/100 g Sodium hydroxide: 0,05 g/100 g Characterisation of the active substance Diclazuril, C17H9Cl3N4O2, (±)-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 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 | Guinea fowls | — | 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. The holder of the authorisation shall carry out a post-market monitoring programme on the resistance to bacteria and Eimeria spp. | 16 March 2021 | 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 |
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