LegalizeCommission 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
Article 1
The 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 2
The entry in Annex II to Regulation (EC) No 2430/1999 concerning the diclazuril for turkeys, identified with registration number 27, is deleted.
Article 3
Premixtures 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 4
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-dichloro-4-(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. | 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 | 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: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx |
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