Commission Implementing Regulation (EU) No 888/2011Show full title

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)

ANNEX

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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

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 %
Coccidiostats and histomonostats
5 1 771Janssen Pharmaceutica N.V.

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 a:

    • 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—11

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