Document ID: 02010R1118-20190219
Language: ENG

02010R1118 — EN — 19.02.2019 — 002.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION REGULATION (EU) No 1118/2010</p><p>of 2 December 2010</p><p>concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 317 3.12.2010, p. 5)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#160;M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) No 160/2013&#160;of 21 February 2013</a></p></td><td><p>&#160;&#160;L&#160;49</p></td><td><p>50</p></td><td><p>22.2.2013</p></td></tr><tr><td><p><a>&#9658;M2</a></p></td><td><p><a>COMMISSION IMPLEMENTING REGULATION (EU) 2019/138&#160;of 29&#160;January 2019</a></p></td><td><p>&#160;&#160;L&#160;26</p></td><td><p>1</p></td><td><p>30.1.2019</p></td></tr></table>
COMMISSION REGULATION (EU) No 1118/2010
of 2 December 2010
concerning the authorisation of diclazuril as a feed additive for chickens for fattening (holder of authorisation Janssen Pharmaceutica NV) and amending Regulation (EC) No 2430/1999
(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
In Annex I to Regulation (EC) No 2430/1999, the entry under the registration number of additive E 771, concerning diclazuril for chickens for fattening, is deleted.
Article 3
Premixtures and compound feed containing diclazuril labelled in accordance with Directive 70/524/EEC may continue to be placed on the market and used until 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
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>Identification number of the additive</p></td><td><p>Name of the holder of authorisation</p></td><td><p>Additive (Trade name)</p></td><td><p>Composition, chemical formula, description, analytical method</p></td><td><p>Species or category of animal</p></td><td><p>Maximum age</p></td><td><p>Minimum content</p></td><td><p>Maximum content</p></td><td><p>Other provisions</p></td><td><p>End of period of authorisation</p></td><td><p>Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin</p></td></tr><tr><td><p>mg of active substance/kg of complete feedingstuff with a moisture content of 12&#160;%</p></td></tr><tr><td><p><span>Coccidiostats and histomonostats</span></p></td></tr><tr><td><p>5 1 771</p></td><td><p><span><a><span>&#9658;M2</span></a></span>&#160;Elanco GmbH<span>&#160;&#9668;</span></p></td><td><p>Diclazuril 0,5 g/ 100 g</p><p>(Clinacox 0,5&#160;%)</p></td><td><p><span>Additive composition</span></p><p>Diclazuril: 0,50 g/100 g.</p><p>Protein-poor soybean meal: 99,25 g/100 g</p><p>Polyvidone K 30: 0,20 g/100 g</p><p>Sodium hydroxide: 0,05 g/100 g</p><p><span>Characterisation of the active substance</span></p><p>Diclazuril, C<span>17</span>H<span>9</span>Cl<span>3</span>N<span>4</span>O<span>2</span>,</p><p>(&#177;)-4-chlorophenyl[2,6-dichloro4-</p><p>(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,</p><p>CAS number: 101831-37-2</p><p>Related impurities:</p><p>Degradation compound (R064318): &#8804; 0,1&#160;%</p><p>Other related impurities (T001434, R066891, R068610, R070156, R070016):</p><p>&#8804; 0,5&#160;% individually</p><p>Total impurities: &#8804; 1,5&#160;%</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Regulation (EC) No 152/2009)</p><p>For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two product ions.</p></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>1</p></td><td><p>1</p></td><td><p>1.&#160;&#160;The additive shall be incorporated in compound feed in form of a premixture.</p><p>2.&#160;&#160;Diclazuril shall not be mixed with other coccidiostats.</p><p>3.&#160;&#160;For safety: breathing protection, glasses and gloves shall be used during handling.</p><p>4.&#160;&#160;A post-market monitoring program on the resistance to bacteria and<span>Eimeria</span> spp. shall be planned and executed by the holder of authorisation.</p></td><td><p>23 December 2020</p></td><td><p>1&#160;500  &#956;g diclazuril/kg of wet liver</p><p>1&#160;000  &#956;g diclazuril/kg of wet kidney</p><p>500 &#956;g diclazuril/kg of wet muscle</p><p>500 &#956;g diclazuril/kg of wet skin/fat</p></td></tr><tr><td><p><a>(<span>1</span>)&#160;&#160;&#160;</a>Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives</p></td></tr></tbody></table>