Document ID: 02013R0667-20190219
Language: ENG

02013R0667 — EN — 19.02.2019 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) No 667/2013</p><p>of 12 July 2013</p><p>concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation<span><a><span>&#9658;M1</span></a></span>&#160;Elanco GmbH<span>&#160;&#9668;</span>) and repealing Regulation (EC) No 162/2003</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 192 13.7.2013, p. 35)</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>&#9658;M1</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 IMPLEMENTING REGULATION (EU) No 667/2013
of 12 July 2013
concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Elanco GmbH ) and repealing Regulation (EC) No 162/2003
(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
Regulation (EC) No 162/2003 is repealed.
Article 3
The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 2 February 2014 in accordance with the rules applicable before 2 August 2013 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 twentieth day following that of 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</p><p>(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>51771</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Elanco GmbH<span>&#160;&#9668;</span></p></td><td><p>Diclazuril 0,5&#160;g/100&#160;g</p><p>(Clinacox 0,5&#160;%)</p></td><td><div><p><span>Additive composition</span></p><div><p>Diclazuril: 0,50&#160;g/100&#160;g</p></div><div><p>Protein-poor soybean meal: 99,25&#160;g/100&#160;g</p></div><div><p>Polyvidone K 30: 0,20&#160;g/100&#160;g</p></div><div><p>Sodium hydroxide: 0,05&#160;g/100&#160;g</p></div></div><div><p><span>Characterisation of the active substance</span></p><div><p>Diclazuril, C<span>17</span>H<span>9</span>Cl<span>3</span>N<span>4</span>O<span>2</span>, (&#177;)-4-chlorophenyl[2,6-dichloro-4- (2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,</p></div><div><p>CAS number: 101831-37-2</p></div><div><p>Related impurities:</p><div><p>Degradation compound (R064318): &#8804; 0,1&#160;%</p></div><div><p>Other related impurities (T001434, R066891, R068610, R070156, R070016): &#8804; 0,5&#160;% individually</p></div><div><p>Total impurities: &#8804; 1,5&#160;%</p></div></div></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><div><p>For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280&#160;nm (Commission Regulation (EC) No 152/2009&#160;<a>(<span>2</span>)</a>).</p></div><div><p>For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two diagnostic product ions.</p></div></div></td><td><p>Chickens reared for laying</p></td><td><p>16 weeks</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 the 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 programme concerning the resistance to bacteria and<span>Eimeria</span> spp. shall be carried out by the holder of authorisation.</p></td><td><p>2 August 2023</p></td><td><p>Commission Regulation (EU) No 37/2010&#160;<a>(<span>3</span>)</a></p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>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</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>OJ L 54, 26.2.2009, p. 1.</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>OJ L 15, 20.1.2010, p. 1.</p></div></td></tr></tbody></table>