Document ID: 02008R0971-20190219
Language: ENG

02008R0971 — 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 (EC) No 971/2008</p><p>of 3 October 2008</p><p>concerning a new use of a coccidiostat as additive in feedingstuffs</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 265 4.10.2008, p. 3)</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>
Corrected by:
<table><col/><col/><col/><col/><col/><tr><td><p><a>&#9658;C1</a></p></td><td><p><a>Corrigendum, OJ&#160;L&#160;267, 8.10.2008, p. &#160;32&#160;(971/2008)</a></p></td></tr></table>
COMMISSION REGULATION (EC) No 971/2008
of 3 October 2008
concerning a new use of a coccidiostat as additive in feedingstuffs
(Text with EEA relevance)
Article 1
The preparation belonging to the group ‘Coccidiostats and other medicinal substances’, as specified in the Annex, is authorised for use for ten years as additive in animal nutrition under the conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the 20th 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>Registration number of additive</p></td><td><p>Name and registration number of person responsible for putting additive into circulation</p></td><td><p>Additive</p><p>(Trade name)</p></td><td><p>Composition, chemical formula, description</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</p></td></tr><tr><td><p>Coccidiostats and other medicinal substances</p></td></tr><tr><td><p>E 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;% Premix)</p></td><td><p><span>Additive composition:</span></p><div><p>Diclazuril: 0,5 g/100 g</p></div><div><p>Soybean meal: 99,25 g/100 g</p></div><div><p>Polyvidone K 30: 0,2 g/100 g</p></div><div><p>Sodium hydroxide: 0,0538 g/100 g</p></div><p><span>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><p><span>Related impurities:</span></p><div><p>Degradation compound (R064318): &lt; 0,2&#160;%</p></div><div><p>Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): &lt; 0,5&#160;% individually</p></div><div><p>Total impurities: &lt; 1,5&#160;%</p></div></td><td><p>Rabbits</p></td><td><p>&#8212;</p></td><td><p>1</p></td><td><p>1</p></td><td><p>Use prohibited at least one day before slaughter.</p></td><td><p>24 October 2018</p></td><td><p>2&#160;500 &#160;&#956;g diclazuril/kg of wet liver</p><p>1&#160;000 &#160;&#956;g diclazuril/kg of wet kidney</p><p>150&#160;&#956;g diclazuril/kg of wet muscle</p><p>300&#160;&#956;g diclazuril/kg of wet fat</p></td></tr></tbody></table>