Document ID: 02008R0167-20160617
Language: ENG

02008R0167 — EN — 17.06.2016 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION REGULATION (EC) No 167/2008</p><p>of 22 February 2008</p><p>concerning a new authorisation for ten years of a coccidiostat as an additive in feedingstuffs</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 050 23.2.2008, p. 14)</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) 2016/842&#160;of 27 May 2016</a></p></td><td><p>&#160;&#160;L&#160;141</p></td><td><p>47</p></td><td><p>28.5.2016</p></td></tr></table>
COMMISSION REGULATION (EC) No 167/2008
of 22 February 2008
concerning a new authorisation for ten years of a coccidiostat as an 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 third 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 766</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;<br/> Huvepharma EOOD,<br/> Bulgaria<span>&#160;&#9668;</span></p></td><td><p>Salinomycin sodium</p><p>(<span><a><span>&#9658;M1</span></a></span>&#160;Huvesal 120 G<span>&#160;&#9668;</span>)</p></td><td><div><p>Additive composition:</p><div><p>Salinomycin sodium: 120&#160;g/kg</p></div><div><p>Calcium carbonate to 1&#160;000 &#160;g/kg</p></div><div><p>Sucrose: 80-100&#160;g/kg</p></div><div><p>Corn starch: 20&#160;g/kg</p></div></div><div><p>Active substance:</p><div><p>Salinomycin sodium,</p></div><div><p>C<span>42</span>H<span>69</span>O<span>11</span>Na,</p></div><div><p>CAS number: 55721-31-8,</p></div><div><p>sodium salt of a polyether monocarboxylic acid produced by fermentation of<span>Streptomyces albus</span> (CBS 101071)</p></div></div><div><p>Related impurities:</p><div><p>&lt;&#160;42&#160;mg elaiophylin/kg salinomycin sodium</p></div><div><p>&lt;&#160;40&#160;g 17-epi-20-desoxy-salinomycin/kg salinomycin sodium</p></div></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>60</p></td><td><p>70</p></td><td><p>Use prohibited at least three days before slaughter.</p><p>Indicate in the instructions for use of compound feedingstuffs:</p><div><p>&#8216;Dangerous for equines and turkeys&#8217;</p></div><div><p>&#8216;This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated&#8217;</p></div></td><td><p>26 February 2018</p></td><td><p>5&#160;&#956;g salinomycin sodium/kg of all wet tissues</p></td></tr></tbody></table>
<note>
( 1 ) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).
( 2 ) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).
( 3 ) OJ L 183, 29.6.1989, p. 1. Directive as last amended by Directive 2007/30/EC of the European Parliament and of the Council (OJ L 165, 27.6.2007, p. 21).
</note>