Document ID: 02006R1443-20170719
Language: ENG

02006R1443 — EN — 19.07.2017 — 002.002
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION REGULATION (EC) No 1443/2006</p><p>of 29 September 2006</p><p>concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 271 30.9.2006, p. 12)</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 REGULATION (EC) No 887/2009&#160;of 25 September 2009</a></p></td><td><p>&#160;&#160;L&#160;254</p></td><td><p>68</p></td><td><p>26.9.2009</p></td></tr><tr><td><p><a>&#160;M2</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2017/1145&#160;of 8 June 2017</a></p></td><td><p>&#160;&#160;L&#160;166</p></td><td><p>1</p></td><td><p>29.6.2017</p></td></tr><tr><td><p><a>&#9658;M3</a></p></td><td><p>Amended by:&#160;<a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2018/353&#160;of 9&#160;March 2018</a></p></td><td><p>&#160;&#160;L&#160;68</p></td><td><p>3</p></td><td><p>12.3.2018</p></td></tr></table>
COMMISSION REGULATION (EC) No 1443/2006
of 29 September 2006
concerning the permanent authorisations of certain additives in feedingstuffs and an authorisation for 10 years for a coccidiostat
(Text with EEA relevance)
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Article 2
The preparation belonging to the group ‘Coccidiostat and other medicinal substances’, as specified in Annex II, is authorised for 10 years as additive in animal nutrition under the conditions laid down in that Annex.
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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.
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ANNEX II
<table><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></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 773</p></td><td><p>Phibro Animal Health, s.a.</p></td><td><p>Semduramicin sodium</p><p>(Aviax 5&#160;%)</p></td><td><div><p><span>Additive composition</span>:</p><p>Semduramicin sodium: 51,3&#160;g/kg</p><p>Sodium carbonate: 40&#160;g/kg</p><p>Mineral oil: 30-50&#160;g/kg</p><p>Sodium aluminosilicate: 20&#160;g/kg</p><p>Soybean mill run: 838,7-858,7&#160;g/kg</p></div><div><p><span>Active substance</span>:</p><p>Semduramicin</p><p>C<span>45</span>H<span>76</span>O<span>16</span></p><p>CAS number: 113378-31-7</p><p>Semduramicin sodium</p><p>C<span>45</span>H<span>75</span>O<span>16</span>Na</p><p>CAS number: 119068-77-8</p><p>sodium salt of a monocarboxylic acid polyether ionophore produced by<span>Actinomadura roseorufa</span> (ATCC 53664)</p><p>Related impurities:</p><p>Descarboxylsemduramicin, &#8804;&#160;2 %</p><p>Desmethoxylsemduramicin, &#8804;&#160;2 %</p><p>Hydroxysemduramicin, &#8804; 2&#160;%</p><p>Total: &#8804; 5&#160;%</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>20</p></td><td><p>25</p></td><td><p>Use prohibited at least five days before slaughter.</p><p>Simultaneous use of semduramicin and tiamulin may induce a temporary reduction of feed consumption and water intake.</p></td><td><p>10 years from the date to entry into force of Regulation</p></td></tr></tbody></table>
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