Document ID: 02009R0903-20170714
Language: ENG

02009R0903 — EN — 14.07.2017 — 003.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION REGULATION (EC) No 903/2009</p><p>of 28 September 2009</p><p>concerning the authorisation of the preparation of<span><a><span>&#9658;M1</span></a></span>&#160;<span>Clostridium butyricum</span> FERM-BP 2789<span>&#160;&#9668;</span> as a feed additive for chickens for fattening (<span><a><span>&#9658;M3</span></a></span>&#160;holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium<span>&#160;&#9668;</span>)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 256 29.9.2009, p. 26)</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) No 373/2011&#160;of 15 April 2011</a></p></td><td><p>&#160;&#160;L&#160;102</p></td><td><p>10</p></td><td><p>16.4.2011</p></td></tr><tr><td><p><a>&#9658;M2</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) No 357/2013&#160;of 18 April 2013</a></p></td><td><p>&#160;&#160;L&#160;109</p></td><td><p>22</p></td><td><p>19.4.2013</p></td></tr><tr><td><p><a>&#9658;M3</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2017/1126&#160;of 23 June 2017</a></p></td><td><p>&#160;&#160;L&#160;163</p></td><td><p>13</p></td><td><p>24.6.2017</p></td></tr></table>
COMMISSION REGULATION (EC) No 903/2009
of 28 September 2009
concerning the authorisation of the preparation of Clostridium butyricum FERM-BP 2789 as a feed additive for chickens for fattening ( holder of authorisation Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium )
(Text with EEA relevance)
Article 1
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
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/><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></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></tr><tr><td><p>CFU/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: gut flora stabilisers</span></p></td></tr><tr><td><p>4b1830</p></td><td><p><span><a><span>&#9658;M3</span></a></span>&#160;Miyarisan Pharmaceutical Co. Ltd represented by Huvepharma NV Belgium<span>&#160;&#9668;</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;<span>Clostridium butyricum</span> FERM-BP 2789<span>&#160;&#9668;</span></p></td><td><div><p>Additive composition:</p><p>Preparation of<span><a><span>&#9658;M1</span></a></span>&#160;<span>Clostridium butyricum</span> FERM-BP 2789<span>&#160;&#9668;</span> containing a minimum of solid form 5 &#215; 10<span>8</span> CFU/g additive</p></div><div><p>Characterisation of the active substance:</p><p><span><a><span>&#9658;M1</span></a></span>&#160;<span>Clostridium butyricum</span> FERM-BP 2789<span>&#160;&#9668;</span></p></div><div><p>Analytical method&#160;<a>(<span>1</span>)</a>:</p><div><p>Quantification: iron sulphite agar for the additive and premixtures and selective<span><a><span>&#9658;M1</span></a></span>&#160;<span>Clostridium butyricum</span> FERM-BP 2789<span>&#160;&#9668;</span> agar for feedingstuffs</p></div><div><p>Identification: pulsed-field gel electrophoresis (PFGE) method</p></div></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p><span><a><span>&#9658;M2</span></a></span>&#160;2,5 &#215; 10<span>8</span><span>&#160;&#9668;</span></p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p><p>2.&#160;&#160;The use is allowed in feed containing the permitted coccidiostats: monensin sodium, diclazuril, maduramicin ammonium, robenidine, narasin, narasin/nicarbazin, semduramycin, decoquinate,<span><a><span>&#9658;M1</span></a></span>&#160; monensin sodium or lasalocid<span>&#160;&#9668;</span>.</p><p>3.&#160;&#160;For safety reasons: breathing protection shall be used during handling.</p></td><td><p>19 October 2019</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: www.irmm.jrc.be/crl-feed-additives</p></div></td></tr></tbody></table>