Document ID: 02013R0306-20230309
Language: ENG

02013R0306 — EN — 09.03.2023 — 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 306/2013</p><p>of 2 April 2013</p><p>concerning the authorisation of a preparation of<span><a><span>&#9658;M1</span></a></span>&#160;<span>Bacillus velezensis</span> ATCC PTA-6737<span>&#160;&#9668;</span> for weaned piglets and weaned Suidae other than<span>Sus scrofa domesticus</span> (holder of authorisation Kemin Europa N.V.)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 091 3.4.2013, p. 5)</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) 2023/366&#160;of 16&#160;February 2023</a></p></td><td><p>&#160;&#160;L&#160;50</p></td><td><p>59</p></td><td><p>17.2.2023</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 306/2013
of 2 April 2013
concerning the authorisation of a preparation of Bacillus velezensis ATCC PTA-6737 for weaned piglets and weaned Suidae other than Sus scrofa domesticus (holder of authorisation Kemin Europa N.V.)
(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 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/><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&#160;%</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: gut flora stabilisers</span></p></td></tr><tr><td><p>4b1823</p></td><td><p>Kemin Europa N.V.</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;<span>Bacillus velezensis</span></p><p>ATCC PTA-6737<span>&#160;&#9668;</span></p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span><a><span>&#9658;M1</span></a></span>&#160;<span>Bacillus velezensis</span> ATCC PTA-6737<span>&#160;&#9668;</span> containing a minimum of 1&#160;&#215;&#160;10<span>10</span> CFU/g additive</p></div><div><p><span>Characterisation of the active substance</span></p><p>Viable spores of<span><a><span>&#9658;M1</span></a></span>&#160;<span>Bacillus velezensis</span> ATCC PTA-6737<span>&#160;&#9668;</span></p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><div><p>Enumeration: spread plate method using tryptone soya agar with pre heat-treatment of feed samples.</p></div><div><p>Identification: pulsed-field gel electrophoresis (PFGE) method.</p></div></div></td><td><p>(Weaned) piglets and (weaned) Suidae other than<span>Sus scrofa domesticus</span></p></td><td><p>&#8212;</p></td><td><p>1&#160;&#215;&#160;10<span>7</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;For use in (weaned) piglets up to approximately 35&#160;kg.</p></td><td><p>23 April 2023</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></td></tr></tbody></table>