Document ID: 02017R2312-20220526
Language: ENG

02017R2312 — EN — 26.05.2022 — 002.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2017/2312</p><p>of 13 December 2017</p><p>concerning the authorisation of a new use of the preparation of<span><a><span>&#9658;M2</span></a></span>&#160;<span>Bacillus velezensis</span> DSM 15544<span>&#160;&#9668;</span> as a feed additive for sows, suckling piglets and dogs (holder of the authorisation<span><a><span>&#9658;M1</span></a></span>&#160;<span><a><span>&#9658;M2</span></a></span>&#160;Asahi Biocycle Co. Ltd.<span>&#160;&#9668;</span>, represented in the European Union by Pen &amp; Tec Consulting S.L.U.<span>&#160;&#9668;</span>)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 331 14.12.2017, p. 41)</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) 2020/146&#160;of 3 February 2020</a></p></td><td><p>&#160;&#160;L&#160;31</p></td><td><p>3</p></td><td><p>4.2.2020</p></td></tr><tr><td><p><a>&#9658;M2</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2022/703&#160;of 5&#160;May 2022</a></p></td><td><p>&#160;&#160;L&#160;132</p></td><td><p>5</p></td><td><p>6.5.2022</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/2312
of 13 December 2017
concerning the authorisation of a new use of the preparation of Bacillus velezensis DSM 15544 as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Biocycle Co. Ltd. , represented in the European Union by Pen & Tec Consulting S.L.U. )
(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 %</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: gut flora stabilisers</span></p></td></tr><tr><td><p>4b1820</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;<span><a><span>&#9658;M2</span></a></span>&#160;Asahi Biocycle Co. Ltd.<span>&#160;&#9668;</span>, represented in the European Union by Pen &amp; Tec Consulting S.L.U.<span>&#160;&#9668;</span></p></td><td><p><span><a><span>&#9658;M2</span></a></span>&#160;<br/><span>Bacillus velezensis</span><br/> DSM 15544<span>&#160;&#9668;</span></p></td><td><p><span>Additive composition</span></p><p>Preparation of<span><a><span>&#9658;M2</span></a></span>&#160;<span>Bacillus velezensis</span></p><p>DSM 15544<span>&#160;&#9668;</span> containing a minimum of 1 &#215; 10<span>10</span> CFU/g additive in solid form</p><p><span>Characterisation of the active substance</span></p><p>Viable cells of<span><a><span>&#9658;M2</span></a></span>&#160;<span>Bacillus velezensis</span></p><p>DSM 15544<span>&#160;&#9668;</span></p><p><span>Analytical method</span></p><p>Enumeration: spread plate method using tryptone soya agar in all target matrices (EN 15784:2009)</p><p>Identification: pulsed-field gel electrophoresis (PFGE).</p></td><td><p>Sows</p><p>Suckling piglets</p></td><td><p>&#8212;</p></td><td><p>3 &#215; 10<span>8</span></p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.</p><p>2.&#160;&#160;Indicate in the instruction for the use:</p><p>&#8216;The additive shall be fed to lactating sows and suckling piglets simultaneously&#8217;</p><p>3.&#160;&#160;For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.</p></td><td><p>3 January 2028</p></td></tr><tr><td><p>Dogs</p></td><td><p>1 &#215; 10<span>9</span></p></td></tr></tbody></table>