Document ID: 02017R2308-20231219
Language: ENG

02017R2308 — EN — 19.12.2023 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2017/2308</p><p>of 13 December 2017</p><p>concerning the authorisation of the preparation of<span>Bacillus subtilis</span> (DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 331 14.12.2017, p. 19)</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) 2023/2647&#160;of 28&#160;November 2023</a></p></td><td><p>&#160;&#160;L&#160;</p></td><td><p>1</p></td><td><p>29.11.2023</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/2308
of 13 December 2017
concerning the authorisation of the preparation of Bacillus subtilis (DSM 5750) and Bacillus licheniformis (DSM 5749) as a feed additive for suckling piglets (holder of authorisation Chr. Hansen A/S)
(Text with EEA relevance)
Article 1
Authorisation
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
Entry into force
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/><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>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><td><p>CFU/l of water for drinking</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: gut flora stabilisers</span></p></td></tr><tr><td><p>4b1700i</p></td><td><p>Chr.Hansen A/S</p></td><td><p><span>Bacillus subtilis</span> (DSM&#160;5750) and<span>Bacillus licheniformis</span> (DSM 5749)</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Bacillus subtilis</span> (DSM 5750) and<span>Bacillus licheniformis</span>&#160;(DSM 5749) containing&#160;a minimum of 3,2&#160;&#215;&#160;10<span>10</span> CFU/g of additive</p><p>(1:1 ratio)</p><p>Solid form</p><p><span>Characterisation of the active substance</span></p><p>Viable spores of<span>Bacillus subtilis</span></p><p>(DSM 5750) and<span>Bacillus licheniformis</span> (DSM 5749)</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Identification and enumeration of<span>Bacillus subtilis</span> (DSM&#160;5750) and<span>Bacillus licheniformis</span> (DSM 5749) in the feed additive, premixtures, feedingstuffs and water:</p><div><p>&#8212;&#160;Identification: Pulsed Field&#160;Gel Electrophoresis (PFGE)</p></div><div><p>&#8212;&#160;Enumeration: Spread&#160;plate method using tryptone soya agar &#8212; EN&#160;15784.</p></div></td><td><p>Suckling piglets</p></td><td><p>&#8212;</p></td><td><p>1,3 &#215; 10<span>9</span></p></td><td><p>&#8212;</p></td><td><p>6,5 &#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.<br/> 2.&#160;&#160;The additive may be used in water for drinking.<br/> 3.&#160;&#160;For use of the additive in water for drinking&#160;a homogeneous&#160;dispersion of the additive shall be ensured.<span><a><span>&#9658;M1</span></a></span>&#160;<br/> 4.&#160;&#160;Indicate in the instructions for use:<br/> &#8216;It is recommended to feed the additive to lactating sows and suckling piglets simultaneously.&#8217;<span>&#160;&#9668;</span><br/> 5.&#160;&#160;For users of the additive and premixtures, feed&#160;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&#160;premixtures shall be used&#160;with personal protective equipment,&#160;including&#160;breathing protection and skin protection.</p></td><td><p>3 January 2028</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 Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports</p></div></td></tr></tbody></table>