Document ID: 02020R1760-20220225
Language: ENG

02020R1760 — EN — 25.02.2022 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2020/1760</p><p>of 25 November 2020</p><p>concerning the authorisation of the preparation of<span>Bacillus subtilis</span> DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 397 26.11.2020, p. 6)</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) 2022/271&#160;of 23&#160;February 2022</a></p></td><td><p>&#160;&#160;L&#160;43</p></td><td><p>10</p></td><td><p>24.2.2022</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2020/1760
of 25 November 2020
concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in 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&#160;%</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>4b1902</p></td><td><p>Chr. Hansen A/S</p></td><td><p><span>Bacillus subtilis</span></p><p>DSM 25841</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Bacillus subtilis</span> DSM 25841 containing a minimum of 1,25 &#215; 10<span>10</span> CFU/g of additive</p><p>Solid form</p><p><span>Characterisation of the active substance</span></p><p>Viable spores of<span>Bacillus subtilis</span> DSM 25841</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For identification of<span>Bacillus subtilis</span> DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)</p><p>For enumeration of<span>Bacillus subtilis</span> DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar &#8211; EN 15784</p></td><td><p>All porcine species, including sows,</p><p>other than lactating sows in order to have a benefit in suckling piglets</p></td><td><p>-</p></td><td><p>5 &#215; 10<span>8</span></p></td><td><p>-</p></td><td><p>1,7 &#215; 10<span>8</span></p></td><td><p>-</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.</p><p>2.&#160;&#160;The additive may be used in water for drinking.</p><p>3.&#160;&#160;For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.</p><p>4.&#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 its use: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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.</p></td><td><p>16.12.2030</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>