Document ID: 02021R0422-20210831
Language: ENG

02021R0422 — EN — 31.08.2021 — 001.001
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) 2021/422</p><p>of 9&#160;March 2021</p><p>concerning the authorisation of a preparation of<span>Enterococcus faecium</span> DSM 7134 as a feed additive for laying hens (holder of authorisation: Lactosan GmbH &amp; Co KG)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 083 10.3.2021, p. 25)</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) 2021/1414&#160;of 27&#160;August 2021</a></p></td><td><p>&#160;&#160;L&#160;304</p></td><td><p>21</p></td><td><p>30.8.2021</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2021/422
of 9 March 2021
concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 as a feed additive for laying hens (holder of authorisation: Lactosan GmbH & Co KG)
(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/><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>4b1841</p></td><td><p>Lactosan GmbH &amp; Co KG</p></td><td><p><span>Enterococcus faecium</span> DSM 7134</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Enterococcus faecium</span></p><p>DSM 7134</p><p>containing a minimum of:</p><p>Powder: 1x10<span>10</span> CFU/g of additive</p><p>Granules (microencapsulated): 1x10<span>10</span></p><p>CFU/g of additive</p></td><td><p>Laying hens</p></td><td><p>-</p></td><td><p>1 x 10<span>9</span></p></td><td><p>-</p></td><td><p>5 x 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 via 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 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 appropriate personal protective equipment, including breathing and skin protection.</p></td><td><p><span>30.3.2031</span></p></td></tr><tr><td><p><span>Characterisation of the active substance:</span></p><p>Viable cells of<span>Enterococcus faecium</span> DSM 7134</p></td></tr><tr><td><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>For enumeration: Spread plate method using bile esculin azid agar (EN 15788).</p><p>For identification: Pulsed Field Gel Electrophoresis (PFGE).</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>