Document ID: 02013R0544-20150729
Language: ENG

02013R0544 — EN — 29.07.2015 — 001.002
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) No 544/2013</p><p>of 14 June 2013</p><p>concerning the authorisation of a preparation of<span>Bifidobacterium animalis</span> ssp.<span>animalis DSM 16284, Lactobacillus salivarius</span> ssp.<span>salivarius DSM 16351</span> and<span>Enterococcus faecium DSM 21913</span> as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 163 15.6.2013, p. 13)</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) 2015/1105&#160;of 8 July 2015</a></p></td><td><p>&#160;&#160;L&#160;181</p></td><td><p>65</p></td><td><p>9.7.2015</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 544/2013
of 14 June 2013
concerning the authorisation of a preparation of Bifidobacterium animalis ssp. animalis DSM 16284, Lactobacillus salivarius ssp. salivarius DSM 16351 and Enterococcus faecium DSM 21913 as a feed additive for chickens for fattening (holder of authorisation Biomin GmbH)
(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&#160;<a>(<span>1</span>)</a>/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>4b1890</p></td><td><p>Biomin GmbH</p></td><td><p><span>Bifidobacterium animalis</span> ssp.<span>animalis</span></p><p>DSM 16284,<span>Lactobacillus salivarius</span> ssp.<span>salivarius</span> DSM 16351 and<span>Enterococcus faecium</span> DSM 21913</p></td><td><div><p><span>Additive composition</span></p><p>Preparation in form of a mixture of:</p><div><p><span>Bifidobacterium animalis</span> ssp.<span>animalis</span> DSM 16284 containing a minimum of 3 &#215; 10<span>9</span> CFU/g additive</p></div><div><p><span>Lactobacillus salivarius</span> ssp.<span>salivarius</span> DSM 16351 containing a minimum of 1 &#215; 10<span>9</span> CFU/g additive</p></div><div><p><span>Enterococcus faecium</span> DSM 21913 containing a minimum of 6 &#215; 10<span>9</span> CFU/g additive</p></div><p>Solid preparation (ratio 3:1:6)</p></div><div><p><span>Characterisation of active substance</span></p><p>Viable cells of<span>Bifidobacterium animalis</span> ssp.<span>animalis</span> DSM 16284,<span>Lactobacillus salivarius</span> ssp.<span>salivarius</span> DSM 16351, and<span>Enterococcus faecium</span> DSM 21913</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>2</span>)</a></p><p>For the enumeration of:</p><div><p><span>Bifidobacterium animalis</span> ssp.<span>animalis</span> DSM 16284: spread plate method EN 15785</p></div><div><p><span>Lactobacillus salivarius</span> ssp.<span>salivarius</span> DSM 16351: spread plate method EN 15787</p></div><div><p><span>Enterococcus faecium</span> DSM 21913 spread plate method EN 15788</p></div><p>For the identification:</p><p>Pulsed Field Gel Electrophoresis (PFGE)</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>1 &#215; 10<span>8</span></p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;&#8212;<span>9</span><span>&#160;&#9668;</span></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.<span><a><span>&#9658;M1</span></a></span>&#160;<br/> 2.&#160;&#160;The use is permitted in feed containing the authorised coccidiostats: maduramicin ammonium, diclazuril, robenidine hydrochloride, decoquinate, narasin, nicarbazin or narasin/nicarbazin.<span>&#160;&#9668;</span><br/> 3.&#160;&#160;For safety: breathing protection, glasses and gloves shall be used during handling.</p></td><td><p>5 July 2023</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>As total content of the mixture.</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx</p></div></td></tr></tbody></table>