Document ID: 02011R0361-20150416
Language: ENG

02011R0361 — EN — 16.04.2015 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) No 361/2011</p><p>of 13 April 2011</p><p>concerning the authorisation of<span>Enterococcus faecium</span> NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 100 14.4.2011, p. 22)</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) 2015/518&#160;of 26 March 2015</a></p></td><td><p>&#160;&#160;L&#160;82</p></td><td><p>75</p></td><td><p>27.3.2015</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 361/2011
of 13 April 2011
concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005
(Text with EEA relevance)
Article 1
The preparation specified in Annex I, 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
Annex I to Regulation (EC) No 943/2005 is replaced by the text in Annex II to this Regulation.
Article 3
Premixtures and compound feed containing Enterococcus faecium NCIMB 10415 labelled in accordance with Directive 70/524/EEC may continue to be placed on the market and used until stocks are exhausted.
Article 4
This Regulation shall enter into force on the 20th day following 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 I
<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&#160;%</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: gut flora stabilisers</span></p></td></tr><tr><td><p>4b1705</p></td><td><p>DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o</p></td><td><p><span>Enterococcus faecium</span></p><p>NCIMB 10415</p></td><td><div><p><span>Additive composition</span></p><p>Preparation of<span>Enterococcus faecium</span></p><p>NCIMB 10415 containing a minimum of:</p><div><p>coated form (with shellac):</p><p>2 &#215; 10<span>10</span> CFU/g of additive;</p></div><div><p>Other microencapsulated forms:</p><p>1 &#215; 10<span>10</span> CFU/g additive</p></div></div><div><p><span>Characterisation of the active substance</span></p><p><span>Enterococcus faecium</span></p><p>NCIMB 10415</p></div><div><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Enumeration: spread plate method using bile esculin azide agar</p><p>Identification: Pulsed- Field Gel Electrophoresis (PFGE)</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#160;</p><div/></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, 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: decoquinate, monensin sodium, robenidine hydrochloride, diclazuril, semduramycin, lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin or salinomycin sodium.<span>&#160;&#9668;</span></p></td><td><p>4 May 2021</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 European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives</p></div></td></tr></tbody></table>
ANNEX II
Annex I to Regulation (EC) No 943/2005 is replaced by the following:
‘ANNEX I
<table><col/><col/><col/><col/><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>EC No</p></td><td><p>&#160;</p><div/></td><td><p>Additive</p></td><td><p>Chemical formula, description</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</p></td></tr><tr><td><p><span>Micro-organisms</span></p></td></tr><tr><td><p>E 1705</p></td><td><p>&#160;</p><div/></td><td><p><span>Enterococcus faecium</span></p><p>NCIMB 10415</p></td><td><p>Preparation of<span>Enterococcus faecium</span> containing a minimum of:</p><div><p>Microencapsulated form:</p><p>1,0 &#215; 10<span>10</span> CFU/g of additive;</p></div><div><p>Granulated form:</p><p>3,5 &#215; 10<span>10</span> CFU/g additive</p></div></td><td><p>Pigs for fattening</p></td><td><p>&#8212;</p></td><td><p>0,35 &#215; 10<span>9</span></p></td><td><p>1,0 &#215; 10<span>9</span></p></td><td><p>In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting.</p></td><td><p>Without a time limit&#8217;</p></td></tr></tbody></table>
<note>
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 243, 15.7.2004, p. 10.
( 4 ) OJ L 159, 22.6.2005, p. 6.
( 5 ) OJ L 195, 27.7.2005, p. 6.
( 6 ) OJ L 44, 15.2.2006, p. 3.
( 7 ) OJ L 34, 4.2.2009, p. 8.
( 8 ) EFSA Journal 2010; 8(7):1661.
</note>