Document ID: 02017R0440-20190330
Language: ENG

02017R0440 — EN — 30.03.2019 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2017/440</p><p>of 13 March 2017</p><p>concerning the authorisation of the preparation of<span>Bacillus amyloliquefaciens</span> (PTA-6507),<span>Bacillus amyloliquefaciens</span> (NRRL B-50013) and<span>Bacillus amyloliquefaciens</span> (NRRL B-50104) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying (holder of authorisation<span><a><span>&#9658;M1</span></a></span>&#160;Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.<span>&#160;&#9668;</span>)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 067 14.3.2017, p. 74)</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) 2019/221&#160;of 6&#160;February 2019</a></p></td><td><p>&#160;&#160;L&#160;35</p></td><td><p>28</p></td><td><p>7.2.2019</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2017/440
of 13 March 2017
concerning the authorisation of the preparation of Bacillus amyloliquefaciens (PTA-6507), Bacillus amyloliquefaciens (NRRL B-50013) and Bacillus amyloliquefaciens (NRRL B-50104) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and minor poultry species reared for laying (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V. )
(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/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>4b1827</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.<span>&#160;&#9668;</span>,</p></td><td><p><span>Bacillus amyloliquefaciens</span> PTA-6507,<span>Bacillus amyloliquefaciens</span> NRRL</p><p>B-50013 and<span>Bacillus amyloliquefaciens</span> NRRL B-50104</p></td><td><p><span>Additive composition</span></p><p>Preparation of<span>Bacillus amyloliquefaciens</span> PTA-6507,<span>Bacillus amyloliquefaciens</span> NRRL</p><p>B-50013 and<span>Bacillus amyloliquefaciens</span> NRRL B-50104 containing a minimum of 2,5&#160;&#215;&#160;10<span>9</span> CFU/g (total) with a minimum of bacterial concentration of 8,3 &#215; 10<span>8</span> of each strain/g additive.</p><p>Solid form</p><p><span>Characterisation of the active substance</span></p><p>Viable spores of<span>Bacillus amyloliquefaciens</span> PTA-6507,<span>Bacillus amyloliquefaciens</span> NRRL</p><p>B-50013 and<span>Bacillus amyloliquefaciens</span> NRRL B-50104</p><p><span>Analytical method</span>&#160;<a>(<span>1</span>)</a></p><p>Identification and enumeration of<span>Bacillus amyloliquefaciens</span> PTA-6507,<span>Bacillus amyloliquefaciens</span> NRRL</p><p>B-50013 and<span>Bacillus amyloliquefaciens</span> NRRL B-50104 in the feed additive, premixtures and feedingstuffs</p><div><p>&#8212;&#160;Identification: Pulsed Field Gel Electrophoresis (PFGE)</p></div><div><p>&#8212;&#160;Enumeration: Spread plate method following heat treatment &#8212; EN 15784</p></div></td><td><p>Chickens for fattening</p><p>Chickens reared for laying</p><p>Minor poultry species for fattening and reared for laying</p></td><td><p>&#8212;</p></td><td><p>7,5&#160;&#215;&#160;10<span>7</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.</p><p>2.&#160;&#160;The use is compatible in feed containing the following authorised coccidiostats: narasin/nicarbazin, maduramicin ammonium, lasalocid A sodium, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, decoquinate, semduramycin sodium or nicarbazin.</p><p>3.&#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. 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>3 April 2027</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>