Document ID: 02009R1087-20190330
Language: ENG

02009R1087 — 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 REGULATION (EC) No 1087/2009</p><p>of 12 November 2009</p><p>concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma reesei</span> (ATCC PTA 5588), subtilisin produced by<span>Bacillus subtilis</span> (ATCC 2107) and alpha-amylase produced by<span>Bacillus amyloliquefaciens</span> (ATCC 3978) as a feed additive for chickens for fattening, for ducks and for turkeys for fattening (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 297 13.11.2009, p. 4)</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 REGULATION (EC) No 1087/2009
of 12 November 2009
concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), subtilisin produced by Bacillus subtilis (ATCC 2107) and alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) as a feed additive for chickens for fattening, for ducks and for turkeys for fattening (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 ‘digestibility enhancers’, 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 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
<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>Units of activity /kg of complete feedingstuff with a moisture content of 12&#160;%</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: digestibility enhancers</span></p></td></tr><tr><td><p>4a10</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>Endo-1,4-beta-xylanase</p><p>EC 3.2.1.8</p><p>Subtilisin</p><p>EC 3.4.21.62</p><p>Alpha-amylase</p><p>EC 3.2.1.1</p></td><td><div><p>Additive composition:</p><p>Preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma reesei</span> (ATCC PTA 5588), subtilisin produced by<span>Bacillus subtilis</span> (ATCC 2107) and alpha-amylase produced by<span>Bacillus amyloliquefaciens</span> (ATCC 3978) having a minimum activity of</p></div><div><p>Solid form:</p><div><p>Endo-1,4-beta-xylanase 1&#160;500 &#160;U&#160;<a>(<span>1</span>)</a>/g</p></div><div><p>Subtilisin (protease) 20&#160;000 &#160;U&#160;<a>(<span>2</span>)</a>/g</p></div><div><p>Alpha-amylase 2&#160;000 &#160;U&#160;<a>(<span>3</span>)</a>/g</p></div></div><div><p>Characterisation of the active substance:</p><p>Endo-1,4-beta-xylanase produced by<span>Trichoderma reesei</span> (ATCC PTA 5588), subtilisin produced by<span>Bacillus subtilis</span> (ATCC 2107) and alpha-amylase produced by<span>Bacillus amyloliquefaciens</span> (ATCC 3978)</p></div></td><td><p>Chickens for fattening</p></td><td><p>&#8212;</p></td><td><p>Endo-1,4-beta-xylanase 187,5&#160;U</p><p>Subtilisin 2&#160;500 &#160;U</p><p>Alpha-amylase 250&#160;U</p></td><td><p>&#160;</p><div/></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;For use in feed rich in non-starch polysaccharides (mainly beta-glucans and arabinoxylans), e. g. containing more than 40&#160;% maize.</p><p>3.&#160;&#160;For safety reasons: breathing protection, glasses and gloves shall be used during handling.</p><p>4.&#160;&#160;An appropriate method for control purposes shall be developed.</p></td><td><p>3 December 2019</p></td></tr><tr><td><p>Ducks</p></td><td><p>Endo-1,4-beta-xylanase 75&#160;U</p><p>Subtilisin 1&#160;000 &#160;U</p><p>Alpha-amylase 100&#160;U</p></td></tr><tr><td><p>Turkeys for fattening</p></td><td><p>Endo-1,4-beta-xylanase 300&#160;U</p><p>Subtilisin 4&#160;000 &#160;U</p><p>Alpha-amylase 400&#160;U</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>1&#160;U of endo-1,4-&#946;-xylanase is the amount of enzyme that liberates 0,5&#160;&#956;mol of reducing sugar (xylose equivalents) per minute from a cross-linked oat spelt xylan at pH&#160;5,3 and 50&#160;&#176;C.</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>1&#160;U of subtilisin is the amount of enzyme that liberates 1&#160;&#956;mol of phenolic compound (tyrosine equivalents) per minute from a casein substrate at pH&#160;7,5 and 40&#160;&#176;C.</p></div><div><a>(<span>3</span>)&#160;&#160;&#160;</a><p>1&#160;U of &#945;-amylase is the amount of enzyme that liberates 1&#160;&#956;mol of glucosidic linkages per minute from a water insoluble cross-linked starch polymer substrate at pH&#160;6,5 and 37&#160;&#176;C.</p></div></td></tr></tbody></table>