Document ID: 02011R1110-20181108
Language: ENG

02011R1110 — EN — 08.11.2018 — 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 1110/2011</p><p>of 3 November 2011</p><p>concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma reesei</span> (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 287 4.11.2011, p. 27)</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) 2018/1569&#160;of 18&#160;October 2018</a></p></td><td><p>&#160;&#160;L&#160;262</p></td><td><p>37</p></td><td><p>19.10.2018</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 1110/2011
of 3 November 2011
concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei (CBS 114044) as a feed additive for laying hens, minor poultry species and pigs for fattening (holder of authorisation Roal Oy)
(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.&#160;Functional group: digestibility enhancers.</span></p></td></tr><tr><td><p>4a8</p></td><td><p>Roal Oy</p></td><td><p>Endo-1,4-beta-xylanase</p><p>EC 3.2.1.8</p></td><td><p><span>Additive composition</span></p><p>Preparation of endo-1,4-beta-xylanase produced by<span>Trichoderma reesei</span> (CBS 114044) having a minimum activity of:</p><div><p>solid form: 4 &#215; 10<span>6</span> BXU&#160;<a>(<span>1</span>)</a>/g</p></div><div><p>liquid form: 4 &#215; 10<span>5</span> BXU/g</p></div><p><span>Characterisation of the active substance</span></p><p>endo-1,4-beta-xylanase produced by<span>Trichoderma reesei</span> (CBS 114044)</p><p><span>Analytical method</span>&#160;<a>(<span>2</span>)</a></p><p>In the additive and the premixture: reducing sugar assay for endo-1,4- beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield at pH 5,3 and 50&#160;&#176;C</p><p>In the feedingstuffs: colorimetric method measuring water soluble dye released by the enzyme from azurine crosslinked wheat arabinoxylan substrate</p></td><td><p>Minor poultry species other than laying birds</p></td><td><p>&#8212;</p></td><td><p>8&#160;000  BXU</p></td><td><p>&#8212;</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;For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks to 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 personal protective equipment.</p></td><td><p>24 November 2021</p></td></tr><tr><td><p>Laying hens</p></td><td><p>12&#160;000  BXU</p></td></tr><tr><td><p>Laying birds of minor poultry species</p></td><td><p>24&#160;000  BXU</p></td></tr><tr><td><p>Pigs for fattening</p></td><td><p>20&#160;000  BXU</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>1 BXU is the amount of enzyme which liberates 1 nmol reducing sugars as xylose from birch xylan per second at pH 5,3 and 50&#160;&#176;C.</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: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports</p></div></td></tr></tbody></table>