Document ID: 02016R0899-20190330
Language: ENG

02016R0899 — 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) 2016/899</p><p>of 8 June 2016</p><p>concerning the authorisation of a 6-phytase produced by<span>Trichoderma reesei</span> (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (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 152 9.6.2016, p. 15)</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) 2016/899
of 8 June 2016
concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (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 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>Units of active substance/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><span>Category: Zootechnical additives. Functional group: digestibility enhancers.</span></p></td></tr><tr><td><p>4a24</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>6-phytase EC 3.1.3.26</p></td><td><p><span>Additive composition</span></p><p>Preparation of 6-phytase produced by<span>Trichoderma reesei</span> (ATCC SD-6528) having a minimum activity of 15&#160;000  U&#160;<a>(<span>1</span>)</a>/g.</p><p>Liquid form</p><p><span>Characterisation of the active substance</span></p><p>6-phytase (EC 3.1.3.26) produced by<span>Trichoderma reesei</span> (ATCC SD-6528)</p><p><span>Analytical method</span>&#160;<a>(<span>2</span>)</a></p><p>For the quantification of 6-phytase activity in the feed additive:</p><div><p>&#8212;&#160;colorimetric method based on the enzymatic reaction of phytase on the phytate.</p></div><p>For the quantification of 6-phytase activity in premixtures and feedingstuffs:</p><div><p>&#8212;&#160;colorimetric method based on&#160;the enzymatic reaction of phytase on the phytate EN ISO&#160;30024.</p></div></td><td><p>All poultry species</p><p>All porcine species (other than suckling piglets)</p></td><td><p>&#8212;</p></td><td><p>250 U</p></td><td><p>&#8212;</p></td><td><p>1.&#160;&#160;In the directions for use of the additive and premixture the storage conditions and stability to pelleting shall be indicated.</p><p>2.&#160;&#160;Maximum recommended dose: 2&#160;000  U/kg feed.</p><p>3.&#160;&#160;For users of the additive and premixtures in a feed business, operational procedures and appropriate organisational measures shall be established to address hazards by inhalation, dermal contact or eye contact. Where the dermal, inhalator or eye exposure cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.</p></td><td><p>29 June 2026</p></td></tr><tr><td><div><a>(<span>1</span>)&#160;&#160;&#160;</a><p>1 U is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37&#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>