Document ID: 02016R0329-20171225
Language: ENG

02016R0329 — EN — 25.12.2017 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2016/329</p><p>of 8 March 2016</p><p>concerning the authorisation of 6-phytase as a feed additive for all avian species and for weaned piglets, pigs for fattening, sows and minor porcine species (<span><a><span>&#9658;M1</span></a></span>&#160;holder of the authorisation Kaesler Nutrition GmbH<span>&#160;&#9668;</span>)</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 062 9.3.2016, p. 5)</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) 2017/2231&#160;of 4 December 2017</a></p></td><td><p>&#160;&#160;L&#160;319</p></td><td><p>28</p></td><td><p>5.12.2017</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) 2016/329
of 8 March 2016
concerning the authorisation of 6-phytase as a feed additive for all avian species and for weaned piglets, pigs for fattening, sows and minor porcine species ( holder of the authorisation Kaesler Nutrition GmbH )
(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 activity/kg of complete feedingstuff with a moisture content of 12 %</p></td></tr><tr><td><p><span>Category of zootechnical additives. Functional group: digestibility enhancers</span></p></td></tr><tr><td><p>4a23</p></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;Kaesler Nutrition GmbH<span>&#160;&#9668;</span></p></td><td><p>6-phytase</p><p>EC 3.1.3.26</p></td><td><p><span>Additive composition</span></p><p>Preparation of 6-phytase produced by<span>Komagataella pastoris</span> (DSM 25375) having a minimum activity of: 40&#160;000  U&#160;<a>(<span>1</span>)</a>/g</p><p>Liquid and solid form</p><p><span>Characterisation of the active substance</span></p><p>6-phytase (EC 3.1.3.26) produced by<span>Komagataella pastoris</span> (DSM 25375)</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><p>colorimetric method based on the enzymatic reaction of phytase on the phytate &#8212; VDLUFA Method Book, Vol. III, 27.1.1</p><p>For the quantification of 6-phytase activity in premixtures and mineral feeds:</p><p>colorimetric method based on the enzymatic reaction of phytase on the phytate &#8212; VDLUFA Method Book, Vol. III, 27.1.3</p><p>For the quantification of 6-phytase activity in feedingstuffs:</p><p>colorimetric method based on the enzymatic reaction of phytase on the phytate &#8212; EN ISO 30024.</p></td><td><p>Chickens for fattening and reared for laying, all avian species for fattening and reared for laying other than turkeys for fattening and reared for breeding</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, indicate the storage conditions and stability to heating treatment.</p><p>2.&#160;&#160;For safety: breathing protection, safety glasses and gloves shall be used during handling.</p></td><td><p>29 March 2026</p></td></tr><tr><td><p>All avian species for laying</p></td><td><p>125 U</p></td></tr><tr><td><p>Turkeys for fattening and reared for breeding</p></td><td><p>500 U</p></td></tr><tr><td><p>Piglets (weaned), pigs for fattening, sows and minor porcine species</p></td><td><p>250 U</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 &#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: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx</p></div></td></tr></tbody></table>