Document ID: 02013R0636-20160727
Language: ENG

02013R0636 — EN — 27.07.2016 — 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 636/2013</p><p>of 1 July 2013</p><p>concerning the authorisation of zinc chelate of methionine (1:2) as a feed additive for all animal species</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 183 2.7.2013, p. 3)</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) 2016/1095&#160;of 6 July 2016</a></p></td><td><p>&#160;&#160;L&#160;182</p></td><td><p>7</p></td><td><p>7.7.2016</p></td></tr></table>
COMMISSION IMPLEMENTING REGULATION (EU) No 636/2013
of 1 July 2013
concerning the authorisation of zinc chelate of methionine (1:2) as a feed additive for all animal species
(Text with EEA relevance)
Article 1
The product specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, 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>Maximum content of element (Zn) in mg/kg of complete feedingstuff with a moisture content of 12&#160;%</p></td></tr><tr><td><p><span>Category of nutritional additives. Functional group: compounds of trace elements</span></p></td></tr><tr><td><p>3b611</p></td><td><p>&#8212;</p></td><td><p>Zinc chelate of methionine (1:2)</p></td><td><div><p><span>Characterisation of the additive</span></p><p>Powder with a minimum content of 78&#160;% DL-methionine and a zinc content between 17,5&#160;% and 18,5&#160;%</p></div><div><p><span>Characterisation of the active substance</span></p><p>Zinc chelate of methionine: Zinc-Methionine 1:2 (Zn(Met)<span>2</span>)</p><p>Chemical formula: C<span>10</span>H<span>20</span>N<span>2</span>O<span>4</span>S<span>2</span>Zn</p><p>CAS number: 151214-86-7</p></div><div><p><span>Analytical methods</span>&#160;<a>(<span>1</span>)</a></p><div><p>For the quantification of methionine in feed additive:</p><div><p>&#8212;&#160;ISO/CD 17180: ion exchange chromatography method with post-column derivatisation and photometric or fluorometric detection.</p></div></div><div><p>For the quantification of total zinc in the feed additive and premixtures:</p><div><p>&#8212;&#160;EN 15510: Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry (ICP-AES), or</p></div><div><p>&#8212;&#160;CEN/TS 15621: Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry (ICP-AES) after pressure digestion.</p></div></div><div><p>For the quantification of total zinc in the feedingstuffs:</p><div><p>&#8212;&#160;Commission Regulation (EC) No 152/2009&#160;<a>(<span>2</span>)</a> &#8212; Atomic Absorption Spectrometry (AAS), or</p></div><div><p>&#8212;&#160;EN 15510: Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry (ICP-AES), or</p></div><div><p>&#8212;&#160;CEN/TS 15621: Inductively Coupled Plasma &#8212; Atomic Emission Spectrometry (ICP-AES) after pressure digestion.</p></div></div></div></td><td><p>All species</p></td><td><p>&#8212;</p></td><td><p>&#160;</p><div/></td><td><p><span><a><span>&#9658;M1</span></a></span>&#160;<br/> Dogs and cats: 200 (total)<br/> Salmonids and milk replacers for calves: 180 (total)<br/> Piglets, sows, rabbits and all fish species other than salmonids: 150 (total)<br/> Other species and categories: 120 (total)<span>&#160;&#9668;</span></p></td><td><p>1.&#160;&#160;The additive shall be incorporated into the feed in form of a premixture.</p><p>2.&#160;&#160;For user safety: breathing protection, safety glasses and gloves should be worn during handling.</p><p>3.&#160;&#160;The contribution of the additive to the dietary supply with methionine should be taken into account.</p></td><td><p>22 July 2023</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: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx</p></div><div><a>(<span>2</span>)&#160;&#160;&#160;</a><p>OJ L 54, 26.2.2009, p. 1.</p></div></td></tr></tbody></table>