Document ID: 32015R0639
Language: ENG

<table><col/><col/><col/><col/><tbody><tr><td><p>24.4.2015&#160;&#160;&#160;</p></td><td><p>EN</p></td><td><p>Official Journal of the European Union</p></td><td><p>L 106/16</p></td></tr></tbody></table>
COMMISSION REGULATION (EU) 2015/639
of 23 April 2015
amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of silicon dioxide (E 551) in polyvinyl alcohol-polyethylene glycol- graft -co-polymer (E 1209)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives ( 1 ) , and in particular Article 10(3) thereof,
Whereas:
<table><col/><col/><tbody><tr><td><p>(1)</p></td><td><p>Annex III to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food additives, food enzymes, flavourings, nutrients and their conditions of use.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(2)</p></td><td><p>That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council<a>&#160;(<span>2</span>)</a>, either on the initiative of the Commission or following an application.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(3)</p></td><td><p>Commission Regulation (EU) No 685/2014<a>&#160;(<span>3</span>)</a> authorises the use of polyvinyl alcohol-polyethylene glycol-<span>graft</span>-co-polymer (PVA-PEG<span>graft</span> co-polymer) (E 1209) in food supplements in solid form.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(4)</p></td><td><p>In order to improve the flow properties of the polymer powder, silicon dioxide (E 551) is used in PVA-PEG<span>graft</span> co-polymer. The expected carry-over of silicon dioxide in the final food via the use of PVA-PEG<span>graft</span> co-polymer is 300-500 mg/kg. At this level silicon dioxide has no technological function in the food supplement.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(5)</p></td><td><p>The European Food Safety Authority evaluated the safety of PVA-PEG<span>graft</span> co-polymer when used as a food additive and concluded that its use in food supplements as film coating is of no safety concern for the proposed uses<a>&#160;(<span>4</span>)</a>. The safety assessment also included the specified use of silicon dioxide in PVA-PEG<span>graft</span> co-polymer.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(6)</p></td><td><p>It is therefore appropriate to authorise the use of silicon dioxide in PVA-PEG<span>graft</span> co-polymer.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(7)</p></td><td><p>Part 2 of Annex III to Regulation (EC) No 1333/2008 should therefore be amended accordingly.</p></td></tr></tbody></table>
<table><col/><col/><tbody><tr><td><p>(8)</p></td><td><p>The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,</p></td></tr></tbody></table>
HAS ADOPTED THIS REGULATION:
Article 1
Part 2 of Annex III to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.
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.
Done at Brussels, 23 April 2015.
For the Commission
The President
Jean-Claude JUNCKER
( 1 ) OJ L 354, 31.12.2008, p. 16 .
( 2 ) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings ( OJ L 354, 31.12.2008, p. 1 ).
( 3 ) Commission Regulation (EU) No 685/2014 of 20 June 2014 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards polyvinyl alcohol-polyethylene glycol-graft-co-polymer in solid food supplements ( OJ L 182, 21.6.2014, p. 23 ).
( 4 ) EFSA Journal 2013; 11(8):3303.
ANNEX
In Part 2 of Annex III to Regulation (EC) No 1333/2008 the following entry is inserted after the third entry for food additive E 551:
<table><col/><col/><col/><col/><tbody><tr><td><p>&#8216;E 551</p></td><td><p>Silicon dioxide</p></td><td><p>5&#160;000 &#160;mg/kg in the preparation</p></td><td><p>E 1209 polyvinyl alcohol-polyethylene glycol-<span>graft</span>-co-polymer&#8217;</p></td></tr></tbody></table>