(EU) 2015/639：就二氧化硅(E 551)在聚乙烯醇-聚乙二醇接枝共聚物(E 1209)中的使用，修订欧洲议会和理事会条例(EU) 1333/2008附录 III

　　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:

 

　　(1)

 

　　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.

 

　　(2)

 

　　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 (2), either on the initiative of the Commission or following an application.

 

　　(3)

 

　　Commission Regulation (EU) No 685/2014 (3) authorises the use of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (PVA-PEG graft co-polymer) (E 1209) in food supplements in solid form.

 

　　(4)

 

　　In order to improve the flow properties of the polymer powder, silicon dioxide (E 551) is used in PVA-PEG graft co-polymer. The expected carry-over of silicon dioxide in the final food via the use of PVA-PEG graft co-polymer is 300-500 mg/kg. At this level silicon dioxide has no technological function in the food supplement.

 

　　(5)

 

　　The European Food Safety Authority evaluated the safety of PVA-PEG graft 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 (4). The safety assessment also included the specified use of silicon dioxide in PVA-PEG graft co-polymer.

 

　　(6)

 

　　It is therefore appropriate to authorise the use of silicon dioxide in PVA-PEG graft co-polymer.

 

　　(7)

 

　　Part 2 of Annex III to Regulation (EC) No 1333/2008 should therefore be amended accordingly.

 

　　(8)

 

　　The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

 

　　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:

 

　　‘E 551

 

　　Silicon dioxide

 

　　5 000 mg/kg in the preparation