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(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

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放大字体  缩小字体 2015-04-28 08:33:50  来源: EUROPEAN  浏览次数:3877
核心提示:(EU)2014/685规定聚乙烯醇-聚乙二醇接枝共聚物可用于固体食品补充剂中,为提高共聚物粉末的流动性,可以在聚乙烯醇-聚乙二醇接枝共聚物中使用二氧化硅,使用聚乙烯醇-聚乙二醇接枝共聚物所致最终食品中二氧化硅预期量为300-500mg/kg时,该水平二氧化硅在食品补充剂中没有任何技术作用,欧洲食品安全局就聚乙烯醇-聚乙二醇接枝共聚物用作食品添加剂的安全性进行了评估,结论为聚乙烯醇-聚乙二醇接枝共聚物用作食品补充剂的薄膜包衣不存在安全问题,另外EFSA还就其中二氧化硅的具体使用进行了安全评估。综上,批准二
发布单位
EUROPEAN COMMISSION
EUROPEAN COMMISSION
发布文号 (EU) 2015/639
发布日期 2015-04-23 生效日期 暂无
有效性状态 废止日期 暂无
备注
(EU)2014/685规定聚乙烯醇-聚乙二醇接枝共聚物可用于固体食品补充剂中,为提高共聚物粉末的流动性,可以在聚乙烯醇-聚乙二醇接枝共聚物中使用二氧化硅,使用聚乙烯醇-聚乙二醇接枝共聚物所致最终食品中二氧化硅预期量为300-500mg/kg时,该水平二氧化硅在食品补充剂中没有任何技术作用,欧洲食品安全局就聚乙烯醇-聚乙二醇接枝共聚物用作食品添加剂的安全性进行了评估,结论为聚乙烯醇-聚乙二醇接枝共聚物用作食品补充剂的薄膜包衣不存在安全问题,另外EFSA还就其中二氧化硅的具体使用进行了安全评估。综上,批准二氧化硅用于聚乙烯醇-聚乙二醇接枝共聚物是恰当的,最大限量为5000mg/kg,同时修订(EU) 1333/2008附录III第二部分的相应内容。
  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
 
E 1209 polyvinyl alcohol-polyethylene glycol-graft-co-polymer’ 
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