{
  "url": "https://openlegislation.uk/eu-regulation-2015-639/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2015-639/introduction.json",
  "legislation": "eur/2015/639",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2015-639",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2015/639\nof 23 April 2015\namending 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)\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, and in particular Article 10(3) thereof,\nWhereas:\n(1)\nAnnex 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.\n(2)\nThat 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, either on the initiative of the Commission or following an application.\n(3)\nCommission Regulation (EU) No 685/2014 authorises the use of polyvinyl alcohol-polyethylene glycol-graft-co-polymer (PVA-PEG graft co-polymer) (E 1209) in food supplements in solid form.\n(4)\nIn 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.\n(5)\nThe 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. The safety assessment also included the specified use of silicon dioxide in PVA-PEG graft co-polymer.\n(6)\nIt is therefore appropriate to authorise the use of silicon dioxide in PVA-PEG graft co-polymer.\n(7)\nPart 2 of Annex III to Regulation (EC) No 1333/2008 should therefore be amended accordingly.\n(8)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 354, 31.12.2008, p. 16."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "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)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "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)."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "EFSA Journal 2013; 11(8):3303."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2015/639/introduction",
    "retrieved_at": "2026-11-01T14:46:43.834328+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}