{
  "url": "https://openlegislation.uk/eu-regulation-2013-256/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-256/introduction.json",
  "legislation": "eur/2013/256",
  "legislation_title": "Commission Regulation (EU) No 256/2013 of 20 March 2013 amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Sodium ascorbate (E 301) in vitamin D preparations intended for use in foods for infants and young children (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-256",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) No 256/2013\nof 20 March 2013\namending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of Sodium ascorbate (E 301) in vitamin D preparations intended for use in foods for infants and young children\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 Articles 10(3) and 30(5) 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, food flavourings, nutrients and their conditions of use.\n(2)\nThat list may be amended in accordance with the procedure referred to in 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.\n(3)\nPursuant to Article 3(1) of Regulation (EC) No 1331/2008, the Union list of food additives may be updated either on the initiative of the Commission or following an application.\n(4)\nAn application for the authorisation of use of Sodium ascorbate (E 301) as an antioxidant in vitamin D preparations intended for use in infant formulae and follow-on formulae as defined by Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC, was submitted on 15 December 2009 and has been made available to the Member States.\n(5)\nIngredients used in the manufacture of infant formulae and follow-on formulae must meet a much stricter microbiological standard than general food, in particular for Enterobacteria and Cronobacter sakazakii. In order to achieve this, ingredients such as vitamin D preparations are subjected to a heat treatment. Such treatment in turn requires the presence of an antioxidant which is water-soluble and of neutral pH. Sodium ascorbate (E 301) was identified and proved to be the suitable antioxidant to meet that technological need.\n(6)\nPursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority in order to update the Union list of food additives set out in Annex III to Regulation (EC) No 1333/2008.\n(7)\nThe European Food Safety Authority evaluated the use of Sodium ascorbate (E 301) as a food additive in vitamin D preparations intended for foods for infants and young children and expressed its opinion on 8 December 2010. It concluded that the proposed extension of use of the food additive Sodium ascorbate (E 301) to be used as an antioxidant for the vitamin D preparations for use in infant formulae and follow-on formulae is not of safety concern.\n(8)\nIt is therefore appropriate to authorise the use of Sodium ascorbate (E 301) as an antioxidant in vitamin D preparations intended for use in foods for infants and young children.\n(9)\nFor that reason, Annex III to Regulation (EC) No 1333/2008 should be amended accordingly.\n(10)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,\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": "OJ L 354, 31.12.2008, p. 1."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 401, 30.12.2006, p. 1."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the use of sodium ascorbate as a food additive in vitamin D preparations intended to be used in formulae and weaning food for infants and young children. EFSA Journal 2010;8(12):1942."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/256/introduction",
    "retrieved_at": "2026-11-01T14:48:46.750577+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."
}