{
  "url": "https://openlegislation.uk/eu-decision-2016-375/annex-II",
  "json_url": "https://openlegislation.uk/eu-decision-2016-375/annex-II.json",
  "legislation": "eudn/2016/375",
  "legislation_title": "Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of lacto-N-neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2016) 1419) (Only the Danish text is authentic)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2016-375",
  "path": "annex/II",
  "kind": "annex",
  "number": "II",
  "heading": "AUTHORISED USES OF LACTO-N-NEOTETRAOSE",
  "text": "From 20 July 2016 the category ‘Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009’ shall be replaced by the following: ‘Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014’.\nThe maximum level refers to the products ready to use.\nFood category\nMaximum levels\nUnflavoured pasteurised and sterilised (including UHT) milk-based products\n0,6 g/l\nUnflavoured fermented milk-based products\n0,6 g/l for beverages\n9,6 g/kg for products other than beverages\nFlavoured fermented milk-based products including heat-treated products\n0,6 g/l for beverages\n9,6 g/kg for products other than beverages\nDairy analogues, including beverage whiteners\n0,6 g/l for beverages\n6 g/kg for products other than beverages\n200 g/kg for whitener\nCereal bars\n6 g/kg\nTable-top sweeteners\n100 g/kg\nInfant formulae as defined in Directive 2006/141/EC\n0,6 g/l in combination with 1,2 g/l of 2′-O-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer\nFollow-on formulae as defined in Directive 2006/141/EC\n0,6 g/l in combination with 1,2 g/l of 2′-O-fucosyllactose at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer\nProcessed cereal-based food and baby food for infants and young children as defined in Directive 2006/125/EC\n6 g/kg for products other than beverages\n0,6 g/l for liquid food ready for use, marketed as such or reconstituted as instructed by the manufacturer\nMilk-based drinks and similar products intended for young children\n0,6 g/l for milk-based drinks and similar products added alone or in combination with 2′-O-fucosyllactose, at concentrations 1,2 g/l, at a ratio of 1:2 in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer\nDietary foods for special medical purposes as defined in Directive 1999/21/EC\nIn accordance with the particular nutritional requirements of the persons for whom the products are intended\nFoods intended for use in energy-restricted diets for weight reduction as defined in Directive 96/8/EC (only for products presented as a replacement for the whole of the daily diet)\n2,4 g/l for drinks\n20 g/kg for bars\nBread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009\n30 g/kg\nFlavoured drinks\n0,6 g/l\nCoffee, tea (excluding black tea), herbal and fruit infusions, chicory; tea, herbal and fruit infusions and chicory extracts; tea, plant, fruit and cereal preparations for infusions, as well as mixes and instant mixes of these products\n4,8 g/l\nFood supplements as defined in Directive 2002/46/EC, excluding food supplements for infants\n1,5 g/day for general population\n0,6 g/day for young children",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "From 20 July 2016 the category ‘Bread and pasta products for people intolerant to gluten as defined in Regulation (EC) No 41/2009’ shall be replaced by the following: ‘Bread and pasta products bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014’."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "The maximum level refers to the products ready to use."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2016/375/annex/II",
    "retrieved_at": "2026-11-01T15:14:02.234830+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."
}