{
  "url": "https://openlegislation.uk/eu-regulation-2016-128",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-128.json",
  "id": "eur/2016/128",
  "title": "Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (Text with EEA relevance)",
  "short_title": "Regulation (EU) 2016/128 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the…",
  "long_title": "Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes (Text with EEA relevance)",
  "citation": "EU Regulation 2016/128",
  "type": "eur",
  "year": "2016",
  "number": "128",
  "version": "current",
  "date": "2015-09-25",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 6,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Placing on the market",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Compositional requirements",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Requirements on pesticides in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Name of the food",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Specific requirements on food information",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Specific requirements on the nutrition declaration",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/7",
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      "number": "7",
      "heading": "Nutrition and health claims",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Specific requirements for food for special medical purposes developed to satisfy the nutritional requirements of infants",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Notification",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Directive 1999/21/EC",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-10",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Entry into force and application",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/article-11",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(3)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I/part/A",
      "kind": "division",
      "number": "PART A",
      "heading": "Food for special medical purposes developed to satisfy the nutritional requirements of infants",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-I/part-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/part/A/division/1",
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      "number": "1",
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      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-I/part-A/division-1",
      "extent": "E+W+S+N.I.",
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    },
    {
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    {
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    },
    {
      "path": "annex/I/part/A/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-I/part-A/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/part/A"
    },
    {
      "path": "annex/I/part/B",
      "kind": "division",
      "number": "PART B",
      "heading": "Food for special medical purposes other than that developed to satisfy the nutritional requirements of infants",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-I/part-B",
      "extent": "E+W+S+N.I.",
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      "extent": "E+W+S+N.I.",
      "status": null,
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      "path": "annex/I/part/B/division/2",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/part/B"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": "ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(3)",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-II",
      "extent": "E+W+S+N.I.",
      "status": null,
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    },
    {
      "path": "annex/III",
      "kind": "annex",
      "number": "III",
      "heading": "ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 3(4)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III/division/1",
      "kind": "division",
      "number": null,
      "heading": "Chemical name of the substance (residue definition)",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-III/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III"
    },
    {
      "path": "annex/IV",
      "kind": "annex",
      "number": "IV",
      "heading": "NAME REFERRED TO IN ARTICLE 4",
      "url": "https://openlegislation.uk/eu-regulation-2016-128/annex-IV",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
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  "changes_made_to_url": "https://openlegislation.uk/eu-regulation-2016-128/changes.json",
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/128",
    "retrieved_at": "2026-11-01T14:46:05.440965+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."
}