{
  "url": "https://openlegislation.uk/eu-regulation-2016-355/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-355/introduction.json",
  "legislation": "eur/2016/355",
  "legislation_title": "Commission Regulation (EU) 2016/355 of 11 March 2016 amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-355",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) 2016/355\nof 11 March 2016\namending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption\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 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin, and in particular Article 10(1) thereof,\nWhereas:\n(1)\nRegulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. That Regulation provides in particular that food business operators are to ensure compliance with specific requirements for raw materials for the production of gelatine and collagen intended for human consumption.\n(2)\nIt is necessary to ensure that raw materials for the production of gelatine and collagen for human consumption come from sources that meet the public and animal health requirements laid down in Union legislation.\n(3)\nThe Union is highly dependent on imports of raw materials for the production of gelatine and collagen. Establishments producing those raw materials apply specific treatments to exclude public and animal health risks linked to those raw materials. It is therefore appropriate to allow those treatments prior to placing on the market in the Union.\n(4)\nIt is appropriate to adapt the requirements for the production process for collagen to allow practical changes in cases where a change does not result in a different level of public health protection.\n(5)\nAnalytical methods for verifying residue limits in gelatine and collagen should be adapted to the most appropriate and most recently validated methods.\n(6)\nIn order to ensure the safety of certain highly refined products, to ensure the enforcement of EU provisions and to ensure fair competition as regards raw materials coming from within the Union and from third countries, it is appropriate to harmonise conditions and lay down specific requirements for the production of certain highly refined products of animal origin intended for human consumption. The import of other products of animal origin for which Annex III to Regulation (EC) No 853/2004 does not lay down specific requirements, remains allowed in accordance with Commission Regulation (EU) No 1079/2013.\n(7)\nAnnex III to Regulation (EC) No 853/2004 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 139, 30.4.2004, p. 55."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Commission Regulation (EU) No 1079/2013 of 31 October 2013 laying down transitional measures for the application of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council (OJ L 292, 1.11.2013, p. 10)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/355/introduction",
    "retrieved_at": "2026-11-01T14:45:59.877048+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."
}