{
  "url": "https://openlegislation.uk/eu-regulation-2017-2469/article-4",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-2469/article-4.json",
  "legislation": "eur/2017/2469",
  "legislation_title": "Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-2469",
  "path": "article/4",
  "kind": "article",
  "number": "4",
  "heading": "Administrative data requirements",
  "text": "In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the following administrative data:\n(a)the name(s) of the manufacturer(s) of the novel food, if different than the applicant's, address and contact details;\n(b)the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the appropriate authority;\n(c)the date of submission of the dossier;\n(d)a table of contents of the dossier;\n(e)a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;\n(f)a list of the parts of the dossier to be treated as confidential and verifiable justification in accordance with Article 23 of Regulation (EU) 2015/2283 and the rules set out in Annex II to this Regulation. Where the production process contains confidential data, a non-confidential summary of the production process shall be provided;\n(g)information and explanations substantiating the existence of the applicant's right of reference to the proprietary scientific evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/2283. That information shall be included in a separate folder.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Art. 4(b) substituted (31.12.2020) by The Novel Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/702), regs. 1, 54; 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2017/2469/article/4",
    "retrieved_at": "2026-11-01T14:44:19.510135+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."
}