{
  "url": "https://openlegislation.uk/eu-regulation-2004-1935/article-11",
  "json_url": "https://openlegislation.uk/eu-regulation-2004-1935/article-11.json",
  "legislation": "eur/2004/1935",
  "legislation_title": "Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2004-1935",
  "path": "article/11",
  "kind": "article",
  "number": "11",
  "heading": "... Authorisation",
  "text": "1. The authorisation of a substance must be determined by the appropriate authority and may contain such restrictions or conditions as the appropriate authority may specify , having regard to the opinion of the Food Safety Authority.\n1A. Where the appropriate authority determines that a substance is, or is not to be, authorised, the appropriate authority must:\n(a) in the event of a determination to authorise the substance, specify the date on which the authorisation is to have effect; and\n(b) communicate the determination to the Food Safety Authority.\n2. In determining whether to authorise a substance, and what restrictions or conditions, if any, to specify, the appropriate authority must take account of relevant provisions of assimilated law and other legitimate factors relevant to the matter under consideration. Where the determination is not in accordance with the opinion of the Food Safety Authority, the appropriate authority must provide without delay an explanation of the reasons for the differences. If the appropriate authority does not intend to authorise a substance after a favourable opinion by the Food Safety Authority, it must inform the applicant without delay and provide the applicant with an explanation.\n3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n4. After the authorisation of a substance in accordance with this Regulation, any business operator using the authorised substance or materials or articles containing the authorised substance must comply with any condition or restriction attached to such authorisation.\n5. The applicant or any business operator using the authorised substance or materials or articles containing the authorised substance must immediately inform the Food Safety Authority of any new scientific or technical information, which might affect the safety assessment of the authorised substance in relation to human health. If necessary, the Food Safety Authority must then review the assessment.\n6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Art. 11(1) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(b); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in Art. 11(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 11(5)(a)(i) (with reg. 23)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Art. 11(1) substituted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 11(5)(a)(ii) (with reg. 23)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Art. 11(1A) inserted (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 11(5)(b) (with reg. 23)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Art. 11(2) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(c); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Word in Art. 11(2) substituted (27.2.2025) by The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendments) Regulations 2025 (S.I. 2025/82), reg. 1(2), Sch. 11 para. 8(b)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Art. 11(3) omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(d); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Art. 11(4) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(e); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Art. 11(5) substituted (31.12.2020) by The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(f); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Art. 11(6) omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(g); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Word in Art. 11 heading omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 20(a); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2004/1935/article/11",
    "retrieved_at": "2026-11-01T14:55:08.337254+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."
}