{
  "url": "https://openlegislation.uk/eu-regulation-2020-2160/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2020-2160/annex.json",
  "legislation": "eur/2020/2160",
  "legislation_title": "Commission Regulation (EU) 2020/2160 of 18 December 2020 amending Annex XIV to Regulation (EU) No 1907/2006 of the European Parliament and of the Council as regards the substance group 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and substances of unknown or variable composition, complex reaction products or biological materials, polymers and homologues) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2020-2160",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "In the table in Annex XIV to Regulation (EC) No 1907/2006, entry 42 concerning 4-(1,1,3,3 Tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and UVCB substances, polymers and homologues) is amended as follows:\n(1) the text of column 4 ‘Latest application date’ is replaced by the following text:\n(a) ‘4 July 2019 (*);\n(b) by way of derogation from point (a), 22 June 2022 for uses as follows:\nfor the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746 of the European Parliament and of the Council, in view of their use for the diagnosis, treatment or prevention of the coronavirus disease (COVID-19),\nin medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.’;\n(2) the text of column 5 ‘Sunset date’ is replaced by the following text:\n(a) ‘4 January 2021 (**);\n(b) by way of derogation from point (a), 22 December 2023 for uses as follows:\nfor the research, development and production of medicinal products falling within the scope of Directive 2001/83/EC or medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, in view of their use for the diagnosis, treatment or prevention of COVID-19,\nin medical devices or accessories to medical devices falling within the scope of Directive 93/42/EEC, Regulation (EU) 2017/745, Directive 98/79/EC or Regulation (EU) 2017/746, for the diagnosis, treatment or prevention of COVID-19.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).’;"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2020/2160/annex",
    "retrieved_at": "2026-11-01T14:42:11.442891+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."
}