{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.4/division-5.4.3/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.4/division-5.4.3/division-1.json",
  "legislation": "eur/2013/283",
  "legislation_title": "Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2013-283",
  "path": "annex/section/5/division/5.4/division/5.4.3/division/1",
  "kind": "division",
  "number": null,
  "heading": "Circumstances in which required",
  "text": "The necessity for conducting these tests shall be considered on a case by case basis, taking into account information regarding toxicokinetics, use and anticipated exposure.\nFor most of the active substances recognised as in vivo somatic cell mutagens no further genotoxicity testing shall be necessary since they will be considered to be potential genotoxic carcinogens and potential germ cell mutagens.\nHowever, in some specific cases germ cells studies may be undertaken to demonstrate whether a somatic cell mutagen is or is not a germ cell mutagen.\nThe type of mutation produced in earlier studies namely gene, numerical chromosome or structural chromosome changes, shall be considered when selecting the appropriate assay.\nA study for the presence of DNA adducts in gonad cells may also be considered.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/283/annex/section/5/division/5.4/division/5.4.3/division/1",
    "retrieved_at": "2026-11-01T14:48:46.014078+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."
}