{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-3/division-5.5/division-2",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/part-B/division-5/division-3/division-5.5/division-2.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/part/B/division/5/division/3/division/5.5/division/2",
  "kind": "division",
  "number": null,
  "heading": "Circumstances in which required",
  "text": "When any result of an in vivo study in somatic cells is positive, in vivo testing for germ cell effects may be justified. The necessity for conducting these tests will have to be considered on a case-by-case basis, taking into account other relevant information available including use and expected exposure. Suitable tests would need to examine interaction with DNA (such as the dominant lethal assay), to look at the potential for inherited effects and possibly make a quantitative assessment of heritable effects. It is recognised that in view of their complexity, the use of quantitative studies would require strong justification.\n(END OF TIER II)",
  "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/part/B/division/5/division/3/division/5.5/division/2",
    "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."
}