{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.6/division-5.6.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.6/division-5.6.2.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/section/5/division/5.6/division/5.6.2",
  "kind": "division",
  "number": "5.6.2",
  "heading": "Developmental toxicity studies",
  "text": "The developmental toxicity studies reported, taken together with other relevant data and information on the active substance, shall be sufficient to permit the assessment of effects on embryonic and foetal development, following repeated exposure to the active substance, and in particular shall be sufficient:\n(a)to identify direct and indirect effects on embryonic and foetal development resulting from exposure to the active substance;\n(b)to identify any maternal toxicity;\n(c)to establish the relationship between observed responses and dose in both dam and offspring;\n(d)to establish NOAELs for maternal toxicity and pup development;\n(e)to provide additional information on adverse effects in pregnant as compared with non-pregnant females;\n(f)to provide additional information on any enhancement of general toxic effects of pregnant animals.",
  "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/5.6/division/5.6.2",
    "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."
}