{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.5",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/section-5/division-5.5.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/5.5",
  "kind": "division",
  "number": "5.5",
  "heading": "Long-term toxicity and carcinogenicity",
  "text": "The results of the long-term studies conducted and reported, taken together with other relevant data and information on the active substance, shall be sufficient to permit the identification of effects, following repeated exposure to the active substance, and in particular shall be sufficient to:\nidentify adverse effects resulting from long-term exposure to the active substance,\nidentify target organs, where relevant,\nestablish the dose-response relationship,\nestablish the NOAEL and, if necessary, other appropriate reference points.\nCorrespondingly, the results of the carcinogenicity studies taken together with other relevant data and information on the active substance, shall be sufficient to permit the evaluation of hazards for humans, following repeated exposure to the active substance, and in particular shall be sufficient:\n(a)to identify carcinogenic effects resulting from long-term exposure to the active substance;\n(b)to establish the species, sex, and organ specificity of tumours induced;\n(c)to establish the dose-response relationship;\n(d)where possible, to identify the maximum dose eliciting no carcinogenic effect;\n(e)where possible, to determine the mode of action and human relevance of any identified carcinogenic response.",
  "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/5.5",
    "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."
}