{
  "url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.4/division-II.6.4.2/division-II.6.4.2.1/division-II.6.4.2.1.3",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-II/division-II.6/division-II.6.4/division-II.6.4.2/division-II.6.4.2.1/division-II.6.4.2.1.3.json",
  "legislation": "eur/2018/782",
  "legislation_title": "Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2018-782",
  "path": "annex/I/division/II/division/II.6/division/II.6.4/division/II.6.4.2/division/II.6.4.2.1/division/II.6.4.2.1.3",
  "kind": "division",
  "number": "II.6.4.2.1.3",
  "heading": null,
  "text": "Details shall be provided of all immunological studies performed with the substance as part of any aspect of the assessment (e.g. sensitisation assays performed for user safety or efficacy studies performed on immune-modulatory substances). Any reports of adverse effects in humans shall also be provided.",
  "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/2018/782/annex/I/division/II/division/II.6/division/II.6.4/division/II.6.4.2/division/II.6.4.2.1/division/II.6.4.2.1.3",
    "retrieved_at": "2026-11-01T14:44:06.594245+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."
}