{
  "url": "https://openlegislation.uk/eu-regulation-2017-12/annex/chapter-2/division-A",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-12/annex/chapter-2/division-A.json",
  "legislation": "eur/2017/12",
  "legislation_title": "Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-12",
  "path": "annex/chapter/2/division/A",
  "kind": "division",
  "number": "A",
  "heading": "Safety file",
  "text": "The dossier of safety tests shall include the following documents:\nan index of all studies included in the dossier,\na statement confirming that all data known to the applicant/requestor at the time of submission, whether favourable or unfavourable, are included,\na justification for the omission of any type of study,\nan explanation for the inclusion of an alternative type of study,\nin cases where a study pre-dates Directive 2004/10/EC or Good Laboratory Practice status is unknown, a discussion of the contribution that any non-GLP study can make to the overall risk assessment.\nEach study report shall include the following documents:\na copy of the study plan (protocol, including amendments and deviations),\na signed statement of compliance with good laboratory practice, where applicable,\na description of the methods, apparatus and materials used,\na description and justification of the test system,\na description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author,\na statistical analysis of the results where appropriate,\na discussion of the results, with comment on observed (adverse) effect levels and NO(A)ELs, and on any unusual findings,\na detailed description and a thorough discussion of the results of the study.",
  "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/2017/12/annex/chapter/2/division/A",
    "retrieved_at": "2026-11-01T14:45:15.764642+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."
}