{
  "url": "https://openlegislation.uk/eu-regulation-2017-12/annex/chapter-2/division-B",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-12/annex/chapter-2/division-B.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/B",
  "kind": "division",
  "number": "B",
  "heading": "Residue File",
  "text": "The dossier of residue 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 GLP 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 GLP, 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;\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/B",
    "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."
}