{
  "url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-III/division-III.2/division-III.2.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2018-782/annex-I/division-III/division-III.2/division-III.2.2.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/III/division/III.2/division/III.2.2",
  "kind": "division",
  "number": "III.2.2",
  "heading": null,
  "text": "The detailed and critical summary shall:\n(a)include a clear position on the adequacy of the data presented, in light of current scientific knowledge;\n(b)have an introduction describing the actual or proposed pattern of use of the substance under review in animal husbandry and a summary of any other experience of its use;\n(c)consider the extent to which the substance concerned has similarities to other known substances, which may be relevant for the evaluation;\n(d)cover all standard data requirements, as set out in Implementing Regulation (EU) 2017/12 provide a critical evaluation of the available experimental studies and an interpretation of the results;\n(e)provide scientific justification for the omission of any standard studies;\n(f)provide a description and explanation of the key findings for each study. The following issues shall be discussed: the animal species used (species, strain, sex, age, weight, etc.), test conditions (husbandry, diet, etc.), time points and numbers of animals per time point, milk and egg production if applicable, sampling (sampling size, collection and storage), and analytical methods used;\n(g)summarise and discuss relevant scientific literature, including reports of evaluations undertaken by other scientific bodies (such as EFSA or JECFA). If detailed references to published scientific literature are used, all the requirements set out under General principles point 5 (I.5) shall be met, as far as possible;\n(h)include information on the quality of batches of test substances used in the residue studies. Any association between findings and the quality of the test substances and/or the medicinal products shall be indicated. When necessary, a critical evaluation of the impurities present in the active ingredient shall be presented and information shall be provided on their potential influence on pharmacokinetics, metabolism, residue kinetics and analytical methods for the determination of residues. The implications of any differences of the chirality, chemical form and impurity profile between the substance used in the residues studies and the form to be marketed shall be discussed;\n(i)discuss the GLP status of the studies submitted;\n(j)discuss possible deficiencies in the design and conduct of the studies and their documentation, making reference to published ... guidance. Any deviations from applicable guidance shall be highlighted and the impact of the deviation discussed and scientifically justified;\n(k)comment on the use of experimental animals in the studies and whether the studies were conducted in accordance with the Animals (Scientific Procedures) Act 1986;\n(l)justify the omission of particular studies and discuss the requirements for additional studies;\n(m)provide a section on risk management considerations, addressing the issues described in Annex II below, and explaining the derivation of the proposed MRLs.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex 1 para. 3(2) omitted (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 10(4)(h); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex 1 para. 3(2) substituted (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 10(4)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2018/782/annex/I/division/III/division/III.2/division/III.2.2",
    "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."
}