{
  "url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-3/division-3.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2013-283/annex/division-INTRODUCTION/division-3/division-3.2.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/division/INTRODUCTION/division/3/division/3.2",
  "kind": "division",
  "number": "3.2",
  "heading": "By way of derogation from point 3.1:",
  "text": "3.2.1.For active substances consisting of micro-organisms or viruses, tests and analyses done to obtain data on the properties and safety with respect to other aspects than human health, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements under points 3.2 and 3.3 of the introduction of the Annex to Commission Regulation (EU) No 284/2013.\n3.2.2.For tests and analyses made to obtain data for minor crops required under points 6.3 and 6.5.2 of Part A:\nthe field phase may have been conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements as laid down in points 3.2 and 3.3 of the introduction of the Annex to Regulation (EU) No 284/2013;\nthe analytical phase, if not done in accordance with the GLP requirements, shall be conducted by laboratories accredited for the relevant method in accordance with the European standard EN ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories’.\n3.2.3.Studies conducted before 1st January 2014, although not fully compliant with GLP requirements or with current test methods, may be integrated into the assessment, when accepted by the competent authorities as scientifically valid, thereby removing the need for repeating animal tests, especially for carcinogenicity and reprotoxicity studies. This derogation applies to studies on all vertebrate species.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex Introduction point 3.2.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 21(5)(a)(vi); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "See page 85 of his Official Journal."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2013/283/annex/division/INTRODUCTION/division/3/division/3.2",
    "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."
}