{
  "url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-1",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-544/annex/division-1/division-1.json",
  "legislation": "eur/2011/544",
  "legislation_title": "Commission Regulation (EU) No 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substances (Text with EEA relevance) (repealed)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-544",
  "path": "annex/division/1/division/1",
  "kind": "division",
  "number": "1",
  "heading": null,
  "text": "The information required shall:\n1.1.include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the active substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;\n1.2.where relevant, be generated using test guidelines, in accordance with the latest adopted version, referred to or described in this Annex; in the case of studies initiated before 14th June 2011 the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;\n1.3.in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this Annex has been used, include a justification, which is acceptable to the competent authority for the guidelines used. In particular, when reference is made in this Annex to a method laid down in Commission Regulation (EC) No 440/2008 which consists in the transposition of a method developed by an international organisation (e.g. OECD), the competent authority may accept that the required information is generated in accordance with the latest version of that method if at the initiation of the studies the method under Regulation (EC) No 440/2008 has not yet been updated;\n1.4.include, when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;\n1.5.include a full and unbiased report of the studies conducted as well as full description of them or a justification, which is acceptable to the competent authority where:\nparticular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or\nit is not scientifically necessary, or technically possible to supply information and data;\n1.6.where relevant, have been generated in accordance with the requirements of the Animals (Scientific Procedures) Act 1986.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Repealed (subject to transitional measures in Arts. 3, 4) by 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."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Annex Introduction point 1.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 16(5)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Annex Introduction point 1.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 16(5)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Annex Introduction point 1.6 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 16(5)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/544/annex/division/1/division/1",
    "retrieved_at": "2026-11-01T14:50:06.051752+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."
}