{
  "url": "https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-A/division-2",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-546/annex/part-II/division-A/division-2.json",
  "legislation": "eur/2011/546",
  "legislation_title": "Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-546",
  "path": "annex/part/II/division/A/division/2",
  "kind": "division",
  "number": "2",
  "heading": null,
  "text": "In evaluating applications for granting authorisations competent authorities shall:\n(a)ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of part B of the Annex to Regulation (EU) No 545/2011, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,\nensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,\nevaluate, where relevant, justifications submitted by the applicant for not supplying certain data;\n(b)take into account the data referred to in part B of the Annex to Regulation (EU) No 544/2011, concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of approval of the micro-organism concerned as active substances under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009;\n(c)take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Annex Pt. 2.A points 1, 2, 4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/546/annex/part/II/division/A/division/2",
    "retrieved_at": "2026-11-01T14:50:05.430430+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."
}