{
  "url": "https://openlegislation.uk/eu-regulation-2011-188/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2011-188/introduction.json",
  "legislation": "eur/2011/188",
  "legislation_title": "Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2011-188",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Regulation (EU) No 188/2011\nof 25 February 2011\nlaying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market, and in particular Article 6(5) thereof,\nWhereas:\n(1)\nIt is necessary to adopt rules on a procedure for the submission and appraisal of applications for inclusion in Annex I to Directive 91/414/EEC of active substances which were not yet on the market 2 years after the date of notification of that Directive. In particular periods should be set for the different steps of that procedure to ensure that they are carried out rapidly.\n(2)\nAdditional information submitted after the application and the dossiers should only be taken into account if it was requested by the European Food Safety Authority, hereinafter ‘the Authority’, or the rapporteur Member State and submitted within the time period set.\n(3)\nAs regards applications submitted before the entry into force of this Regulation transitional measures should be provided for. In particular, it is appropriate to extend the period which may be granted to the applicant to submit additional information requested by the Authority or the rapporteur Member State. As regards such applications, it is further necessary to set periods for the circulation of the draft assessment report by the Authority and the submission of comments by the Member States, other than the rapporteur Member State, and the applicant.\n(4)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 230, 19.8.1991, p. 1."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2011/188/introduction",
    "retrieved_at": "2026-11-01T14:50:17.305418+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."
}