{
  "url": "https://openlegislation.uk/eu-regulation-2015-1731/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2015-1731/introduction.json",
  "legislation": "eur/2015/1731",
  "legislation_title": "Commission Implementing Regulation (EU) 2015/1731 of 28 September 2015 approving medetomidine as an active substance for use in biocidal products for product-type 21 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2015-1731",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Regulation (EU) 2015/1731\nof 28 September 2015\napproving medetomidine as an active substance for use in biocidal products for product-type 21\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular Article 90(2) thereof,\nWhereas:\n(1)\nThe United Kingdom received on 27 April 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council, for the inclusion of the active substance medetomidine in its Annex I for use in product-type 21, antifouling products, as defined in Annex V to that Directive, which corresponds to product-type 21 as defined in Annex V to Regulation (EU) No 528/2012.\n(2)\nMedetomidine was not on the market on 14 May 2000 as an active substance of a biocidal product.\n(3)\nThe United Kingdom submitted an assessment report, together with its recommendations, to the European Chemicals Agency on 12 March 2014 in accordance with Article 8(1) of Regulation (EU) No 528/2012.\n(4)\nThe opinion of the European Chemicals Agency was formulated on 3 February 2015 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.\n(5)\nAccording to that opinion, biocidal products used for product-type 21 and containing medetomidine may be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain conditions concerning its use are complied with.\n(6)\nIt is therefore appropriate to approve medetomidine for use in biocidal products for product-type 21 subject to compliance with certain specifications and conditions.\n(7)\nThe opinion concludes that the characteristics of medetomidine render it very persistent (vP) and toxic (T) in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council. In addition, the opinion concludes that the active substance contains a significant proportion of non-active isomers or impurities.\n(8)\nMedetomidine meets the conditions set out in points (d) and (f) of Article 10(1) of Regulation (EU) No 528/2012 and should therefore be considered a candidate for substitution.\n(9)\nPursuant to Article 10(4) of Regulation (EU) No 528/2012, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding seven years.\n(10)\nSince medetomidine meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating medetomidine should be appropriately labelled when placed on the market.\n(11)\nThe measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,\nHAS ADOPTED THIS REGULATION:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 167, 27.6.2012, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2015/1731/introduction",
    "retrieved_at": "2026-11-01T14:46:26.446591+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."
}