{
  "url": "https://openlegislation.uk/eu-decision-2017-802/introduction",
  "json_url": "https://openlegislation.uk/eu-decision-2017-802/introduction.json",
  "legislation": "eudn/2017/802",
  "legislation_title": "Commission Implementing Decision (EU) 2017/802 of 10 May 2017 not approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 5 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2017-802",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Decision (EU) 2017/802\nof 10 May 2017\nnot approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 5\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 the third subparagraph of Article 89(1) thereof,\nWhereas:\n(1)\nCommission Delegated Regulation (EU) No 1062/2014 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes PHMB (1600; 1.8).\n(2)\nPHMB (1600; 1.8) has been evaluated for use in products of product-type 5, drinking water, as defined in Annex V to Regulation (EU) No 528/2012.\n(3)\nFrance was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 23 November 2015.\n(4)\nIn accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 12 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.\n(5)\nAccording to that opinion, biocidal products used for product-type 5 and containing PHMB (1600; 1.8) may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. For that product-type, the scenarios evaluated in the environmental risk assessments identified unacceptable risks.\n(6)\nIt is therefore not appropriate to approve PHMB (1600; 1.8) for use in biocidal products for product-type 5.\n(7)\nThe measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,\nHAS ADOPTED THIS DECISION:",
  "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": "Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2017/802/introduction",
    "retrieved_at": "2026-11-01T15:13:30.427869+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."
}