{
  "url": "https://openlegislation.uk/eu-regulation-2016-124/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2016-124/annex.json",
  "legislation": "eur/2016/124",
  "legislation_title": "Commission Implementing Regulation (EU) 2016/124 of 29 January 2016 approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 4 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2016-124",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.\nRegulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).\nRegulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).\nCommon Name\nIUPAC NameIdentification Numbers\nMinimum degree of purity of the active substance\nDate of approval\nExpiry date of approval\nProduct type\nSpecific conditions\nPHMB (1600; 1.8) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8)\nIUPAC Name:\nCoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride), (iminoimidocarbonyl, hexamethylene hydrochloride)\nEC No: n.a.\nCAS No: 27083-27-8 and 32289-58-0\n956 g/kg (calculated dry weight specification).\nThe active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1600; 1.8)\n1 July 2017\n30 June 2027\n4\nPHMB (1600; 1.8) is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012.\nThe product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.\nThe authorisations of biocidal products are subject to the following conditions:\n(1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.\n(2) In view of the risks identified for human health and the aquatic and soil compartments, products shall not be authorised for use as disinfectant of utensils by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level.\n(3) In view of the risks identified for human health and the aquatic compartment, products shall not be authorised for surface disinfection by mopping, unless it can be demonstrated that risks can be reduced to an acceptable level.\n(4) In view of the risks identified for human health, labels, and where provided, safety data sheets of ready-to-use wipes shall indicate that the use is restricted to areas not accessible to the general public, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.\n(5) For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.\n(6) Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of PHMB (1600; 1.8) into food or it has been established pursuant to that Regulation that such limits are not necessary.\nThe placing on the market of treated articles is subject to the following condition:\nThe person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1600; 1.8) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2016/124/annex",
    "retrieved_at": "2026-11-01T14:46:05.641463+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."
}