{
  "url": "https://openlegislation.uk/eu-regulation-2015-1981/annex",
  "json_url": "https://openlegislation.uk/eu-regulation-2015-1981/annex.json",
  "legislation": "eur/2015/1981",
  "legislation_title": "Commission Implementing Regulation (EU) 2015/1981 of 4 November 2015 approving Formaldehyde released from N,N-Methylenebismorpholine as an existing active substance for use in biocidal products for product-types 6 and 13 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2015-1981",
  "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.\nCommon Name\nIUPAC NameIdentification Numbers\nMinimum degree of purity of the active substance\nDate of approval\nExpiry date of approval\nProduct type\nSpecific conditions\nFormaldehyde released from N,N-Methylenebismorpholine (hereafter referred to as ‘MBM’)\nIUPAC Name:\nN,N-Methylenebismorpholine\nEC No: 227-062-3\nCAS No: 5625-90-1\n92,1 % w/w\n1 April 2017\n31 March 2022\n6\nMBM is considered a candidate for substitution in accordance with Article 10(1)(a) 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. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.\nThe authorisations of biocidal products are subject to the following conditions:\n(1) Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met.\n(2) 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(3) In view of the risks to professional users, mixing and loading of products to formulation vessels shall be automated, unless it can be demonstrated that potential exposure of skin, eye and respiratory tracts to MBM can be reduced to an acceptable level by other means.\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 MBM 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.\n13\nMBM is considered a candidate for substitution in accordance with Article 10(1)(a) 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. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.\nThe authorisations of biocidal products are subject to the following conditions:\n(1) Products shall only be authorised for use in Member States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met.\n(2) 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(3) In view of the risks to professional users, mixing and loading of products to formulation vessels shall be automated, unless it can be demonstrated that potential exposure of skin, eye and respiratory tracts to MBM can be reduced to an acceptable level by other means.\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 MBM 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."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2015/1981/annex",
    "retrieved_at": "2026-11-01T14:46:20.390582+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."
}