{
  "url": "https://openlegislation.uk/eu-regulation-2019-1844/introduction",
  "json_url": "https://openlegislation.uk/eu-regulation-2019-1844/introduction.json",
  "legislation": "eur/2019/1844",
  "legislation_title": "Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’ (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2019-1844",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Implementing Regulation (EU) 2019/1844\nof 22 October 2019\ngranting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’\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 first subparagraph of Article 44(5) thereof,\nWhereas:\n(1)\nOn 7 August 2015, Applied Biocide GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘BPF_Iodine_VET’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Austria had agreed to evaluate the application. The application was recorded under case number BC-XJ019074-33 in the Register for Biocidal Products.\n(2)\n‘BPF_Iodine_VET’ contains iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.\n(3)\nOn 22 August 2018, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).\n(4)\nOn 4 April 2019, the Agency submitted to the Commission an opinion, including the draft summary of the biocidal product characteristics (‘SPC’) of ‘BPF_Iodine_VET’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that ‘BPF_Iodine_VET’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.\n(5)\nOn 4 June 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.\n(6)\nThe Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘BPF_Iodine_VET’.\n(7)\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": "Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1)."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "ECHA opinion of 27 February 2019 on the Union authorisation of ‘BPF_Iodine_VET’ (ECHA/BPC/219/2019)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2019/1844/introduction",
    "retrieved_at": "2026-11-01T14:43:02.675889+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."
}