{
  "url": "https://openlegislation.uk/eu-directive-2012-41/introduction",
  "json_url": "https://openlegislation.uk/eu-directive-2012-41/introduction.json",
  "legislation": "eudr/2012/41",
  "legislation_title": "Commission Directive 2012/41/EU of 26 November 2012 amending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2012-41",
  "path": "introduction",
  "kind": "introduction",
  "number": null,
  "heading": "Introductory text",
  "text": "Commission Directive 2012/41/EU\nof 26 November 2012\namending Directive 98/8/EC of the European Parliament and of the Council to extend the inclusion in Annex I thereto of the active substance nonanoic acid to product type 2\n(Text with EEA relevance)\nTHE EUROPEAN COMMISSION,\nHaving regard to the Treaty on the Functioning of the European Union,\nHaving regard to 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, and in particular the second subparagraph of Article 16(2) thereof,\nWhereas:\n(1)\nCommission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes nonanoic acid.\n(2)\nCommission Directive 2011/13/EU of 8 February 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include nonanoic acid as an active substance in Annex I thereto included nonanoic acid as an active substance in Annex I to Directive 98/8/EC for use in product type 19, repellents and attractants, as defined in Annex V to Directive 98/8/EC.\n(3)\nPursuant to Regulation (EC) No 1451/2007, nonanoic acid has now been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive.\n(4)\nAustria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 6 August 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.\n(5)\nThe competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 25 May 2012, in an assessment report.\n(6)\nIt appears from the evaluations that biocidal products used as private area and public health area disinfectants and other biocidal products as defined in Annex V to Directive 98/8/EC and containing nonanoic acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to extend the inclusion of nonanoic acid in Annex I to that Directive to product type 2.\n(7)\nNot all potential uses have been evaluated at Union level. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.\n(8)\nIn view of the irritant properties of the substance, it is appropriate to require that exposure during non-professional use is minimised through the design of the packaging, unless it can be demonstrated in the application for product authorisation that risks for human health can be reduced to acceptable levels by other means.\n(9)\nThe provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product type 2 containing the active substance nonanoic acid and also to facilitate the proper operation of the biocidal products market in general.\n(10)\nA reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.\n(11)\nAfter inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.\n(12)\nDirective 98/8/EC should therefore be amended accordingly.\n(13)\nIn accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.\n(14)\nThe measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,\nHAS ADOPTED THIS DIRECTIVE:",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ L 123, 24.4.1998, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ L 325, 11.12.2007, p. 3."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ L 34, 9.2.2011, p. 52."
    },
    {
      "type": "footnote",
      "label": "f4",
      "text": "OJ C 369, 17.12.2011, p. 14."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2012/41/introduction",
    "retrieved_at": "2026-11-01T15:21:55.791777+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."
}