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 (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
There are currently no known outstanding effects by UK legislation for Regulation (EU) No 528/2012 of the European Parliament and of the Council, Article 67.
[F11.From the date on which the [F2Secretary of State issues a decision] providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information [F3, where] held by the [F4competent authority] on that active substance shall be made publicly and easily available free of charge:]
(a)where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
(b)if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
(c)the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
(d)physicochemical endpoints and data on pathways and environmental fate and behaviour;
(e)the result of each toxicological and ecotoxicological study;
(f)acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
(g)the guidance on safe use provided in accordance with Annexes II and III;
(h)analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
2.[F5From the date on which a biocidal product is authorised, the following up-to-date information, where held by the competent authority, shall be made publicly and easily available free of charge—]
(a)the terms and conditions of the authorisation;
(b)the summary of the biocidal product characteristics; and
(c)analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.
[F13.From the date on which the [F6Secretary of State issues a decision] providing that an active substance is approved, as referred to in point (a) of Article 9(1), the [F7competent authority] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority F8... as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information [F9where held by the competent authority] on that active substance:]
(a)if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
(b)the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
(c)information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
(d)the trade name(s) of the substance;
(e)the assessment report.
4.From the date on which a biocidal product is authorised, the [F10competent authority] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority F11... as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information [F12where held by the competent authority]:
(a)study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and
(b)the assessment report.
Textual Amendments
F1Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).
F2Words in Art. 67(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Art. 67(1) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 67(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(2)(c); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Art. 67(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(3); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Art. 67(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Art. 67(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Art. 67(3) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
F9Words in Art. 67(3) inserted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(4)(d); 2020 c. 1, Sch. 5 para. 1(1)
F10Words in Art. 67(4) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 113(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.
