Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

SECTION 1 U.K. Monitoring and reporting

Article 65 U.K. Compliance with requirements

1. [F1 The competent authority] shall make the necessary arrangements for the monitoring of biocidal products and treated articles which have been placed on the market to establish whether they comply with the requirements of this Regulation. Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products(1) shall apply accordingly.

2. [F2 The competent authority] shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation.

In order to facilitate such enforcement, manufacturers of biocidal products placed [F3 on the market in Great Britain] shall maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product to be placed on the market and shall store production batch samples. The documentation shall include as a minimum:

(a) safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;

(b) records of the various manufacturing operations performed;

(c) results of internal quality controls;

(d) identification of production batches.

F4 ...

Measures taken pursuant to this paragraph shall avoid causing disproportionate administrative burden to economic operators and [F5 the competent authority].

F6 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 65(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. 111(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 65(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. 111(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 65(2) substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 111(3)(b) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 31)

F4 Words in Art. 65(2) 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. 111(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 65(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. 111(3)(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 65(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. 111(4); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 65(4) 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. 111(5); 2020 c. 1, Sch. 5 para. 1(1)

Article 66 U.K. Confidentiality

F8 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. The [F9 competent authority] shall refuse access to information where disclosure would undermine the protection of the commercial interests or the privacy or safety of the persons concerned.

Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned:

(a) details of the full composition of a biocidal product;

(b) the precise tonnage of the active substance or biocidal product manufactured or made available on the market;

(c) links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product;

(d) names and addresses of persons involved in testing on vertebrates.

However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the [F10 competent authority] shall disclose the information referred to in this paragraph.

3. Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused:

(a) the name and address of the authorisation holder;

(b) the name and address of the biocidal product manufacturer;

(c) the name and address of the active substance manufacturer;

(d) the content of the active substance or substances in the biocidal product and the name of the biocidal product;

(e) physical and chemical data concerning the biocidal product;

(f) any methods for rendering the active substance or biocidal product harmless;

(g) a summary of the results of the tests required pursuant to Article 20 to establish the product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;

(h) recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;

(i) safety data sheets;

(j) methods of analysis referred to in Article 19(1)(c);

(k) methods of disposal of the product and of its packaging;

(l) procedures to be followed and measures to be taken in the case of spillage or leakage;

(m) first aid and medical advice to be given in the case of injury to persons.

[F11 4. Any person submitting information related to an active substance or a biocidal product to the F12 ... competent authority for the purposes of this Regulation may request that the information in Article 67(3) and (4) not be made available, including a justification as to why the disclosure of the information could be harmful for that person’s commercial interests or those of any other party concerned.]

Textual Amendments

F8 Art. 66(1) 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. 112(2); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 66(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. 112(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 66(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. 112(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F11 Substituted 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).

F12 Words in Art. 66(4) 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. 112(4); 2020 c. 1, Sch. 5 para. 1(1)

Article 67 U.K. Electronic public access

[F11 1. From the date on which the [F13 Secretary 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 [F14 , where] held by the [F15 competent 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. [F16 From 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.

[F11 3. From the date on which the [F17 Secretary of State issues a decision] providing that an active substance is approved, as referred to in point (a) of Article 9(1), the [F18 competent authority] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority F19 ... 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 [F20 where 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 [F21 competent authority] shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority F22 ... 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 [F23 where 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

F11 Substituted 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).

F13 Words 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)

F14 Word 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)

F15 Words 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)

F16 Words 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)

F17 Words 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)

F18 Words 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)

F19 Words 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)

F20 Words 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)

F21 Words 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)

F22 Words in Art. 67(4) 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(5)(b); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Art. 67(4) 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(5)(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 68 U.K. Record-keeping and reporting

1. Authorisation holders shall keep records of the biocidal products they place on the market for at least 10 years after placing on the market, or 10 years after the date on which the authorisation was cancelled or expired, whichever is the earlier. They shall make available the relevant information contained in these records to the competent authority on request.

F24 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F24 Art. 68(2) 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. 114; 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ L 218, 13.8.2008, p. 30.