1.[F1The 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.[F2The 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 [F3on 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 [F5the competent authority].
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Textual Amendments
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
F5Words 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)
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2.The [F9competent 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 [F10competent 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.
[F114.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
F8Art. 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)
F9Words 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)
F10Words 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)
F11Substituted 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).
[F111.From the date on which the [F13Secretary 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 [F15competent 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.[F16From 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.
[F113.From the date on which the [F17Secretary of State issues a decision] providing that an active substance is approved, as referred to in point (a) of Article 9(1), the [F18competent 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 [F20where 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 [F21competent 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 [F23where 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
F11Substituted 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).
F13Words 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)
F14Word 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)
F15Words 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)
F16Words 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)
F17Words 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)
F18Words 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)
F19Words 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)
F20Words 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)
F21Words 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)
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.
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Textual Amendments
1.Authorisation holders shall ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of biocidal product characteristics, in particular the hazard statements and the precautionary statements, as referred to in point (i) of Article 22(2) F25... and, where applicable, Regulation (EC) No 1272/2008.
In addition, products which may be mistaken for food, including drink, or feed shall be packaged to minimise the likelihood of such a mistake being made. If they are available to the general public, they shall contain components to discourage their consumption and, in particular, shall not be attractive to children.
2.In addition to compliance with paragraph 1, authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications. In addition, the label must show clearly and indelibly the following information:
(a)the identity of every active substance and its concentration in metric units;
(b)the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;
(c)the authorisation number allocated to the biocidal product by the competent authority F26...;
(d)the name and address of the authorisation holder;
(e)the type of formulation;
(f)the uses for which the biocidal product is authorised;
(g)directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;
(h)particulars of likely direct or indirect adverse side effects and any directions for first aid;
(i)if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;
(j)directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;
(k)the formulation batch number or designation and the expiry date relevant to normal conditions of storage;
(l)where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;
(m)where applicable, the categories of users to which the biocidal product is restricted;
(n)where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;
(o)for biocidal products containing micro-organisms, labelling requirements in accordance with [F27the Control of Substances Hazardous to Health Regulations 2002].
By way of derogation from the first subparagraph, where this is necessary because of the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.
3.[F28The competent authority] may require:
(a)the provision of models or drafts of the packaging, labelling and leaflets;
(b)that biocidal products made available on the market [F29be labelled in English].
Textual Amendments
F25Words in Art. 69(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. 115(2); 2020 c. 1, Sch. 5 para. 1(1)
F26Words in Art. 69(2)(c) 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. 115(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F27Words in Art. 69(2)(o) substituted (31.12.2020) by virtue of S.I. 2019/720, Sch. 2 para. 115(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. 32)
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Textual Amendments
[F321.The competent authority shall establish and maintain a system for the exchange of information between the competent authority and applicants.]
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3.Applicants shall use the [F34system referred to in paragraph 1] to submit applications and data for all procedures covered by this Regulation.
4.Upon submission of applications and data by applicants, the [F35competent authority] shall check that these have been submitted in the correct format F36....
Where the [F35competent authority] decides that the application has not been submitted in the correct format, it shall reject the application and inform the applicant accordingly.
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Textual Amendments
F31Art. 71 heading 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. 117(2); 2020 c. 1, Sch. 5 para. 1(1)
F32Art. 71(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. 117(3); 2020 c. 1, Sch. 5 para. 1(1)
F33Art. 71(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. 117(4); 2020 c. 1, Sch. 5 para. 1(1)
F34Words in Art. 71(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. 117(5); 2020 c. 1, Sch. 5 para. 1(1)
F35Words in Art. 71(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. 117(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
1.Any advertisement for biocidal products shall, in addition to complying with Regulation (EC) No 1272/2008, include the sentences ‘Use biocides safely. Always read the label and product information before use.’. The sentences shall be clearly distinguishable and legible in relation to the whole advertisement.
2.Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type being advertised.
3.Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy. In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or any similar indication.
Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.