Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

SECTION 2 U.K. Information about biocidal products

Article 69 U.K. Classification, packaging and labelling of biocidal products

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) F1 ... 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 F2 ...;

(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 [F3 the 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. [F4 The 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 [F5 be labelled in English].

Textual Amendments

F1 Words 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)

F2 Words 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)

F3 Words 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)

F4 Words in Art. 69(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. 115(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 69(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. 115(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F6 Article 70 U.K. Safety data sheets

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Textual Amendments

F6 Art. 70 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. 116; 2020 c. 1, Sch. 5 para. 1(1)

Article 71 U.K. [F7 Exchange of information]

[F8 1. The competent authority shall establish and maintain a system for the exchange of information between the competent authority and applicants.]

F9 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. Applicants shall use the [F10 system 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 [F11 competent authority] shall check that these have been submitted in the correct format F12 ....

Where the [F11 competent 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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F13 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F13 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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F13 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F7 Art. 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)

F8 Art. 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)

F9 Art. 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)

F10 Words 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)

F11 Words 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)

F12 Words in Art. 71(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. 117(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F13 Art. 71(5)-(9) 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(7); 2020 c. 1, Sch. 5 para. 1(1)

Article 72 U.K. Advertising

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 73 U.K. Poison control

Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.