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

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)

CHAPTER IIU.K.APPROVAL OF ACTIVE SUBSTANCES

Article 4U.K.Conditions for approval

1.An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). An active substance that falls under Article 5 may only be approved for an initial period not exceeding five years.

2.The approval of an active substance shall be restricted to those product-types for which relevant data have been submitted in accordance with Article 6.

3.The approval shall specify the following conditions, as appropriate:

(a)the minimum degree of purity of the active substance;

(b)the nature and maximum content of certain impurities;

(c)the product-type;

(d)manner and area of use including, where relevant, use in treated articles;

(e)designation of categories of users;

(f)where relevant, characterisation of the chemical identity with regard to stereoisomers;

(g)other particular conditions based on the evaluation of the information related to that active substance;

(h)the date of approval and the expiry date of the approval of the active substance.

4.The approval of an active substance shall not cover nanomaterials except where explicitly mentioned.

Article 5U.K.Exclusion criteria

1.Subject to paragraph 2, the following active substances shall not be approved:

(a)active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;

(b)active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;

(c)active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;

(d)active substances which [F1meet the criteria in Regulation (EU) No 2100/2017] are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;

(e)active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.

2.Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:

(a)the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment;

(b)it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or

(c)not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.

When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration.

The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. F2...

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Textual Amendments

Article 6U.K.Data requirements for an application

1.An application for approval of an active substance shall contain at least the following elements:

(a)a dossier for the active substance satisfying the requirements set out in Annex II;

(b)a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and

(c)if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.

2.Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:

(a)the data are not necessary owing to the exposure associated with the proposed uses;

(b)it is not scientifically necessary to supply the data; or

(c)it is not technically possible to generate the data.

However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the F4... competent authority under Article 8(2).

3.An applicant may propose to adapt the data as part of the dossiers required under points (a) and (b) of paragraph 1 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.

4.The [F5Secretary of State may by regulations amend the criteria] for determining what constitutes adequate justification to adapt the data requirements under paragraph 1 of this Article on the grounds referred to in point (a) of paragraph 2 of this Article.

[F65.Regulations made under paragraph 4 above are subject to the consent requirement.

6.Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 4 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.]

Textual Amendments

Article 7U.K.Submission and validation of applications

[F71.The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, to the competent authority.]

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3.Within 30 days of the [F9competent authority receiving] an application, [F10it] shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1), and any justifications for the adaptation of data requirements, have been submitted.

In the context of the validation referred to in the first subparagraph, the F11... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

The F12... competent authority shall, as soon as possible after [F13it has received] an application, inform the applicant of the fees payable F14... and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

4.Where the F15... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F15... competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.

The F15... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F16.... In such cases, part of the fees paid F17... shall be reimbursed.

5.On validating an application in accordance with paragraph 3 or 4, the F18... competent authority shall without delay inform the applicant F19... accordingly, indicating the date of the validation.

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Textual Amendments

Article 8U.K.Evaluation of applications

1.The F21... competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and [F22produce] an assessment report and [F23evaluation conclusions].

[F24The competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The competent authority shall take due account of those comments.]

2.Where it appears that additional information is necessary to carry out the evaluation, the F25... competent authority shall ask the applicant to submit such information within a specified time limit F26.... As specified in the second subparagraph of Article 6(2), the F25... competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1). The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.

[F272A.The competent authority may request from the applicant available information on, and take into account, evaluations undertaken by third countries in order to complete its evaluation. The weight given to those third country evaluations shall take into account the equivalence of the evaluation process.]

3.Where the F28... competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.

[F294.Within 270 days of producing its assessment reports and evaluation conclusions the competent authority shall prepare and submit an opinion on the approval of the active substance to the Secretary of State and the Devolved Authorities.]

Textual Amendments

[F30Article 8AU.K.The GB List

The competent authority shall establish, maintain and make electronically available to the public a list of approved active substances (“the GB List”).]

Textual Amendments

Article 9U.K.Approval of an active substance

1.The [F31Secretary of State] shall, on receipt of the opinion of the [F32competent authority] referred to in Article 8(4), either:

(a)[F33issue a decision] providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or

(b)in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, [F34issue a] decision that an active substance is not approved.

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[F361A. A decision issued under paragraph 1 is subject to the consent requirement.]

[F372.Approved active substances shall be included in the GB List established under Article 8A of this Regulation.]

Textual Amendments

Article 10U.K.Active substances which are candidates for substitution

1.An active substance shall be considered a candidate for substitution if any of the following conditions are met:

(a)it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);

(b)it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;

(c)its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;

(d)it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;

(e)there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;

(f)it contains a significant proportion of non-active isomers or impurities.

2.When preparing its opinion on the approval or renewal of the approval of an active substance, the [F38competent authority] shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and address the matter in its opinion.

3.Prior to submitting its opinion on the approval or renewal of the approval of an active substance to the [F39Secretary of State and the Devolved Authorities], the [F40competent authority] shall make publicly available, without prejudice to Articles 66 and 67, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. The [F40competent authority] shall take due account of the information received when finalising its opinion.

4.By way of derogation from Article 4(1) and Article 12(3), the approval of an active substance that is considered as a candidate for substitution and each renewal shall be for a period not exceeding seven years.

5.Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in the relevant [F41decision issued] in accordance with Article 9.

Textual Amendments

F42Article 11U.K.Technical guidance notes

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