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

Article 30 U.K. Evaluation of applications

1. [F1 Subject to paragraph 1A,] the F2 ... competent authority shall, within 365 days of the validation of an application in accordance with Article 29, decide whether to grant an authorisation in accordance with Article 19. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

[F3 1A. Where an application for a relevant product is validated in accordance with Article 29 before 31st December 2026, the competent authority must decide before 31st December 2027 whether to grant an authorisation in accordance with Article 19. It must take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

1B. In paragraph 1A a “relevant product” is a product containing an active substance in respect of which the implementing regulation providing that the substance is approved entered into force before IP completion day.

1C. In paragraph 1B “implementing regulation” has the same meaning as in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products as it had effect immediately before IP completion day.]

2. [F4 Subject to paragraph 2A,] where it appears that additional information is necessary to carry out the evaluation, the F2 ... competent authority shall ask the applicant to submit such information within a specified time limit. The 365-day period referred to in paragraph 1 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.

The F2 ... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

[F5 2A. Where paragraph 1A applies and it appears that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 1A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 180 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.

The competent authority must reject the application if the applicant fails to submit the requested information within the specified time limit and must inform the applicant accordingly.]

3. [F6 Subject to paragraph 4,] within the 365-day period referred to in paragraph 1, the F2 ... competent authority shall:

(a) draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the ‘assessment report’);

(b) send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and

(c) take due account of those comments when finalising its assessment.

[F7 4. Where paragraph 1A applies, the competent authority must comply with the requirements in paragraph 3(a), (b) and (c)—

(a) before 31st December 2027; or

(b) where the applicant has been asked to submit additional information under paragraph 2A, before the date to which the deadline of 31st December 2027 has been extended under that paragraph.]

Textual Amendments

F1 Words in Art. 30(1) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(4)(a)

F2 Word in Art. 30 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. 91; 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 30(1A)-(1C) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(4)(b)

F4 Words in Art. 30(2) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(4)(c)

F5 Art. 30(2A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(4)(d)

F6 Words in Art. 30(3) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(4)(e)

F7 Art. 30(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(4)(f)