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

CHAPTER VI U.K. NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

Article 29 U.K. Submission and validation of applications

1. Applicants wishing to apply for a national authorisation in accordance with Article 17 shall submit an application to the F1 ... competent authority. The F1 ... competent authority shall inform the applicant of the [F2 appropriate fees], and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly. Upon receipt of the [F2 appropriate fees], the F1 ... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

[F3 1A. Where the application is one that has been resubmitted by virtue of any of the Articles listed in paragraph 1B, paragraph 1 applies as if for “shall inform the applicant of the appropriate fees” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fees”.

1B. The Articles are—

(a) Article 95B;

(b) Article 95D;

(c) Article 95F;

(d) Article 95H.]

2. Within 30 days of acceptance, the F1 ... competent authority shall validate the application if [F4 the relevant information referred to in Article 20 has been submitted]

F5 (a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

In the context of the validation referred to in the first subparagraph, the F1 ... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

3. Where the F1 ... 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 F1 ... 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 requirements laid down in paragraph 2.

The F1 ... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

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

5. If paragraph 3 does not apply and the F1 ... competent authority considers that the application is complete, it shall validate the application and without delay inform the applicant accordingly, indicating the date of the validation.

Textual Amendments

F1 Word in Art. 29 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. 90(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 29(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. 90(3); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 29(1A)(1B) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(3)

F4 Words in Art. 29(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. 90(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 29(2)(a) 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. 90(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 29(2)(b) 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. 90(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 29(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. 90(5); 2020 c. 1, Sch. 5 para. 1(1)

Article 30 U.K. Evaluation of applications

1. [F8 Subject to paragraph 1A,] the F9 ... 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.

[F10 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. [F11 Subject to paragraph 2A,] where it appears that additional information is necessary to carry out the evaluation, the F9 ... 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 F9 ... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.

[F12 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. [F13 Subject to paragraph 4,] within the 365-day period referred to in paragraph 1, the F9 ... 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.

[F14 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

F8 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)

F9 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)

F10 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)

F11 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)

F12 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)

F13 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)

F14 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)

Article 31 U.K. Renewal of a national authorisation

1. An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the F15 ... competent authority at least 550 days before the expiry date of the authorisation. Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.

2. The F15 ... competent authority shall renew the national authorisation, provided that the conditions set out in Article 19 are still satisfied. It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.

3. When applying for renewal, the applicant shall submit:

(a) without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and

(b) its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.

4. The F15 ... competent authority shall inform the applicant of the [F16 appropriate fees] and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

Upon receipt of the [F16 appropriate fees], the F15 ... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

5. On the basis of an assessment of the available information and the need to review the conclusions of the initial evaluation of the application for authorisation or, as appropriate, the previous renewal, the F15 ... competent authority shall, within 90 days of accepting an application in accordance with paragraph 4, decide whether, in the light of current scientific knowledge, a full evaluation of the application for renewal is necessary taking account of all product-types for which renewal is requested.

6. Where the F15 ... competent authority decides that a full evaluation of the application is necessary, it shall decide on the renewal of the authorisation after carrying out an evaluation of the application in accordance with paragraphs 1, 2 and 3 of Article 30.

Where the F15 ... competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.

7. Where, for reasons beyond the control of the holder of a national authorisation, no decision is taken on the renewal of that authorisation before its expiry, the F15 ... competent authority shall grant a renewal for the period necessary to complete the evaluation.

Textual Amendments

F15 Word in Art. 31 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. 92(a); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 31(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. 92(b); 2020 c. 1, Sch. 5 para. 1(1)