Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

Changes over time for: Article 8

Alternative versions:

Changes to legislation:

There are currently no known outstanding effects by UK legislation for Commission Implementing Regulation (EU) No 354/2013, Article 8.

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

Article 8U.K.Procedure for major changes of products

1.The authorisation holder, or its representative, shall submit [F1to the competent authority] an application complying with Article 5.

2.[F2The competent authority] shall inform the applicant of the [F3appropriate fee]. If the applicant fails to pay the fee within 30 days, [F4the competent authority] shall reject the application and inform the applicant F5... accordingly. Upon receipt of the fee, [F4the competent authority] shall accept the application and inform the applicant accordingly indicating the date of acceptance.

[F62A.Where the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.]

3.The [F7competent authority] shall validate the application within 30 days of its acceptance if it complies with the requirements laid down in Article 5 and inform the applicant F8... accordingly.

In the context of the validation referred to in the first subparagraph, the [F7competent authority] shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

Where the [F7competent 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 [F7competent 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 Article 5.

The [F7competent authority] shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F8... accordingly.

4.[F9Subject to paragraph 4A,] within 180 days of validating an application, the [F7competent authority] shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics F10... to the applicant.

[F114A.Where the application is validated but not authorised before 4th July 2027, the competent authority must, before 31st December 2027—

(a)evaluate the application;

(b)draft an assessment report;

(c)send the report to the applicant; and

(d)where relevant, send the revised summary of the biocidal product characteristics to the applicant.]

5.[F12Subject to paragraph 5A] where it appears that additional information is necessary to carry out the evaluation, the [F7competent authority] shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4 shall be suspended from the date of the request until the date on which the information is received. The time limit given to the applicant shall not exceed 90 days in total unless justified by the nature of the data requested or by exceptional circumstances.

The [F7competent authority] shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant F13... accordingly.

[F145A.Where paragraph 4A applies and it appears to the competent authority 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 4A 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 90 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 deadline and must inform the applicant accordingly.]

F156.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F167.Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.]

Textual Amendments

F1Words in Art. 8(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. 186(3); 2020 c. 1, Sch. 5 para. 1(1)

F2Words in Art. 8(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. 186(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3Words in Art. 8(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. 186(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

F4Words in Art. 8(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. 186(4)(c); 2020 c. 1, Sch. 5 para. 1(1)

F5Words in Art. 8(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. 186(4)(d); 2020 c. 1, Sch. 5 para. 1(1)

F6Art. 8(2A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(a)

F7Words in Art. 8 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. 186(2); 2020 c. 1, Sch. 5 para. 1(1)

F8Words in Art. 8(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. 186(5); 2020 c. 1, Sch. 5 para. 1(1)

F9Words in Art. 8(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(b)

F10Words in Art. 8(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. 186(6); 2020 c. 1, Sch. 5 para. 1(1)

F11Art. 8(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(c)