Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

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)