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Article 5 Validation of applications for approval or inclusion in category B of the Simplified Active Substance ListF11F12

United Kingdom

Original text. Later amendments are not shown.

F11.

Where an application for approval or inclusion in F2category B of the Simplified Active Substance List containing the data required in accordance with Article 6(1) and (2) of Regulation (EU) No 528/2012 has been accepted by the competent authority and the appropriate fee has been paid pursuant to Article 4 the competent authority shall validate the application within 30 days of that payment.

F32.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.

In the cases referred to in F4paragraph 1, the F5... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

4.

Where the F6... competent authority considers that the application is incomplete, it shall inform the participant 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 ... 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 F71.

The ... competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant F8... accordingly. In such cases, part of the F9appropriate fees paid shall be reimbursed.

On validating an application, the ... competent authority shall without delay inform the participant, F10... indicating the date of the validation.

Annotations

Textual amendments

F1

Art. 5(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. 217(3); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in Art. 5(1) substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 10(3)

F3

Art. 5(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. 217(4); 2020 c. 1, Sch. 5 para. 1(1)

F4

Words in Art. 5(3) 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. 217(5)(i); 2020 c. 1, Sch. 5 para. 1(1)

F5

Word in Art. 5(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. 217(5)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F6

Word in Art. 5(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. 217(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F7

Word in Art. 5(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. 217(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F8

Words in Art. 5(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. 217(6)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F9

Words in Art. 5(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. 217(6)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F10

Words in Art. 5(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. 217(6)(d); 2020 c. 1, Sch. 5 para. 1(1)

F11

Words in Art. 5 heading substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 10(2)

F12

Words in Art. 5 heading 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. 217(2); 2020 c. 1, Sch. 5 para. 1(1)