Article 4 Evaluation of applications

United Kingdom

The F1... competent authority shall evaluate whether there is evidence that the substance does not give rise to concern in accordance with Article 28(2) of Regulation (EU) No 528/2012 and, where relevant, to which restrictions its use should be subject. It shall send an F2opinion to the F3Secretary of State, the Scottish Ministers and the Welsh Ministers. Where the application concerns inclusion in F4category A of F5the Simplified Active Substance List under Regulation (EU) No 528/2012, F6the opinion shall be submitted within 180 days of the payment of the fees referred to in the third subparagraph of Article 7(3) of that Regulation. Where the application concerns inclusion in F7category B of F8the Simplified Active Substance List under Regulation (EU) No 528/2012, F9the opinion shall be submitted within 365 days of validation of that application.

Prior to submitting its F10opinion to the F11Secretary of State, the Scottish Ministers and the Welsh Ministers,, the F12... competent authority shall give the applicant the opportunity to provide written comments on the F13opinion within 30 days. The F14... competent authority shall take due account of those comments when finalising its F15opinion.

Where it appears that additional information is necessary to F16provide the opinion, the F17... competent authority shall request that the applicant submit such information within a specified time limitF18.... The periods referred to in paragraph 1 of this Article shall be suspended from the date of issue of that 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.

An application concerning inclusion of an active substance in category A of F19the Simplified Active Substance List under Regulation (EU) No 528/2012, which, following a request for additional data pursuant to paragraph 2, complies fully with Article 6 of Regulation (EU) No 528/2012 shall, where the applicant so requests,

(a)

be considered as an application for inclusion in category B of the Simplified Active Substance List under that Regulation; and

(b)

be subject to validation pursuant to Article 3(2).

F204.

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Annotations

Textual amendments

F1: Word in Art. 4(1) 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. 209(2)(a)(i) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F2: Word in Art. 4(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. 209(2)(a)(ii) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in Art. 4(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. 209(2)(a)(iii) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in Art. 4 substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 11(4)(a)
F5: Words in Art. 4(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. 209(2)(a)(iv) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F6: Words in Art. 4(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. 209(2)(a)(v) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F7: Words in Art. 4 substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 11(4)(b)
F8: Words in Art. 4(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. 209(2)(a)(vi) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F9: Words in Art. 4(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. 209(2)(a)(vii) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F10: Word in Art. 4(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. 209(2)(b)(i) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F11: Words in Art. 4(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. 209(2)(b)(ii) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F12: Word in Art. 4(1) 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. 209(2)(b)(iii) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F13: Word in Art. 4(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. 209(2)(b)(iv) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F14: Word in Art. 4(1) 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. 209(2)(b)(v) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F15: Word in Art. 4(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. 209(2)(b)(vi) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 66); 2020 c. 1, Sch. 5 para. 1(1)
F16: Words in Art. 4(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. 209(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F17: Word in Art. 4(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. 209(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F18: Words in Art. 4(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. 209(3)(c); 2020 c. 1, Sch. 5 para. 1(1)
F19: Words in Art. 4(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. 209(4); 2020 c. 1, Sch. 5 para. 1(1)
F20: Art. 4(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. 209(5); 2020 c. 1, Sch. 5 para. 1(1)