Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance)

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Article 14U.K.Evaluation of applications for renewal

1.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 approval or, as appropriate, the previous renewal, the F1... competent authority shall, within 90 days of [F2receiving] an application in accordance with Article [F313], 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.

2.Where the F4... competent authority decides that a full evaluation of the application is necessary, the evaluation shall be carried out in accordance with paragraphs 1, 2 and 3 of Article 8.

Where the F4... competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of [F5receiving] the application in accordance with Article [F613], prepare and submit to the [F7Secretary of State and the Devolved Authorities] a recommendation on the renewal of the approval of the active substance. It shall provide the applicant with a copy of its recommendation.

The F4... competent authority shall, as soon as possible after [F8it has received] an application, notify the applicant of the [F9appropriate fees]. The F4... competent authority shall reject the application if the applicant fails to pay the fees within 30 days of the notification and shall inform the applicant accordingly.

3.Within 270 days of [F10the completion of the evaluation conclusions], if it has carried out a full evaluation of the application, or 90 days otherwise, the [F11competent authority] shall prepare and submit to the [F12Secretary of State and the Devolved Authorities] an opinion on renewal of the approval of the active substance.

4.The [F13Secretary of State] shall, on receipt of the opinion of the [F14competent authority], [F15issue]:

(a)[F16a decision] providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or

(b)[F17a] decision that the approval of an active substance is not renewed.

F18...

Article 9(2) shall apply.

[F194A.The competent authority shall update the GB List with details of the renewal of the approval of the active substance]

[F205.Where, for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been taken on its renewal, the Secretary of State shall issue a decision postponing the expiry date of approval for a period sufficient to enable the competent authority to examine the application.]

[F215A.A decision issued under paragraph 4 or 5 above is subject to the consent requirement.]

6.Where the [F22Secretary of State] decides not to renew or decides to amend the approval of an active substance for one or more product-types, the [F23competent authority] shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.

Textual Amendments

F1Word in Art. 14(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. 75(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2Word in Art. 14(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. 75(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3Word in Art. 14(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. 75(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4Word in Art. 14(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. 75(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F5Word in Art. 14(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. 75(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F6Word in Art. 14(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. 75(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F7Words in Art. 14(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. 75(3)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F8Words in Art. 14(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. 75(3)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F9Words in Art. 14(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. 75(3)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F10Words in Art. 14(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. 75(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F11Words in Art. 14(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. 75(4)(b); 2020 c. 1, Sch. 5 para. 1(1)