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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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There are currently no known outstanding effects for the Regulation (EU) No 528/2012 of the European Parliament and of the Council, Article 26.
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1.Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the [F1competent authority], F2....
2.The F3... competent authority shall inform the applicant of the [F4appropriate 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 [F4appropriate fees], the F3... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
[F52A.Where the application is one to which paragraph 2B applies, paragraph 2 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”.
2B.This paragraph applies to—
(a)an application in respect of a relevant category B product that is resubmitted by virtue of Article 95E; or
(b)an application that is resubmitted under Article 95FA.
2C.A “relevant category B product” is a product containing an active substance falling within category B of the Simplified Active Substance List that before IP completion day was—
(a)approved; or
(b)included in Annex 1 to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.]
3.[F6Subject to paragraph 3A,] within 90 days of accepting an application, the F3... competent authority shall authorise the biocidal product if satisfied that the product meets the conditions laid down in Article 25.
[F73A.Where a relevant application is accepted before 2nd October 2027, the competent authority must authorise the application before 31st December 2027 if it is satisfied that the product meets the conditions laid down in Article 25.
3B.In paragraph 3A, “relevant application” is one that is submitted in respect of a product containing an active substance that before IP completion day was—
(a)approved; or
(b)included in Annex 1 to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.]
4.Where the F3... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.
The F3... competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25.
[F8Where paragraph 3A applies, the deadline of 31st December 2027 referred to in that paragraph is to be extended by a number of days equal to the number of days beginning with the date on which the competent authority requested additional information and ending with the date on which the information was received by the competent authority plus 90 days.]
The F3... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, where fees have been paid, part of the fees F9... shall be reimbursed.
Textual Amendments
F1Words in Art. 26(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. 87(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 26(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. 87(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3Word in Art. 26 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. 87(2); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 26(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. 87(4); 2020 c. 1, Sch. 5 para. 1(1)
F5Art. 26(2A)-(2C) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(a)
F6Words in Art. 26(3) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(b)
F7Art. 26(3A)(3B) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(c)
F8Words in Art. 26(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(d)
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