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

Article 64 U.K. Use of data for subsequent applications

1. Where the relevant data protection period according to Article 60 has expired in relation to an active substance, [F1 the competent authority] may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant [F2 , where the data was provided to the competent authority,] in so far as the subsequent applicant can provide evidence that the active substance is technically equivalent to the active substance for which the data protection period has expired, including the degree of purity and the nature of any relevant impurities.

Where the relevant data protection period according to Article 60 has expired in relation to a biocidal product, [F1 the competent authority] may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant [F2 , where the data was provided to the competent authority,] in so far as the subsequent applicant can provide evidence that the biocidal product is the same as the one already authorised, or the differences between them are not significant in relation to the risk assessment and the active substance(s) in the biocidal product are technically equivalent to those in the biocidal product already authorised, including the degree of purity and the nature of any impurities.

An appeal may be brought, in accordance with Article 77, against decisions of the [F3 competent authority] under the first and second subparagraphs of this paragraph.

2. Notwithstanding paragraph 1, subsequent applicants shall provide the following data accordingly to the [F4 competent authority] F5 ...:

(a) all necessary data for the identification of the biocidal product, including its composition;

(b) the data needed to identify the active substance and to establish technical equivalence of the active substance;

(c) the data needed to demonstrate the comparability of the risk from and efficacy of the biocidal product to that of the authorised biocidal product.

Textual Amendments

F1 Words in Art. 64(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. 110(2)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 64(1) inserted (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. 110(2)(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 64(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. 110(2)(c); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 64(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. 110(3); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 64(2) omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 9(3)