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

Article 20 U.K. Requirements for applications for authorisation

1. The applicant for an authorisation shall submit the following documents together with the application:

(a) for biocidal products other than biocidal products meeting the conditions laid down in Article 25:

(i) a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;

(ii) a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;

(iii) a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;

[F1 the competent authority may refuse to accept a letter of access for the purposes of this Article if it does not hold the relevant data.]

(b) for biocidal products that the applicant considers meet the conditions laid down in Article 25:

(i)

a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;

(ii)

efficacy data; and

(iii)

any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.

[F2 2. Applications must be submitted in English.]

F3 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Words in Art. 20(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. 81(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Art. 20(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. 81(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Art. 20(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. 81(c); 2020 c. 1, Sch. 5 para. 1(1)