CHAPTER IV

GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

Requirements for applications for authorisation
Article 20
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;
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:
1. a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;
2. efficacy data; and
3. any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.
2
Applications must be submitted in English.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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)
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)
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)