CHAPTER II

APPROVAL OF ACTIVE SUBSTANCES

Data requirements for an application
Article 6
1
An application for approval of an active substance shall contain at least the following elements:
a
a dossier for the active substance satisfying the requirements set out in Annex II;
b
a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and
c
if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.
2
Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:
a
the data are not necessary owing to the exposure associated with the proposed uses;
b
it is not scientifically necessary to supply the data; or
c
it is not technically possible to generate the data.
However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the ... competent authority under Article 8(2).
3
An applicant may propose to adapt the data as part of the dossiers required under points (a) and (b) of paragraph 1 in accordance with Annex IV. The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.
4
The Secretary of State may by regulations amend the criteria for determining what constitutes adequate justification to adapt the data requirements under paragraph 1 of this Article on the grounds referred to in point (a) of paragraph 2 of this Article.
5
Regulations made under paragraph 4 above are subject to the consent requirement.
6
Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 4 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.
Art. 6(5)(6) 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. 66(4); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 6(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. 66(2); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 6(4) 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. 66(3); 2020 c. 1, Sch. 5 para. 1(1)