CHAPTER V

SIMPLIFIED AUTHORISATION PROCEDURE

Amendment of the Simplified Active Substance List
Article 28
1
The competent authority must, after receiving the decision of the Secretary of State, update the Simplified Active Substance List in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.
2
Active substances give rise to concern where:
a
they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:
- explosive/highly flammable,
- organic peroxide,
- acutely toxic of category 1, 2 or 3,
- corrosive of category 1A, 1B or 1C,
- respiratory sensitiser,
- skin sensitiser,
- germ cell mutagen of category 1 or 2;
- carcinogen of category 1 or 2,
- human reproductive toxicant of category 1 or 2 or with effects on or via lactation,
- specific target organ toxicant by single or repeated exposure, or
- toxic to aquatic life of acute category 1;
b
they fulfil any of the substitution criteria set out in Article 10(1); or
c
they have neurotoxic or immunotoxic properties.
Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.
3
The Secretary of State may agree to the restriction or removal of an entry of an active substance to the Simplified Active Substance List on the recommendation of the competent authority if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25.
4
Paragraph 1 or 3 shall apply at the initiative of the Secretary of State or at the request of an economic operator or at the request of a Devolved Authority providing the necessary evidence as referred to in those paragraphs.
5
The Secretary of State may make regulations to further specify the procedures to be followed with respect to the amendment of the Simplified Active Substance List.
6
A decision issued or a function carried out under paragraph 1, 3 or 5 is subject to the consent requirement.
7
Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 5 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.
Words in Art. 28 heading 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. 89(a); 2020 c. 1, Sch. 5 para. 1(1)
Art. 28(3)-(7) substituted for (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. 89(c); 2020 c. 1, Sch. 5 para. 1(1)
Art. 28(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. 89(b); 2020 c. 1, Sch. 5 para. 1(1)