Article 47 Obligation for notification of unexpected or adverse effects
United Kingdom
On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority F1.... In particular, the following shall be notified:
new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;
any data indicating the potential of the active substance for the development of resistance;
new data or information indicating that the biocidal product is not sufficiently effective.
The competent authority F2..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
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Annotations
Textual amendments
- F1
Words in Art. 47(1) 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. 94(a); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Words in Art. 47(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. 94(b); 2020 c. 1, Sch. 5 para. 1(1)
- F3
Art. 47(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. 94(c); 2020 c. 1, Sch. 5 para. 1(1)