# Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance), Article 47: Obligation for notification of unexpected or adverse effects

Extent: E+W+S+N.I.

1. 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 .... In particular, the following shall be notified:
(a) 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;
(b) any data indicating the potential of the active substance for the development of resistance;
(c) new data or information indicating that the biocidal product is not sufficiently effective.
2. The competent authority ..., shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/eur/2012/528/article/47 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-528/article-47
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.