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)
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Status:
Point in time view as at 31/12/2020.
Changes to legislation:
There are currently no known outstanding effects for the Regulation (EU) No 528/2012 of the European Parliament and of the Council, Article 47.
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Article 47U.K.Obligation for notification of unexpected or adverse effects
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.
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