Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

Article 47 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 that granted the national authorisation and the Agency or, in the case of a Union authorisation, the Commission and the Agency. 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 that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.

3. The competent authority that granted the national authorisation or, in the case of a Union authorisation, the Agency, shall without delay notify competent authorities of other Member States and, where appropriate, the Commission of any such data or information it receives.

Competent authorities of Member States that have issued a national authorisation for the same biocidal product under the mutual recognition procedure shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.