# 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), Division 4

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

A risk assessment on the active substance(s) present in the biocidal product is always required. This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.

---
Source: https://www.legislation.gov.uk/eur/2012/528/annex/VI/division/2/division/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-528/annex-VI/division-2/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.