# 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 18: The risk assessment shall determine:

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

(a) the hazards due to the physico-chemical properties,
(b) the risk to humans and animals,
(c) the risk to the environment,
(d) the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.

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Source: https://www.legislation.gov.uk/eur/2012/528/annex/VI/division/3/division/1/division/18 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-528/annex-VI/division-3/division-1/division-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.