# 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 73

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

The competent authority shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of non-target organisms being exposed to the biocidal product, if for any active substance or substance of concern:
the PEC/PNEC is above 1, or
the concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.

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Source: https://www.legislation.gov.uk/eur/2012/528/annex/VI/division/4/division/3/division/6/division/73 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-528/annex-VI/division-4/division-3/division-6/division-73
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.