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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 · European Union

8.5.4. For biocidal products that are intended to be authorised for use with other biocidal products, the risks to human health, animal health and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried out using combinations of the products Testing on the mixture of products does not need to be conducted if: there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.