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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

8.3. Skin sensitisationThe assessment of this endpoint shall comprise the following consecutive steps: 1. an assessment of the available human, animal and alternative data 2. in vivo testing The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided Testing on the product/mixture 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 the available information indicates that the product should be classified for skin sensitisation or corrosivity; or the substance is a strong acid (pH < 2,0) or base (pH > 11,5)

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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.