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Development and optimisation of alternative methods and approaches Main gaps identified: high rate of misleading/false genotoxic positives Existing in vitro methods, whilst having a high sensitivity (and thus low false negative rate), have a relatively low specificity and thus high rate of false (misleading) positive results, which typically has led to unnecessary follow-up testing in vivo for the confirmation of these results

This necessitates a fundamental shift towards a proactive safe-and-sustainable-by-design (SSbD) framework, where considerations of ecological safety and lifecycle sustainability are not an afterthought, but are integral components of the material innovation process from its inception.185,186 The SSbD framework defined by the European Commissions Joint Research Centre (JRC) 2023 report, which integrates safety assessment into the earliest stages of innovation, is advocated