On 8 January 2026, the Directorate-General for Health and Food Safety (European Commission) announced the publication of a new open-access article in the scientific journal Archives of Toxicology, titled "The way forward for assessing the human health safety of cosmetics in the EU: Proceedings of Workshop 2." This article reports on the outcomes of a December 2024 workshop organised by the Scientific Committee on Consumer Safety (SCCS) Methodology Working Group, focusing on advancing non-animal methods for cosmetics safety assessments under the EU Cosmetics Regulation (No 1223/2009), which has banned animal testing since 2013.
The workshop addressed challenges in using New Approach Methodologies (NAMs) and Next Generation Risk Assessment (NGRA) for endpoints like systemic toxicity, where validated animal-free alternatives are lacking for sub-acute/chronic effects, carcinogenicity, developmental/reproductive toxicity, and toxicokinetics. Key discussions included criteria for verifying physiologically based kinetic (PBK) models without in vivo data, quantitative in vitro-in vivo extrapolation (QIVIVE), toxicodynamic tools (e.g., cell stress panels, pharmacology profiling), Bioactivity Exposure Ratio (BER) interpretation, and expansions of Threshold of Toxicological Concern (TTC) and internal TTC (iTTC) for non-dermal routes like inhalation.
Progress highlighted includes NGRA case studies (e.g., on daidzein and benzyl salicylate), OECD QSAR Toolbox guidance, and a proposed JRC template for NAM readiness criteria. The article emphasises the need for harmonised guidance, stakeholder collaboration, and further work on gaps like nanomaterials, mixtures, and adversity distinctions to enhance regulatory acceptance of animal-free approaches for safer cosmetics in the EU.