Assessment of endocrine disruptors in the European Union: Current regulatory framework, use of new approach methodologies (NAMs) and recommendations for improvements
Marie Louise Holmer, Rikke Donchil Holmberg, Caroline Despicht, Nora Bouftas, Marta Axelstad, Anna Beronius, Johanna Zilliacus, Majorie B.M. van Duursen, Terje Svingen
Abstract
Exposure to endocrine disruptors (EDs) are associated with significant risks to human health and the environment. The European Union (EU) thus prioritizes their identification and regulation and is developing a roadmap to phase out animal testing in chemical safety assessments while advancing New Approach Methodologies (NAMs). This review outlines EU's practices for ED identification, focusing on the use of NAMs, as well as Defined Approaches and read-across. We assessed the current EU framework under the Classification, Labelling and Packaging (CLP) Regulation, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Plant Protection Products Regulation (PPPR), and the Biocidal Products Regulation (BPR), evaluating current use of NAMs and reflection on potential future use. We find that EU legislation and guidance documents allow the use of NAMs in ED identification, including for assessment of endocrine activity and adversity. However, guidance on predicting adversity using NAMs remains limited, and ED identifications have largely depended on animal data to assess endocrine-mediated adversity. Continued in vivo testing until reliable methodologies are accepted as alternatives and routinely applied is required. The report concludes with short- and long-term recommendations for updates to the information requirements across regulations and further development of methods to predict endocrine-mediated adversity.