According to the 2002 World Health Organization definition, “an Endocrine Disruptor (ED) is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.” A wide range of substances, both natural and man-made, may be classified as endocrine disruptors.

In Europe, new hazard-based criteria for ED identification were introduced by EFSA (European Food Safety Authority)/ECHA (European Chemicals Agency) in 2018 under Regulation (EU) No 2018/605 (Plant Protection Products) and Regulation (EU) No 2017/2100 (Biocidal Products). These criteria apply to all substances including those already undergoing evaluation as part of the approval or renewal process. Under REACH (Regulation (EC) 1907/2006), endocrine disruptors can be identified as substances of very high concern alongside chemicals known to cause cancer, mutations and toxicity to reproduction.

In North America, the US Environmental Protection Agency (EPA) uses a risk-based approach to screen pesticides, chemicals, and environmental contaminants for their potential effect on estrogen, androgen, thyroid and steroidogenesis (EATS) pathways under the Endocrine Disruptor Screening Program (EDSP).

Our staff in both Europe and North America have considerable practical and regulatory experience in conducting ED assessments under both EU and US legislation, including the provision of advice on assessment strategies, the design, conduct and interpretation of studies to support ED evaluations and the analysis of evidence.