Endocrine disrupting properties require specific evaluation under European Commission legislation, including the regulation for Plant Protection Products (PPP) (EC 1107/2009), the Biocidal Products Regulation (BPR) (EU 528/2012), and REACH (EC 1907/2006).
Hazard based criteria for the identification of an endocrine disrupter has been accepted under the BPR (EC 2017/2100) and PPP (EC 2018/605). These regulations only support the marketing and use of chemicals on the basis that they do not meet these criteria in humans or non-target wildlife species. An assessment of the endocrine disrupting properties of the active substance must now be submitted as part of product registrations under the BPR and PPP regulations. The European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) have developed guidance for implementing these criteria. The guidance specifically covers endocrine disrupting substances affecting Estrogen, Androgen, Thyroid and Steroidogenesis (EATS) modalities.
The identification of endocrine disrupters requires a review of all relevant information on the adverse effects and endocrine activity of a substance, mode of action analysis and application of a weight of evidence approach to determine if a substance fulfils the criteria. wca has considerable experience in conducting weight of evidence assessments for endocrine disruption and has contributed to advancing the science in this area. We also have experience on relevant test methods for both EATS and other endocrine pathways and supported a EC workshop on this topic.
Our services extend to:
- Weight of evidence reviews of endocrine disrupting properties for substances
- Mode of Action analysis
- Data gap analysis (or analysis of data sufficiency)
- Development of testing strategies
- Placement and monitoring of specific studies to detect endocrine disruption
- Assessment of endocrine disrupting properties relative to standard endpoints for the derivation of Environmental Quality Standards.