Expert guidance to navigate evolving EU endocrine disruption requirements
Endocrine Disruption
The identification and regulation of endocrine disruptors (EDs) in the EU is evolving rapidly, with increasing scrutiny across multiple regulatory frameworks -including REACH, BPR, PPPR, and CLP.
EU authorities require a thorough and scientifically robust assessment to determine the endocrine disruptive potential of substances, with the goal of protecting human health and the environment.
The identification of an endocrine disruptor requires demonstration of:
- An adverse effect,
- An endocrine mode of action (MoA), and
- A biologically plausible link between the two.
These three criteria must be addressed through a weight-of-evidence (WoE) approach, drawing on adversity endpoints and mechanistic data (e.g. receptor binding, hormone modulation), while ensuring study reliability and regulatory relevance.
As guidance and criteria continue to evolve across sectors, staying compliant requires both technical expertise and strategic insight.
Our expertise and services
ARCHE Consulting offers tailored support to help you meet the EU's complex and evolving endocrine disruption (ED) requirements:
- Screening for ED potential through literature and database reviews for both the environmental and human health endpoints, supported by continuous monitoring of regulatory developments and application of grouping or read-across strategies where appropriate
- Relevance and reliability assessments and data gap analysis to ensure study quality and regulatory compliance
- Weight-of-Evidence (WoE) evaluations aligned with CLP, ECHA/EFSA (2018) guidance and OECD GD 150
- Designing testing strategies to clarify adversity and endocrine activity through both EATS and non-EATS pathways
- Preparation of IUCLID dossiers and Chemical Safety Reports (CSRs) for REACH, BPR and PPPR
- Recommendations for ED classifications under the CLP regulation
- Liaison with regulatory authorities and the EU Commission, including preparing responses to requests from ECHA, EFSA or Commission services
Work with ARCHE Consulting to confidently address the challenges of endocrine disruption assessment and ensure regulatory compliance across all relevant EU frameworks.
Andreas Fettweis
Senior Project Scientist
andreas.fettweis@arche-consulting.be
+32 491 73 70 73
Guillaume Richer
Project Scientist
guillaume.richer@arche-consulting.be
+32 16 28 49 06