With classification, labelling and packaging (CLP) criteria for endocrine disruptors now fully in force, companies face growing scrutiny from regulators under EU REACH (Regulation (EC) No 1907/2006). This makes proactive endocrine disruption (ED) screening of registered substances more critical than ever.
As of May 2025, the new CLP classification rules for endocrine disruptors are legally binding. That means substances with ED properties can now be formally classified under health or environmental hazard classes – with real regulatory consequences. This step brings endocrine disruption on a par with other hazard classes such as CMRs (carcinogenic, mutagenic or toxic to reproduction), impacting Safety Data Sheets, downstream user obligations, and potentially, market access.
Fully reviewing available data, conducting strategic in silico (e.g., (Q)SAR modelling), and/or in vitro screening studies for substances where existing information for ED is inconclusive or lacking, can help you further understand potential ED concerns early, giving you a strategic advantage.
Why Conduct ED Screening Now?
Pre-Empt Costly Data Requests
If a Member State initiates a substance evaluation and ED endpoints are triggered, you may be required to conduct complex and expensive in vivo studies if you don’t have a valid defence against such requests. Early screening helps you stay ahead of such demands and argue for a more reasoned approach using robust evidence.
Informed Testing Strategy
Robust initial screening informs the weight-of-evidence approach encouraged by ECHA, allowing you to design fit-for-purpose, cost-effective testing where endocrine disruption concerns are evident.
Control Regulatory Costs
A well-supported ED screening program can potentially avoid unnecessary studies, saving both time and money.
What Does ED Screening Involve?
Under REACH and the revised CLP framework, screening for endocrine disruption involves assessing endocrine activity and adverse effects across key endocrine modalities.
The EFSA/ECHA guidance (2018) lays out a comprehensive stepwise approach for identifying ED properties, starting with data gathering, followed by evidence integration and mode of action (MoA) analysis.
Don’t wait for regulatory authorities to enforce your substance – initiate your ED screening now. At Blue Frog Scientific, we offer tailored strategies and regulatory foresight, designed to align with ECHA’s latest guidance and optimise your REACH dossier for defence against ED challenges.
Blue Frog is a chemical regulatory compliance consultancy with specific expertise in ED. Call and speak with one of our endocrine disruption experts today.
