New ECHA requirement for prallethrin dossiers

Key regulatory updates for prallethrin

• Mandatory dietary risk assessment: ECHA has clarified that a dietary risk assessment (DRA) is required for all prallethrin uses, regardless of application method
• Risk Mitigation Measures (RMMs): Statements such as “not to be used in kitchens or food preparation areas” are unlikely to be accepted, as they might not be followed by non-professional users
• Trigger for OECD 507 study: If estimated exposure exceeds 10% of the ADI/ARfD, an OECD 507 study using radiolabelled prallethrin will be required
• Hydrolysis data: Must demonstrate stability above 50°C due to degradation risks under acidic conditions at elevated temperatures
• Letter of Access: ECHA is expected to announce next week that ONE OECD 507 should be shared via Letter of Access

Next steps for prallethrin dossier holders

To ensure your dossier remains compliant with the updated requirements, we recommend the following actions:

1. Reassess reliance on Risk Mitigation Measures: Given ECHA’s position on exclusion statements, evaluate whether your current RMMs are sufficient and realistic for non-professional use scenarios
2. Review your Dietary Risk Assessment: Contact us to discuss your current approach and explore potential refinements, particularly in the light of the expanded requirement for all prallethrin uses
3. Secure access to the OECD 507 study: Reach out to us or your supplier for support in obtaining a Letter of Access

This clarification emerged from our early interpretation of ECHA’s BPR Volume III – Human Health, Part D: Dietary Risk Assessment and Livestock Exposure (August 2025), followed by subsequent engagement between Sagentia Regulatory’s Biocides team and the authorities. Our close monitoring of regulatory developments continues to provide early visibility into emerging requirements.