California Proposed Prop 65 “Safe Harbor” Level for Diethanolamine

by | Oct 15, 2025 | California Cosmetic Regulations, California Office of Environmental Health Hazard Assessment, Cosmetics, FDA, Our View, U.S. Regulatory, U.S. State Updates

California’s Office of Environmental Health Hazard Assessment (OEHHA) has announced a significant proposed rule for the cosmetics and personal care industry. The agency is proposing to establish a formal No Significant Risk Level (NSRL), or “safe harbor” limit, for dermal exposure to diethanolamine under Proposition 65.

The proposed NSRLs are 54 µg/day for 1-bromopropane and 6.4 µg/day for dermal exposures to diethanolamine.

Why this Matters for the Cosmetic Industry

This is a critical development for any brand selling products in California. Diethanolamine has been a frequent target of Prop 65 enforcement and litigation often due to its presence as a low-level contaminant or as an impurity in the widely used ingredient triethanolamine (TEA). Products ranging from lotions and sunscreens to shampoos and color cosmetics have been subject to notice of violation.

The establishment of a formal NSRL provides much needed clarity and a legal safe harbor. If a company can demonstrate through exposure assessments that a consumer’s dermal exposure to diethanolamine from their products is below this 6.4µg/day threshold, they will be exempt from Prop 65’s warning requirements for that chemical.

The proposal is currently open for public comment. OEHHA is accepting electronic comments until the deadline of November 7, 2025. Industry stakeholders are encouraged to review the proposed regulatory text and provide feedback.

Please contact us if you would like assistance with formula reviews or exposure assessments to ensure compliance with Prop 65.