Key Takeaways:
- RHP delivers end-to-end Proposition 65 (Prop 65) compliance support – from hazard identification and exposure assessment to labeling, reformulation, and risk management strategy.
- Our integrated exposure science, toxicology, and epidemiology approach produces scientifically defensible, audit-ready outcomes.
- We translate complex data into clear, decision-ready compliance strategies, including warnings, controls, or product changes.
- Clients rely on RHP for rigorous, objective analyses that withstand regulatory and legal scrutiny.
Proposition 65 Compliance: Simplified, Defensible, and Strategic
Navigating California’s Prop 65 requirements can be complex, costly, and legally risky. RHP Risk Management helps companies confidently assess exposure risks, determine when warnings are required, and implement compliant, defensible solutions – backed by rigorous science and regulatory expertise.
Prop. 65, more formally known as The Safe Drinking Water and Toxic Enforcement Act of 1986, is a list of chemicals “known to have carcinogenic, teratogenic, or reprotoxic effects.” Since its inception in 1987, the State of California has updated the list of chemicals annually. Currently, the list has expanded to include approximately 900 chemicals.
Once added to the Prop 65 list, the Office of Environmental Health Hazard Assessment (OEHHA) may develop No Significant Risk Level (NSRL) values for cancer-causing chemicals or Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity.
Manufacturers, importers, distributors, and retailers selling products in California must evaluate whether exposures to listed chemicals exceed established safe harbor levels and, if so, provide “clear and reasonable warnings.” These requirements demand accurate exposure data, sound scientific interpretation, and defensible documentation.
RHP combines expertise in exposure science, toxicology, and epidemiology to evaluate potential risks, characterize exposures under real-world conditions, and support compliance decisions that align with regulatory expectations and business objectives.
How RHP Supports Prop 65 Compliance
Exposure Assessment
We measure and model real-world exposures using advanced laboratory testing and exposure modeling to generate accurate, defensible data. RHP’s in-house Exposure Sciences Laboratory (ESL) offers the rare capability enabling real-world exposure testing and simulation.
Hazard and Risk Characterization
RHP integrates toxicological and epidemiologic data to evaluate the hazards. Our team determines whether exposures exceed OEHHA safe harbor levels (NSRLs and MADLs) and supports scientifically sound risk conclusions. When safe harbor levels are not readily available, RHP can derive proposed values that align with current best practices in risk assessment and with regulatory and policy considerations, allowing clients to proactively evaluate their products before regulations are finalized.
Regulatory Strategy and Compliance Decision-Making
RHP translates scientific findings into clear compliance strategies – whether that involves no warning, product reformulation, exposure controls, or warning implementation. We provide documentation suitable for regulatory review and legal defense.
Labeling, SDS, and Product Review
We evaluate product formulations, labeling, and safety data sheets (SDSs) to ensure alignment with Prop 65 and broader regulatory requirements (e.g., GHS/CLP), helping maintain consistency across markets.
Risk Reduction and Product Safety and Stewardship
When exposures exceed acceptable thresholds, we support practical risk management solutions, including reformulation strategies, engineering controls, and communication approaches that reduce liability while maintaining product performance.
Ongoing Regulatory Monitoring
Our team tracks developments from OEHHA, EPA, and TSCA to help clients stay ahead of evolving requirements and proactively manage compliance risks.
Prop 65 compliance requires more than screening-level assessments – it requires integration of multiple scientific disciplines to support defensible conclusions. By integrating across our health and human risk science disciplines, RHP develops transparent, reproducible assessments that support both compliance and litigation readiness.
What RHP Delivers
- Defensible exposure and risk assessments aligned with Prop 65 requirements.
- Clear determination of warning requirements based on NSRLs and MADLs.
- Product labeling and SDS evaluations for regulatory consistency.
- Risk management strategies, including reformulation and exposure controls.
- Scientific documentation suitable for regulatory submissions and legal proceedings.
Contact RHP experts to reduce uncertainty and enable confidence in decision-making by delivering reliable, reproducible, and relevant data. Through early and active stakeholder engagement, we provide customized solutions that support clients with their specific goals.