California Proposition 65 compliance
Proposition 65 compliance made clear. Expert guidance to protect your products and market access
California’s Proposition 65 – officially the Safe Drinking Water and Toxic Enforcement Act of 1986 – continues to evolve, with new chemical listings and regulatory requirements placing increasing demands on businesses. From identifying listed substances in complex supply chains to evaluating exposure against Safe Harbor Levels, companies face a range of technical and legal challenges. For businesses selling into California, understanding these obligations and taking proactive, evidence-based steps is essential to avoid disruption and maintain compliance.
Why Proposition 65 compliance matters to you
Proposition 65 presents a complex compliance landscape. It’s not just about identifying listed chemicals – it’s about understanding exposure thresholds, interpreting evolving labeling requirements, and managing the legal risk.
Many companies struggle with limited supply chain transparency, uncertainty around Safe Harbor Levels, and the growing threat of private enforcement actions. These challenges can lead to costly litigation, product reformulation, or even market withdrawal if not addressed early.
With the right scientific and regulatory support, Proposition 65 compliance becomes a manageable part of your product development and market access strategy.
How Sagentia Regulatory supports you with Prop 65 compliance
With Proposition 65 updates occurring regularly – such as the 2025 revisions to warning content and Safe Harbor methods – maintaining compliance requires ongoing attention and expert interpretation. We bring scientific rigor and regulatory insight to help you:
- Assess exposure risks using the latest OEHHA guidance, including No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs)
- Develop compliant labeling strategies aligned with California’s “clear and reasonable” warning requirements
- Monitor chemical listings and anticipate regulatory shifts that could impact your formulations or supply chain
- Engage with OEHHA through Safe Use Determinations (SUDs) and interpretive guidance tailored to your products
- Respond to change with proactive compliance strategies that support product continuity and brand protection
Why Sagentia Regulatory for Prop 65 compliance?
Our experts apply deep toxicology and regulatory expertise to help you interpret Proposition 65 requirements, assess exposure against Safe Harbor Levels, and maintain market access amid evolving chemical regulations.
