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.
Entering the US market? Get to grips with California’s Proposition 65
Companies outside the US are often unsure about the reach and relevance of California’s Proposition 65. Sagentia Regulatory’s Insight – Proposition 65: Decision-making guidance for exporters to the US – outlines how the Safe Drinking Water and Toxic Enforcement Act of 1986 impacts products sold in the state of California, how technical evaluation and assessment can guide warning decisions, and key considerations when it is deemed appropriate to place a warning.
Frequently asked questions – California Proposition 65
Does my product need to comply with Proposition 65?
If your product is sold or distributed in California and may expose individuals to any chemical listed under Proposition 65, then yes – compliance is required.
Proposition 65 applies to a wide range of consumer products, packaging, workplace exposures, and environmental discharges. Businesses must determine whether their products or operations expose people in California to any of the 900+ listed chemicals known to cause cancer, birth defects, or other reproductive harm.
To assess compliance, businesses should:
- Review the Proposition 65 chemical list to identify any relevant substances in their products or processes
- Evaluate exposure levels against OEHHA’s published Safe Harbor Levels (NSRLs and MADLs)
- Provide a clear and reasonable warning if exposures exceed these thresholds
If exposure is below Safe Harbor Levels, no warning is required – but the burden of proof lies with the business.
Sagentia Regulatory helps you navigate this process with scientific precision and regulatory insight – so you can assess risk, ensure compliance, and protect your brand with confidence.
What is a Safe Use Determination (SUD)?
A Safe Use Determination (SUD) is a formal, written decision issued by California’s Office of Environmental Health Hazard Assessment (OEHHA). It provides clarity on whether a specific exposure to a Proposition 65-listed chemical – resulting from a particular product or business activity – requires a warning under the law.
SUDs are typically requested by businesses or trade groups seeking confirmation that their product’s exposure levels are at or below the Safe Harbor Levels (i.e., No Significant Risk Levels for carcinogens or Maximum Allowable Dose Levels for reproductive toxicants). If OEHHA determines that the exposure is within safe limits, the product or activity is exempt from Proposition 65 warning requirements.
Sagentia Regulatory routinely supports clients throughout the SUD process – from exposure assessment and data preparation to strategic submission and regulatory engagement. To chat with our consultants about how we can help you, please email [email protected]