California Proposition 65 Support

Evaluating Compliance and Potential Risks Associated with Listed Chemicals in Commercial and Consumer Products

California’s Proposition 65 (“Prop 65”), officially known as Safe Drinking Water and Toxic Enforcement Act of 1986, requires businesses to provide a “clear and reasonable” warning before knowingly and intentionally exposing individuals to a listed chemical that may cause cancer, birth defects, or reproductive harm in humans. Nearly 1,000 substances to date are listed for consideration, which impacts firms conducting business in the state.

Compliance with Prop 65 requires knowledge of the many complexities for warning exemptions. In particular, warnings are not required if the anticipated exposure level to a substance is below the Safe Harbor Level: the level that does not pose a significant risk of cancer or observed to cause birth defects and other reproductive harm.

Roux supports manufacturers, distributors, retailers, and attorneys as they navigate the complexities of California Proposition 65 compliance. We work with clients across a broad range of industries—including commercial and consumer products, apparel, and food and beverage—to help them understand regulatory obligations and manage potential risks.  Our team brings deep technical expertise in toxicology, exposure assessment, and the challenges companies face when addressing Prop 65 requirements. Roux provides tailored solutions for each client including science-supported guidance.

Prop 65 Services:

  • Product formulation reviews to identify potential Prop 65-listed chemicals in ingredients, raw materials, processes, or product use
  • Exposure assessments to evaluate compliance and to determine potential health risks to consumers
  • Development and performance of simulation studies to collect exposure data under specific conditions of use
  • Comparison of exposure estimates to established Safe Harbor Levels to determine warning requirements
  • Development of Safe Harbor Levels (No Significant Risk Levels) and Maximum Allowable Dose Levels (NSRLs/MADLs) for the hundreds of chemicals without established values
  • Oversight and coordination of product testing for Prop 65-listed chemicals by an analytical laboratory
  • Provision of expert witness testimony in litigation matters

 

 

Recent Projects

  • Developed an exposure calculation tool for the evaluation of Prop 65 compliance for chemicals in a wide variety of apparel products.
  • Coordinated analytical testing and evaluated exposures to metals (e.g. lead, cadmium) from ingestion of seafood, dietary supplements, and other food products with respect to Prop 65 regulations. Designated as testifying expert in Prop 65 litigation.
  • Assisted manufacturer with determining appropriate testing, compliance with state PFAS laws in food packaging, and identifying sources of total organic fluoride contamination in production chain.
  • Assisted a manufacturer of PFAS-containing product and navigated compliance with numerous state regulations in addition to Prop 65.
  • Reviewed ingredients and manufacturing processes to identify chemicals of concern, derived Safe Harbor Levels for chemicals lacking such information, and performed exposure assessments for comparison to guidance values, as necessary.
  • Comprehensive review of ingredients, supply chains, and manufacturing processes at a baked goods manufacturer to identify chemicals of concern and address potential Prop 65 concerns via ingredient substitution and exposure assessments.
  • Conducted simulation study of formaldehyde release from textile products to determine anticipated consumer exposure and Prop 65 warning requirements.
  • Advised clients on warning requirements across a wide variety of industrial and consumer products related to heavy metals (e.g., lead, cadmium, arsenic), formaldehyde, methanol, methyl isobutyl ketone, furfuryl alcohol, acrylamide, phthalates, and more.

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