California Prop 65

California-Proposition-65-Warning-Toxicological-Assessment

  • Prop 65 Compliance Assessment: Identify the presence of California Prop 65 positive substances in the product through product assessment

  • Exposure Assessment: Determine exposure to the Prop 65 substances by conducting exposure assessments

  • Toxicology Evaluation: Perform a toxicological risk assessment to determine if the exposure to the Prop 65 substances exceeds the safe harbor level

  • Labeling Review: Review the product labeling to ensure compliance with Prop 65 labeling requirements

  • Analytical Testing: Arrange analytical study placement to quantify the identified Prop 65 chemicals

  • Risk Communication: Assist in developing risk management strategies to communicate the risks associated with Prop 65 substances

Frequently Asked Questions

  • California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses provide "clear and reasonable" warnings to Californians if products expose consumers to chemicals known to cause cancer, birth defects, or reproductive harm.

  • A Proposition 65 warning label informs consumers that a product may contain listed chemicals above the state-defined safe harbor levels. It helps Californians make informed decisions about product use while maintaining transparency and compliance with state law.

  • If your product is sold in California and contains any Proposition 65 listed chemicals at levels above the safe harbor threshold under normal or foreseeable use. Even trace amounts can trigger labeling obligations if exposure exceeds state-established limits.

  • Failure to comply exposes companies to civil penalties per violation, lawsuits from private enforcers, forced labeling changes, and reputational harm. Compliance not only mitigates legal risk but also demonstrates a proactive commitment to consumer transparency.

  • Yes. Proposition 65 is a state-level requirement that operates independently of federal agencies. A product may fully comply with FDA or EU standards yet still be subject to Prop 65 warnings and enforcement. This unique overlap often leads to lawsuits, making expert risk assessment essential.