The California Prop 65 regulation relates to the Safe Drinking Water and Toxic Enforcement Act, 1986 (also known as Proposition 65), which is a California law that was set out to promote clean drinking water and inform the public about the presence of toxic substances that cause cancer and/or birth defects in consumer products and their environment. The CA Prop 65 regulation is overseen by the Office of Environmental Health Hazard Assessment (OEHHA), which is part of the California Environmental Protection Agency (Cal EPA) and the regulation is enforced through the Office of the Attorney General.

As per the Prop 65 regulation, if a product, including foods and supplements, sold in California contains one or more chemical that is listed on the Prop 65 list of chemicals(http://oehha.ca.gov/proposition-65-list) that are “known to the state of California to cause cancer or reproductive toxicity”, then businesses need to notify customers about their presence with a warning for the product which may be required if exposure to that chemical is above the Safe Harbor Level (if one has been established). Failure to comply with the regulations can result in your company being issued a “60-Day Notice” of non-compliance or “Notice of Violation” and your company can be taken to court if a settlement is not reached. Settlement fees can cost companies tens of thousands to as much as several hundred thousand dollars. Compliance with this regulation cannot be ignored.

Our Subject Matter Experts (SME) provide consulting services for Prop65 compliance, in addition to regulatory training. A documented strategy and plan will be delivered at the end of the consulting services. Beyond the initial consulting, we assist with collecting the Prop65 declarations from the supply base via a multipronged and proactive supplier engagement program. This ensures that the compliance program is effective and meets regulatory guidelines.

Our California Prop 65 Services include:

  • Assess current “As Is” and determine next steps for compliance
  • Identify Warning Label Requirements
  • Supply chain analysis and collection of declarations
  • Compliance Assurance Process implementation and certification
  • Assessing areas of risk for California Prop 65 substances, and providing compliance strategies
  • Preparing Prop 65 related positional statements for your company (i.e., in relation to providing arguments against the listing of a chemical on the Proposition 65 list or for de-listing a chemical)
  • Deriving “No Significant Risk Levels (NSRLs)” and “Maximum Allowable Dose Levels (MADLs)” for chemicals in the absence of OEHHA derived Safe Harbor Levels
  • Conducting exposure assessments to evaluate whether your company’s product complies with the regulations and whether a warning may be required
  • Assisting in obtaining Safe Use Determinations for your product(s) from OEHHA
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