California Proposition 65 Regulatory Review
California Proposition 65 Regulatory Review
To establish and maintain a robust regulatory compliance program to ensure packaging and labeling meet the requirements under California Proposition 65 and relevant federal regulations. This includes identifying regulated substances in product formulations or packaging, evaluating risk levels, and ensuring label statements are correctly applied to reduce the risk of non-compliance, regulatory actions, or consumer misinformation.
Scope of Work
Product Formulation & Ingredient Review
Gather detailed product information, including formulation, ingredient list, additive concentrations, and product pH. Identify potential presence of Proposition 65-listed substances from active or inactive ingredients. Verify if the product includes substances such as lead, acrylamide, or phthalates.
Packaging Material & Exposure Assessment
Evaluate all packaging components (e.g., containers, labels, seals, inks, adhesives) for presence of chemicals subject to Proposition 65, such as BPA or other leachable contaminants. Review headspace interaction, packaging structure, and likelihood of consumer exposure. Determine if chemical exposure exceeds established Safe Harbor Levels.
Labeling & Warning Review
Assess existing product labels (front, back, side panels) for compliance with Proposition 65 formatting and placement standards as set by OEHHA. Evaluate use of mandatory symbols, signal words, font size, and color contrast. Provide recommendations for new or updated warning language if required.
Exemption & Justification Evaluation
Determine if applicable exemptions apply such as: - Naturally occurring chemicals - No significant risk level (NSRL) - No observable effect level (NOEL) Support with appropriate scientific references and documentation.
Deliverables
Includes:
• Regulatory Compliance Review Report (PDF) • Product and packaging chemical assessment findings • Label Compliance Checklist and recommendations • Summary of Proposition 65 compliance or exemption status • Suggested language and layout for warning statements (if needed)
Fees and Subscriptions
Standard Regulatory Review – $850 USD per product
Includes:
• Full review of formulation and packaging • Compliance verification under California Proposition 65 • Label evaluation and correction suggestions • Regulatory report with references, findings, and recommendations
Ideal For:
Exporters, U.S. manufacturers, and brand owners seeking to: • Enter or maintain presence in the California market • Ensure products are compliant with Proposition 65 requirements • Avoid costly warning label violations and consumer litigation • Provide documentation to buyers and retailers as proof of compliance