Understanding and Complying with California Proposition 65

California’s Proposition 65 ("Prop. 65"), formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a state law that requires businesses to provide a "clear and reasonable warning" if their products expose individuals to chemicals known to cause cancer or reproductive toxicity. With over 900 chemicals on The Proposition 65 List, compliance is a critical and often complex process for businesses. Here, we break down the key aspects of the regulation and provide guidance for companies aiming to meet its requirements.

The Scope of Proposition 65

Prop. 65 applies to all businesses selling products in California. Its key provisions include:

• Warning Requirement: Companies must warn consumers if their product contains chemicals listed under Prop. 65.

• Broad Liability: All entities in the supply chain, including manufacturers, importers, distributors, and retailers, can be held liable for violations.

• Legal Enforcement: Actions can be initiated by the state, private enforcers, or "any person in the public interest," who are entitled to 25% of any penalties collected.

• Penalties: Businesses face fines of up to $2,500 per day for each violation.

Given that foreign manufacturers are not subject to Prop. 65, U.S.-based companies often bear the brunt of legal and financial liabilities.

Compliance Strategies for Businesses

Compliance with Prop. 65 requires a proactive and systematic approach. Here are key strategies:

Know Your Products and Supply Chain:

• Understand the chemical composition of your products.

• Require suppliers to disclose all chemicals and provide testing data.

Implement a Robust Testing Program:

• Use accredited, experienced laboratories for product testing.

• Ensure testing methods are reliable and legally defensible.

• Regularly update your testing protocols to address new chemicals, including PFAS, which are likely to attract increasing scrutiny.

Document Everything:

• Maintain detailed records of testing, sampling, and product evaluations.

• Keep retains of tested products for future reference.

Indemnity Agreements:

• Where feasible, include indemnity clauses in supplier or manufacturer contracts to share liability.

Consider Preemptive Warnings:

• Use Prop. 65 warnings proactively if you suspect potential exposures, even in small quantities.

Safe Harbor Limits: Proposition 65 No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs)

Safe harbor levels, which include No Significant Risk Levels (NSRLs) for cancer-causing chemicals and Maximum Allowable Dose Levels (MADLs) for chemicals causing reproductive toxicity, have been established for many of the chemicals listed under Proposition 65. Exposure levels and discharges to drinking water sources that are below the safe harbor levels are exempt from the requirements of Proposition 65.

In some instances, enforcement actions may have resulted in negotiated exposure levels relative to specific settlement agreements. Businesses can find further information about specific enforcement actions on the Attorney General's Proposition 65 website at https://oag.ca.gov/prop65.

OEHHA has also prioritized certain chemicals for NSRL development. Staying updated on these developments can help businesses maintain compliance and mitigate risk.

Preparing for Legal Challenges

In some cases, Prop. 65 warnings can be contested on constitutional grounds. For example, ongoing cases involving acrylamide and glyphosate may determine whether listing these chemicals infringes on First Amendment rights. Businesses should monitor these developments closely, as they may reshape compliance requirements.

The Evolving Regulatory Landscape

Prop. 65 is not static. Recent and proposed changes include:

• Short-Form Warning Updates: California has proposed regulations requiring expanded text for short-form warnings, potentially increasing compliance burdens.

• Chemical Additions: New chemicals are regularly added to The Proposition 65 List, requiring businesses to stay vigilant.

  
  

Moreover, Prop. 65 operates within a broader framework of California’s chemical regulations, including Green Chemistry laws, cookware reporting requirements, and recyclable packaging mandates. Other states are also adopting similar chemical regulations, further emphasizing the need for vigilance.

General overview

Navigating Prop. 65 requires a combination of due diligence, robust systems, and legal awareness. By taking proactive measures such as supplier engagement, rigorous testing, and comprehensive documentation, businesses can mitigate risks and ensure compliance. Remaining attentive to regulatory updates and broader trends will further position companies to succeed in a challenging regulatory environment.

Compliance with Prop. 65 is not just about avoiding penalties; it’s an opportunity to demonstrate commitment to consumer safety and environmental stewardship. Companies that prioritize transparency and proactive risk management can turn regulatory compliance into a competitive advantage.

What to Do if Your Product Does Not Contains a Chemical Listed in Proposition 65

A letter with the statement below can be used to inform your customers about the complince of your product.

California's Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act, mandates that the Governor of California maintain and publish a list of chemicals recognized by the state as causing cancer or reproductive harm. [Company Name] confirms that its supplied products are manufactured in compliance with the California Safe Drinking Water and Toxic Enforcement Act as of [date] and adhere to all Proposition 65 regulatory requirements.

What to Do if Your Product Contains a Chemical Listed in Proposition 65

Prop 65 Labeling Requirements for Manufacturers and Distributors

If a product contains a chemical listed in Proposition 65, manufacturers and distributors must ensure compliance by placing clear warnings on the product. These warnings are essential to inform consumers about potential risks. The following requirements must be met:

1. Specific Warnings for Risks:

   • Separate warnings must be provided for chemicals causing cancer and those causing reproductive harm.

   • If a product contains chemicals associated with both risks, both warnings are required.

2. Warning Formats:

3. Manufacturers and distributors may use short-form or long-form versions of warnings, depending on the size of the product and its packaging.

4. Warnings should include:

   • A large, yellow caution triangle.

   • The word "Warning" in a larger font.

   • Translations in other languages to match the product’s packaging.

   • A web URL directing consumers to the official Prop 65 website (www.P65warnings.ca.gov).

   • The phrase "expose you" instead of "contain."

5. Warnings for Online Purchases:

6. For online transactions, warnings must be displayed before or during the transaction process.

7. Examples of Long-Form Notifications:

8. Cancer Risk: "This product can expose you to chemicals including [names of any present chemicals], which is [are] known to the State of California to cause cancer. For more information, go to www.P65warnings.ca.gov."

9. Reproductive Health Risk: "This product can expose you to chemicals including [names of any present chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information, go to www.P65warnings.ca.gov."

Retailer Responsibility

If a foreign manufacturer does not comply with Prop 65, the retailer selling their products in California may be held liable for not providing the necessary warnings.

Exemptions to Proposition 65

Certain organizations and scenarios are exempt from Prop 65’s warning requirements:

• Government Agencies and Utility Companies: These entities are not subject to Prop 65 requirements.

• Small Businesses: Companies with nine or fewer employees are exempt.

• No Significant Risk Exposures: Businesses can assess the exposure level of a chemical in their product and compare it to the established NSRL for that chemical. If the exposure is below the NSRL, they are generally not required to provide a Prop 65 warning.

• Naturally Occurring Chemicals: Chemicals naturally present in foods are exempt.

• Insignificant Discharges: Discharges that do not result in a significant amount of the chemical entering a water supply are not subject to Prop 65.

By adhering to these requirements and understanding the exemptions, businesses can effectively navigate the complexities of Proposition 65 compliance.

California Updates Short-Form Warning Requirements under Proposition 65

On December 6, 2024, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced the approval of amendments to the short-form warning requirements under Proposition 65. Beginning January 1, 2025, short-form warnings must identify at least one specific chemical for each endpoint (e.g., carcinogenicity or reproductive toxicity) covered by the warning. However, manufacturers will have a three-year grace period to update on-product short-form warnings.

Additionally, the amendments clarify that short-form warnings may now be used for safe harbor warnings on food products, reversing current regulations that prohibit such usage.

References

Prop. 65 List of Chemicals: https://oehha.ca.gov/proposition-65/proposition-65-list

Safe Harbor Limits: https://oehha.ca.gov/proposition-65/general-info/current-proposition-65-no-significant-risk-levels-nsrls-maximum#:~:text=Safe harbor levels, which include No Significant,exempt from the requirements of Proposition 65.