California Proposition 65 (also known as Safe Drinking Water and Toxic Enforcement Act or simply "Prop 65") was enacted as a ballot initiative in November 1986. Prop 65 businesses are required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical “Known to the State” to cause cancer or reproductive harm.

List of Prop 65

Prop 65 requires that the Governor revise and republish at least once per year the list of chemicals known to the State to cause cancer or reproductive toxicity. Up to now, there are nearly 1,000 chemical listings. Businesses using the listed chemicals shall provide a warning unless they can demonstrate the inhalation concentration of the listed chemical is lower than safe harbour level during normal use by consumers by virtue of scientific data.

New Updates

The competent authority of California announced the addition of bisphenol S (BPS) into the Prop 65 list, as a result of its reproductive toxicity (female reproductive endpoint), effective from December 29, 2023.

Core Requirements

1. Prohibition on contaminating drinking water: Businesses producing, using or releasing the listed chemicals or conducting other activities involving the listed chemicals must not discharge such chemicals into drinking water;

2. A clear and reasonable warning: Once a chemical is listed, businesses have 12 months to comply with warning requirements, unless exposure is low enough to pose no significant risk;

3. Limit for hazardous substances: The Act itself sets no limits for hazardous substances but only safe harbour levels. Rather, product limits are established based on settlements resulting from litigation brought forward by individuals or groups challenging the safety of chemical levels in particular products. Usually, the limits are subject to the settlement agreements;

4. During Prop 65 compliance, businesses should first compare the requirements identified in litigation cases for the particular product category before taking them as a reference.

Scope

Prop 65 covers almost all products intended for sale in California, including jewellery, garments, luggage, sports equipment, toys, ceramic ware and glassware, aluminum cookware, bicycles and their attachments, electric equipment, and electric wires and cables. 

Settlement Agreements

The Prop 65 compliance procedures are quite complicated. Prop 65 itself sets no limits for hazardous substances but only safe harbour levels. While substantial data are required from businesses to apply such safe harbour levels. Currently, Prop 65 regulates hazardous substances in products as per limits and test methods provided in the existing lawsuits or settlement agreements for the same product category.

Among all cases, some products are forbidden to be sold in California if they contain dangerous levels of hazardous substances, while some are required to be labeled with a warning.

How to Comply with Prop 65?

1. Understand the chemicals used in your products and manufacturing procedures.

2. Communicate chemical requirements of Prop 65 in your company as well as the entire supply chain.

3. Support and monitor your supply chain by:

• Training and raising awareness:
• Bill of Materials and Bill of Substances;
• Managing and reviewing chemicals in a systematic manner;
• Sustainable compliance and review; and
• Product compliance testing.

CIRS Testing Proposition 65 Compliance Services

1. Analytical Testing for Listed Chemicals

– Quantitative analysis of Prop 65-listed substances (e.g., lead, cadmium, phthalates, BPA, BPS, etc.) in finished products and raw materials.

2. Exposure Risk Assessment Testing and Evaluation Services 

– Scientific evaluation of consumer exposure scenarios (oral, dermal, inhalation) under normal use conditions.

– Determination of whether exposure levels fall below the “no significant risk level” (NSRL) or “maximum allowable dose level” (MADL), thereby exempting the need for a warning.

3. Testing According to Settlement Agreements

– Customized test protocols aligned with existing Prop 65 litigation settlements for specific product categories (e.g., jewelry, ceramics, apparel, electronics).

4. Compliant Warning Label Design

– Development of legally compliant, clear, and reasonable warning statements that meet the requirements of the latest Prop 65 regulations (including short-form warnings where applicable).

5. Supply Chain Support & Documentation Review

– Assistance with Bill of Materials (BOM) and Bill of Substances (BOS) compilation.

– Review of supplier declarations and safety data to support due diligence.

6. Regulatory Consulting & Strategy Guidance

– Interpretation of enforcement trends, settlement terms, and regulatory updates.

– Strategic advice on product reformulation or labeling to minimize legal risk.

7. Global Standards-Based Testing

– Integrated testing services aligned with international regulations (e.g., EU REACH, CPSIA, RoHS) alongside Prop 65, ensuring holistic compliance.

If you need any assistance or have any questions, please get in touch with us via test@cirs-group.com.