How to Build an Effective Cal Prop 65 Compliance Program

What Is California Proposition 65?

California Proposition 65, also known as Prop 65, is a law that requires businesses to provide warnings to California consumers about significant exposures to chemicals that cause cancer, birth defects, or other reproductive harm. It was passed as a ballot initiative in 1986, and is officially titled the Safe Drinking Water and Toxic Enforcement Act of 1986. In addition to its warning requirements, Prop 65 also imposes an obligation on the State of California to maintain a list of chemicals known to cause cancer, birth defects, or other reproductive harm. Businesses are required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical. 

Prop 65 warnings are typically seen on products sold in California, in workplaces where significant exposures to listed chemicals may occur, and in rental housing. The warnings can take various forms, such as labels on products, signs at entrances to buildings, or notices distributed with products (including manuals). The law is intended to empower consumers to make more informed choices about what they purchase while also encouraging businesses to reduce or eliminate the use of toxic chemicals. Prop 65 is not without its detractors, however, and has faced criticism over the years for leading to excessive warnings and causing confusion among consumers.

What Products Does California Prop 65 Apply To?

Prop 65 applies to a wide range of products and environments where exposure to listed chemicals is possible. Businesses that sell products in California are responsible for ensuring compliance with Prop 65 requirements, including providing clear and reasonable warnings when

necessary. Some examples of products subject to Prop 65’s warning requirements include food and beverages, building materials, environmental exposures, and workplace environments. The most common category that Cal Prop applies to, though, is consumer products. Goods like electronics, jewelry, clothing, furniture, and household items may contain chemicals like lead, phthalates, and flame retardants—putting them under the purview of the law’s warning requirements. 

What Are the Compliance Requirements?

Businesses subject to California Proposition 65 have several compliance requirements to fulfill to ensure that they’re meeting the law's regulations. First, they must determine if their products contain any of the listed chemicals. If so, they must provide clear and reasonable warnings. These warnings must be prominently displayed on the product or at the point of sale, such as on

packaging, labels, signs, or notices. The warnings should contain appropriate language provided by OEHHA, such as "WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm." The warning language may vary depending on the type of exposure (e.g., ingestion, inhalation, or skin contact) and the specific chemicals present. 

If a product is sold in California and its labeling, instructions, or accompanying literature are provided in a language other than English, the Prop 65 warning must also be provided in those languages. Businesses should also regularly review their products and update warnings as necessary to reflect changes in the composition or use of chemicals, as well as any updates to the list of Prop 65 chemicals. Due diligence records documenting compliance efforts—including any testing conducted to determine chemical levels in products and the placement of warnings—should also be kept and maintained for as long as that product is on the market. Enforcement of these regulations comes from post market surveillance companies that escalate cases through the California Attorney General’s Office. Such cases can result in costly fines and fees.

How Do I Manage Compliance at Every Stage of the Supply Chain?

Because of the variability of compliance requirements, it’s best to have an organized compliance software that can track and maintain your due diligence efforts. To start, businesses should consider their final product and identify the parts that could expose a consumer to any substances used to make that part. 

Consider Exposure On A Consumer & Manufacturing Level

Companies must also consider whether their manufacturing plant is located in the state of California, and the additional requirements that apply to the workers who are exposed to all parts of a product (in addition to the final version sold on shelves). While your part may not be intended for consumer contact, if it’s incorporated into other products further down the supply chain it may be unintentionally exposing them to Prop 65 chemicals. As a result, it’s important to have clear language. 

Have Access To Your Full Material Declarations (FMDs)

Under ideal circumstances, the best practice for manufacturers is to have and be able to regularly consult full material declarations. That’s not always possible, however, as FMDs are not always readily available. When companies utilize parts that they’re not manufacturing directly, they’ll have to conduct due diligence efforts in order to create a risk profile. This can be relatively difficult for suppliers, who may claim that the regulation is not applicable to their products, or simply offer to label their product without disclosing specific substances. By identifying parts that they know can come into contact with users, businesses can sort through those responses and develop a compliance plan.

Create SOPs For Handling Supplier Contact Documents

When analyzing supplier contact documents, companies will have to draw up a set of rules to follow. If they decide to ignore non-contact parts, they must consider whether they want to simply mark them out of scope or continue to collect material information about them. Companies that choose to collect that material information may want to adopt specific language around its status instead of using the terms “compliant” and “not compliant.” This could help them to properly indicate when substances are present but do not affect the overall status. 

For parts that a user would come into contact with, meanwhile, it’s a much more straightforward process. While a supplier may claim that a part is compliant because they label it with the appropriate warning, manufacturers should not necessarily consider it compliant because they could miss the need to carry that label through to the end product. If a product contains a label, companies can assume it contains a substance on the Prop 65 list. It’s best to mark these cases as non-compliant and record the substances present. That way, when you make your final determinations on your product status, you are aware of the need to clear labels. Finding a good compliance software and a compliance advisor can help you decipher these responses and ensure you have the information you need when determining if your product should be labeled with a clear and reasonable warning. 

Seek Outside Expertise Where Necessary

Finally, an advisor can also help you develop a risk profile to make the final decisions on parts where supplier contacting was unsuccessful. These reviews often include data analysis of industry-wide parts and literature reviews of datasheets and standards. They can help you understand whether you can assume the likelihood of a substance being present in your part or product and include it in the warning to cover your gap in due diligence for Prop 65. 

Your Product Needs A California Prop 65 Warning. Now What?

Once a business has determined that it’s legally obligated to include a warning, it can begin developing that label using the guides on the California proposition website. A clear warning statement explains that the “product contains chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm.” Where possible, you should also include the name of the chemical present in the product and a link to the California Proposition 65 official website. The label should also include a symbol, such as an exclamation mark inside a yellow triangle, to further highlight the warning. Some manuals may also provide additional information about the potential risks associated with exposure to the listed chemicals or instructions on how to minimize exposure.

Any time your product experiences changes to its design (such as a new part) or there are updates to the Prop 65 regulations, you should reassess all your compliance documentation. You’ll want to update your documentation as promptly as possible, and have it ready to provide to both consumers and regulatory bodies if required. While it’s mandatory for the state of California to update the list at least once per year, it can do so as many times as needed. Your compliance manager or your compliance software should monitor these changes and help you understand how they apply to you and your products.