California Proposition 65 Compliance for Manufacturers and Distributors

Any California manufacturer or distributor with 10 or more employees or whose products are sold or distributed within the state of California are subject to Proposition 65 regulations. The proper labeling of products containing Prop 65 chemicals is not the responsibility of retailers. 

The CA Prop 65 list of over 900 chemicals known to cause cancer, birth defects, or other reproductive harm contains solvents and chemicals ranging from naturally occurring compounds to man-made or synthetic chemicals. These compounds and chemicals can be found in a variety of goods including drugs, foods, household products, agricultural products, and construction materials. Chemicals used for manufacturing processes as well any byproducts associated with those processes are also included. 

The state of California has published a searchable list of chemicals that are associated with the legislation. The chemicals used in the formulation, manufacturing, and packaging of your product can be searched within the online database. If, when your product is used as intended, a harmful chemical regulated by the law is produced as a result, a warning label may be required. Warning labels refer to the exposure level and associated risk of the chemical(s) to consumers. 

Short-form warnings are placed directly on products and do not list the specific chemical compound(s) of concern. They are typically found on products that are small and cannot accommodate larger, more detailed labels. Some companies are relying on short-form warnings to satisfy their obligations; however, there is still some debate as to the validity of the less restricted Prop 65 short-form warning format. 

Safe harbor levels dictate the level at which a chemical of concern can be present where it no longer poses no significant risk of reproductive harm, birth defects, or cancer. Businesses are exempt, i.e., having “safe harbor” status from warning requirements or discharge prohibitions for the more than 300 chemicals the state of California has published that are associated with safe harbor levels. However, if the chemical used by your business does not appear on the list of safe harbor levels, by default, a warning label must be applied to the product, unless an exemption is granted, as detailed below. 

Some businesses may qualify for Proposition 65 exemptions from the Office of Environmental Health Hazard Assessment (OEHHA) if the level of exposure for chemicals present in their products are lower than their “safe harbor” level, which is typically up to 1,000 times lower than levels set by regulatory agencies. 

Per the California Code of Regulations Title 27, Articles 7 and 8, it is the responsibility of the business to demonstrate the safety of a chemical. This can be accomplished by partnering with a qualified laboratory that has experience in material characterization, identification, classification, and toxicity evaluation of major and minor components. Determining the chemical composition and related risk is a complex, precise process that requires an established, experienced analytical assessment. The State of California recommends businesses work with an analytical lab and scientists with experience in Prop 65 risk assessment to avoid violating the established law.