The Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, is a regulation designed to protect California residents from exposure to chemicals known to adversely affect reproductive health, and/or cause cancer or birth defects. The regulation requires businesses operating in or selling into the state of California to warn residents, prior to purchase, about exposures that could result from intended or foreseeable product use. Companies are also prohibited from discharging any listed substances into the California water supply.

Chemicals on the Proposition 65 List

The California Environmental Protection Agency (EPA) Office of Environmental Health Hazard Assessment (OEHHA) maintains a list of substances and their effects on human health. Highly enforced substances include the following:

  • Phthalates made up 62 percent of 2019 legal actions and are found in softened plastics and vinyl materials.
  • Lead made up 30 percent of 2019 legal actions and is found in copper alloys and solder.
  • Cadmium made up six percent of 2019 legal actions and is often in yellow, red, or orange pigments.
  • Hexavalent chromium made up one percent of 2019 legal actions and is used in metals passivation and anodizing.
  • Acrylamide (can form during cooking).

The substances on OEHHA’s substance list are used for a variety of applications, including cosmetics, pharmaceuticals, and manufacturing. It is important to note that during intended use, products that release substances on the OEHHA list, such as charcoal or gas-fired grills that can generate carbon monoxide, are in scope of Proposition 65.

Discover how Proposition 65 affects supply chains in our whitepaper, Proposition 65: Understanding the Safe Drinking Water and Toxic Enforcement Act.

Proposition 65 Warnings

Under Proposition 65, companies selling products that contain any substances the OEHHA lists as having effects on human health must, prior to purchase, provide a clear and reasonable warning for potential consumer (B2C) and worker (B2B) exposures for intended and foreseeable product use.

Failure to comply with Proposition 65 is enforceable by penalties of up to $2,500 USD per day. Additionally, although the California Attorney General’s Office is tasked with the primary enforcement of the regulation, companies that do not properly label their products also risk enforcement through private litigation. In fact, some “bounty hunter” law firms in the state of California subsist primarily off of Proposition 65 lawsuits.

Companies are exempt from labeling requirements if their use of named substances causing cancer is maintained at the no significant risk level, or if substances identified as causing birth defects are maintained at 0.1 percent of the no observable effect level. The no significant risk level of a cancer-causing substance is defined as no more than one in 100,000 cases of cancer over a 70-year lifetime. Businesses with less than 10 employees are exempt from Proposition 65.

Labeling Requirements for Proposition 65

Beginning August 2018, Proposition 65 warning requirements were updated. One change impacted the sale of products through online platforms. Products sold online must have their warnings in their product listings to ensure prospective customers are able to view any warnings prior to purchase, enabling them to make informed decisions before purchasing products that contain harmful substances.

Multiple versions of these updated warnings were also authorized: short-form warnings, which can be used directly on product packaging, and long-form. Updates were also made to the verbiage and iconography of warnings, including the addition of the URL for the Proposition 65 Warnings webpage where customers can more easily access substance information. Additionally, requirements for non-English warnings were expanded, specifying that where product information is provided in languages other than English, the warning must also appear in that language.

The Importance of Complying With Proposition 65

Companies whose products enter the state of California risk fines, litigation, and brand damage if they are not compliant with Proposition 65. The Assent Compliance Platform automates the data collection process necessary to meet Proposition 65 requirements. Assent will automatically flag the presence of declared substances in a product by cross-referencing an automatically updated database. To learn more about how Assent can help your program, contact us today.

Dr. Bruce Jarnot
Regulatory & Sustainability Expert, Product Sustainability

Bruce is a board certified toxicologist with over 30 years of industry experience managing product safety and global materials compliance programs with large organizations,  Read More

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