In 1986, California voters passed the Safe Drinking Water and Toxic Enforcement Act, otherwise known as Proposition 65. It requires the California Office of Environmental Health Hazard Assessment (OEHHA) to publish a list of chemicals known to cause cancer, birth defects, or other reproductive harm. The current list includes over 800 chemicals. Proposition 65 further requires companies to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone in California to a listed chemical.

A great deal of controversy developed over the years as to what constitutes a “clear and reasonable” warning. Although Proposition 65 contains a safe harbor provision wherein a manufacturer or distributor may protect itself by placing warnings on its products, historically, the regulations dealing with the safe harbor provision have been difficult to understand and apply to specific situations.

Timeline of Proposition 65 Proposed Amendments

Three years ago, California’s Governor Jerry Brown announced his proposal to reform Proposition 65. In response, OEHHA issued a notice to repeal and replace the requirements under Proposition 65 for a “clear and reasonable” warning. However, OEHHA’s January 2015 proposal arguably made compliance even more burdensome. For instance, the January 2015 proposal considerably changed the warnings requirements specified in Proposition 65, including the establishment of a proposed requirement that warning labels identify each specific chemical in any product sold in California, among a list of 12 chemicals (the “dirty dozen”), identified by OEHHA as commonly found in consumer products. Chemicals listed among the “dirty dozen” included lead, phthalates, chlorinated Tris, benzene, and mercury.

In November 2015, due in part to considerable opposition, OEHHA formally withdrew its January 2015 proposal and released new draft amendments to Proposition 65. Significantly, the November 2015 proposal for Proposition 65 eliminated the “dirty dozen” provision and made several other clarifications. Modifications to the November 2015 proposals were issued in March 2016.

The New Amendments

In August 2016, the November and March proposals modifying Proposition 65’s safe harbor warning label requirements were adopted. Below is a list of the new requirements for product warnings under Proposition 65 as amended:

  • Warnings on nonfood products must contain a symbol with a black exclamation point in a yellow equilateral triangle with a black outline (“the symbol”):
  • The warning should also contain the word “WARNING” in all capital letters and bold type (“the warning identification”);
  • Warnings must state that the product “can expose” a user to chemicals known to the state of California to cause cancer, birth defects, and/or other reproductive harm. The prior version of Proposition 65 only required a statement that the product “contained” a chemical.
  • Warnings must identify one or more chemicals for each potential health effect (i.e., cancer, birth defects, reproductive harm).
  • Warnings must include a link to a new Proposition 65 website that will be operated by OEHHA.
  • Warnings on product labels can be shortened to only include the symbol and warning identification discussed above, a statement that the product can expose the user to one or more chemicals that can cause cancer, birth defects, and/or reproductive harm (it does not need to list the specific chemicals), and a link to the new OEHHA website.
  • Warnings must be presented in additional languages under certain circumstances.
  • Product-specific warnings may be provided via electronic device/process that automatically provides the warning to the purchaser prior to or during the purchase of the product.
  • For internet sales, warnings must be provided on the product display page, or a clearly marked hyperlink using the warning identification discussed above.

The new provisions will not take effect until August 30, 2018. Before that date, product manufacturers and distributors may continue to use the current safe harbor warning language of Proposition 65, or warning language approved by California courts as “clear and reasonable.”