Proposition 65 Warning Changes Go into Effect Soon

July 16, 2018
By Brett Johnson

California’s Proposition 65 requires businesses to provide warnings with products or at facilities if they contain any chemicals (out of a list of around 900) at levels above specified safe harbor levels.

Back in August of 2016, regulations to significantly change the warnings required under Proposition 65 were adopted by California’s Office of Environmental Health Hazard Assessment (OEHHA). Those regulations are set to become effective Aug. 30, 2018, and, despite suggestions from some that these regulations expand warning obligations for medical device makers, they do not alter the pre-existing obligations on medical device makers to provide warnings if a listed chemical is present above safe harbor levels.

The regulations set to go into effect generally will require a warning label to specifically identify at least one chemical found in the product. The current regulations allow for a “generic” warning label, which does not specifically identify chemicals present. If the warning is on the product itself, however, a generic warning will still be permitted. Other specific requirements include:

  • The warning must include a black exclamation point in a yellow equilateral triangle with a black outline.
  • The word “WARNING” must appear in bold print and in all capital letters.
  • The warning must include the full chemical name of at least one chemical found in the product that is identified by OEHHA that is known to cause cancer or birth defects or other reproductive harm. If the product contains a chemical on both lists, at least one chemical from each list must be identified.
  • If a consumer product label or packaging contains consumer information in a language other than English, the Prop 65 warning must also be provided in that language in addition to English.

For a primer on the new requirements of Proposition 65, click here.

CLSA will continue monitoring implementation of the changes and working with members to ensure any concerns are communicated to the appropriate parties. Any CLSA members who would like to provide input or would like further information on the Prop 65 changes discussed herein are asked to reach out to Oliver Rocroi, CLSA’s Senior Director of State Government Relations ( or Brett Johnson, CLSA’s Senior Director of Policy & Regulatory Affairs (