January 25, 2021

Volume XI, Number 25


January 22, 2021

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California Proposes Limits on the “Short-Form” Warning Option under Proposition 65

On January 8, 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced proposed Proposition 65 rulemaking that would limit use of the short-form version of the safe harbor warning.  Since it became an option in 2016, manufacturers have gravitated toward the short-form warning, which does not require the disclosure of chemical name(s) in the warning.

OEHHA is seeking to limit the use of short-form warnings by proposing various changes, including:

  • Only allowing the short-form warning (a) on products with 5 square inches or less of “label space” (which is not defined) and (b) when the standard warning will not fit.

  • Prohibiting the short-form warning for internet and catalog sales (even if the short-form warning is provided on the product itself in compliance with the regulations).

  • Requiring that the name of at least one chemical per relevant toxicity endpoint be included in the short-form warning; and

  • Including the words “Risk” and “Exposure” in the warning.

Under the proposal, the new warning would read (when warning for both toxicity endpoints), “ WARNING: Cancer Risk from [insert chemical name] and Reproductive Risk from [insert chemical name] Exposure – www.P65Warnings.ca.gov.”  (The existing minimum type size requirements under the current regulations would not change.)  In addition to requiring more transparency concerning the identity of chemicals in the warning, OEHHA intends the proposed changes to dissuade businesses from over-warning.

© 2020 Keller and Heckman LLPNational Law Review, Volume XI, Number 11



About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...