United States: Warning: New Proposition 65 Warning Regulations Taking Effect

Last Updated: August 16 2017
Article by Robert L. Falk

A year from now, dramatic changes to California's Proposition 65 warning regulations take full effect. The new regulations (formally published by the State in August 2016) significantly alter the "safe harbor" rules for providing Prop 65 warnings. Companies that have not yet started preparing for the implications of these new rules will need to do so before the new regulations go into full effect on August 30, 2018.


Under Prop 65, businesses with 10 or more employees must provide "clear and reasonable warning" before knowingly and intentionally exposing individuals in California to a chemical listed by the state as known to cause cancer or reproductive toxicity. The Prop 65 regulations provide a safe harbor for warning language and methods of transmission officially deemed "clear and reasonable." That safe harbor will shrink significantly under the new regulations. A generic Prop 65 warning that does not identify a specific chemical will no longer be sufficient in most circumstances. Many warnings will also have to contain the exclamation point within a triangle symbol shown above and be given in multiple languages. Finally, virtually all warnings will need to include either the URL "www.P65Warnings.ca.gov," or the food-product-specific "www.P65Warnings.ca.gov/food."

Consumer Product Warning Contents

The new regulations impose major new requirements specific to label, sign, and shelf tag warnings for consumer products offered for sale in California, which apply to all units of the product manufactured after August 30, 2018. Rather than generically stating that the product "contains a chemical" connected with cancer or reproductive harm effects, unless a short form which suggests an actual cancer or reproductive risk is being posed, the updated Prop 65 warnings will have to announce that the product "can expose" users "to chemicals including [one or more chemicals identified by name]" before setting forth the health effect or effects for which the identified chemical has been listed by California under Prop 65.

The identification requirement also applies separately to chemicals causing cancer and those listed as causing reproductive effects. To meet the safe harbor regulations' requirements, companies will need to name at least one listed carcinogen if one is present, and name at least one chemical listed for reproductive toxicity if one is present. (However, if the state lists a single chemical as both a carcinogen and a reproductive toxicant, that one chemical's name will be sufficient to support a warning about both effects if the identified chemical is present in the product or exposure.)

The new safe harbor regulations also require warnings for consumer products to be followed by the "www.P65Warnings.ca.gov" URL and, except for foods, that be preceded by the exclamation point within a triangle "designated symbol" shown above.

A Potential Trap for Internet Retailers

Retailers selling consumer products over the internet must pay special attention to their new obligations under the updated rules. A compliant product label will no longer be sufficient to qualify the internet seller for the safe harbor protection even if the label complies with the updated warning content requirements of the new regulation. For internet sales, retailers must provide a Prop 65 warning for the product on the retailer's website to fall within the safe harbor. Such website warnings must either: (1) be placed on the product's display page, (2) be given via a hyperlink using the word "WARNING" placed on the product display page, or (3) be displayed, with a tie to the product for which the warning is being given, to the consumer before their purchase is completed (such as having the warning appear in the virtual shopping cart or on the last page before the consumer authorizes use of their credit card during the checkout process). The new rules will therefore likely require many retailers to alter the coding of their websites and may force website redesigns.

Environmental/Facility Exposure Warnings

The updated Prop 65 warning regulations impose highly specific safe harbor warning requirements for facilities as diverse as enclosed parking facilities, amusement parks, vehicle service stations, and designated smoking areas. In some cases, these line up with warning programs that have been in effect as the result of prior consent judgments or industry-wide warning programs; in other cases, businesses may have to implement changes to existing warning programs before August 2018. The new regulations also have new safe harbor requirements for other types of environmental and occupational exposures arising at facilities located within California. These new provisions specify, among other things, the necessary content of these warnings (including the designated symbol, specific chemical name identification, and multiple language requirements), as well as their location and format.

Foreign Language Requirements

Many products feature more than one language on their labels. Under the new regulations, if a consumer product's sign, label, or shelf tag displays consumer information in languages other than English, that product's Prop 65 warning must also appear in those additional languages. Similarly, warnings for environmental and occupational exposures must be given in any language in which other signs at the facility appear. The takeaway here is that, even if English language signs and other warnings are updated to otherwise satisfy the safe harbor content requirements that will go into full effect under the updated regulations in August of 2018, those warnings may need to include translated language as well.

Final Tweaks

On July 21, 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a proposed rulemaking to clean up some minor issues in the final version of its updated Prop 65 safe harbor warning regulations as adopted last year. The proposed changes are largely technical and non-substantive, but for those interested, they may be found on the OEHHA site along with their associated statement of reasons (preamble). (OEHHA is accepting public comments on this set of proposed refinements to the updated Prop 65 warning regulations until close of business on September 7, 2017.)

Concluding Thoughts

These regulatory changes have significant implications for businesses both within and beyond California. With only one year remaining before the updated Prop 65 safe harbor warning regulations take full effect, companies will need to make changes over the coming months to ensure compliance.

Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP. All rights reserved

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Robert L. Falk
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