California voters approved Prop 65 in 1986 in an effort to provide transparency to the public on which specific chemicals are known to cause cancer or reproductive toxicity. (Link {}.) OEHHA is the agency responsible for overseeing the Prop 65 program for the State of California and the Attorney General for the State of California acts as the principle enforcement agency under the Prop 65 program. OEHHA maintains and updates the list of chemicals known to cause cancer or birth defects once a year.  The list now contains more than 800 chemicals since its 1987 enactment. (Link {}.)

In August of 2016, the warning label requirements under the California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Prop 65”) were changed and the deadline for compliance was set for August 31, 2018.   With these new requirements now in effect, if you haven’t done so already, it is now time to make sure your organization is complying with these new requirements.

Businesses selling products in the state are required to provide a “clear and reasonable” warning label prior to exposing anyone to a listed chemical. (27 C.C.R. §25600.) While the language listed in the statute is ambiguous as to what constitutes a “clear and reasonable” warning, the new label requirements under Prop 65 provide several options for a manufacturer to warn consumers of the dangers of Prop 65 listed chemicals in their products.

In August 2016, the legislature passed a regulatory update further clarifying the requirements to meet compliance. (27 C.C.R. §§25600-25607 [August 30, 2016].)  The 2016 update to the regulations include: 1) updates to the safe-harbor warning label language; 2) new regulations for internet warnings; 3) limited warning requirements for retailers; 4) the grace period for implementing the new regulations; and 5) whether warnings need to be provided on all products.  The important changes to the regulations for manufacturers lie in point five regarding whether a warning needs to be provided on all products. 

Sufficiency of Warning Labels

OEHHA stated that under the new system, producers/manufacturers (“producer” and “manufacturer” are used interchangeably herein) have the primary responsibility for providing Prop 65 warnings. (27 C.C.R. §25600.2(b).)  Manufacturers can choose the form of compliance for the warnings so long as consumers receive “clear and reasonable warnings” prior to exposure of Prop 65 listed chemicals.  The manufacturer first needs to determine how their product is reaching a consumer and then must look to the applicable regulatory section to determine whether their operations comply with the OEHHA’s guidance for “clear and reasonable warnings.” (27 C.C.R. §25601.)  Manufacturers providing consumer products with a Prop 65 listed chemical needs to follow the guidance provided under 27 California Code of Regulations sections 25602-25603. Manufacturers with products containing Prop 65 chemicals that reach consumers through environmental exposure or occupational exposure must look to 27 California Code of Regulations sections 25604-25606.

The most significant changes to the regulations on consumer products labels are as follows: 

  1. New labels will now say “can expose you to” rather than saying “contains the chemical;
  1. The labels must contain at least one listed chemical that prompted the warning;
  1. The labels must include OEHHA’s new Proposition 65 web site:; and
  1. Most warning labels will require a triangular yellow warning symbol;
  1. Certain types of exposures require “tailored” warnings with more specific information;
  1. Website warnings for products sold over the internet;
  1. Warnings in languages other than English when signs, labels, or shelf tags include consumer information in a language other than English ; and
  1. Provides more clarification for the roles and responsibilities of manufacturers and retailers in providing warnings.

This last change seeks to clarify how the duty to warn is shared in the manufacturer/retailer relationship. Manufacturers can choose to put warning labels on their products or provide notice to distributors, importers or retail outlets that the product requires a warning and provide warning signs or other warning materials. Alternatively, manufacturers can shift the burden to retailers through written agreements that include terms that ensure the consumers will receive a clear and reasonable warning prior to exposure. Retailers must confirm they received notice and must use the warnings provided by manufacturers when transferring products to consumers. (27 C.C.R. §25601(b).)  Thus, if a producer is transferring materials to a third party distributor, labels must be consistently displayed on each section to comply with the regulations. 

OEHHA is seeking consistency and transparency to the reasonable consumer.  If manufacturers can prove their actions were consistent and reasonable, then their duty to warn consumers has been met under the regulations. Manufacturers do not have a duty to warn every possible consumer about chemical exposure.  They do, however, need to ensure that notice was proper, consistent, and unambiguous.  Further, note that occupational exposure depends almost entirely on compliance with OSHA since they would be the lead enforcement agency. 

In light of these newly enforced regulations, manufacturers can consider a conservative approach by applying the new warning system to each of their products prior to distribution or use.  As stated previously, the manufacturer carries the primary liability to warn consumers as to the dangers of their product.  In order to avoid costly litigation, it would be within the manufacturers’ best interest to provide more warning labels rather than less.  There is no bright line test to apply to insure that you are complying with the regulations.  However, after a cursory scan of the Attorney General’s enforcement recovery for Prop 65 violations we noted that settlements between manufacturers in violation of Prop 65 and the DTSC averaged in the millions of dollars.  Further, OEHHA has seen instances of industry manufacturers failing to meet the minimum standard for warnings in abundance prior to the enactment of the 2016 regulatory update.  Therefore, a conservative approach that is consistent and unambiguous is best, although that may vary depending upon the product and who the final consumer is. 

However a business chooses to comply, make sure that no one can say “you didn’t warn me about that!”

Diane G. Kindermann is a shareholder at Abbott & Kindermann, Inc.  For questions relating to this article or any other California land use, real estate, environmental and/or planning issues contact Abbott & Kindermann, Inc., at (916) 456-9595.

The information presented in this article should not be construed to be formal legal advice by Abbott & Kindermann, Inc., or the formation of a lawyer/client relationship. Because of the changing nature of this area of the law and the importance of individual facts, readers are encouraged to seek independent counsel for advice regarding their individual legal issues.