The California Office of Environmental Health Hazard Assessment (OEHHA) recently amended its regulations concerning requirements for consumer product warnings to qualify for “safe harbor” protection from enforcement actions brought under the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65 (“Prop 65”).
Prop 65 is a “right to know” law — it requires businesses to provide a “clear and reasonable warning” before knowingly and intentionally exposing consumers in California to a chemical listed as known to the state of California to cause cancer or reproductive harm. OEHHA, the lead agency implementing compliance regulations for Prop 65, has adopted certain regulations detailing specific language and methods for warnings that businesses can use to comply with Prop 65 — i.e., “safe harbor warnings.” See Cal. Code Regs., tit. 27, § 25600, et seq.
On December 6, 2024, OEHHA issued a notice stating that the California Office of Administrative Law (OAL) approved changes to the Prop 65 regulations for “short-form” warnings that OEHHA proposed on October 27, 2023, among other changes.
The effective date of the new regulations is January 1, 2025, but there is a three-year implementation period for businesses to transition to the new warning language (by January 1, 2028). As discussed further below, this final regulation largely follows OEHHA’s October 27, 2023, proposal.
New Required Content for Short-Form Warnings: Short-form warnings are not so short anymore[1]. The new regulations now require that short-form warnings identify at least one chemical for each applicable endpoint (i.e., cancer or reproductive harm) and additional language, of which businesses have the choice of two phrases. Cal. Code Regs., tit. 27, § 25603(b). As further illustrated below, these changes are bound to have a substantial impact on businesses.
For example, short-form warnings for carcinogens only must now include one of the following phrases:
“Cancer risk from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”
or
“Can expose you to [name of chemical], a carcinogen. See www.P65Warnings.ca.gov.”
See Cal. Code Regs., tit. 27, § 25603(b)(3)(A).
As another example, short-form warnings for both listed carcinogens and reproductive toxicants must include either of the two following phrases:
“Risk of cancer from exposure to [name of chemical] and reproductive harm from exposure to [name of chemical]. See www.P65Warnings.ca.gov.”
or
“Can expose you to [name of chemical], a carcinogen, and [name of chemical], a reproductive toxicant. See www.P65Warnings.ca.gov.”
See id. at § 25603(b)(3)(C).
According to OEHHA’s comments in its Final Statement of Reasons (“FSOR”) for the new regulations, these changes were made to provide consumers with more information about the warning being given, consistent with the long-form warning. FSOR, at 20. However, the changes will likely require businesses using the old short-form warnings on product labels, which are much shorter, to substantially redesign their labels to accommodate this new language.
Identification of Specific Chemicals: Perhaps the most controversial change is that the new regulations now require short-form warnings to name at least one chemical that is listed for cancer or reproductive harm. Cal. Code Regs., tit. 27, § 25603; see also id., at § 25601 (b). Previously, only long-form warnings had to identify a specific chemical. In the FSOR, OEHHA states that it believes listing at least one chemical in short-form warnings is necessary to provide “consumers sufficient information to make informed decisions about their exposures to listed chemicals” and to discourage the widespread business practice of providing short-form warnings “prophylactically, as a litigation avoidance strategy.” FSOR, at 20. OEHHA also commented in its FSOR:
Under existing law, companies currently may provide a warning with no chemical name for a product that does not cause any significant exposure to a listed chemical, because they would rather apply a generic warning to everything rather than determine which of their products actually create such an exposure and which do not. This litigation-avoidance strategy does not serve the interests of the Act because it does not provide accurate information. By including a chemical, companies will be encouraged to actually determine which chemicals—if any—could expose consumers of their products.
Id., at 30-31.
This significant change may require businesses to reconsider their testing protocols and use of short-form warnings if they are unable to identify a specific carcinogen and/or reproductive toxicant. Regardless of how businesses work to comply with the new regulations, their risk of costly enforcement actions is now undoubtedly higher.
New Options for Warning Labels: Companies are no longer limited to using “WARNING”, and now have the option of using “CA WARNING” or “CALIFORNIA WARNING” instead. Cal. Code Regs., tit. 27, § 25603. These options providebusinesses with the ability to identify the warnings as California-specific warnings, which may be beneficial for products that are also sold outside California. FSOR, at 45. Short-form warnings can also be given on any label size, provided the text is at least 6-point font and is “conspicuous” as defined in the regulations (i.e., “must be displayed with such conspicuousness as compared with other words, statements, designs or devices on the label, labeling, or sign, as to render the warning likely to be seen, read, and understood by an ordinary individual under customary conditions of purchase or use”). Cal. Code Regs., tit. 27, § 25601(c). Under the new regulations, the warning no longer needs to be “in a type size no smaller than the largest type size used for other consumer information.” See id.
Requirements for Catalog and Internet Purchases: OEHHA initially proposed clarifying language for products ordered through a catalog, but that clarifying language was not incorporated into the final regulations. However, the proposed edits to clarify the labeling requirements for products ordered through the Internet were enacted. Specifically, OEHHA clarified that, for one of the warning methods for internet purchases, the warning must be provided on the product display page, not on the internet site generally. Cal. Code Regs., tit. 27, § 25602(b).
Short-Form Warnings for Food Exposure: OEHHA also revised the regulations to specifically allow for a short-form warning for food products. Cal. Code Regs., tit. 27, § 25607.2. As with the safe harbor warning for consumer products, the warning for food products must identify the name of at least one chemical that is a carcinogen and/or reproductive toxicant. Warnings for food products do not need to include the warning symbol required for consumer products (i.e., a yellow equilateral triangle with a bold black exclamation point).
Warnings for Passenger or Off-Highway Motor Vehicle Parts and Recreational Marine Vessels: Businesses involving passenger or off-highway motor vehicle parts and recreational marine vessel parts can comply with Prop 65 by warning for phthalates and lead and suggesting best handling practices on a sign no smaller than 5 inches by 5 inches placed at each retail point of sale or display of products. Cal. Code Regs., tit. 27, §§ 25607.51(a)(3), 25607.50(a)(3), and 25607.52. If a business chooses this form of warning, it may not add to, remove, or substitute the chemicals identified. Id. at §§ 25607.51(b) and 25607.53(b). If the product is sold through the internet or through a catalog, the business must provide a long-form or short-form warning on the webpage or in the catalog for its products.
Three-Year Transition Period: Businesses have three years — until January 1, 2028 — to transition to the new short-form warning requirements. Thus, short-form warnings on any products manufactured on or after January 1, 2028, must adhere to the new regulations to qualify for safe harbor protection. However, any products manufactured and labeled with the old “safe harbor” short-form warning language prior to January 1, 2028, may continue to be sold indefinitely without the need for relabeling. Cal. Code Regs., tit. 27, § 25603(c).
Grace Period for Internet Retailers: Additionally, for internet purchases, a retailer is not responsible for posting or displaying the new warning online until 60 calendar days after the retailer receives a warning or written notice from the manufacturer that updates the short-form warning. Cal. Code Regs., tit. 27, § 25602(b)(2). This provision is effective for purchases made before January 1, 2028. Id. Retailers who have been issued notices of violation for not updating their short-form warnings after notice from manufacturers may have success in challenging those violations under the new rule.
Key Changes:
- Effective January 1, 2028, short-form warnings must include at least one chemical name for each applicable endpoint (i.e., cancer and/or reproductive toxicity).
- Businesses now have the option of using “WARNING,” “CA WARNING” or “CALIFORNIA WARNING” in warnings.
- The short-form warning can be used on any label size, provided the text is at least 6-point font and is “conspicuous” as defined in the regulations.
- Short-form warnings can now be used on food products.
- Alternative retail sign warning options for phthalates and lead for passenger or off-highway motor vehicle parts and recreational marine vessel parts are now available.
- Businesses have until January 1, 2028, to transition to these revised short-form warning requirements on products manufactured and labeled on or after that date.
- Any products manufactured and labeled before January 1, 2028, can have the old short-form warnings, regardless of when the products are sold.
- 60-day grace period for internet retailers during the three-year transition period.
结论
If you would like assistance with complying with the new Prop 65 warning requirements or if you have questions about how these requirements may apply to your products, please contact Sarah Slack, Erik Swanholt, Alexandra Jernigan, or Katie Plachta.
[1] The prior iteration of the rule required that businesses provide a truly “short” warning – (e.g., “Cancer – www.P65Warnings.ca.gov.”).
