Vol. 946 | 18 Jan 2017

On August 31, 2016, following nearly two years of deliberation, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted regulatory amendments to the clear and reasonable warnings section of the Proposition 65 (Prop 65) regulations. These regulations repeal the current Article 6 addressing clear and reasonable warnings and replace them with an aim to provide clarity in terms of responsibilities while offering framework guidance for what constitutes a ‘clear and reasonable’ warning.

The new language required for the warning labels is effective August 30, 2018. In the interim period, both the current and new versions of the labels may be used.

Summary of key provisions of the new Subarticle 1 for clear and reasonable warnings include:

  • This is the mandatory portion of the regulations.
  • The Subarticle provides definitions, elaborates on the roles and responsibilities of a retailer vs. a manufacturer and the chain of responsibility to provide consumer product exposure warnings placing responsibility primarily on the manufacturer.
    • A manufacturer may either affix a warning on the product or fulfill their obligations by providing a written notice to the authorized agent for the retail seller.
    • If providing a written notice, the manufacturer is required to collect a confirmation of receipt of warning initially within the first six months of the product’s placement on the market and annually thereafter for each renewed notice.
    • The retailer is required to properly place and maintain the warnings received on products and further convey them for internet sales.
    • Retailers responsibility for providing the warnings themselves have been clarified to be only for the following circumstances:
      • Retailer-owned or licensed brands trademarks
      • Instances where the retailer knowingly introduces a chemical listed by Prop 65 into the product
      • When the retailer has covered, obscured or otherwise altered the warning on the product
      • When the retail seller received a notice and warning materials from the manufacturer
      • And when the retailer has no knowledge of the potential consumer exposure

Subarticle 2 that provides revised Prop 65 warnings are meant as guidelines. Manufacturers/retailers may choose to offer warnings that differ from those listed as long as they comply with the content and format requirements. Key changes to the warning formats for consumer product exposure include:

  • Warnings shall consistent of a symbol of a black exclamation point within a yellow equilateral triangle. Where the sign, label or shelf tag for the pro duct is not printed using the color yellow, the symbol may be printed in black and white. The symbol is to be placed to the left of the word ‘WARNING’ and in a font size no smaller than the signal word.
  • The word ‘WARNING’ needs to be in bold and capital letters.
  • Warnings shall list the name of one or more chemicals on the Prop 65 list contained in the product for which the warning is being provided as well as the harm from exposure, i.e., cancer or reproductive harm.
  • On product abbreviated warnings are sufficient as long as the harmful exposure is listed. Listing the chemical is not required.

For instance:

  • Example of a new warning label:
    WARNING: This product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
  • Example of a new abbreviated warning label:
    WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov.

In addition to the warning label amendments adopted, the California Attorney General (AG) also adopted amendments to the Prop 65 regulations with regard to the enforcement actions by private parties. The amendments adopted by the AG address:

  • Transparency:
    • Where settlements require reformulation, plaintiffs are expected to provide proof that at least some of the products contained higher than agreed-upon levels of a chemical.
    • Where the plaintiff seeks investigation costs, good record-keeping of all costs to be documented.
  • Settlements and Additional Settlement Payments (ASP):
    • Private enforcer reaching a settlement for noticed violation without complaint shall notify the AG office within five days of settlement.
    • The AG provides a list of criteria for determining whether or not they will object to ASPs included in a settlement including but not limited to activity funded by the ASPs, ASPs to not exceed the OEHHA portion of civil penalties, etc.
  • Civil Penalties:
    • Amendments provide for the waiver of civil penalties for the defendant in favor of positive conduct by the defendant by requiring settlements to have verification mechanisms.

The Final Regulations can be viewed at:

For questions, please contact Laxmi Ravikumar (laxmi.ravikumar@intertek.com, 630-209-9265) or Dr. Pratik Ichhaporia (pratik.ichhaporia@intertek.com, 312-906-7720)

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