Proposition 65, Prop 65 for short, is the Californian law requiring companies to warn consumers if they may be exposed to chemicals from a product, any product, that the State of California has deemed as having potential reproductive toxicity or cancer-causing risks. Prop 65 is famous in California for its litigious nature. Any company who may have neglected to issue warnings about its products can be sued under this Act by private citizens, advocacy groups and attorneys on behalf of the state.
Last year we discussed how companies need to be wary of commonly used ingredients potentially triggering a warning under this Act. For example, caramel contains furfuryl alcohol which is listed on Prop 65 as a carcinogen (a cancer-causing chemical) with no safe harbour limit. This means that if you use caramel in your food, either as caramel or as part of the color or flavor, you may need to put a warning on your product alerting consumers.
Recently, there has been an increase in discussion of acrylamide in coffee and if this deserves a Prop 65 warning. Acrylamide is listed in the Prop 65 database with No Significant Risk Levels (NSRL) of 0.2 micrograms (mcg)/day for cancer and a Maximum Allowable Dose Level (MADL) for reproductive toxicity of 140 mcg/day. If a consumer is potentially exposed to levels above these from using your product a, Prop 65 warning is likely needed. Since 2010, a case has been moving through the courts on a coffee company’s failure to alert consumers of the acrylamide content in their coffee. The result of this case is expected to come out in the next couple of months.
This is not the first time acrylamide has been center stage in a Prop 65 lawsuit. In 2002, a Prop 65 case was filed against McDonald’s and Burger King for not warning consumers about the acrylamide hazard in french fries. In 2008, the case was settled with McDonald’s and Burger King both agreeing to provide cancer hazard warnings, paying civil penalties and paying for significant legal fees.
Acrylamide is not only found in french fries and coffee. A number of other foods have levels of this chemical including cereal, cookies, bread and prune juice. While we wait for the ruling on the Prop 65 acrylamide-in-coffee case, it is important to ensure you have a handle on your responsibility to provide consumers the appropriate warnings for your products that could contain acrylamide, or any other Prop 65 listed chemical. Further to this, changes in the warning requirements are being implemented this summer requiring companies to be more specific in their warnings alerting consumers to which chemicals they are potentially being exposed to.
From these cases it is clear that Prop 65 may be impacting your products more than you originally anticipated.
For more information on how Prop 65 could impact your business and options available to you to help mitigate the litigation risk, please contact dicentra for more information.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We can be reached at 1-866-647-3279 or info@dicentra.com.