Naturally produced in various foods, California Proposition 65 has made acrylamide a costly thorn in the side of the food industry for over a decade – but that could change.
Acrylamide was initially added to the Prop 65 list in 1990 as a carcinogen based the “authoritative bodies” mechanism following the US EPA’s conclusion that acrylamide was carcinogenic (“likely carcinogenic to humans”). OEHHA set an NSRL for acrylamide of 0.2 ug/day, which is an extremely low threshold. In 2011, acrylamide was also listed by OEHHA as a developmental, as well as a male reproductive toxin, with an MADL of 140 ug/day.
Although acrylamide has been used for industrial applications since the 50’s in the production of polymers and other chemicals, the real issues with acrylamide and Prop 65 centered around the fact that acrylamide is naturally formed in various foods that are roasted or contain carbohydrates that are fried/baked at high temperatures, called the Maillard reaction. This reaction occurs in many foods, such as breads, potato chips, crackers, coffee, pastries, fries, cereals, and oatmeal. The presence of acrylamide in foods was only discovered in the early 2000’s but created a big problem for food companies. In the early days of this discovery, numerous multinational fast-food companies were targeted under Prop 65, who paid out millions in settlements. To date, approximately 393 NOVs have been sent out in relation to acrylamide.
However, as summarized by the National Cancer Institute (NCI), the American Cancer Institute (ACI), and recent reviews, there is no consistent evidence to suggest that the presence of acrylamide in foods constitutes a cancer risk in humans. The available evidence for carcinogenicity comes from animal studies, in which animals consumed very high doses of acrylamide in drinking water (1,000 to 10,000 higher levels than what might be consumed in foods). There are concerns that acrylamide may be metabolized to glycidamide, a DNA-damaging metabolite; however, it appears that humans absorb and metabolize acrylamide far less than rodents do so the cancer risks may be even lower than anticipated.
Given the state of the science, OEHHA has now proposed a regulation to exempt the need to put warnings on coffee related to the presence of acrylamide. The US FDA recently issued its own statement in strong support of the exemption, as it considered that cancer warnings on coffee would be misleading to the public. The US FDA has been working with industry to reduce levels of acrylamide in foods where technically feasible (fries and potato chips are generally the highest single food sources), but reiterates that a balanced diet high in fruit and vegetables is the best course of action and not to fear foods that have healthful properties. In fact, coffee consumption has been associated with the reduction of numerous cancers.
This would be a very welcome turn of events for the coffee industry; however, it still faces numerous challenges: 1) the judge that originally ruled that coffee did require cancer warnings has refused to stay the coffee-acrylamide case based on a regulation that is not yet enacted and is therefore proceeding to the penalties phase of the trial; and 2) CERT (the plaintiff that brought forth the case) has countered OEHHA that the exemption regulation is unlawful. There is a more detailed legal summary of the situation here.
It would seem inevitable that OEHHA will need to backtrack on warning requirements for other foods that contain acrylamide and are part of a healthy diet (i.e., breads, cereals). Indeed, a California appellate court sided with breakfast cereal manufacturers in stating that federal law pre-empts California state law and these companies were not required to put Prop 65 warnings on breakfast cereals due to the presence of acrylamide. So what about other foods containing acrylamide or other listed chemicals that naturally produced in cooking processes, such as furfuryl alcohol?
We will continue to monitor this situation and provide updates. If you have any questions about Proposition 65 compliance, please contact our experts.
- Update (regulatory change of June 1, 2019 -> effective October 1, 2019):
OHHEA has ruled that acrylamide in coffee does not pose a significant cancer risk and therefore coffee and coffee products do not require cancer warnings! This is great news but raises questions about acrylamide in other foods. It’s at least a start.