Emerging Regulatory Issues and Exposure Assessment of Furfuryl Alcohol

摘要

Furfuryl alcohol (FFA) is a flavoring agent used in a variety of consumer food products, including coffee, tea, cocoa, milk products, nuts, breads, popcorn, and cask-stored alcoholic beverages. FFA in food products is typically produced as a byproduct of thermal processing or aging of alcoholic beverages. A National Toxicology Program (NTP) study in 1999 indicated that there may be "some" evidence of carcinogenic activity in male F344/N rates and male B6C3F1 mice through the inhalation route. The ingestion route was not evaluated. As such, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) concluded in 2000 that there is "No safety concern at current levels of intake when used as a flavoring agent." A panel on Food Additives, Flavorings, processing Aids and Materials in Contact with Food also came to the same conclusion. However, the U.S. Environmental Protection Agency (EPA) classified FFA as "likely to be a human carcinogen", followed by California's Office for Environmental Health Hazard Assessment (OEHHA) adding FFA to its Proposition 65 list as a carcinogen. There are several limitations of the NTP study, yet this study serves as the backbone of several regulations. The NTP study did not evaluate ingestion, yet conclusions based on inhalation are being used to inform policy that primarily pertains to ingestion. Additionally, neoplastic changes were only observed at the highest doses, which may have exceeded the maximum tolerated dose. We suggest that a linear extrapolation to estimate exposures at human-relevant doses may not be appropriate for FFA. Therefore, we propose an alternate nonlinear model to more accurately estimate low dose exposures, with examples of exposure assessments for certain food products.