A news article published this month, April 2013, in the scientific journal Environmental Health Perspectives reviews the application of the Generally-Recognized-As-Safe (GRAS) principle. In the U.S. food additives, both direct and indirect such as substances used in food contact materials, may be marketed without notification to the Food and Drug Administration (FDA) if the substance is considered safe by the manufacturer according to scientific principles. In order to take advantages of this principle, manufacturers have to publish a scientific study establishing the substance’s safety in a peer-reviewed scientific journal. Due to safety concerns, the FDA modified the process from the early seventies until the 1990s. During this time the FDA announced new GRAS petitions in the Federal Registry, reviewed all data and denied or affirmed GRAS status. Citing limited staff and resources, the process was replaced by a voluntary notification program in 1997. Under the notification program the FDA reviews the risk assessment submitted by the company but does not complete its own evaluation of safety. The number of GRAS substances directly or indirectly added to foods since 1958 is assumed to amount to 3700 substances.


Wendee, N (2013). “Secret Ingredient: Who knows what’s in your food.” Environ Health Perspect 121:A126-A133