Chapter 16 - Foods, Food Additives, and Generally Regarded as Safe (GRAS) Food Assessments

Abstract

The United States (US) Food and Drug Administration (FDA) defines substances added to food as food additives, which require premarket review unless they are generally regarded as safe (GRAS). The GRAS designation is applied when a group of qualified experts agree the product is commonly known to be safe when used as intended. US FDA regulations require either a clear history of use before 1958 or an assessment of safety through rigorous scientific procedures to assign a GRAS label to a substance. The GRAS Final Rule was released by the FDA in August 2016 and this chapter reviews the process for determining the GRAS status of previously determined substances and for documenting a substance to be GRAS as a new activity. Two regulatory pathways are currently available including self-affirmation of GRAS status (with documentation on file) or FDA submission of a GRAS Notification (GRN) (with a public GRAS determination notice made by the FDA).