The GRAS provision - The FEMA GRAS program and the safety and regulation of flavors in the United States

Abstract

With the Food Additives Amendment of 1958 the U.S. Congress established the pre-market approval requirement for food additives unless such food ingredients were "generally recognized as safe" (GRAS). Beginning in 2010 with the publication of an audit by the U.S. Government Accountability Office, the GRAS provision has received much attention from regulators and policy-makers, the media, and non-governmental organizations. This report provides an overview and update of the policies, procedures, and scope of the GRAS program for flavor ingredients sponsored by the Flavor and Extract Manufacturers Association of the United States (FEMA), and its alignment with the requirements for GRAS conclusions established by Congress and FDA.

Keywords: FEMA GRAS; Flavor safety; Flavors; GRAS.