Today FDA issued the final rule, “Substances Generally Recognized as Safe” (GRAS). The rule outlines what kind of scientific evidence can be used to demonstrate safety, along with the role of publications in assessing whether scientific evidence of safety is “generally available and accepted”, according to an FDA release. “The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.”

GRAS substances are not subject to FDA premarket approval but must meet the same safety standards as approved food additives. The agency “strongly encourages” companies to tell FDA of GRAS conclusions through the notification procedure found in the final rule, because the procedure provides the agency with important food safety monitoring information. The document will be published on the Federal Register on Wednesday, August 17.