FDA’s Final Rule on Food Ingredients (August 2016)The U.S. Food and Drug Administration (FDA) is publishing a final rule to help companies make more informed decisions in evaluating whether a substance used in human or animal food is “generally recognized as safe” (GRAS). Although GRAS substances do not require premarket approval, FDA strongly recommends that companies participate in the GRAS notification procedure, as it provides the agency significant data to help further its efforts towards food safety.
The rule defines the authorized types of scientific evidence and publications that can provide reliable evidence of safety, as well as certain eligibility requirements for which a substance can be classified as GRAS. According to the Federal Register’s notice, the rule also provides guidance regarding the newly prescribed GRAS notification procedure, including:
FDA is authorizing a comment period of 60 days ending on October 17, 2016.
|FDA Final Rule: Food Ingredients that May Be "Generally Recognized as Safe"|
|Substances Generally Recognized as Safe|