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Final Rule on Food Ingredients (8/19/16)

August 19, 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:

  • Definitions for relevant terms
  • A clear statement of the opportunity for any person to submit a GRAS notice
  • Information on available formats (electronic and paper)
  • Where to send a GRAS notice
  • Data and other information to be incorporated into a GRAS notice

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