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FDA issues final GRAS ruleFDA issues final GRAS rule

Rule addresses types of scientific evidence that can be used to demonstrate GRAS status of ingredients used in human or animal food.

August 15, 2016

2 Min Read
FDA issues final GRAS rule

In a step to strengthen its oversight of food ingredients, the U.S. Food & Drug Administration issued Aug. 12 a final rule detailing the criteria for concluding that the use of a substance in human or animal food is “generally recognized as safe” (GRAS).

Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives, the agency said.

The rule addresses the types of scientific evidence that can be used to demonstrate safety as well as the role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted.”

FDA said the GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts. The final rule also formalizes the voluntary GRAS notification procedure, which was originally established under an interim policy and pilot program for human food in 1997 and animal food in 2010.

FDA strongly encourages companies to inform the agency of GRAS conclusions through the notification procedure finalized with the new final rule. While FDA can question the basis for an independent GRAS conclusion, whether notified or not, and take action as appropriate, the notification procedure yields important information that aids the agency’s food safety monitoring efforts.

The GRAS final rule is the most recent step the agency is taking to strengthen FDA’s oversight of substances added to human and animal food. Next steps include issuing additional guidances related to the GRAS regulations. As part of the Foods & Veterinary Medicine Program’s Strategic Plan, FDA will develop and implement innovative regulatory and compliance strategies to improve premarket oversight and safety evaluation of human and animal food additives and GRAS substances.

For more information, see "Final Rule: Substances Generally Recognized as Safe Rule."

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