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FDA Issues Final Rule on GRAS Ingredients

Aug 17, 2016

In an effort to strengthen its oversight of substances added to human and animal food, the Food and Drug Administration last week issued a final rule explaining the criteria the agency will use to determine when the use of a substance is “generally recognized as safe” (GRAS). Unlike food additives, GRAS substances are not subject to FDA pre-market approval, but they must meet the same safety standards as approved food additives.

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.” The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by “appropriate qualified experts.”

The final rule also formalizes the voluntary GRAS notification procedure, which was established under an interim policy and pilot program for human food in 1997 and animal food in 2010.

IDFA is reviewing the 329-page final rule and will provide members with an analysis later this month.

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

Members with questions may contact John Allan, IDFA vice president of regulatory affairs and international standards, at

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