The US Food and Drug Administration has issued a final rule detailing the criteria of concluding that the use of a substance in human or animal food is generally recognised 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 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 recognised by the appropriate qualified experts. The final rule also formalises the voluntary GRAS notification procedure. This was originally established under an interim policy and pilot programme for human food in 1997 and animal food in 2010.
The GRAS final rule is the most recent step taken to strengthen the 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 and Veterinary Medicine Program’s Strategic Plan, the 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.