As part of its overall effort to strengthen its oversight of substances added to human and animal food, the U.S. Food and Drug Administration (FDA) has issued a final rule outlining the criteria for determining whether the use of a substance in human or animal food is “generally recognized as safe” (GRAS).
Although so-called GRAS substances are not currently subject to FDA pre-market approval, they are still expected to demonstrate compliance with the same safety standards that are applicable to FDA-approved food additives. The FDA’s GRAS rule establishes specific criteria for demonstrating the safety of a given substance, and also formalises the FDA’s voluntary GRAS notification procedure.
Under the new rule, the safety of GRAS substances added to food must be validated by scientific evidence of safety that is “generally available and accepted,” and that such evidence is “widely recognized by the appropriate qualified experts.” In addition, food producers are strongly encouraged to inform the FDA of conclusions regarding the safety of GRAS substances through a notification procedure established with the rule, since it can provide critical safety information that can support the FDA’s food safety monitoring efforts.
The complete text of the final FDA rule on GRAS substances is available here.