FDA’s New Rules for GRAS Provide Clarity on what is Safe Food 
[Posted on: Thursday, August 18, 2016]

This week FDA announced the final rule for determining the “Generally Recognized as Safe” (GRAS) status of food ingredients. The new process replaces the current process of petitioning FDA to affirm the GRAS status, with a voluntary notification about a conclusion that a substance is GRAS under the conditions of its intended use in human food or animal food. This is a significant change from the previous process that involved intensive rulemaking process in response to a petition for GRAS status. Now any person can notify FDA of the basis for a self-conclusion that a substance is GRAS under the conditions of its intended use. The notifying person will need to justify that the available data and information satisfy the safety standard for a food additive based on common knowledge based on either “scientific procedure” or experience with the substance since 1958. The notifying person will also need to assure that there is a reasonable certainty that the substance is not harmful under the conditions of its intended use. The applicant must base the assessment upon generally available and accepted scientific data, information, or methods, which ordinarily are published, as well as the application of scientific principles, and may be corroborated by the application of unpublished scientific data, information, or methods. The detailed final rule provides definition of a notified substance, notifier, qualified expert, and supplement. The final rule also provides information on the format of the notification, where to send a GRAS notice, what data and other information to be incorporated into a GRAS notice, self certification and statements, the methods used to determine safety, dietary exposure, and self-limiting levels of use, in circumstances where the amount of the notified substance that can be added to human food or animal food is limited because the food containing levels of the notified substance above a particular level would become unpalatable or technologically impractical. The notifier should provide the history of consumption of the substance for food use by a significant number of consumers (or animals in the case of animal food) along with a narrative that provides the basis for one’s conclusion of GRAS status, including why the scientific data, information, methods, and principles described in the notice provide a basis for one’s conclusion that the notified substance is generally recognized, among qualified experts, to be safe under the conditions of its intended use.  Upon submission of the notice, FDA will respond within 180 days regarding a GRAS notice to be publicly released. The rule is effective on 17th Oct 2016 after which FDA will close the docket for any pending GRAS affirmation petition and ask the petitioners to incorporate the applicable petition into a new GRAS notice. FDA believes that this new process will free its resources enabling it to evaluate more, and higher priority, substances. To petitioners of GRAS notice, the process is much simplified and faster. It seems like a win-win.