The Food and Drug Administration has issued a rule that modifies and clarifies the criteria for the use of substances in foods for people and animals.

The Food and Drug Administration has issued a final rule that, from October17, to modify and clarify the criteria for when the use of a substance in food for humans or animals is not subject to the requirements of pre-market approval of Federal Food, Drug, and Cosmetic Act if the substance is generally recognized as safe with the conditions of their intended use. In particular, this rule is directed to the types of scientific evidence that can be used to demonstrate the safety, as well as the role of the publications to assess whether the scientific evidence of safety is generally available and accepted. The different FDA rules indicate that the criteria clarified must help the users  more informed conclusions about whether the prescribed conditions for use of a substance in food for humans or animals complies with the FD&C Act.

This rule also replaces the GRAS (Generally Recognized as Safe) affirmation petition process with a voluntary notification procedure that was originally established under an interim policy and pilot program for human food in 1997 and food of animal origin in 2010. Under this procedure, any person may notify the FDA of a conclusion that a substance is GRAS under the conditions of its intended use. The FDA indicates that this procedure will allow interested parties to be aware of if the agency has cast doubt on the basis of a conclusion of the status of GRAS.

The FDA indicates that this final rule is your last step to strengthen the supervision of the substances added to food and animal feed, thereby enabling established rules of food safety equal and safe for consumers. The next steps include the issuance of additional guides related to the GRAS regulations and develop and implement strategies of regulation and compliance solutions for improving the assessment prior to the placing of surveillance and security of the human and animal food additives and GRAS substances.