Zdrowie i gospodarka · 4/17/1997

Substances Generally Recognized as Safe

The Food and Drug Administration (FDA) is proposing to clarify the criteria for exempting the use of a substance in human food or in animal feed from the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the act) because such use is generally recognized as safe (GRAS). FDA is also proposing to replace the current GRAS affirmation process with a notification procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS. Under the proposed notification procedure, the agency intends to evaluate whether the submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. This proposal reflects FDA's commitment to achieving the goals for the Reinventing Food Regulations part of the President's National Performance Review (hereinafter referred to as Reinventing Food Regulations). The proposed notification procedure would allow FDA to direct its resources to questions about GRAS status that are a priority with respect to public health protection.