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29-111 Audio CD: SYMPOSIUM: The recipe for a successful GRAS

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Glenn Sipes
Ricardo Carvajal
Antonia (Toni) Mattia

29-111 Audio CD: SYMPOSIUM: The recipe for a successful GRAS


Issues regarding the safety of the food supply include the determination of the safe use of ingredients that are part of a complex food matrix. One pathway to evaluate and substantiate the safety of a food ingredient is via a Generally Recognized As Safe (GRAS) determination. According to the Federal Food Drug and Cosmetic Act Section 201(s), a substance is determined GRAS when it is recognized as safe by experts qualified by scientific training and experience. To evaluate the safety of an ingredient under the conditions of intended use, the expert panel uses scientific procedures to evaluate the data. (Or in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food.) However, the quantity or quality of the studies required to meet the scientific procedures standard is not clearly stated in the regulation, as the safety in use on an ingredient depends on the strength (quality and quantity) of the scientific data. This session will outline the concepts and the level of scientific evaluation required to meet the reasonable certainty of no harm safety standard, with input from both the industry and the U.S. Food and Drug Administration.