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U.S. Department of Health and Human Services


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Regulatory Background of the Food Contact Substance Notification Program

In 1997, the Food and Drug Administration Modernization Act (FDAMA), amended the Food Drug and Cosmetic Act (FD&C Act) to streamline the way in which the FDA conducted business. One of the new procedures established to accomplish this goal was a notification process for food-contact substances. The amended FD&C Act (United States, 1998a) defined a food-contact substance as "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food."

This notification process is intended to replace the petition process as the primary means for authorizing new uses of food additives that are food-contact substances. However, discretion is given to the FDA for deciding when the petition process is more appropriate for evaluating data to provide an adequate assurance of safety.