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  5. Regulatory Background of the Food Contact Substance Notification Program
  1. Packaging & Food Contact Substances (FCS)

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.

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