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 FDA

FDA

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.

 

 

 Consult 21 CFR 174-179 to see if the use of the component is an appropriately regulated indirect additive.

 

l  General Indirect Food Additives (21 CFR 1745)

l  Adhesives and Components of Coatings (21 CFR 1756)

l  Paper and Paperboard Components (21 CFR 1767)

l  Polymers (21 CFR 1778)

l  Adjuvants, Production Aids, and Sanitizers (21 CFR 1789)

l  Irradiation in the Production, Processing and Handling of Food (21 CFR 17910)

 

The requirement for premarket approval in section 409 of the FD&C Act in 1958 resulted in the development of a petition process by which a person could request approval of a food additive for an intended use. The approval resulted in a regulation listed in 21 CFR. Components of a food packaging material used in compliance with a regulation in 21 CFR (174-179) need no further FDA review. Most of the regulated indirect food additives can be found in CFSAN's "Indirect Additive" Database

 

 

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