Food Contact Notification (FCN)
| In 1997, the Food and Drug Administration Modernization Act (FDAMA),
amended the Food Drug and Cosmetic 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 (and the Threshold of Regulation program) 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. The listing of effective notifications, the proposed regulation, guidances, and additional information regarding the notification program are listed on this page
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170.100 | Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA). | |
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170.101 | Information in a premarket notification for a food contact substance (FCN). | |
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170.102 | Confidentiality of information in a premarket notification for a food contact substance (FCN). | |
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170.103 | Withdrawal without prejudice of a premarket notification for a food contact substance (FCN). | |
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170.104 | Action on a premarket notification for a food contact substance (FCN). | |
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170.105 | The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. |
More information can be found in the following Keller and Heckman publications: