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Food and Drug Administration Modernization Act of 1997 amended the
Federal Food, Drug, and Cosmetic Act to provide for the submission of
food-contact notifications (FCNs). Under the FCN system, a manufacturer
or supplier of a food-contact material may submit an FCN to FDA
regarding the identity and use of a new food-contact substance (FCS),
along with information supporting the conclusion that the substance is
safe for the intended use.
If FDA does not object in writing within 120 days to the substance's
use based on safety grounds, the submitter and its customers may market
the substance. Once the notification becomes effective, FDA will add it
to its Inventory of Effective FCS Notifications. For more background on
submission of FCNs, please see the PackagingLaw.com article, "What is the Best Approach to Obtaining hedp acid Clearance for Food Contact Substances?"