Answer: The Food and Drug Administration Modernization Act of 1997, which was signed into law by President Clinton on Nov. 21, 1997, amended the Federal Food, Drug, and Cosmetic Act to provide for the submission of notifications for food-contact substances in lieu of Food Additive Petitions and threshold of regulation submissions.
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 within 120 days to the substance's use based on safety grounds, in writing, the submitter and its customers may market the substance.
Unlike Food Additive Petitions, notifications are proprietary and may be relied upon only by the submitter and its customers. On Jan. 18, 2000, FDA formally began accepting FCNs to permit the use of new food-contact materials and new uses of food-contact materials.
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