Answer: FDA will permit FCNs for formulated products, extending even to semi-finished or finished food-contact articles, such as a film or molded package or part, where the article contains at least one otherwise uncleared food-contact substance. If the formulated product, however, contains more than one uncleared FCS, a separate FCN will be needed for each uncleared component.
FDA proposed a notification system for formulated products where all of the components are already cleared. In such a case, it appears that FDA will not commit to completing the review within 120 days, as such a notification is not legally required.
While FDA has published a form for such submissions, the agency's proposed rule reserves to FDA the right, in the future, to decline to accept FCNs for this type of product because of concerns regarding the potential burden these FCNs might place on FDA.
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