Food contact notifications process

It is explained that the Food Contact Notification process of the US Food Drug Administration has been in place officially for three months This article asks, and then strives to answer, many questions about the system. 

Within the FDA s Center for Food Safety and Applied Nutrition, the Office of Food Additive Safety administers premarket approval processes for new direct food additives and food additives that are components of food contact materials. Most food contact materials are regulated via the food contact notification process and authorization of new food contact materials is administered by the Division of Food Contact Notifications (see Chapter 2 for further information). The notifier has the primary responsibility to demonstrate the safety of the proposed use of the food contact material. Review scientists within FDA perform a fair evaluation of the data in a food contact notification, as well as other relevant information, to determine if the knowledge base supports the finding with reasonable certainty that no harm will result from the intended use of the food additive. FDA maintains a number of public online listings that include useful information... 

Table 2.2 Regulatory options relevant to food contact materials with regard to the food additive petition (petition), food contact notification (FCN) and threshold of regulation (TOR) exemption processes...

As discussed above, the Delaney clause applies to substances proposed for use as food additives, but does not apply to individual constituents of a food additive. Examples of constituents would include residual monomers or catalysts. The constituents policy, subjected to judicial review in Scott v. FDA, 728 F. 2d 322 (6th cir. 1984), states that FDA may consider the potential risks of constituent exposure under the general safety standards set forth in FFDCA. The notification process places the responsibility upon the notifier for addressing the carcinogenic risk of constituent exposure from a proposed use of a food additive. FDA recommends that notifiers include in their food contact notification a safety narrative that addresses the safety of each carcinogenic constituent at any exposure (in addition to the recommendations listed in Table 7.1). This narrative should include an estimate of the potential human cancer risk from the constituent due to the proposed use of the food contact material (FDA, 2002). 

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