A study published online on December 20, 2014 in the peer-reviewed journal Food Additives and Contaminants, Part A analyzed selected aspects of Food Contact Notifications (FCNs) received over the period 2001-2010. The FCN program was authorized by the U.S. Food and Drug Administration (FDA) Modernization Act of 1997. FCNs for food contact substances may be filed after a reasonable certainty of no harm for the intended use has been demonstrated by the manufacturer. During the 10-year study period, 703 out of a total of 924 FCNs became effective within the statutory 120-day review process. A total of 212 FCNs were withdrawn based on different deficiencies, as it was stated in the deficiency letters sent to the notifiers by the U.S. FDA. According to Neal-Kluever and colleagues, 85% of the withdrawn FCNs had chemical and/or toxicological deficiencies. Nine out of 924 FCNs were not accepted, but none received an objection. The study authors observed an effect of the company size on the result of the FCN review process; large companies had a higher percentage of FCNs becoming effective than smaller companies.
Neal-Kluever, A. et al. (2014). “Ten-year retrospective assessment of the performance of the Food Contact Notification (FCN) programme.” Food Additives and Contaminants, Part A (published online December 20, 2014).