Ten-year retrospective assessment of the performance of the Food Contact Notification (FCN) programme

Abstract

The Food Contact Notification (FCN) programme was authorised by the US Food and Drug Administration (USFDA) Modernization Act of 1997. Manufacturers may file FCNs for food contact substances (FCSs) not already authorised or pre-sanctioned by the USFDA by demonstrating a reasonable certainty of no harm for their intended uses. The Division of Food Contact Notifications (DFCN) 10-year Retrospective Assessment Group was formed to collect and develop metrics associated with the first decade of the FCN Programme and determine the extent selected aspects of the review process contributed to the effective FCN. Comparative analysis of 924 FCNs revealed that 76% become effective, 23% were withdrawn and 1% received a not accepted status. The focus of the Group was to identify factors impacting the likelihood of an FCN becoming effective.

Keywords:

• food contact
• regulatory toxicology
• regulatory chemistry
• health policy
• safety assessment

Acknowledgements

The Group acknowledges the advice and guidance of Michelle Twaroski, PhD, during her employment at the USFDA in the conceptual framework of this project and in the analysis of pilot data presented at the 2012 Society of Toxicology Annual Meeting.