title: 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 Comparative analysis of 924 FCNs revealed that 76% become effective, 23% were withdrawn and 1% received a not accepted status.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.
authors.affiliation: a US Food and Drug Administration, Center for Food Safety and Applied Nutrition , Division of Food Contact Notifications , College Park , MD , USA.
authors.forename: April
authors.initials: A
authors.lastname: Neal-Kluever
authors.forename: Jessica
authors.initials: J
authors.lastname: Cooper
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Zebovitz
authors.forename: Kyla M
authors.initials: KM
authors.lastname: Butts
mesh_terms: D005504:Food Analysis; D005506:Food Contamination / Q000032:analysis*; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
keywords: food contact; health policy; regulatory chemistry; regulatory toxicology; safety assessment