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FCNs and EU Dossiers

Food Contact Notifications

In the U.S. a number of options exist for gaining the necessary clearance for new food contact substances. Firstly, the substance may already be regulated by the FDA, under a relevant Part of the Title 21 of the Code of Federal Regulations.

If not already regulated, a number of options exist for achieving FDA clearance

• Submission of a FCN (Food Contact Notification)
• Submission of a FAP (Food Additive Petition)
• Submission of a TOR (Threshold of regulation exemption)
• ‘No migration’ exemption.

In many cases these options require that validated migration studies are carried out as described by the FDA (Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations April 2002). The Analytical Group at Pira International has successfully performed many such studies and has extensive experience in drawing up test protocols and calculation of estimated daily intakes (EDI).

Other possibilities for generating migration data are by calculation assuming total mass transfer to foods or using migration modelling.