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FDA Updates FCN Submission Form

The Food and Drug Administration (FDA) announced on July 15 that as of October 14, 2014, it will no longer accept old versions of Form 3480 for Food Contact Notification (FCN) submissions. The expiration date for Form 3480 can be found in the upper right-hand corner of page 1. The version of Form 3480 that will be accepted after October 14 can be found here, along with instructions for its completion. This version of Form 3480 also may be used to request a pre-notification consultation (PNC) with FDA or to establish a food master file (FMF) at the Agency, but the Form is not required for these submissions as it is for FCNs. While the form may be printed and mailed to FDA, the instructions make clear that electronic submissions are preferable and provide steps for submitting of the Form electronically.

For more background on the preparation and submission of FCNs, please see the article, "What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?"