The FDA requires all registered food facilities to renew their registration biennially in each even-numbered year. The current renewal period began 1 October 2020 and runs through 11:59 p.m. on 31 December 2020.1 There is a new component of facility registration renewal this year: Facilities are required to provide a UFI recognized as acceptable by FDA as part of their registration renewal. In August 2018, the FDA issued guidance recognizing the DUNS number as an acceptable UFI for purpose of food facility registration.2 The DUNS number must be associated with the specific facility, not the company’s corporate headquarters. DUNS numbers are assigned and managed by Dun & Bradstreet and are available free of charge.
On 1 December, the FDA announced through guidance that while it expects all registrants to provide their DUNS number with their registration or renewal submission, the agency recognizes that there may be a delay in obtaining the number, based on stakeholder feedback.3 Accordingly, the FDA intends to allow registrants to enter “PENDING” in the UFI field of their registration if they anticipate that they will not be able to obtain a DUNS number before the conclusion of the 2020 biennial renewal period on 31 December 2020. Users will then have 90 days to obtain and submit a DUNS number to the FDA. Failure to update the registration with a valid DUNS number will result in cancellation of the registration. In turn, this can have commercial impacts and regulatory consequences.
We will continue to monitor updates related to food facility registration. Please feel free to reach out to us if you have any questions.
1 FDA Food Facility Registration User Guide: Biennial Registration Renewal (Updated 1 December 2020) available at https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-biennial-registration-renewal?utm_medium=email&utm_source=govdelivery.
2 FDA Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (August 2018) available at https://www.fda.gov/media/85043/download.
3 FDA Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period: Guidance for Industry (December 2020) available at https://www.fda.gov/media/143997/download.
Authored by Maile Hermida, Elizabeth Fawell, Leigh Barcham, and Anneke Altieri.