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The mandatory biennial renewal of US FDA registration for Philippine food and food supplement exporters to the US will be open between 1 October to 31 December 2022. The US Food Safety Modernization Act (FSMA) which expands the registration mandate under the Bioterrorism Act of 2002 requires that all facilities that manufactures, processes, packs, or holds food for human or animal consumption in the US must re-register to renew such registration every two (2) years between October 1 and December 31 of each even-numbered year.
According to the US FDA, “updating” your registration is a different function than “renewing” your registration. During the renewal period, you will not see the “Update” button listed on the FFRM main menu, until the registration is renewed. If a registration is not renewed by 11:59 PM on December 31, 2022, the registration is considered expired and will be removed from your account.
Starting this year, a new step requires enterprises to obtain a Data Universal Numbering System (DUNS) number with Dunn & Bradstreet. The FDA issued guidance formally recognizing the Data Universal Numbering System (DUNS) number as an acceptable unique facility identifier (UFI) for Foreign Supplier Verification Programs (FSVP).
The identification of importers will help the FDA effectively implement, monitor compliance with, and enforce the FSVP requirements, which are designed to help ensure that imported foods meet U.S. safety standards. The DUNS number, assigned and managed by Dun & Bradstreet can be obtained by contacting D&B by via email at email@example.com or by visiting D&B’s website https://www.dnb.com/duns-number.html.
Additional information on US FDA Registration and Renewal can be found in the following:
- Food Facility Registration Site: http://www.fda.gov/furls
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-food-facility-registration-seventh-edition
- Food Facility Registration User Guide: Biennial Registration Renewal: Food Facility Registration User Guide: Biennial Registration Renewal | FDA
- US FDA Webinar Recording (August 11, 2022) on Food Facility Registration, Biennial Renewal, and obtaining an acceptable Unique Facility Identifier: https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/webinar-food-facility-registration-ffr-biennial-renewal-and-unique-facility-identifiers-ufi-08112022
For more information, please email Ms. Gina Yap of DTI-Market Innovation Division at GinaYap@dti.gov.ph.