Renewal of US FDA food facility registration until Dec. 31

Philippine food and food supplement exporters to the United States (US) are advised to renew food facility registration (FFR) with the Food and Drug Administration (FDA) until the year’s end to avoid disruption in their shipments.

With the mandatory biennial renewal of US FDA registration, it said “updating” registration is a different function than “renewing” registration.

“During the renewal period, you will see the ‘update’ button listed on the FFRM (food facility registration module) main menu until the registration is renewed. If a registration is not renewed by 11:59 p.m. on December 31, 2022, the registration is considered expired and will be removed from the account,” the US FDA said.

It said all facilities must include a unique facility identifier (UFI) recognized as acceptable to FDA with the registration submission. To date, FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI.

The DUNS number, which is assigned and managed by Dun & Bradstreet, can be obtained and verified visiting D&B’s website.

Robert Spear, acting food facility registration program manager for FDA, said acquiring a DUNS number can take up to 45 days.

“The cost is free for one facility to register and up to four changes, 90 days after the initial registration. If a company has more than one facility to register or require the registration quicker than 45 days, they may be interested in the DUNS premium service,” he said in a webinar.

Spear said the requirement for an UFI is not new as it has been a requirement since 2020.

“For the last two years, FDA has extended the flexibility of allowing users to submit a UFI pending when they’re doing the food facility registration. However, this will end Dec. 31st, 2022,” he said.

Nicole Shokatz, management analyst at FDA’s Center for Food Safety and Applied Nutrition, said there is no fee for initial registration and renewing or updating registration.

“If you are a food facility and a qualified facility under the Food Safety Modernization Act rules, you will still need to register,” she said.

The US Food Safety Modernization Act (FSMA), which expands the registration mandate under the Bioterrorism Act of 2002, requires all facilities that manufactures, processes, packs, or holds food for human or animal consumption in the US to re-register to renew such registration every two years between Oct. 1 and Dec. 31 of each even-numbered year.

Spear said facilities’ failure to update the registration with an accurate and valid DUNS number within 90 days can result in cancellation of the registration in January 2023.

“When the old, canceled FFRs are submitted in (an) electronic database, they will be rejected and the entries submitted and the entry will not be processed. If an entry is submitted without a valid, accurate FFR, the shipment will be held at the port of entry until a valid FFR is submitted. If a valid, accurate FFR is not received in a timely manner, the shipment will be reexport(ed),” he said.

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