Food facilities that are required to register with the U.S. Food and Drug Administration must renew their registration this year between October 1 and December 31. This fact sheet provides information about this biennial food facility registration renewal period.
Why are food facilities required to register with the FDA?
Food facility registration helps FDA determine the location and source of potential bioterrorism or foodborne illness outbreak incidents, and also helps the agency quickly notify facilities that may be affected. Food facility registration requirements were initially brought about by The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.
The FDA Food Safety Modernization Act (FSMA) then amended the FD&C Act to require domestic and foreign facilities to submit certain additional new information to FDA and to renew registrations every other year. In 2016, FDA issued a final rule updating FDA’s registration regulation, including to reflect the FSMA amendments.
What food facilities must register with the FDA?
If you are the owner, operator, or agent in charge of either a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, you are required to register with the FDA, unless an exemption applies.
When must facilities initially register?
If you are required to register you must do so before your facility begins manufacturing/
processing, packing or holding operations.
When are food facilities required to renew their registration?
Food facilities are required to renew their registration every other year, during the period beginning on October 1 and ending on December 31 of each even-number year. This year’s renewal period begins October 1, 2024 and ends December 31, 2024.
What facilities are exempt from the registration requirement?
Establishments that meet the definition of a primary production farm, secondary activities farm, retail food establishment, restaurant, or nonprofit food establishment are not required to register (These definitions can be found in 21 CFR 1.227).
In addition, certain other entities are not required to register, including: certain fishing vessels; foreign facilities if the food from the facility undergoes further manufacturing/processing by another facility outside the United States; and facilities that are regulated exclusively throughout the entire facility by the U.S. Department of Agriculture under certain statutes (For more information on who does not need to register see 21 CFR 1.226).
However, mixed-type facilities must register. These are facilities that conduct activities that are both exempt and covered by the registration requirement. An example of such a facility is a “farm mixed-type facility,” which is an establishment that is a farm, but also conducts activities outside the “farm” definition that require the establishment to be registered.
Please note that FDA intends to initiate a rulemaking that could change the definition of “farm.” Such a rulemaking could change the status of an entity from a facility required to register to a farm. We do not anticipate that the rulemaking would result in an entity that is currently a “farm” becoming a “facility.” While FDA intends to initiate this rulemaking, the rulemaking has not yet taken place, and establishments that are domestic and foreign facilities are required to register, and to renew their registrations biennially.
What happens if facilities don’t renew their registration?
FDA will consider a registration for a food facility to be expired if the registration is not renewed as required. FDA will consider a food facility with an expired registration as having failed to meet their registration requirements, and failure to register a food facility is a prohibited act under the FD&C Act. FDA will cancel a registration if the facility’s registration has expired because the facility has failed to renew its registration as required.
How can food facilities go about renewing their registration?
Owners and operators of facilities can renew their registration by using the professional services, here at BBI International Inc .
We want to know your needs exactly so that we can provide the perfect solution. Let us know what you want and we’ll do our best to help.
Is there a way to save time during the renewal process?
Yes! By having BBI International review your renewal information
Does the registration include an assurance that FDA can inspect the facility?
Yes. Registration for both domestic and foreign food facilities include an assurance that the FDA
can inspect at the times and in the manner authorized by the FD&C Act.
Can FDA suspend a facility’s registration?
FDA can suspend a registration if the agency determines that food manufactured, processed, packed, received, or held by the facility has a reasonable probability of causing severe adverse health consequences or death to humans or animals and that facility either created, caused, or was otherwise responsible for the reasonable probability or knew of (or had reason to know of) the reasonable probability and packed, received, or held such food.