Who must register or renew registration?
Owners, operators, or agents in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. must register with the FDA, unless the facility is exempt under 21 CFR 1.226 from the requirements to register. If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf.
I operate a farm; do I need to register with the FDA?
No. Currently farms, restaurants, retail food establishments, and non-processing fishing vessels are not required to register or renew food facility registrations with the FDA.
When do I need to renew my food facility registration information?
The FSMA stipulates that food facilities must renew their registration every even-numbered year between October 01 and December 31.
What kind of information do I need to provide when registering or renewing my registration?
Registrants need to provide the following:
- The email address for the contact person of the facility, or if a foreign facility, the email address of the U.S. agent for the facility.
- Appropriate additional food categories (as determined by the FDA) of any food manufactured, processed, packed, or held at the facility.
- An assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.
Do I need a U.S. agent?
Every non-U.S. food facility must have a U.S. agent that acts as the domestic communications representative for that facility.
RLE offers this U.S. agency service to foreign importers. This is a fee-based service that requires special payment terms and an agreement.
Can the FDA suspend a facility’s registration?
Yes, the FDA has the authority to suspend the registration of a registered food facility.
Under what conditions can the FDA suspend a facility’s registration?
If it reasonably determines that the food being manufactured, processed, packed, received, or held by a registered facility can have serious adverse health effects or cause death to humans or animals, the FDA can suspend that facility’s registration.
A facility’s registration can also be suspended if:
There is a reasonable probability that the facility created, caused, or was otherwise responsible for serious adverse health consequences or death to humans or animals.
The facility packed, received, or held food knowing or having reason to know of the reasonable probability of causing serious adverse health consequences or death to humans or animals.
What is the impact to a facility if its registration is suspended?
If a facility’s registration is suspended, the business cannot import or export food into the United States.
What happens if I fail to renew my registration?
If you do not renew, your registration will be cancelled, and you will need to obtain a new one in order to import or export food into/out of the United States.
When is a UFI required for registration?
Beginning October 1, 2020, the facility’s Unique Facility Identifier (UFI) will be required to be submitted with the
registration information. FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an
acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet.