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To streamline the food facility registration for manufacturers in the United States (US), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) has added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the Section 415 of the FD&C Act (21 U.S.C. 350d), domestic and foreign facilities in the US that manufacture, process, pack, or hold food for human or animal consumption are required to register with the US Food and Drug Administration (FDA). The revised Guidance for Industry “Small Entity Compliance Guidance (SECG)” issued by the FDA intends to help small entities comply with the food facility registration regulations set forth in the 21 CFR. Section 415 of the FD&C Act, as amended by the FDA Food Safety Modernization Act (FSMA), also requires food facilities to register with the FDA to renew such registrations every other year. The section also provides the FDA with authority to suspend the registration of a food facility in certain circumstances. The initial registration with the FDA is required once and must be renewed every other year between October 1 and December 31 of each even-numbered year. However, before applying for food facility registration to the FDA, manufacturers must first understand its Regulatory requirements to ensure end-to-end compliance. Let’s take a look at a step-by-step guide better understanding of the FDA’s food facility registration in the US.
What is a Food Facility Registration?
In the US, food facility registration requires domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption to register with the FDA.
Which Facilities are Required to Apply for Food Facility Registration?
Domestic and foreign food manufacturers/processors, packers, and storage operations that handle food for consumption in the US. For purposes of registration, “food” is defined in 21 CFR 1.227.
When Should a Facility be Registered?
Before a facility begins to manufacture, process, pack, or hold food for consumption in the US, it must be registered with the FDA.
Who Can Register a Food Facility?
The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, can register that facility.
Foreign facilities must designate a US agent, who lives or maintains a place of business in the US and is physically present in the US, for purposes of communication between the facility and FDA. The US agent also may be authorized to register the facility.
How to Register a Food Facility with the FDA?
Registration can be done either online or by mail or fax.
What Kind of Information is Required for Registration?
- Facility name, full address, phone number
- Facility’s Unique Facility Identifier (UFI) recognized as acceptable by the FDA
- Preferred mailing address, if different from that of the facility
- Parent company name, address and phone number (if applicable)
- Email address for the contact person of the facility or, in case of a foreign facility, the name, address, phone number, and email address of the US Agent for the facility
- An emergency contact phone number and email address (for domestic facilities, the email address is required only if this is different from the contact person)
- Name, full address and phone number of the owner, operator, or agent in charge. Additionally, the email address of the owner, operator, or agent in charge is required, unless the FDA has granted a waiver under 21 CFR 1.245
- All trade names that the facility uses
- Applicable food product categories, as listed on the registration form
- The type of activity conducted at the facility for each food product category identified
- Assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
- Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so
How is the Registration Confirmed?
The FDA confirms the registration either electronically (online registration) or by mail (paper) and assigns a registration number.
As mentioned before, to manufacture/process, pack, or hold food for consumption in the US requires registration of the facility with the FDA. However, FAILING TO REGISTER FACILITY, RENEWING REGISTRATION, UPDATING REQUIRED ELEMENTS, or CANCELLLING REGISTRATION in accordance with the applicable regulations may create unwanted consequences. In addition to this, if a foreign facility is required to register but fails to do so, food from that facility that is offered for import into the US is subject to being held at the port of entry or a secure facility until the foreign facility is registered. Therefore, it is crucial for manufacturers to understand the requirements of the Food Facility Registration to avoid last-minute challenges and delays. Devise the best of Regulatory methodologies and strategies. Stay informed. Stay compliant.
