Do you know that food products, pharmaceuticals, and medical devices must be registered with the United States Food and Drug Administration (FDA) before being circulated in the market? One of the mandatory pieces of information to provide when registering with the FDA is the Unique Facility Identifier (UFI) code. So, what is the UFI code, and why is it necessary when registering with the FDA? Let’s delve deeper into this topic with GOL in the following article!

1. What is a UFI?

The Unique Facility Identifier (UFI) code is a critical piece of information that all businesses registering or renewing FDA registrations for food, pharmaceuticals, and medical devices are required to provide for FDA validation.

According to FDA regulations, all facilities registering with the FDA are required to provide a unique identifier known as the Unique Facility Identifier (UFI). This requirement was established by the FDA in 2020, and as of now, the FDA accepts businesses using the D&B D-U-N-S number as the unique identifier (UFI) for the purpose of validating the registered business address. The Data Universal Numbering System (DUNS) number, comprising 9 unique digits, is assigned and managed by Dun and Bradstreet (D&B) and is used globally to identify businesses in the database.

The FDA requires a DUNS number for each facility with a different address. Therefore, each company must have a separate DUNS number for each address registered with the FDA. Additionally, businesses should be aware that the information registered to obtain the DUNS number must exactly match the information registered with the FDA. Discrepancies in information may lead to FDA requests for adjustments and verifications. In cases where the DUNS number is not promptly updated, the FDA registration of the business may be deleted or not allowed to renew in the FDA system.

The UFI code structure:

• Company identifier: The UFI code consists of four distinct sections, starting with the company identifier. This identifier is assigned by the European Chemicals Agency (ECHA) and signifies the company that has registered the product.
• Product identifier: The second section is the product identifier, which is assigned by the company itself. It uniquely identifies the specific product in question.
• Batch number (optional): The third section allows for a batch number to be included, aiding in identifying specific product batches.
• Check digit: The fourth and final section is the check digit, calculated using a formula to ensure the accuracy of the UFI code.

2. HOW WILL THE UFI BE USED?

The UFI and the other information you have provided will primarily be used by poison centers in the event of an emergency call. For example, the UFI can be read directly from the label of a product to a poison center operator, in addition to the trade name, to precisely identify the product involved in an incident.

3. WHAT DO YOU NEED TO CREATE A UFI?

To create a UFI for your mixture, you need your company’s VAT number (or ‘company key’, in specific cases) and a mixture-specific formulation number. Entering these two numbers into ECHA’s UFI Generator online tool will provide you with your UFI code. The VAT number is a key element to ensure that your UFI is unique so that no overlap occurs between UFIs generated by different companies.

Most likely, your company already uses internal formulation codes. If they are numerical only – between 0 and 268,435,255 – you can use them directly in the UFI Generator. In other cases, such as when they are alphanumeric or contain other characters, you will need to first assign new formulation numbers to your mixtures that follow the required format. It is essential that you do not re-use the same formulation number using the same VAT number when the mixtures have different compositions.

You can find the UFI Generator and the user guide on ECHA’s Poison Centres website in 23 EU languages. If you manage a large product portfolio, you may want to develop your own generator in your company’s IT system for more efficient bulk creation of UFIs. For this, you will need to consult the UFI developer’s manual.

4. WILL THE UFI KEEP YOUR BUSINESS INFORMATION CONFIDENTIAL?

The UFI also respects the integrity of your confidential business information. For example, it is not possible to decode information on the mixture composition from the UFI. Only poison centres will know which mixture composition corresponds to the UFI provided. In this way, the UFI protects your confidential business information.

5. The regulations regarding UFI registration

• Each facility must have a separate UFI. This means that if a business has multiple facilities for manufacturing, processing, packaging, or distributing food, pharmaceuticals, or medical devices, each facility will have its own unique UFI. The UFI is used to identify a specific facility and helps the FDA trace the origin of products in case of incidents.
• The information on the UFI must match the FDA registration information. This means that the name, address, and tax identification number on the UFI must match the name, address, and tax identification number on the FDA registration. If the information does not match, the FDA registration information becomes invalid.
• Companies can assist businesses in UFI registration. There are companies specializing in providing UFI registration services for businesses. These companies can help businesses save time and effort in the UFI registration process. To facilitate businesses in the convenient UFI registration process, GOL Company offers support services at cost savings. This helps businesses save time and effort in ensuring that their business licenses are fully prepared. 
• Businesses need to prepare a valid business license. A valid business license is one of the necessary requirements for UFI registration. Businesses should prepare a valid business license before registering for the UFI.

The mentioned regulations not only ensure accuracy but also enhance the efficiency and compliance of the UFI registration process, making it easy for businesses to track and manage their products.

6. The consequences of not registering a UFI

The repercussions of neglecting to register a Unique Facility Identifier (UFI) are substantial, particularly as it impedes businesses from the vital process of renewing their FDA code in the year 2022. Presently, the prevailing laws in the United States explicitly articulate that any goods imported into the country must be duly registered with the FDA; failure to comply with this mandate constitutes a violation of federal laws. Consequently, businesses found in contravention of this requirement may face prosecution by the U.S. government.

In the specific context of foreign goods imported into the United States, the ramifications of non-registration become even more pronounced. Should these goods be discovered to be in violation, the entire shipment is subject to detainment at the port, a process overseen by both the FDA and CBP (Bureau of Customs and Border Protection). The subsequent proceedings are carried out in accordance with section 801(m)(1) and the pertinent Federal regulations.

The onus of responsibility for all associated costs, including those incurred for storage, relocation, and disposal, lies squarely on the consignee. This, in turn, exerts a significant and adverse impact on the overall operations and financial health of the business involved, underscoring the critical importance of complying with UFI registration requirements.

7. Some frequently asked questions related to UFI registration

7.1 How to Acquire Your UFI

Establishments have the option to make a submission to obtain their DUNS numbers via the D&B online platform. For those who are new users, it is essential to fill out the registration form. After the form is successfully filled out, an email will be sent to you, providing instructions to activate your user account.

7.2 The Consequences of Inaccurate Information

While the process of requesting a DUNS number is free, there is a limitation of four requests per facility within a 90-day period following user registration. Once this 90-day timeframe or the allowance of four requests is exhausted, a fee for premium services becomes applicable for each subsequent request. If there is incorrect information in D&B’s records, utilizing one of your allocated requests is necessary to rectify the information. 

Due to the FDA’s requirement for each facility to possess a distinct DUNS number, D&B might already have a DUNS number associated with your company. However, this number may not correspond to the correct facility, or it could be outdated information. If your facility undergoes a name change and D&B cannot locate it, the attempt to find your facility will be considered a request. Failure to respond within 48 hours will result in D&B closing the request, necessitating the submission of a new inquiry. 

7.3 How does the UFI system work?

The UFI system operates through the following process:

• Manufacturers and importers of hazardous chemical products initiate the registration of their products with the European Chemicals Agency (ECHA). During this registration, they are allotted a company identifier by the ECHA.
• Subsequently, these manufacturers and importers create a distinctive product identifier for each of their products. This identifier is interconnected with the previously assigned company identifier, constituting the initial segment of the UFI code.
• Manufacturers and importers have the option to incorporate an additional batch number into the UFI code, enabling them to distinguish a particular product batch when necessary.
• The concluding element of the UFI code is a check digit, calculated through a specific formula to guarantee the precision of the UFI code.
• The finalized UFI code is then imprinted on the label of the hazardous chemical product, providing a unique identification for that specific product in the market.

7.4 When is it necessary to generate a new UFI code?

The UFI code can persist unchanged even in the presence of alterations to the product, such as adopting new packaging or a revised trade name, provided that the mixture composition remains unaltered. A new UFI must only be generated and affixed to the label when a modification in the mixture composition transpires. This occurs when a component is introduced, eliminated, or substituted, or when the concentrations of components deviate beyond the permissible variation range.

7.5 How to Obtain Your UFI  easier?

While the basic service is cost-free, modifications in information or mistakes made by the user may lead to extra inquiries, thereby escalating the overall expenses associated with obtaining your UFI.

When partnering with GOL, we handle information updates on your behalf, and you won’t incur charges for these supplementary inquiries. We address D&B’s queries related to your pending requests to ensure a more streamlined and prompt resolution of issues. Assistance is also provided in multiple languages, and we can expedite your request at no additional cost as your designated FDA agent.

Given the anticipated surge in requests for DUNS numbers from FDA-registered food facilities during the 2020 renewal period, it’s advisable for companies to take measures to reduce potential delays. Outsourcing this responsibility can enhance efficiency and accuracy, increasing the likelihood of obtaining your DUNS number before the deadline.

Additionally, GOL provides FDA registration services for various sectors, including food, cosmetics, medical equipment, etc. We assist businesses in registering with the FDA quickly and accurately, meeting the requirements set by the FDA. Contact us today for enthusiastic consultation and support!

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