Since 2021, a new labeling requirement has been in effect for imported products in the European Union (EU): the 16-character unique formula identifier (UFI) code. Up until now, this requirement has only been in effect for imported products for professional users. However, beginning in 2025, the UFI code will be mandatory for all products, including industrial products, that have health or physical hazards.
Importers and downstream users placing such products on the market will have to provide specific product information, including the UFI code, that will be used by EU Poison Centres.
Information on how to generate a UFI code is available on the European Chemical Agency (ECHA) Poison Centre website.
How Are UFI Codes Used?
UFI codes are used by EU Poison Centres for emergency call support. Since UFIs are listed on product labels, Poison Centre operators can identify the product, advise callers on how they can best receive medical attention, and get any affected parties to safety if a hazardous situation exists.
UFIs can also help users prevent issues, similar to the way information on safety data sheets is used.
How Do You Create a UFI Code?
You will need two numbers to establish your UFI: your company’s value-added tax (VAT) number and the mixture’s formulation number. Entering these two numbers into ECHA’s online UFI Generator will provide you with your UFI code.
The VAT number is needed to ensure that your UFI is unique so that no overlap occurs between UFIs generated by different companies.
Formulation numbers can be between 0 and 268 435 255. In cases where your formulation number is alphanumeric or contains other characters, you will need to first assign a new formulation number to your mixture that follows the required format. It is essential that you do not re-use the same formulation number with the same VAT number when the mixtures have different chemical components.
The UFI Generator online tool, along with its user guide, can be found on the ECHA Poison Centres website. For large product portfolios, some companies create their own generator within their IT system for more efficient bulk creation of UFIs. For this, you will need to consult the UFI Developers Manual.
It is important to note that UFI codes protect confidential business information. No one can decode information on the mixture composition from the UFI. Only the ECHA Poison Centres know which mixture composition corresponds to the UFI provided. Thus, the UFI protects companies’ trade secrets.
Does a UFI Code Always Need to Be Included on a Label?
Yes, the UFI code must be printed on or affixed to the label of all your products containing hazardous mixtures. It is also possible to include the UFI on the package of the product, provided it is close to other label elements.
For unpackaged mixtures, the UFI code must be included in section 1.1 of the safety data sheet.
For mixtures at industrial sites, the UFI may also be included in section 1.1 of the safety data sheet.
How Should a UFI Code Be Displayed on a Label?
To display your UFI code, the acronym ‘UFI’ (the same in all EU languages and alphabets, and not to be translated) must be in capital letters, followed by colon and a 16-character alphanumeric code. The code is divided into four blocks, each separated by a hyphen. An example of this would be UFI: N1QV-R02N-J00M-WQD5.
There are no stipulations regarding the font or font size, but the UFI has to be legible on the product label. Even with variations in label sizes and other labelling requirements competing for label space, the UFI should always be positioned so that it is easy to find.
It is up to companies to determine how the UFI is displayed on the product for best communication of hazards.
What Deadlines Are Involved?
Inclusion of the UFI code on the product label should be aligned with the submission of harmonised information. Do not place the UFI code on the label of the product if that UFI has not been included in a valid notification to the relevant member state.
For mixtures not already on the market, you are obliged to submit harmonised information and then place the UFI on the label. An ‘empty UFI’ will not provide any assistance to poison centres in an emergency
These requirements will apply on the following dates:
• Jan 1, 2021—for consumer or professional use
• Jan 1, 2024—for industrial use
In scenarios where industrial use is reformulated further down in the supply chain and incorporated into a consumer use, follow the earliest compliance date for consumer/professional use.
If you alter mixtures, you will need to comply with the harmonised information obligations before you place the changed mixture on the market.
If you already have existing mixtures with notifications in the relevant member state, the transitional period, which ends January 1, 2025, will apply. Right now, this applies for professional and consumer use only. After the transitional period, all mixtures classified as having a health of physical hazard will need to display the UFI code on the label. This means that it will extend to all uses, including industrial users.
What Steps Should Companies Be Taking Now?
While the 2024 and 2025 UFI code deadlines may seem like a long way off, taking action now will prevent a mad rush later. Company compliance professionals should begin considering the new UFI requirements now because it is expected that there will be fines or sanctions levied against companies who do not comply.
Begin by understanding your requirements and deadlines. Then make sure you have the appropriate formulation numbers so you can begin generating the UFI codes you need. You will need to evaluate all of your safety data sheets to make sure they also contain the correct UFIs and are compliant.
If you need help getting started, understanding your requirements, or generating your UFI codes, contact Tetra Tech’s experts at [email protected]. We can help you through the process and assist you in meeting your other poison centre notification requirements so your products can remain compliant.
