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As ONAY, we provide consultancy services for your UFI (Unique Formula Identifier) Unique Formula Identifier registration.
The UFI and other information you provide will be used by the Poison Centers in case of an emergency.
The unique formula identifier, known by its acronym UFI, is a code that will be required on the label of your products that contain a hazardous mixture.
In addition to the UFI, you are also required to provide other information on your mixture and associated products for poison centres to use, such as composition, trade name, colour, packaging, product category and toxicological information.
The UFI aims to establish an unambiguous link between the information you provide with the product you place on the market. The condition for assigning a UFI, is that all products labelled and notified with the same UFI need to share the same mixture composition.
HOW WILL THE UFI BE USED?
The UFI and the other information you have provided, will primarily be used by poison centres in the event of an emergency call. For example, the UFI can be read directly from the label of a product to a poison centre operator in addition to the trade name to precisely identify the product involved in an incident.
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.
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.
HOW IS THE UFI USED IN THE SUPPLY CHAIN FOR A MIXTURE IN MIXTURE?
A mixture placed on the market often consists of a mixture in mixture – in other words, it is made by mixing two or more mixtures together according to the formulator’s specifications. Given that it is not possible to decode confidential information about a mixture composition from the UFI, the UFI can be safely used in the supply chain. You can receive a UFI from your upstream supplier or provide your UFI to your downstream formulator instead of disclosing the full composition. However, before the UFI is exchanged in the supply chain, it must already be known to poison centres.
WHEN DO YOU NEED A NEW UFI CODE?
As long as the mixture composition remains the same, the UFI code can remain the same, even if other changes to the product occur (such as new packaging or a new trade name).
A new UFI only needs to be generated and to be printed on or affixed to the label when a change in the mixture composition occurs – for example, if a component is added, deleted or substituted, or if the concentrations of components change beyond the allowed variation range. You will need to make sure you monitor changes to the mixture composition
and generate a new UFI, inform poison centres and relabel your products as necessary.
CAN YOU USE ONE UFI FOR MULTIPLE PRODUCTS OR SEVERAL UFIS FOR ONE PRODUCT?
As long as the mixture composition in the product is the same, you can use the same UFI on the label of your products in all EEA countries, or you can use the same UFI on the label of the products within the same country, even if you market them under different trade names. For data management or commercial reasons, you may choose to assign more than one UFI to the same mixture. In this case, each product would have its own UFI, even if it contains the same mixture.
Whichever approach you choose, it is essential that you inform the correct UFI to the poison centres in each relevant market area so that emergency health responders can unambiguously identify the product
CAN YOU USE UFIs FOR ANY MIXTURES?
You may find it helpful to assign a UFI to a mixture that is not classified for health or physical hazards or to mixtures that are classified as hazardous to the environment only.
Voluntarily including the UFI on the label of end products containing such mixtures would assist poison centres, as knowledge of any product communicated in a poison centre call, classified or not, allows health responders to give more informed advice.
The UFI can also be used to keep your confidential business information protected when communicating about non classified mixtures in the supply chain. Including the UFI on the label in such cases is optional but it must be provided to poison centres to allow them to make the connection between the mixture in mixture and the relevant information.
DOES THE UFI ALWAYS HAVE TO BE INCLUDED ON THE LABEL?
The UFI must be printed on or affixed to the label of all your products containing hazardous mixtures. It is also possible to indicate the UFI on the package of the product provided it is close to the other label elements. If the mixture is not packaged, the UFI must be included in section 1.1 of the safety data sheet.
Note that in the case of mixtures used at industrial sites, the UFI may be alternatively included in section 1.1 of the safety data sheet.
WHAT ARE THE RULES FOR A UFI CODE ON THE LABEL?
The acronym ‘UFI’ (the same in all EU languages and alphabets, and not to be translated) must be in capital letters and be followed by colon and a 16-character alphanumeric code. The code is divided into four blocks, each separated by a hyphen.
While no specific requirements have been set, for instance, for font type or size, the UFI has to be clearly visible and legible on the label of the product. Given the variation in label sizes, and other labelling requirements competing for label space, the UFI should be positioned so that it is easy to locate (e.g. near the barcode or hazard pictograms). In essence, you must determine how the UFI is displayed on the product in the most effective manner to assist with its communication to poison centres.
BY WHEN SHOULD THE UFI BE ON THE LABEL?
In all situations, the timing for including the UFI on the label of the product should coincide with the submission of harmonised information. It is not recommended to place the UFI on the label of the product if that UFI has not been included in a valid notification to the relevant Member State. In such cases, an ‘empty UFI’ will not provide any assistance to poison centres in the event of an emergency.
For mixtures not already on the market, your obligations to submit harmonised information and place the UFI on the label will apply from:
• 1 Jan 2021(consumer or professional use)
• 1 Jan 2024 (industrial use)
Note that if your mixture for industrial use is reformulated further down in the supply chain and ends up in a consumer use product, you will need to respect the earliest compliance date for consumer/ professional use. If you have existing mixtures already notified at national level according to the current rules in force
in the relevant Member State, you may benefit from a transitional period which ends 1 Jan 2025. If you make a change to such mixtures though, you will need to comply with the harmonised information obligations, before you place the changed mixture on the market. Ultimately, after the end of the transition period, all mixtures classified for health or physical effects will be required to bear the UFI on the label.