May 15, 2023 | Reading time: 9 minutes

UFI: Everything You Need to Know

The Classification, Labelling, and Packaging (CLP) Regulation ensures that hazardous substances and mixtures are managed, communicated, and labelled consistently and securely. Annex VIII to the CLP Regulation dictates the Unique Formula Identifier (UFI) requirements and your obligations to notify Poison Centres of hazardous mixtures on the market as of 2021. Under this regulation, companies and downstream users who manufacture or import hazardous mixtures into the EU must include a UFI on the label of their products.

The unique formula identifier, known by its acronym UFI, is a code required on the label of your products that contain a hazardous mixture. Compliance with UFI requirements is not just a legal obligation; the UFI aims to establish an unambiguous link between the information you provide with the product you place on the market.

In this blog, we will explain its meaning and importance, how it is generated, how to notify the Poison Centre, the implications for your label and SDS, and provide insights into its implementation. We will explore the diverging regulatory requirements between the EU (including Northern Ireland) and the GB (England, Scotland and Wales).

What is UFI?

The UFI is a 16-character alphanumeric code that plays a pivotal role in chemical safety within the European Union. This code is now a mandatory requirement on the labels of products (for consumer and professional use from 1 January 2021) classified for health and physical hazards in the EU.

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.

When and where does a UFI code apply?

Mixtures classified as human health or physical hazards require a UFI on the CLP label and a Poison Centre Notification (PCN) dossier. On the CLP label, the UFI code must be placed in a prominent place (e.g., near the barcode or the hazard pictograms). However, some products, particularly those used in industrial settings, lack a product label, in which case the Safety Data Sheet (SDS) must include the UFI code.

Hazardous mixtures are those that fall into the scope of CLP and have a physical or health hazard classification. Mixtures classified as environmental hazards only can be notified voluntarily.

How does the UFI system work?

Manufacturers and importers of hazardous chemical products register their products with the European Chemicals Agency (ECHA). As part of the registration process, they are assigned a company identifier by the ECHA.
Manufacturers and importers then generate a unique product identifier for each product. This identifier is linked to the company identifier, and together, they form the first part of the UFI code.
Manufacturers and importers can also include an optional batch number in the UFI code, allowing them to identify a specific product batch if needed.
The final part of the UFI code is a check digit, which is calculated using a formula to ensure the accuracy of the UFI code.
The UFI code is then printed on the label of the hazardous chemical product.

How do you generate a UFI code?

To generate a UFI code for your mixture, you will need the following:

Company’s VAT number (or ‘company key’ in specific cases)
The mixture-specific formulation number

You will then need to enter those two numbers into ECHA’s UFI Generator online tool, which will provide you with your UFI code.
For efficiency purposes, if you manage a sizable product portfolio, you can create your generator in your company’s IT system, enabling a more automated method for creating UFIs in bulk. You must refer to the UFI developer’s manual for this option.

Additionally, the UFI respects the integrity of your private business data, as the codes are always encrypted. For example, the UFI cannot be used to decode information about the mixture composition. Only poison centres will know what mixture composition matches the given UFI.

When do you need to produce a new UFI code?

The UFI code can stay the same even if additional changes to the product, such as new packaging or a new trade name, occur, as long as the mixture composition remains the same. Only when a change in the mixture composition happens, such as when a component is added, removed, or substituted, or when the concentrations of components change outside of the permitted variation range, is a new UFI required to be prepared and printed on or adhered to the label.

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Poison Centre Notification

In addition to the UFI, there is a requirement to notify products to the relevant Poison Centre of the country where they are manufactured or imported. This notification takes the form of a Poison Centre Notification product dossier.

In the context of the UFI and CLP regulation, companies must notify Poison Centres about the products they place on the market, providing essential information such as trade name, composition, colour, packaging, product category, and toxicological data. This notification process helps Poison Centres prepare for and respond effectively to potential incidents involving the reported products.

What is a Poison Centre?

A Poison Centre is an organisation that provides emergency medical advice and assistance in cases of exposure to hazardous chemicals or products. The primary role of Poison Centres is to offer expert guidance to healthcare professionals, the general public, and other relevant authorities when dealing with poisonings or chemical exposures.

The ultimate goal of Poison Centres is to safeguard public health by providing timely and accurate information in cases of chemical exposure, contributing to the overall safety and well-being of communities.

Can you use one UFI for multiple products?

Suppose the composition of the mixture in your product remains consistent. In that case, you have the flexibility to use the same UFI on the labels of your products across all countries in the European Economic Area (EEA). Alternatively, you can employ the same UFI for products within the same country, even if they are marketed under distinct trade names. For data management or commercial considerations, you may opt to assign multiple UFIs to a single mixture. In such instances, each product would possess its own UFI, even if they share identical compositions.

Regardless of your chosen approach, it is imperative to communicate the accurate UFI to the relevant Poison Centres in each market area. This ensures that emergency health responders can unequivocally identify the product, facilitating a swift and precise response in case of incidents.

Can you use UFI’s for any mixtures?

Consider assigning a UFI to mixtures without health or physical hazards or those solely classified as hazardous to the environment. Optionally placing the UFI on labels of end products containing these mixtures aids poison centres. Sharing information about any product, classified or not, enhances the advice provided during poison centre calls.

Additionally, the UFI safeguards confidential business information when discussing non-classified mixtures in the supply chain. While including the UFI on labels in these cases is discretionary, it must be provided to poison centres for them to link the mixture to relevant information.

Does the UFI always have to be included on the label?

Ensure the UFI is on or affixed to labels of all products containing hazardous mixtures. Alternatively, it can be placed on the product package, close to other label elements. If the mixture lacks packaging, include the UFI in Section 1.1 of the SDS. The UFI may also be placed in Section 1.1 of the SDS for mixtures at industrial sites.

What are the rules for the UFI code on the label?

The abbreviation ‘UFI’ (uniform across all EU languages and alphabets, not translated) must be in capital letters, followed by a colon and a 16-character alphanumeric code, organised into four blocks with hyphens. For instance:

UFI: P3WB-T03M-K00Q-EWF6

While specific font type or size requirements are absent, the UFI must be visibly and legibly displayed on the product label. To ensure ease of location, considering label size variations and other requirements, position the UFI strategically (e.g., near the barcode or hazard pictograms). Your goal is to determine the most effective display of the UFI for optimal communication with poison centres.

When should the UFI be on the label?

Ensure the timing of UFI inclusion on the product label aligns with the submission of the harmonised Poison Centre Notification. It is not advisable to place a UFI on the label without a valid notification to the relevant Member State, as an ’empty UFI’ provides no assistance to poison centres during emergencies.

For mixtures not yet on the market:

From 1 Jan 2021 (consumer or professional use)
From 1 Jan 2024 (industrial use)

Note that if an industrial-use mixture is reformulated and enters a consumer product, comply with the earliest consumer/professional use date.

Existing mixtures notified nationally by the previous rules could have a transitional period until 1 January 2025. Any changes to these mixtures after that date must adhere to harmonised information obligations before market placement. Ultimately, post-transition, all health or physically classified mixtures must bear a UFI on the label.

Post-Brexit: What are the rules for UFI in GB?

The UK Government has officially announced its intention to remove the requirements of Annex VIII of CLP in GB law before the end of 2023. This will remove the requirement to submit a Poison Centre Notification to the National Poisons Information Service (NPIS) in the UK.

A UFI can still be placed on your product label, and a voluntary notification can be made by emailing a copy of the SDS to NPIS. EU regulation, and thus the requirements of Annex VIII to CLP, remain in place for the Northern Ireland market.

There is no obligation to generate or submit a unique formula identifier (UFI) code in Great Britain. Still, the NPIS will register your product with its associated UFI if one has already been generated. To support the NPIS, please ensure the UFI is identifiable on the front page of the SDS.

Conclusion

Understanding and implementing the UFI is more than a compliance necessity; it is crucial to enhancing chemical safety and effective hazard communication within the European Union. The UFI, as mandated by the CLP Regulation, stands as a pivotal link between your product information and swift emergency responses.

From its structured 16-character code to its label placement, the UFI system offers a clear and systematic approach to identifying hazardous mixtures. By notifying Poison Centres and strategically placing UFIs, you contribute to a safer, more responsive environment in the event of chemical emergencies.

The flexibility in using UFIs across countries or products underscores the system’s adaptability to varied commercial needs while ensuring accurate information for emergency responders. However, maintaining the accuracy and relevance of UFIs through reformulations or changes in product composition remains paramount for their effectiveness.

As regulatory landscapes shift, the guidance provided for UFI application will evolve, particularly in the wake of post-Brexit changes. Understanding the adjusted regulations is essential for those operating within GB to ensure seamless compliance and effective communication with the National Poisons Information Service (NPIS).

By comprehensively integrating UFIs into your product labelling and Poison Centre notifications, you contribute not just to legal obligations but also to the safety and well-being of communities and responders dealing with chemical incidents. Embracing this systematic identification approach is not just about meeting requirements; it is about bolstering chemical safety and protecting public health.

Frequently asked questions

What do I need to do to place my products on the market in the UK?

If placing a product on the GB (England, Scotland and Wales) market only, then you need only submit an SDS to NPIS by email. There is no requirement to generate or submit a UFI to NPIS, but the NPIS will register your product with its associated UFI if one has already been generated.

What do I need to do to place my products on the market in Northern Ireland?

If placing a product on the EU market, including Northern Ireland, you must comply with Annex VIII to CLP. Submit a Poison Centre Notification to ECHA, generate a UFI and display it on labels.

Do I need a new UFI for similar products?

If there is a change to mixture composition, such as when a component is added, removed, or substituted, or when the concentrations of components change outside of the permitted variation range, a new UFI is required.

Need help staying compliant with the regulations?

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