Information concerning the application on the UFI (Unique formula identifier)

Safety data sheet knowledge base – Unique Formula Identifier (UFI)

The Unique Formula Identifier (UFI) is a 16-character code that must be indicated on the label of certain mixtures. The UFI is an element of the harmonised submission of hazardous mixtures in the form of a Poison Centre Notification (PCN).

As a result of the submission, harmonised information becomes available to the relevant bodies in EU/EEA Member States. The UFI enables poison centres to identify a hazardous mixture quickly in emergency situations and provide appropriate information to medical personnel.

Provisions on the application of the UFI and the labelling of mixtures were introduced by Commission Regulation (EU) 2017/542, which amended Regulation (EC) No 1272/2008 (CLP) by adding Annex VIII. These provisions apply in all EEA Member States.

 

The aim of the Unique Formula Identifier

By using the UFI code (which links to composition information provided to the authorities through the PCN submission), a mixture can be identified unambiguously, supporting a rapid response during an emergency.

At the same time, the UFI supports safe handling without requiring the full composition to be disclosed to users.

Only the relevant competent authorities have access to the detailed composition data provided during the submission.

 

Strategic approach

Possible methods for creating the Unique Formula Identifier

Mixture-based approach

One mixture composition is identified by one UFI.

Products with identical composition but different trade names (i.e. the same mixture placed on the market under different commercial names) may use the same UFI.

Product-based approach

Each product/trade name is assigned its own UFI.

In this case, one mixture may have multiple UFI codes (e.g. where the same composition is placed on the market under different trade names).

For a better understanding of the mixture-based and product-based approaches, it is essential to distinguish between a mixture and a product:

Mixture:

Contains at least two ingredients (which may include substances and/or a mixture in mixture (MiM)).

The characteristics of a mixture are mainly determined by its composition and its physical and chemical properties.

Product:

A mixture intended for sale, typically identified by a trade name, and whose market characteristics are also influenced by packaging, labelling and product category.

Market-centred approach

The same mixture may be assigned different UFIs if it is placed on the market in different countries.

For instance, “Product 1” placed on the market in Germany may use one UFI (“UFI 1”), while “Product 1” placed on the market in Spain may use another (“UFI 2”).

Language-/label-centred approach

Similar to the market-centred approach, but it also takes into account that the official language of some countries may be the same (e.g. German in Germany and Austria).

Any of the above strategies can be appropriate as long as the following fundamental principle is not violated:

The UFI must be linked to a specific mixture composition and must not be used for mixtures with different compositions (outside the permitted variation ranges).

 

UFI generator – creation of the Unique Formula Identifier

The UFI generator is a web-based application that can be used online in a browser. Its use is free of charge and it is available in all official languages of the European Union.

A UFI code can be generated by providing the company identifier (e.g. VAT number, where available) and a mixture formulation number.

Important!

  • The system does not save generated UFIs automatically; this must be done by the user.
  • A UFI can be created without a VAT/tax number, but this option should only be used if the company does not have such a number.
  • It is recommended to validate the generated UFI (UFI validation) before use.

 

UFI validity

When do you need a new UFI?

In general, if the mixture’s composition changes significantly, a new UFI and an updated (or new) PCN submission are required. If the change remains within the permitted concentration ranges, you can usually keep the same UFI, but a PCN update may still be necessary.

Creation of a new UFI is typically necessary in the following cases:

  • addition, replacement or removal of an ingredient
  • for mixture in mixture (MiM), if the UFI of the MiM changes and this affects your notification obligations
  • a change in composition that exceeds the concentration limits specified in the applicable rules

Examples of concentration change limits that may trigger the need for a new UFI:

Concentration of the component in the mixture (maximum permitted change):

  • 25–100% (±5%)
  • 10–25% (±10%)
  • 2.5–10% (±20%)
  • < 2.5% (±30%)

 

Steps to be taken after creating a new UFI:

  • update of the label
  • update of the PCN submission (as applicable)
  • communication within the supply chain

 

A new UFI is generally not required if:

  • only the trade name of the mixture (product) changes
  • the change only affects fragrances/perfumes in a way that does not trigger a new notification requirement
  • only the packaging changes

Further information regarding the obligation to update the PCN submission

 

Communication within the supply chain

If a downstream user uses a mixture in mixture (MiM) to formulate their own mixture, it is often sufficient (for PCN purposes) to know the MiM’s UFI instead of receiving the full composition of that MiM.

In practice, the full composition of the MiM has usually already been submitted earlier in the supply chain. By using the UFI, the competent authority can identify the relevant composition information in its system. As a result, unnecessary disclosure of confidential information can be avoided.

Therefore, it is important to communicate any changes affecting a mixture’s UFI within the supply chain, because in such cases, parties using that mixture to formulate their own mixtures may need to update their own PCN submission.

Further information regarding other communication obligations can be found here

 

Application of the UFI in the labelling of mixtures

Further information about the placement of the Unique Formula Identifier and about CLP labelling can be found in our article entitled “CLP labelling in practice”.

For mixtures manufactured outside the EU/EEA, the generation and use of the UFI code must be coordinated with PCN submissions for non-EU companies and their EU legal representatives to ensure compliance.

 

Service recommendation

 

Frequently asked questions and answers

What is a UFI and where must it appear?
The UFI (Unique Formula Identifier) is a 16-character code linking a hazardous mixture to its Poison Centre Notification (PCN) submission data. As a general rule, it must be shown on the label (or, for very small packages, immediately next to the label elements). Including the UFI in the SDS (Section 1.1) is recommended, but it is not mandatory in all cases.

Who is responsible for creating and submitting the UFI?
The entity placing the mixture on the market (typically the manufacturer or importer) generates the code using ECHA’s UFI generator and submits the required information via the PCN process to the ECHA Submission portal, in accordance with the applicable rules.

Is a UFI mandatory for mixtures not classified as hazardous?
In general, the UFI and the Poison Centre Notification (PCN) apply to mixtures that are classified as hazardous based on physical and/or health hazards under the CLP Regulation. For mixtures that are not classified as hazardous, a UFI is generally not required.

 

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