When to update the UFI number?

When is it mandatory to update the UFI number on a chemical product?

Proper management of the Unique Formula Identifier (UFI) is essential for complying with European regulations and ensuring safety in the chemical sector. This code is always linked to a specific composition, allowing each product to be associated with the information required for emergency health response.

Annex VIII of Regulation 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP) establishes that a new UFI must be generated whenever the mixture’s composition changes according to certain criteria. Understanding these cases is key to avoiding penalties and ensuring traceability of chemical products.

When is it necessary to update a product’s UFI?

Below are the main situations in which a new UFI must be generated for chemical mixtures:

1. Changes in the mixture’s composition

• When one or more components that must be included in the notification are added, substituted, or removed.

  It should be noted that, for example, if a component that is not classified for its health or physical effects is modified and is present in a concentration of less than 1%, it is not necessary to create a new UFI.

• Exceptions:
  • It is not necessary to modify the UFI if the change only affects perfumes in group presentations, unless a perfume is removed from all mixtures in the group. If the change only affects components included in an existing Generic Component Identifier (GCI), it will also not be necessary, unless a component is added, replaced, or removed from an existing GCI. However, if a new GCI is added or an individual component is replaced by a GCI, a new UFI must be generated.

2. Changes in concentration outside the declared range

If the concentration of any component exceeds the range declared in the original notification, a new UFI must be generated and the information updated. If the variation stays within the declared range, the UFI does not need to be updated.

3. Changes in concentration outside the permitted limits for exact concentrations

• When a concentration is declared as an exact value, only variations within defined limits are allowed. Exceeding the permitted variation requires a new UFI.
• If the new concentration stays within the permitted variation, the notification can be voluntarily updated without generating a new UFI.

4. Changes affecting standard formulas

If the mixture no longer fits a standard formula as described in Part D of Annex VIII of the CLP (due to addition, removal, or concentration change beyond the allowed range), the UFI and the notification must be updated.

5. Voluntary changes due to business decisions

Even if none of the above conditions apply, a company may choose to change the UFI for internal reasons (e.g., repackaging considered as a new product). In this case, the notification must be updated as if the change were mandatory.

Other specific cases: More detailed cases involving fuels, cements, or concrete can be found in the Guidance on Harmonised Information Relating to Emergency Health Response – Annex VIII to CLP, section 4.2.7 “New UFI as a result of composition changes”.

What about mixture in a mixture (MiM)?

When a raw material is itself a mixture, it is considered a mixture in a mixture (MiM). A change in the UFI of the supplier’s MiM may require updating your notification and, in some cases, the UFI of the final mixture.

• If the change is due to a modification in the composition, the new UFI of the MiM must be reflected in the notification of the final mixture, which means generating a new UFI for the latter.
• If the UFI of the MiM is modified solely for commercial reasons and the composition does not change, it is not necessary to change the UFI of the final mixture.

What should be considered to ensure compliance and improve traceability?

To remain compliant and improve traceability, it is advisable to always consult Annex VIII of the CLP Regulation and the ECHA guidance before making any product modifications. It is essential to keep notifications updated in ECHA’s PCN portal and ensure that the UFI is correctly displayed on the label.

With Chemeter, UFI management is handled automatically, generating the code within the product documentation. Its dedicated module, designed to meet the requirements of Regulation 2017/542, enables the preparation and submission of harmonised notifications in PCN format automatically using the S2S system. These features optimize the control and updating of the entire product catalogue, simplifying legal compliance and streamlining internal processes.