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  • Regulatory Update

The Unique Formula Identifier (UFI): Poison Centre Notification

Man with vial in glass containment

September 1, 2020

What is a UFI number?

UFI stands for Unique Formula Identifier. It forms part of the poison centre notification (PCN) which is an obligation under Annex VIII to CLP, where importers and downstream users need to provide information to Member State appointed bodies relating to emergency health response for products placed on the market. The UFI provides an unambiguous link between the information in the PCN and the product placed on the market. By 1st January 2025, the UFI will be mandatory on the label of all mixtures placed on the market and classified for health and/or physical hazards.

16 digit alpha-numeric code Example: UFI VV53-41GU-X00E-G0K8
4 hyphenated blocks
Letters in uppercase
Preceded with “UFI”

How to generate and assign a unique formula identifier

A single UFI must represent one unique formulation or product composition. A single mixture composition may possess multiple UFIs, however multiple mixture compositions may not possess the same UFI.

Companies will need to generate their UFIs using the UFI generator. This can be done via the ECHA online tool, a third party software provider or an internal system. Two numbers are required to generate a UFI: 1) VAT number (or a “company key” in certain cases) and 2) internal formulation number (number between 0 and 268 435 255); this will ensure there is no duplication across companies.

UFI as hazard identification

The UFI shall be printed or affixed on the product label. It can also be printed or affixed on the inner packaging provided it is in close proximity to the other labelling information. It is not necessary to include the UFI on each layer of packaging, which is in derogation from Article 33 of CLP. If it is impossible to include the UFI on the inner packaging due its shape or size, the UFI can be printed or affixed on the outer packaging, located with the other label elements. The UFI itself shall be preceded by the acronym “UFI” followed by a colon (“UFI:”).

Do I need to put the UFI on the SDS?

For mixtures which are unpackaged, the UFI shall be indicated in the SDS or alternatively included in the copy of label elements [Article 29(3) of CLP]. For industrial-use mixtures, the UFI may be included in the SDS rather than on the product itself. For all other mixtures, the UFI can be included voluntarily in the SDS. Where the UFI is included in the SDS, it shall be in subsection 1.1.

When does a UFI need updating?

As the UFI represents a unique formulation it will need to be updated if there is a change to the composition. A new UFI is required if one or more component is added, substituted or deleted or if there is a change in the % of a component in the mixture beyond a specified range provided in the original submission. If the UFI gets updated both a PCN submission update and product re-labelling are also required.

Poison Centres: What You Need To Know

For more information about Poison Centres, check out our dedicated Poison Centres Homepage, where you can find the latest resources, including White Papers, FAQs and Expert Articles to help you understand your obligations under Annex VIII. You can also learn more about our expert tools and services to help you meet your compliance requirements.


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