A product may have a CLP label and an EU-format SDS yet still fail market-entry checks because of one 16-character code: the unique formula identifier, or UFI.

In an exposure emergency, the UFI links the product name to composition and toxicological information submitted for poison-centre response. It is not simply another label number.

UFI is not a stand-alone registration

A complete process normally includes generating a UFI, preparing a poison centre notification (PCN) dossier under CLP Annex VIII, submitting valid information for the relevant Member States, applying the UFI correctly, and maintaining the notification when the product changes. Printing an unnotified UFI on the label does not create compliance.

Which mixtures are normally in scope?

The key questions are whether the product is a mixture, whether it is classified for health or physical hazards under CLP, and whether it is placed on the EU/EEA market. Mixtures classified only for environmental hazards, non-hazardous mixtures and substances are generally outside the mandatory Annex VIII notification scope. Specific exemptions and special rules may apply.

Harmonised requirements applied to consumer and professional mixtures from 2021 and industrial-use mixtures from 2024. The transitional period for old national submissions ended on 1 January 2025.

Who is responsible?

EU importers and downstream users formulating or reformulating mixtures are common duty holders. The revised CLP also gives distributors direct duties in certain cross-border, rebranding and relabelling situations where they cannot demonstrate that the relevant appointed bodies already received the same information.

A non-EU supplier normally cannot replace the legal responsibility of the EU importer merely by submitting from abroad. A voluntary submission through an EU-based entity and a mixture-in-mixture UFI (MiM UFI) may protect confidential upstream composition while allowing the importer to reference it. Contracts should define who submits, which countries are covered, which trade names and UFIs are used, and how changes are communicated.

What information is needed?

A PCN dataset commonly includes submitter and emergency contacts, trade names, UFI, CLP classification and label elements, packaging, colour and physical state, pH, intended use, toxicological information and sufficiently detailed composition. The intended use must be mapped to an appropriate EuPCS category.

Do not simply copy SDS Section 3. An SDS may lawfully omit some non-hazardous components or use broad ranges, while Annex VIII requires composition data at specified precision. Mixture-in-mixture ingredients require adequate information or a valid MiM UFI covering the target Member State.

Where should the UFI appear?

For packaged hazardous mixtures in scope, the UFI normally appears clearly and durably on the label or inner packaging as “UFI: XXXX-XXXX-XXXX-XXXX”. For mixtures used exclusively at industrial sites, it may be placed in SDS Section 1.1 instead of on the label. Unpackaged mixtures have special arrangements.

Can one composition have several UFIs?

Products with exactly the same composition may share a UFI even when names or pack sizes differ. A company may also assign different UFIs to one composition for brand or market management, provided each code is properly covered. Different compositions must never share one UFI.

Changes beyond permitted Annex VIII limits, or adding, removing or replacing a component, may require a new UFI and notification update. Trade name, packaging, use, classification, toxicology or contact changes may also require an update even when a new UFI is not needed.

Six frequent export errors

• Generating a UFI without submitting a valid PCN.
• Assuming one Member State submission automatically covers the entire EU.
• Allowing the notified composition to drift from production.
• Using inconsistent trade names across the label, SDS and PCN.
• Treating SDS Section 3 as the complete PCN composition.
• Ignoring language, fee and national receiving arrangements.

Official references

ECHA: Generate and apply the UFI

ECHA: Poison Centre Notifications Handbook

EUR-Lex: Regulation (EU) 2024/2865

Related services: Anjian supports CLP classification, SDS and label review, and UFI/PCN data preparation. Visit our SDS FAQs or contact us.

Disclaimer: This article is general compliance information and not legal advice. Assess the product classification, use, target Member States, supply-chain role and current authority requirements before submission.