Poison Centre Notification: format and validation rule updates

What changed

ECHA's Poison Centre Notification (PCN) format is the XML-based format used to structure notifications for hazardous mixtures under Article 45 and Annex VIII of the CLP Regulation. It is built into IUCLID and is also used by companies that prepare dossiers through system-to-system tools.

PCN format Version 8 was updated on 27 April 2026 and released alongside IUCLID 6 version 10. The package includes XSD and Word files for the format elements, a comparison against version 7.0, XML and Excel picklist values, and a change log. ECHA updates the PCN format annually in line with the IUCLID release schedule.

Legal status

This is a format and validation update, not a new CLP legal obligation by itself. It matters because, since 1 January 2025, all Poison Centre Notifications for hazardous mixtures placed on the EU market must be submitted in the harmonised Annex VIII format — national notification routes are no longer available.

Companies using IUCLID, the ECHA Submission Portal, or system-to-system PCN generation tools need to keep their internal dossier logic compatible with the current PCN format and validation rules.

Why this needs attention

PCN compliance failures are now an active enforcement issue. ECHA's 2026 pilot enforcement project inspected 1,597 hazardous mixtures across 18 EU/EEA member states (January–June 2025) and found that 19% had no PCN submitted at all, and 15% of labels were missing the UFI.

For companies, the key risk is no longer only "did we create a UFI?" but:

Is the UFI linked to the correct composition, dossier, market country, product identifier and label?

ECHA also flags a common mistake: the UFI must be included in a valid Poison Centre Notification before the product is placed on the market, and it must appear on the label (or, in specific cases, in SDS Section 1.1) as "UFI:" followed by the identifier.

Compliance impact

This update can affect:

• PCN XML generation
• IUCLID dossier creation
• System-to-system submission interfaces
• Picklist values and validation rules
• UFI/composition consistency
• Market-country notifications and group submissions
• SDS and label consistency
• Internal PCN quality checks

A technically valid SDS is not enough if the PCN dossier is missing, rejected, outdated, or linked to the wrong UFI.

Recommended actions

Format readiness

• Download PCN format Version 8 and compare it against Version 7.0.
• Update internal PCN data models, XML mappings and picklist values.
• Validate system-to-system exports against the new XSD files, and test dossier generation in IUCLID or the ECHA Submission Portal before production submission.

Validation rule control

• Run test submissions with representative mixtures and capture new validation errors and warnings.
• Classify each issue (blocking error, warning, business-rule issue, data-quality issue) and update internal pre-submission checks accordingly.
• Prevent submission of dossiers with unresolved blocking validation errors.

UFI and composition governance

• Apply the rule: one UFI = one composition.
• Link each UFI to its exact formulation, product identifier, legal entity, market country, notification status, label artwork and SDS version.
• Set a change trigger for composition changes, concentration-range changes, classification changes, product-name changes, new Member State placement, or legal-entity changes.
• Do not release a UFI on a label unless the corresponding PCN is valid.

SDS and label alignment

• Verify SDS Section 1.1 product identifiers and trade names match the PCN dossier, and that SDS Section 2 classification matches the notified hazard information.
• Confirm the UFI printed on the label matches the notified UFI, and check Member State language requirements.

Multi-country market control

• Map every hazardous mixture to the Member States where it is placed on the market, confirm notification acceptance per country, and block market release where a country notification is missing or rejected.