ECHA's Pilot Project Reveals Critical Gaps in Poison Centre Notification

If your company manufactures, imports, or distributes hazardous mixtures in the EU, you are subject to the Poison Centre Notification (PCN) requirement. The European Chemicals Agency (ECHA) conducted an enforcement pilot project where inspectors across 18 EU and EEA countries reviewed 1,597 hazardous mixtures placed on the market. They found critical gaps such as:

• 19% of hazardous mixtures placed on the market had not been notified to the relevant poison centres as required. 
• 15% of product labels were missing a unique formula identifier (UFI)
• 250 reported mixtures did not have a UFI present
• Inconsistencies between submitted PCN data, labels, and safety data sheets (SDS).

The CLP Art. 45, Annex VIII (Poison Centre Notification) has been in force for several years. Following the pilot project, the results suggest that compliance is far from a solved problem, and enforcement is likely to intensify.

Why One-Time Notification Isn't Enough

While the majority of hazardous mixtures had an existing PCN submission, the pilot project revealed many inconsistencies. Inspectors found mismatches between PCN submissions, product labels, and safety data sheets. Most commonly, UFIs on labels did not match those in the notification. 

This points to a common misconception: that PCN is a one-time submission. It is not.

Notifications must be kept current whenever a relevant change occurs, such as:

• Product identifier or UFI changes: changes to the trade name, brand, and product identifiers, or the UFI
• Classification changes: changes to the mixture's classification for health or physical hazards
• New toxicological information: changes to toxicological information required in Section 11 of the SDS of the mixture or its components
• Composition changes: changes to the composition of a notified mixture as defined in Annex VIII
• Other changes relevant for emergency health response: for example, contact details, product category, packaging details, component classifications, if relevant for emergency health response

PCN compliance is therefore a continuous process. Keeping submissions, labels, and safety data sheets aligned over time requires ongoing monitoring that manual processes rarely sustain.

How opesus PCN Helps SAP Users Stay Compliant

For companies running SAP Product Compliance, the opesus Poison Center Notification solution closes the gaps the ECHA pilot exposed through the following capabilities:

• Scope assessment: Integrated into your sales process, the solution identifies hazardous mixtures in your SAP system that are in scope for PCN and submits them automatically to the ECHA submission portal.
• Change management: Relevant changes -- for example to product identifier, UFI, formulation, classification, or toxicological information -- are automatically identified, and updated PCN notifications are submitted, turning a manual process into a system-driven workflow.
• PCN Worklist: An overview of every submitted notification, pending update, and outstanding action.
• ECHA portal integration: System-to-system integration with the ECHA Submission Portal removes manual re-keying and the errors that come with it.

Bonus: 5 Questions to Check Your PCN Compliance

Use the following questions as a quick self-assessment. If you cannot answer "yes" to all five with documented evidence, there is likely a gap in your process. Contact us!

1. Scope: Have all relevant hazardous mixtures in your portfolio been assessed for PCN obligations, and is that assessment documented?
2. Notifications: Where notification is required, are submissions in place, and are the resulting PCN numbers and dossiers stored securely?
3. Consistency: Do the UFI, label content, and safety data sheet for each product match the notification?
4. Change management: When products are updated, or when there are formulation or supplier changes, are they systematically flagged for PCN review?
5. Audit readiness: Can you demonstrate compliance with a clear audit trail of submissions, updates, and approvals?

Conclusion

ECHA's pilot found that 19% of inspected hazardous mixtures had not been properly notified, and that many of those that had been notified did not match their own labels or safety data sheets. It is reasonable to expect enforcement activity to intensify in the wake of the project, with national authorities now better equipped to identify non-compliance.

The takeaway is straightforward: treat PCN as an ongoing compliance process, not a one-off submission. Companies that have already invested in automated monitoring and integrated submission workflows are positioned to absorb tighter enforcement without disruption. Those still managing PCN through spreadsheets and email threads face materially greater risk.

To see how opesus Poison Center Notification works within SAP and closes the gaps identified by the ECHA pilot, get in touch with our team for a tailored walkthrough.