ECHA Enforcement Project: 19% of Hazardous Mixtures Not Notified to Poison Centres

Doruksistem ECHA/NR/26/08: Tehlikeli Karışımların %19’u Zehir Merkezlerine Bildirilmemiş

ECHA Enforcement Project: 19% of Hazardous Mixtures Not Notified to Poison Centres

The European Chemicals Agency (ECHA) has published the results of its pilot enforcement project under reference ECHA/NR/26/08, revealing that 19% of inspected hazardous mixtures were not notified to poison centres across the EU/EEA.

The findings highlight ongoing compliance gaps with obligations established under the Classification, Labelling and Packaging Regulation (CLP Regulation).

Scope of the Enforcement Project

The pilot enforcement project conducted by the ECHA Forum aimed to evaluate industry compliance with Poison Centre Notification (PCN) obligations.

Within the project:

  • Inspectors in 18 EU/EEA countries

  • Evaluated 1,597 hazardous mixtures

  • Verified compliance with poison centre notification requirements

The initiative also aimed to strengthen harmonised enforcement across Member States and increase awareness of regulatory obligations among companies placing hazardous mixtures on the market.

Key Findings

The enforcement project revealed several critical compliance issues:

  • 19% of mixtures were not notified to national authorities.

  • 15% of inspected mixtures lacked the required Unique Formula Identifier (UFI) on product labels.

  • Various enforcement actions were initiated by authorities.

These results indicate that companies must pay closer attention to PCN notification requirements and label compliance obligations.

Poison Centre Notification Requirements Under CLP

Under the CLP Regulation, companies placing hazardous mixtures on the EU market are legally required to submit detailed information about mixture compositions to appointed national bodies via the PCN system.

The submitted data is made available to poison centres to support:

  • Rapid medical response

  • Accurate toxicological assessment

  • Emergency risk management

The notification obligation applies to mixtures classified for:

  • Human health hazards

  • Physical hazards

Examples include mixtures that:

  • Cause skin corrosion

  • Cause serious eye damage

  • Are explosive or otherwise hazardous

Importance of the Unique Formula Identifier (UFI)

The UFI is a 16-character alphanumeric code that uniquely links a mixture’s formulation to its poison centre notification.

The UFI must be included on product labels and plays a critical role in emergency response situations by enabling poison centres to quickly identify the exact formulation involved in an exposure incident.

According to the inspection results, 15% of mixtures did not display the required UFI, potentially delaying emergency medical response.

Enforcement Measures Applied

Where non-compliance was identified, enforcement authorities implemented several corrective measures, including:

  • Written advice

  • Verbal warnings

  • Administrative orders

  • Financial penalties

  • Criminal complaints in severe cases

Some cases remained under follow-up at the time of reporting.

Purpose of the Enforcement Initiative

The enforcement project did not disclose company names or brand details. The main objectives were to:

  • Harmonise enforcement practices across the EU

  • Strengthen regulatory compliance

  • Increase industry awareness

  • Improve the effectiveness of poison centre notification systems

Critical Compliance Considerations for Companies

Companies placing hazardous mixtures on the EU market should ensure:

✔ Accurate hazard classification under CLP
✔ Timely submission of PCN notifications
✔ Proper placement of UFI codes on product labels
✔ Re-notification following formulation changes
✔ Country-specific compliance checks when exporting within the EU

Conclusion

The ECHA/NR/26/08 report highlights significant compliance deficiencies related to poison centre notifications across the EU. PCN submissions and UFI labelling are not only legal obligations but also essential components of public health protection.

Manufacturers, importers, and downstream users must implement proactive compliance strategies to ensure regulatory alignment and minimise enforcement risks when placing hazardous mixtures on the European market.

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