Starting January 1, 2025, all Poison Centre Notifications (PCN) for hazardous mixtures marketed in the European Union must be submitted in a harmonized format established in Annex VIII of the Classification, Labeling, and Packaging (CLP) Regulation. This change, set forth in Commission Implementing Regulation (EU) 2017/542, marks the end of the transition period, during which importers and downstream users could comply with non-harmonized national requirements.
Table of Contents
End of the Transition Period and New Obligations
Importance of the UFI and Harmonized Format
Steps to Ensure Compliance
Consequences of Non-Compliance
Resources and Official References
Conclusion
1. End of the Transition Period and New Obligations
The flexibility granted to industry players to continue using previous notification systems will end on December 31, 2024. From January 1, 2025, any company marketing hazardous mixtures must:
Fully comply with the requirements of Annex VIII of the CLP.
Update their notifications if they do not meet the harmonized format.
Include a Unique Formula Identifier (UFI) on the product label to improve traceability and accuracy in emergency situations.
Notifications that do not conform to these new provisions will be considered non-compliant with EU law, potentially resulting in penalties and market restrictions.
2. Importance of the UFI and Harmonized Format
The UFI (Unique Formula Identifier) is a 16-character alphanumeric code that enables Toxicology Information Services (Poison Centers) to quickly identify the exact composition of a mixture. This streamlines response times in cases of exposure or poisoning, benefiting both consumer health and worker safety.
Advantages of a Harmonized Notification Format
Greater clarity for authorities: Reduces errors and data duplication.
More effective emergency management: Uniform information enhances cross-border cooperation within the EU.
Simplified compliance: A single format for all EU Member States, making it easier for companies operating in multiple markets.
3. Steps to Ensure Compliance
To comply with the new PCN requirements, companies should follow these steps:
Internal product audit: Review all marketed hazardous mixtures and verify compliance with Annex VIII requirements.
Generate or verify the UFI: Each mixture must have a unique UFI. It is advisable to integrate UFI management into internal traceability systems.
Prepare documentation: The harmonized format requires details on physicochemical properties, relevant components, and hazard classification.
Use the ECHA portal: The European Chemicals Agency (ECHA) provides an electronic portal to facilitate the preparation and submission of PCN notifications.
Train personnel: Ensure that teams responsible for notification management understand the regulation, deadlines, and official tools.
4. Consequences of Non-Compliance
Companies that fail to transition before 2025 may face:
Inability to market their hazardous mixtures in certain EU markets.
Fines and penalties imposed by competent national authorities.
Reputational damage and loss of trust from customers and business partners.
Proper adaptation to the regulation not only prevents legal risks but also enhances safety and strengthens brand reputation.
5. Resources and Official References
For detailed information on the Poison Centre Notification (PCN) requirements and UFI creation, consult the following official sources:
CLP Regulation (EC) No. 1272/2008 – EUR-Lex (English version)
Commission Implementing Regulation (EU) 2017/542 – EUR-Lex (official text)
European Chemicals Agency (ECHA): PCN Submission Portal
ECHA Guide for UFI Creators – Official ECHA Website
6. Conclusion
The January 2025 deadline marks a significant milestone in the EU regulatory framework for chemical products.
With the adoption of the harmonized format under Annex VIII of the CLP Regulation, companies will strengthen public health protection and environmental safety while ensuring the legal security of their operations. It is crucial for businesses to review their notification and labeling procedures and to correctly create and implement UFIs.
Timely compliance not only mitigates risks and sanctions but also enhances corporate reputation and promotes excellence in hazardous mixture management.
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