New PCN notification obligations for distributors 

New PCN notification obligations for distributors 

New PCN notification obligations for distributors 

The CLP Regulation requires all supply chain entities to comply with the provisions of Annex VIII to the CLP Regulation when placing a hazardous mixture on the market. The recently revised Classification, Labelling and Packaging (CLP) Regulation clarifies distributors’ obligations to notify Poison Centers of mixtures classified as hazardous.  

WHO? 

Any entity that: modifies the product labeling; changes packaging or making confection; rebranding; sells the product at retail, including selling the product by the Internet.  

WHAT TO DO? 

Distributors must ensure that the hazardous mixture has been reported to the appropriate poison centre. The product must be notified in each Member State where the mixture is placed on the market. If the distributor has made sure that all the required information has been reported by upstream users in the supply chain, he is exempt from the obligation to provide the same information to the poison centre concerned. 

WHAT IF NOT NOTIFIED?  

If: 

  • the hazardous mixture notification has not been submitted at all; 
  • the mixture has not been declared in the Member State where the mixture is placed on the market; 
  • the label contains new product identifiers, e.g. a different UFI code 

Then: 

  1. The distributor must ask upstream users in the supply chain to make a new notification or update the existing one. He must provide the original notifier with all the necessary information to be included in the poison centre notification. A confirmation of notification or update by the notifier must be received to meet the ‘make sure’ requirement. 
  1. If the distributor does not have knowledge or confirmation that the mixture he is placing on the market has been correctly notified or updated, he must submit his own notification to the appropriate national poison centre. 

In addition to the changes within the notification authorisation holders, the new CLP regulation clarifies that companies must update their notifications in the Poison Center and include all the information necessary to respond to health emergencies. These changes concern for example: contact details, changes in product classification, toxicological data in section 11 of the safety data sheet, as well as changes in the type of packaging or change in the EuPCS product category.  

In 2025, the European Chemicals Agency is expected to publish guidelines on updating hazardous mixtures notifications at the Poison Center. 

Ekotox: https://ekotox.eu/chemicals-management/