The UFI/PCN Notification seen from outside the EU.

UFI/PCN through the eyes of a supplier from outside the EU

The new rules for placing hazardous mixtures on the EU market require the label to be supplemented with the Unique Formula Identifier (UFI). Notifications to national poison centers must be made using the newly implemented PCN portal, based on the harmonized content and format described in ANNEX VIII of the CLP Regulation. This information on this page specifically outlines the responsibilities and implications for non-EU suppliers with an EU legal entity, or EU distributors of products from outside the EU. It also provides a solution for products that are directly sold on the market by non-EU suppliers without an EU legal entity or distributor.

Note: The CLP Regulation (including ANNEX VIII) applies to the EEA: EU + Iceland, Liechtenstein, and Norway.

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According to Annex VIII of the CLP Regulation, the non-EU supplier is never the responsible party for PCN notification in the EU.

Import into the EU: The importer is the official EU responsible party, but still requires information from the non-EU supplier to comply with Annex VIII of the CLP.

Export to the EU: The non-EU supplier needs a contract with a legal entity in the EU. The EU legal entity in this case becomes the official responsible party, but still requires information from the non-EU supplier to comply with Annex VIII of the CLP.

Negative consequences for sales

A non-EU supplier is not responsible for a PCN notification in the EU. However, the EU-responsible party that receives/distributes/sells the products still requires information that only the non-EU producer/supplier can provide, such as information on the composition of the product.

As a non-EU producer/supplier, this is usually not information that you want to share with customers or even distributors. On the other hand, you must provide certain information to prevent your product from becoming unsellable in the EU.

Providing information in an initial PCN notification is not possible because only EU-based entities have access to the PCN portal.

Solution: Voluntary Notification

The solution in this case is to submit a voluntary PCN Notification through a trusted third party in the EU, such as the ViB factory. The SDS factory has no role in the supply chain and can register products with the PCN Portal as a voluntary PCN Notification under confidentiality. The EU customer/distributor can then link their own notification to this voluntary notification.

  • The EU-responsible party does not gain access to the information in the initial PCN Notification.
  • The composition remains unknown in the supply chain and is only shared with the competent authorities under confidentiality.
  • Linking a Notification creates the opportunity for Poison Control Centers to find the required information in the initial submission in case of an emergency.
  • Products can continue to be traded/sold in the EU.

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