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EU Poison Centre Notification (PCN)

Annex VIII to CLP regulation was released in March 2017 to harmonise the variations between poison centre notifications among members states and the new harmonised system became effective from January 2021 (extended from January 2020).

Importers and downstream users placing hazardous mixtures (with a health and/or physical effect classification) on the EU market are to provide specific information on your mixtures to the centralized EU poison centre before placing theses mixture on the market.

They will have to:

  • Register a unique formula identifier (UFI),

  • Include the UFI on the label for professional and consumer use,

  • Include the UFI in section 1.1 of the Safety Data Sheet (SDS) for industrial use.

 

Provide and submit to the ECHA harmonised submission portal:

  • The full chemical composition of the mixture

  • Toxicological information of the mixture (SDS Section 11)

  • Product category (according to the new EU product categorization system EUPCS)

  • The safety data sheet and label in the country’s language

  • The UFI (a 16-character alphanumeric code that uniquely identifies a formula (mixture composition) in the EU and can be generated on the UFI generator ECHA created)

The obligation lies with EU Legal entity (non-EU supplier of the mixture cannot replace the EU-based duty holder). A duty holder can entrust a third party (e.g. CEHTRA)

to complete the PCN on their behalf.

Importers and downstream users placing mixtures on the market not already notified under national legislation must comply with Annex VIII of the Regulation from the following dates:

  • Hazardous mixtures for consumer and professional use: January 1, 2021

  • Hazardous mixtures for industrial use: January 1, 2024.

  • If the mixture is already on the market and already notified to the local poison centre of the Member State, the date of compliance is 1st January 2025.

 

As an Importer or a downstream user placing hazardous mixtures (with a health and/or physical effect classification) on the EU market you need to provide specific information on your mixtures to the centralized EU poison centre before placing these mixtures on the market –

known as PCN notification/s.

 

CEHTRA can support as a third party representative to assist in these requirements.

Meet our expert

Key Services

Portfolio Review

Review Safety data sheets and labels

Prepare and submit PCN notification

Regulatory support

Screen your Portfolio to identify mixtures that require PCN and notification deadlines

Full compliance review of SDS and labels

 Screen for full notification information and generate UFI codes

Offer regulatory advice on how best to fulfill obligations