Annex VIII to CLP Regulation: Understanding Your Obligations for Poison Centre Notifications (PCN)

In March 2017, Annex VIII to the CLP Regulation was introduced to harmonise the poison centre notification (PCN) process across EU Member States. This harmonised system became fully effective in January 2021 (extended from January 2020).

Who is concerned?

All importers and downstream users placing hazardous mixtures (classified for health and/or physical effects) on the EU market must provide specific information about their mixtures to the centralised EU poison centre before placing them on the market.

Key obligations

To comply with Annex VIII, companies must:

• Register a Unique Formula Identifier (UFI)

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

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

They must also submit a notification via the ECHA harmonised submission portal, including:

• The full chemical composition of the mixture

• Toxicological information (SDS Section 11)

• The product category (according to the EU Product Categorisation System – EUPCS)

• The SDS and label in the national language of the country where the product is placed on the market

• The UFI, a 16-character alphanumeric code that uniquely identifies the mixture and can be generated using ECHA’s UFI Generator

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Who holds the obligation?

The obligation lies with the EU legal entity (importer or downstream user).A non-EU supplier cannot fulfil this requirement on behalf of the EU-based duty holder.However, a duty holder can entrust a third party, such as CEHTRA, to prepare and submit the PCN notification on their behalf.

Compliance timeline

Depending on the use of the mixture, the following deadlines apply:

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

• Hazardous mixtures for industrial use: from 1 January 2024

• Existing mixtures already notified under national systems: by 1 January 2025

  
  

How CEHTRA can support your PCN compliance

CEHTRA provides a full range of regulatory support services to help you ensure compliance with Annex VIII requirements:

• Portfolio Review

  Screen your portfolio to identify mixtures that require PCN and determine notification deadlines.

• Safety Data Sheet and Label Review

  Perform a full compliance review of SDSs and labels to ensure they meet CLP and Annex VIII requirements.

• PCN Preparation and Submission

  Prepare and submit PCN notifications via the ECHA submission portal.

• UFI Generation

  Screen for full notification information and generate UFI codes for each mixture.

• Regulatory Advice

  Offer tailored regulatory advice on how best to fulfil your obligations under the CLP Regulation.

With CEHTRA’s expertise, you can achieve and maintain full compliance with EU poison centre notification requirements efficiently and confidently.

Contact our expert