EU UFI Generation and Poison Centre Notification (PCN): A Practical Guide

Regulatory Background

On 22 March 2017, the European Commission adopted Regulation (EU) 2017/542, which amended the CLP Regulation (EC No 1272/2008) by introducing Annex VIII. This annex established harmonized requirements for poison centre notifications (PCN), aiming to support emergency health response in the event of exposure to hazardous mixtures.

Under this regulation, all mixtures placed on the EU market that present physical or health hazards must be notified to the relevant national appointed bodies. A key new requirement is the inclusion of a Unique Formula Identifier (UFI) on product labels.

What is a UFI?

The UFI is a 16-character alphanumeric code that uniquely identifies a mixture. It is generated using a company’s VAT number and a specific formulation code. The same UFI can be used throughout the supply chain, provided the mixture’s composition remains unchanged.

The UFI also plays a vital role in safeguarding confidential business information (CBI). Non-EU companies, for example, can appoint an EU-based third party to submit a voluntary PCN, thus keeping the formula confidential while still meeting regulatory obligations.

Note: Although UFIs can be self-generated using online tools, they are only considered valid after the PCN submission is successfully completed and accepted.

PCN Submission Deadlines

PCN deadlines are based on the mixture’s intended use:

• Consumer Use → 1 January 2021
• Professional Use → 1 January 2021
• Industrial Use → 1 January 2024

From 1 January 2025, all hazardous mixtures must be submitted through the ECHA Submission Portal, regardless of their use.

Companies should identify end uses carefully and collect downstream use information whenever possible. If new uses are identified later, the notification must be updated accordingly.

PCN Exemptions

PCN requirements do not apply to:

• Substances (only mixtures are covered)
• Mixtures not classified as hazardous under CLP
• Mixtures classified solely for environmental hazards
• Mixtures used exclusively for R&D or PPORDs
• Gases under pressure
• Explosives (unstable and Class 1.1–1.6)

However, voluntary notifications are encouraged even for exempted products to aid emergency responders and preserve confidential information.

Who Must Submit the PCN?

PCNs must be submitted by the entity placing the hazardous mixture on the EU market, including:

• EU importers
• Downstream users (e.g., formulators)

Distributors who simply store or transport mixtures without altering them are generally not obligated to submit a PCN. However, if a distributor rebrands, repackages, or markets the product in a member state where no PCN has been submitted, they become responsible for the notification.

PCN submitters may also delegate the submission to third parties (e.g., consultants or parent companies), but legal responsibility remains with the actual duty holder.

How to Submit a PCN

The PCN format and submission process have been harmonized across the EU:

• Use the standardized PCN format.
• Classify products using the European Product Categorisation System (EuPCS).
• Submit via the ECHA Submission Portal.

Required Information Includes:

Creating a Valid UFI

UFIs are generated by companies—not assigned by regulators. There are two options:

1. With VAT Number: Use your company’s EU VAT number + a formulation code (0–268435455).
2. Without VAT Number: Select the option “No VAT” and enter only a formulation code.

Both methods are valid as long as the UFI passes validation. The UFI does not need to be tied to a specific legal entity; it remains valid even if corporate structure changes, as long as the formulation is unchanged.

Important: UFIs must be linked to a valid PCN submission. They must not be added to labels unless the PCN has been submitted and accepted.

How to Display the UFI

The UFI must appear on the label of any product containing a hazardous mixture. If no label is used (e.g., industrial use with no packaging), the UFI must be included in the Safety Data Sheet (SDS).

Our Services

REACH24H Ireland offers comprehensive PCN and UFI support services:

• Preparation and submission of PCNs via the ECHA Submission Portal
• Creation and validation of UFIs
• SDS and label authoring in full compliance with CLP Regulation
• Post-PCN updates to SDS/label based on accepted notifications
• Multilingual support (English, Chinese, Japanese)