EU Poison Centre Notifications (PCN) – A Compliance Guide for Businesses

Ensuring the safe handling of hazardous mixtures is a top priority in the European Union (EU). Poison Centre Notifications (PCN) play a crucial role in this effort, requiring companies to provide critical information about hazardous mixtures placed on the EU market. Understanding these obligations is essential to maintaining compliance and avoiding penalties.

What is a PCN and Why is it Important?

A PCN is a regulatory requirement under the EU’s Classification, Labelling and Packaging (CLP) Regulation. Since January 1, 2025, manufacturers, importers, and downstream users must submit specific information on hazardous mixtures to designated Poison Centres.

This submission includes detailed information on the mixture’s composition, toxicological profiles, and appropriate emergency measures. Providing accurate information ensures emergency responders can offer precise medical advice in cases of exposure, thereby protecting public health and the environment.

Who Must Comply with PCN Requirements?

Businesses involved in the formulation, import, or distribution of hazardous mixtures within the EU must comply with PCN obligations. This includes:

• Manufacturers and importers placing hazardous chemical mixtures on the EU market;
• Downstream users who modify or repackage hazardous mixtures; and
• Distributors who alter the composition or labeling of a mixture.

How to Submit a PCN

If a product falls under the scope of a PCN submission, you must collect all the necessary data, including chemical composition, toxicological information, and Unique Formula Identifier (UFI). This information must then be submitted to ECHA via its Poison Centre Notification Portal.

The submission must be completed before the product is placed on the market. The new format for notification is harmonized and follows the structure defined by the latest GHS/CLP revisions.

If changes are made to the formulation, classification, or trade names then an updated submission is required.

What Are the Consequences of Non-Compliance?

Failure to comply with PCN obligations can result in enforcement actions, including fines and product withdrawal from the market.

Each member state is responsible for enforcement, with all penalties and fines determined and imposed by the member state’s national enforcement authorities.

Non-compliance can lead to market access restrictions, preventing the sale of non-compliant products. It could also damage a company’s reputation, affecting business relationships and consumer trust.

What is the Situation in Great Britain?

Following Brexit, Great Britain (England, Scotland, and Wales) is no longer part of the EU PCN framework. Instead, businesses must comply with UK REACH and notify the Health and Safety Executive (HSE) about hazardous mixtures under separate requirements.

When the GB CLP regulation was authored, Great Britain copied most of the regulation directly from the existing EU CLP. This meant that Annex VIII (which contains the requirements for PCN) was unintentionally included, making it law. However, due to significant industry backlash, the authorities have stated it is a voluntary requirement.

You can choose to put a UFI code on your product in Great Britain but it must be for a GB poison centre, not an EU poison centre. Please note, that choosing to include a GB UFI code will not lead to a non-classification.

While the principles remain similar, companies placing products on both the EU and UK markets must ensure they fulfil both sets of obligations.

How the CIRS Group Can Help

Navigating PCN compliance can be complex, but the CIRS Group provides expert support to help businesses meet their obligations efficiently.

Our services include:

• Regulatory Consultation: Clarifying PCN requirements and applicability to your products.
• PCN Submission Assistance: Preparing and submitting notifications via the ECHA Portal.
• Compliance Strategy for EU and UK Markets: Ensuring your products meet both the EU and GB requirements.
• Ongoing Compliance Monitoring: Keeping you informed on regulatory changes and necessary updates.

By partnering with the CIRS Group, businesses can confidently achieve compliance, protect public health, and maintain seamless market access. Contact us today to ensure your PCN obligations are met efficiently and effectively via service@cirs-group.com.