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Poison Centre Notification: stricter requirements ahead – what you need to know
The EU has strengthened chemical safety rules with new requirements for Poison Centre Notifications (PCNs). From 2025, businesses must submit detailed mixture data to ensure faster, more effective emergency responses. What are the latest developments? By Adam Hembrecht, CIRS
In an ongoing effort to strengthen chemical safety and facilitate faster emergency responses across Europe, the European Union has introduced updated requirements under the Classification, Labelling and Packaging (CLP) Regulation, aligned with the Globally Harmonised System (GHS) of chemical classification.
One of the key developments in this area is the enhanced Poison Centre Notification (PCN) process. These changes are designed to ensure that national Poison Centres have quick access to detailed information about hazardous mixtures, improving their ability to provide life-saving advice in the event of exposure incidents.
What’s new?
As of 1 January 2025, all businesses that manufacture or import hazardous mixtures into the EU market will be legally required to submit a Poison Centre Notification. This applies not only to chemicals used in industrial settings but also to everyday consumer products such as cleaning agents, paints, and adhesives.
The notification must include detailed data on the mixture’s full composition, toxicological profile, and appropriate first aid and emergency measures. This ensures that medical professionals and first responders can quickly assess the risks and act accordingly during emergencies.
Key requirements
1. Who needs to comply?
– EU-based manufacturers and importers of hazardous mixtures are directly responsible for submitting Poison Centre Notifications.
– Non-EU suppliers may make voluntary submissions via an appointed EU-based representative. This allows them to share sensitive formulation data directly with authorities while maintaining commercial confidentiality.
– Re-branders and re-labellers of hazardous mixtures are also considered “duty holders” under the regulation. They must either submit their own notifications or ensure that the supplier includes their product data in the original Poison Centre Notification submission.
– Notifications must be submitted to the relevant authorities in each EU Member State where the product is marketed.
2. What needs to be submitted?
– 100 % chemical composition of the mixture, including all components present in the mixture and their respective concentrations.
– Toxicological information, indicating the health effects of the mixture and necessary emergency responses.
– Product identifiers, including the trade name, product category, packaging types, and the Unique Formula Identifier (UFI) – a 16-character alphanumeric code that links the product to its exact formulation.
– Intended uses, using the European Product Categorisation System (EuPCS).
3. New notification process
– All submissions must be made through the European Chemicals Agency (ECHA) Submission Portal, which centralises and standardises the process across the EU.
– The notification must be submitted before the product is placed on the market.
– The notification format is harmonised in line with the latest revisions of the CLP Regulation and GHS, ensuring consistency in data across all Member States.
4. Deadlines
– The deadline for products already on the market prior to the regulation’s enforcement is 1 January 2025.
– For all new mixtures placed on the market from this date onward, the Poison Centre Notification must be completed and submitted prior to market entry.
5. Impact on labelling
– Once a Poison Centre Notification is submitted, the product label must include the UFI code and relevant emergency contact information.
– Any updates to the product formulation will require a new UFI and an updated Poison Centre Notification, and the product labelling must be revised accordingly.
Why is this important?
– By harmonising Poison Centre Notification requirements across Europe, the EU aims to improve response times and outcomes in chemical emergencies. These measures not only protect human health but also ensure regulatory compliance, reducing the risk of enforcement actions or product recalls. In addition, aligning with international standards under GHS enhances trust and facilitates trade across borders. Companies that comply demonstrate a commitment to product stewardship and consumer safety.
