Poison Centre notifications must be in PCN harmonised format as of 1 January 2025
PCN harmonised format. As we approach the close of the transition period, a significant change is looming for companies placing hazardous mixtures on the European Union market. Starting January 1, 2025, all poison center notifications will be required to adhere to the standardized format outlined in Annex VIII of the Classification, Labeling, and Packaging (CLP) Regulation.
This shift marks the end of an era where companies could utilize varying national requirements for their hazardous mixtures. Post-transition, any notifications that do not conform to the harmonized format will be deemed non-compliant with the CLP Regulation. Therefore, companies that have previously notified mixtures under the transitional procedures must re-notify them according to the harmonized format. The deadline is December 31, 2024.
For companies seeking to continue marketing these mixtures beyond January 1, 2025, a mandatory step involves submitting a new notification that aligns with Annex VIII’s specifications before that date. Additionally, the unique formula identifier (UFI) must be prominently displayed on the product label.
To streamline the process and ensure accuracy, the European Chemicals Agency (ECHA) strongly encourages notifiers to leverage their submission portal for preparing and submitting information in the harmonized format. This proactive approach will help companies navigate the upcoming regulatory changes seamlessly.
What is PCN harmonised format?
The Poison Centre Notification (PCN) format structures information on mixtures classified for health or physical hazards in accordance with Article 45 and Annex VIII to the CLP Regulation.
This format is XML-based, compatible with IUCLID, and available in the PCN dossier preparation tools offered by ECHA. It is also available for companies to prepare their own tools for dossier preparation, for example when using the system-to-system service.
The PCN format is updated annually in line with the IUCLID release schedule. This format is made available as a set of XML schema definition files (XSDs). The PCN data model shows all relevant fields and their interconnections.
Remember that ECHA’s inspectors are going to focus on Poison Centre Notifications validation, and they will start in January 2025. More information here: ECHA’s inspectors are going to focus on Poison Centre Notifications
Do you need support for preparing your Poison Centre Notifications? Nordiik can help you, contact us!
Source: PCN Portal
Image: Nordiik
