PCN Transition Period Ending Soon

In October 2024, the European Poison Centre (PCN) reminded businesses that the transition period (January-December 2024) is concluding. After December 31, 2024, all hazardous mixture submissions must comply with CLP regulations. Companies must submit new notifications per Annex VIII and include a Unique Formula Identifier (UFI) on product labels to enhance safety and transparency. The European Chemicals Agency (ECHA) recommends using its Submission Portal for standardized submissions.

Poison centre notifications must be in harmonised format as of 1 January 2025

The end of the transition period for poison centre notifications is approaching. This means that all notifications for hazardous mixtures placed on the EU market must be in the harmonised format according to Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation from 1 January 2025.

The transition period has allowed companies to continue placing their hazardous mixtures on the market according to non-harmonised national requirements. From 1 January 2025, these submissions will no longer comply with the CLP Regulation.

If companies intend to keep placing these mixtures on the market after this date, they will have to submit a new notification as required by Annex VIII and include the unique formula identifier (UFI) on the label. ECHA recommends notifiers to use the ECHA Submission portal to prepare and submit their information in the harmonised format.

Compliance Steps for PCN Requirements:

1. Notification Responsibilities

1. Who Must Notify: EU-based importers and downstream users of hazardous mixtures. Exemptions include manufacturers and distributors of pure substances; non-EU suppliers cannot replace EU responsible persons.
2. Notification Scope: All mixtures with health or physical hazards, including biocides and plant protection products. Articles may need specific assessments.
3. Exemptions: Mixtures only classified for environmental hazards, radioactive, under customs control, for R&D, pharmaceuticals, cosmetics, medical devices, foods, feeds, pressurized gases, and explosives.

2. Information Preparation

1. Submitter Details: Include company name, address, contact, VAT number.
2. Product Details: Target market, name, application, downstream use, packaging.
3. Mixture Details: Name, state, color, pH, composition, classification, labeling, toxicology.
4. UFI: Generate using the company’s VAT and mixture formula number, to be displayed on labels.

3. UFI Creation and Labeling

Create the UFI via the ECHA’s online tool and ensure it’s on the label.

4. Update SDS

Adjust Safety Data Sheets to reflect accurate formula and toxicological data as per PCN requirements.

5. Dossier Submission

Prepare and submit the notification dossier using IUCLID format through the ECHA’s portal.