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.
Compliance Steps for PCN Requirements:
1. Notification Responsibilities
- 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.
- Notification Scope: All mixtures with health or physical hazards, including biocides and plant protection products. Articles may need specific assessments.
- 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
- Submitter Details: Include company name, address, contact, VAT number.
- Product Details: Target market, name, application, downstream use, packaging.
- Mixture Details: Name, state, color, pH, composition, classification, labeling, toxicology.
- 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.
Further Information
