PCN Portal (Poison Centre Notification)
The PCN Portal is the harmonised platform for submitting information on hazardous mixtures, as required by Annex VIII of the CLP Regulation. It enables fast access to critical product composition details for poison centres and healthcare professionals in emergencies.
EU Regulation 2020/1677 – PCN Portal Requirements
The obligation to notify hazardous mixtures placed on the EU market stems from Article 45 of the CLP Regulation (EC) No 1272/2008. Products classified as hazardous to health or physical hazards must be reported to the relevant authorities designated by individual Member States.
Annex VIII to the CLP Regulation introduces a harmonized format for the submission of information by importers and downstream users to poison centres.
General Requirements
Notifications must be submitted by manufacturers, importers, and downstream users. In some cases, distributors who place hazardous mixtures on the market are also responsible. Mixtures that only pose environmental hazards are exempt from PCN obligations.
PCN notifications must comply with harmonised content requirements based on the mixture’s use type:
- Consumer and professional use – from 1 January 2021
- Industrial use – from 1 January 2024
The transitional period for mixtures already on the market before 1 January 2021 (and notified in national systems like ELDIOM) ends on 31 December 2024.
Information Required (Annex VIII)
- Product identifier
- Submitter’s contact information
- Exact mixture composition and component details
- EuPCS category
- Hazard classification and labelling elements
- Toxicological information
- UFI code
- Additional data: packaging, pH, colour, physical state
Notifications are submitted via the ECHA Submission Portal. A valid ECHA account and company profile are required.
There are three ways to prepare the PCN dossier:
- IUCLID Cloud: For preparing and submitting notifications online
- IUCLID 6: For offline preparation using the PCN format and uploading via the ECHA portal
- System-to-system integration: For advanced users managing PCN XML data directly (e.g. automated sector software)
Regardless of the method, all submissions must adhere to the harmonised PCN format.
Updating PCN Submissions
A PCN submission must be updated whenever relevant mixture information changes, such as:
- New UFI code
- New hazard classification
- New toxicological data
- Changes in composition (additions, removals, substitutions, or concentration changes outside declared ranges)