By Claudia Ceccone
Premise
After the first submission of a PCN dossier, modifications to the mixture placed on the market may occur, or new relevant information may become available.
It is essential to ensure that the information provided in the notification is always up to date for all marketed products so that poison centers and medical services can respond appropriately in case of poisoning.
When should a new UFI be created, and when should the information in the PCN dossier be updated?
1) Updating the submission is mandatory, without changing the UFI code, in the following cases:
- The product identifier for the mixture (trade name or UFI code) has changed.
- The classification of the mixture regarding health hazards and physicochemical hazards has changed.
- New toxicological information required in section 11 of the SDS becomes available.
2) Updating the submission is mandatory, with a change in the UFI code, if the product composition is modified, particularly if:
- One or more components of the product are added, replaced, or removed.
- The concentration of one or more components varies beyond the tolerance ranges specified in Annex VIII of the CLP regulation.
- The UFI code of a constituent mixture (MIM) in the notified product changes.
3) Other relevant updates:
Other information that does not require a mandatory update may still be relevant for emergency response. This includes changes such as:
- Updates to the contact details of the notifying company or raw material suppliers.
- Physical parameters of the mixture, such as color or pH.
- Changes in packaging used.
Automated PCN Dossier Updates with EpyUFI-PCN
Keeping notifications of hazardous mixtures updated with all possible product and raw material changes (which are included in notification dossiers) can be very demanding. However, the EpyUFI-PCN module can significantly support and accelerate the entire process. It automatically verifies product data changes and assesses whether a new UFI code needs to be generated due to a formula change, in compliance with Annex VIII of the CLP regulation.
Any data variation within a product and its safety data sheet will be automatically managed and updated (if relevant) in the PCN dossier. The system will highlight the necessary update type on the dashboard:
- “No changes since the last submission”
- “New submission required”
- “Ready for an optional update”
- “Notification no longer necessary”
In case of a formula composition change, the software will notify the user of the assignment of a new UFI code, assessing the tolerance ranges allowed by the CLP regulation and performing the following actions:
- Checking bill of materials variations within permitted tolerances.
- Checking for changes in the UFI code of an MIM.
- Automatically generating a new UFI if necessary.
Depending on the selected submission options, updates can be sent directly from the software to ECHA or, alternatively, highlighted for review before submission to the portal.
Through the History section of the module, it will be possible to view and track all dossiers submitted to ECHA, along with their creation and submission dates, reception status, and the UFI codes assigned to the transmissions.
Conclusion
This was the last in-depth look at PCN notification using our dedicated module. If you have any questions or doubts, don’t hesitate to reach out to us, and stay tuned for upcoming insights on the CLP Regulation!
