Europe - Annex VIII: disabling a PCN submission
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Regulatory
Posted By:
Trace One
Annex VIII: what does it bring to the table?
According to Article 45 of CLP regulation, importers and downstream users who put hazardous mixtures on the market must notify relevant information concerning emergency health response to appointed bodies.
The publication of Regulation 2020/1677 takes the place of CLP Annex VIII with the aim of harmonizing this submission process, as well as the data format, for the whole EU.
In order to facilitate the management of the dossier database, ECHA has recently introduced directly at portal level the possibility of disabling previously sent notifications.
Disabling a notification
Disabling a submitted dossier may be needed because:
- the dossier contains wrong information that cannot be deleted or fully replaced due to existing validation rules for updates
- the wrong type of update has been chosen (e.g. a new notification for significant change of composition instead of an update of an existing notification having the same composition)
- a test notification has been mistakenly submitted to the production environment
- the wrong legal entity has been used
This PCN portal – exclusive feature is not to be confused with the “ceased from market” functionality, introduced with the update to PCN format 4.0 (for more information about the ceased from market, please refer to the related previous article).
As reported by ECHA in the latest update of the PCN Practical Guide, disabling a notification is recommended only under specific circumstances where the correction of the submitted information through the notification update process is not a viable option.