We are now approaching 4 years since the harmonised Poison Centre Notification (PCN) requirement came into effect on January 1st 2021. If you are new to the topic, I recommend you start with some introductory reading on the topic here.
During this time, we have learned that gathering all the required data for a successful PCN submission through ECHA submission portal can be a demanding procedure for the duty holders (importers and mixture formulators).
Especially since the information in the supply chain does not always move downstream as it should.
As a result, formulators or importers of hazardous mixtures may not always have the complete data when submitting their PCN.
While incomplete data might still suffice for a successful notification, it can sometimes trigger quality rules at the ECHA submission portal.
What is a quality rule?
“A quality rule (QLT) warns or reminds the notifier of common shortcomings and inconsistencies. Quality rules will not lead to the failure of the submission but can result in further clarification requests from Member State(s) at a later stage.” (source: ECHA, Validation rules for poison centres notifications, Version 9.1, October 2023)
So even though the submission is successful, the appointed body in each Member state can demand clarification if they find it necessary. In many cases they will request the PCN to be updated accordingly to remove the QLT rules.
There have been recent requests from BfR (The German Federal Institute for Risk Assessment), which is the appointed body in Germany.
Basically, they inquire about every submission that has a quality rule to it. In some cases, a written explanation is enough, and they would accept it. In other cases, an update to the PCN is required.
Let me emphasise once again that the quality of the data in the submitted dossier is of great importance. Duty holders should provide the most accurate and complete data possible.
For instance, you should submit a composition that is at least 90 % to avoid receiving a QLT warning. Ideally, full composition (100 %) should be provided.
While the appointed body may not be able to “disable” your submission on ECHA, they do have the authority to send inspection to your company. And let’s face it, nobody wants that.
If you are receiving requests for your submitted PCNs from appointed bodies in Member State(s) and don’t have the time to prepare responses, we can help you.
Just send us the requests from the appointed bodies to our e-mail info@bens-consulting.eu and we can consult you on the appropriate action to remedy any shortcomings of your PCN dossiers.
Image by Mohamed Hassan from Pixabay
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