PCN: What happens if a UFI is missing?
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Those following the new PCN (Poison Centres Notification) legislation have most likely asked themselves the question – what happens if the external component UFI is missing?
Specifications for components in the mixture
The specification is quite clear, really: Own components must be listed with the level of detail specified in Annex VIII of the CLP Regulation, for mixtures in mixtures (MiM), their UFIs are specified instead. Because: Insufficient details are known about the components of the MiM. But what to do if the UFI is missing? Is there a transitional period for end users?
UFI specification and transitional periods
As things stand, the use of UFI (unique formula identifier) and PCN starts for end users at the beginning of 2020, but one year later for commercial use. If a supplier provides you with a mixture, this is commercial use and one might suspect that a UFI does not have to be presented for 2020. However, the ECHA guidelines to Annex VIII to the CLP Regulation provide a more precise differentiation, specifying that the end use of the mixture is decisive. This means that if you supply your product to end users, the external components (MiM) already require UFIs. However, mixtures may have been notified already in a member state in accordance with existing legislation, e.g. via a BfR product notification in Germany. These mixtures have a transition period until 2025 under specified conditions and therefore will not have a UFI until that time.
The UFI is missing – what is specified instead
If a UFI is missing from the external component and is not provided until your mandatory notification is due, you will have to specify selected information from the external component instead. Here too, the ECHA guideline provides assistance. Your European harmonised notification (PCN) requires the following information for the external component with an unknown UFI:
- Safety data sheet of the MiM
- Name, email address and telephone number of the supplier
Sources: Guidance on harmonised information relating to emergency health response, Version 2.0, ISBN: 978-92-9481-265-0 Regulation (EU) 2017/542: Annex VIII of the CLP Regulation (Harmonised information relating to emergency health response and preventative measures), status 23/03/2017