European Product Change Notification – frequently asked questions on UFI and updates

Published On: 23 December 2019By Categories: SDB-Profi, PCNTags:

The topic European Product Change Notification (PCN), including UFI and EuPCS has kept us as well as our users busy in this intense phase of preparation for the new, legally binding notification. In this small series, I summarise frequently asked questions and answers which arose during the webinars and the specialist conference. Part 2 of the series dealt with UFI positioning and basic questions. This article takes a closer look at the unique formula identifier (UFI) and updates.

Questions about UFI and updates for the European Product Change Notification (PCN)

Question: Is the UFI a combination of letters and numbers or is it purely numerical? The UFI is a combination of letters and numbers (alphanumeric). It always consists of 4×4 character blocks, separated by “-“. According to the ECHA guidelines, the only option to separate the UFI by line break is at the second “-“. Question: If I have to update an SDS for an already notified mixture to the BfR (end user), does this mixture already have to contain a UFI? Yes, if there are changes to the mixture which are relevant in accordance with Annex VIII to the CLP Regulation, a European Product Change Notification (PCN) and UFI are required. It is not sufficient to generate a UFI without the corresponding notification to the member states concerned. A UFI is always linked to a PCN.

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Question: If, starting from 01 Jan 2021, I have to notify a mixture, for example, but do not have a UFI for one of my mixtures in my own mixture (MiM), can I simply notify without the UFI of the MiM? There are two ways to notify premixtures (MiM): – By specifying the UFI of the MiM – By depositing the safety data sheet and additional supplier information. This means: if there is no UFI for a premixture (this is predominantly likely in the transition time), the SDS and the contact data of the supplier are sent along instead. However, this way is seen as the last resort. It is therefore mandatory to specify the UFI if it is available. Question: Can I communicate the European Product Change Notification (PCN) to the BfR and will my UFI then be valid throughout Europe? The UFI is only valid for countries for which a notification is present (PCN). It is not enough to notify the BfR to cover other member states as well. In the notification, all member states must be taken into account in which the product with the UFI will be put into circulation (even free of charge). In the notification, it is possible to identify the member states for which this notification is implemented. In addition, all descriptive texts (Section 11) must be available in the accepted languages. A joint notification of this PCN is possible vial the ECHA portal if the states concerned have agreed to a central notification.

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Sources: Regulation (EU) 2017/542: Annex VIII of the CLP Regulation (harmonised information relating to emergency health response and preventative measures), status 23/03/2017 Information on change to end-user date on the websites of the poison centres. Guidance on harmonised information relating to emergency health response, Version 2.0, ISBN: 978-92-9481-265-0

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