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. This is why I attended several seminars by ECHA and BfR in person and via livestream. I am summarising the resulting knowledge, along with questions and experiences which were voiced in our own PCN webinar, in a small series of frequently asked questions and answers. As the date at which the notification becomes mandatory has been delayed by one year, I will start the series with questions on the legal deadlines and the meaning of the different types of placement on the market.
Deadlines and their meaning for the European Product Change Notification (PCN)
Question: Is the end user only seen as a private end user, or also as a commercial end user? With regard to the date on which the notification becomes mandatory, the end user is only a private end user (deadline 01/2021, along with commercial use). Question: Demarcation between commercial – industrial: where can I find out more? The distinction is made in accordance with CLP Regulation, Annex VIII, Part A, 2.4: “(2) ‘Mixture for commercial use’ a mixture which is intended for use by commercial users, but not in industrial plants; (3) ‘mixture for industrial use’ a mixture, which is exclusively intended for use in industrial plants.” For detailed explanations, it is advisable to read the ECHA guidelines: ECHA guideline: Guidance on harmonised information relating to emergency health response – Annex VIII to CLP, ISBN: 978-92-9481-265-0 If questions are not answered satisfactorily, the question can be passed on to the national helpdesk. The helpdesks also collect frequently asked questions over time, which can be viewed on the home pages. Question: If I send a notification to the BfR today and make a delivery to Italy next year for the first time, does the transition period apply? The transition period applies to the country in which a notification is present in the previously valid, national version. If and up to what point these old notifications can still be made varies from member state to member state. This means that in this example, a PCN would be required for Italy because the law is already in force there. For Germany, a new notification in PCN format does not have to be made until the end of the transition period unless there are relevant changes to the mixture in accordance with Annex VIII of the CLP Regulation. 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