EuPCS stands for “European product categorisation system” and is an integral part of the new European Product Change Notification from the start of 2020. In all likelihood, some of our users have already come across different harmonised product categorisations in safety data sheets. An example is the use descriptor system (UDS) for specifying relevant identified uses, for example from substance safety assessments. EuPCS now provides another harmonised categorisation, but why? Who has to carry out these categorisations and how can this work be facilitated? Because of the large volume of information, I also wrote a whitepaper in addition to the blog entries, with a compilation of the issues that the new product notification entails:
What EuPCS is used for
On the new product categorisation system, which is part of the European Product Change Notification, the text of the regulation only directly states that this classification will exist and that it will be specified by the agency. The draft guideline by ECHA on the European communication “Guidance on harmonised information relating to emergency health response –Annex VIII to CLP” mentions this categorisation system and explains that it is a harmonised classification for statistical surveys on poisoning and for the temporary identification of mixtures in emergencies. Statistics on poisoning have been collected before, but now there is a predefined categorisation.
Who is affected by the product categorisation
In short: Everyone who has to create European Product Change Notifications for their products. This means that every importer or downstream user who puts a mixture into circulation has to create a product notification for all relevant membership states. That is to say: Mixtures with at least one H statement starting with 2 or 3, with just a few exceptions (see Annex VIII of the CLP Regulation). If your products are intended for end users, you may already need the information for a complete notification at the start of 2020. The following table shows when the notifications must be implemented for the relevant member states:
Guidance for categorisation
Assistance is provided by the guideline “The European product categorisation system: A practical guide” published by the ECHA itself on the new Poison Centres website. Among other things, this guideline also explains how to import classifications from the use descriptor system (UDS) into this new EuPCS format.
We also provide up-to-date information for you on our PCN information page. Sources: CLP Regulation (EC) No. 1272/2008 consolidated version, status 01/12/2018 Regulation (EU) 2017/542: Annex VIII of the CLP Regulation (harmonised information relating to emergency health response and preventative measures), status 23/03/2017 Guideline The European product categorisation system: A practical guide, ISBN 978-92-9020-599-9, ECHA, Dec. 2018 Draft ECHA guideline: Guidance on harmonised information relating to emergency health response – Annex VII to CLP, Version 1.0, March 2019