The European Chemicals Agency (ECHA) has published the technical format for reports to poison centres (according to CLP Article 45)! The new PCN-Format is based on the internationally harmonised IUCLID format. This article explores the effects the new format will have on industry.
IUCLID format for product notifications
Contrary to the preliminary draft, the new PCN-Format is now based on the IUCLID format. The IUCLID software allows data on chemical properties to be maintained, stored and exchanged. The internationally harmonised IUCLID format is used for this purpose. This format will now also be used for notifications to poison centres in accordance with CLP Article 45.
The IUCLID format consists of a variety of templates for documents, which are structured according to the type of information it contains (e.g. GHS data).
For the PCN format, 15 existing documents are reused. In addition, two new templates are added to the IUCLID format: “Product Information” and “Dossier Header”, which provides notification type details (e.g. update). All completed documents are combined into a dossier, which associates the contained documents through administrative data. The completed dossier will subsequently be sent to the national authorities. The dossier can then be used by national poison centres for emergency calls.
Effects of the PCN-Format for the industry
At opesus, we work in close cooperation with industry, ECHA and SAP to assist companies with their CLP Article 45. We are currently developing a new version of our software opesus EHS Product Notification, which supports the new PCN-Format. Based on our experience, we see the following effects of the new format:
A dossier consists of many documents that are linked by administrative data. The new PCN-Format is therefore very complex and much more comprehensive compared to previous formats.
For example, a very simple notification (a few substances with no “special” types) generates about 1,500 lines of XML code in PCN-Format. In comparison, the notification of the same mixture in the previous German (BfR) format consists of about 150 lines of XML code.
Possible use of IUCLID software
One way to create IUCLID-compatible dossiers is to use the IUCLID software. The software is available for free. However, the data must be maintained manually via the input mask of the software. For this reason, in our opinion the use of IUCLID software is advisable only for smaller companies with very limited mixtures subject to notification.
Note: In the past, SAP EH&S had an IUCLID interface. However, the interface currently only supports the older IUCLID 5.4 version and will be discontinued in SAP S/4HANA. From our point of view therefore, the IUCLID interface in SAP EH&S is not a viable solution.
Annual IUCLID updates
The IUCLID format is subject to annual updates. These updates can be prompted by changes in legislation or to the PCN-format. Also, changes that do not originate from CLP Art. 45 need to be evaluated and may cause adaptions to PCN notifications. For all solutions that creates notifications in PCN-Format, availability of software maintenance is therefore essential to be able to react to changes in time and reliably. We recommend maintenance for all our customers for our opesus EHS Product Notification software.
In April 2016 ECHA released a preliminary draft of the European XML-format on harmonised product notification. The format is supposed to standardise the variety of formats and possibilities of product notification within the EU and to ease the situation of importers and producers of chemicals, biocides, cosmetics and detergents.