Formaat voor Kennisgevingen aan gifcentra
The Poison Centres Notification (PCN) format structures the information on hazardous mixtures classified for health or physical hazards. This information has to be submitted to the Member States appointed bodies. The format is XML based and defined by the requirements laid out in Annex VIII to the CLP Regulation.
The information to be submitted includes the full chemical composition, toxicological information, relevant product and mixture details including the intended use (EuPCS), in addition to the label elements such as the unique formula identifier (UFI). The PCN format aims to harmonise and ensure consistency of the information available to poison centres in cases of poisoning incidents in the EU.
Version 1 of the PCN format is compatible with IUCLID, a tool developed at OECD level, which promotes the harmonisation of chemicals data and is available at the link below.
Note that version 1 of the PCN format may undergo further adjustments as a result of:
- PCN format ‘pilot project’ run by ECHA in conjunction with stakeholders,
- Any regulatory changes following a workability study contracted by the Commission.
Any updates of the PCN format will be synchronised with the yearly IUCLID format update, published in October.
To help with the IT implementation of this format, the following is available:
- PCN format (version 1.0, published on 30 April 2018): the format is made available as a set of XML schema definition files (XSDs). There is also a data model that shows all relevant fields and their interconnections.
- Part A - Preparing a PCN dossier: this document provides a technical background and offers a practical guide to the industry on how to encode, prepare and complete a dossier compliant with the PCN format. The XML content and the inner structure of the PCN format is explained in a simple manner avoiding technical details or jargons.
- Part B - Developers' guide to the IUCLID format: in IUCLID, the exchange of chemical information is facilitated via a zip/archive file with the extension .i6z (IUCLID 6 zip). The information can be exported from one IUCLID 6 installation and imported into another. This file contains information concerning all (inter)related IUCLID 6 entities (documents and attachments), in a well-defined and structured format. This guide explains the structure of the IUCLID file in order for developers to build other systems than IUCLID 6 which can generate this format.
- Examples of PCN files are also provided both for single and group notifications.
- Download a single notification example (197 KB | .i6z) and the corresponding IUCLID 6-generated report (132 KB | .pdf)
- Download a group notifications example (188 KB | .i6z) and the corresponding IUCLID 6-generated report (156 KB | .pdf)
Note: the PCN examples, provided in i6z format are compatible with a future release of IUCLID that will be made available in October 2018 on the IUCLID 6 website. It is currently not possible to import such examples in the current version of IUCLID.