Formato de notificación de los Centros de información toxicológica

The Poison Centre Notification (PCN) format aims to structure the information on hazardous mixtures classified for health or physical hazards available to poison centres in cases of poisoning incidents in the EU.

The format is XML-based and defined by the harmonised requirements laid out in Annex VIII to the CLP Regulation and is incorporated into the PCN dossier preparation tools offered by ECHA. It is also available for companies to prepare their own tools based on the PCN format, for example when using the system to system service. Regardless of which tools are used to prepare, the format must be adhered to.

The PCN format is compatible with IUCLID, a tool developed by ECHA in collaboration with the OECD, which promotes the harmonisation of chemicals data. You can find additional information about this tool on the IUCLID website.

Download the PCN format

Annual updates of the format occur in October in line with the IUCLID release schedule. 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.

  • Version 2.0, published on 30 October 2019 (108 KB | .zip);
  • Version 3.0 (draft), published on 8 September 2020 (3,309 KB | .zip). The official release of the version 3 of the PCN format is scheduled for the end of October 2020.  This draft version includes XSD and Word files for the format elements, a comparison with version 2.0 and the list of picklist values in Excel and XML format.
  • PCN format picklists: note that the list of picklist values contains most of the IUCLID phrases, including (but not only) the ones relevant for PCN.

IT Implementation

The Developers' guide to the IUCLID format is available for implementing the PCN format into a company’s own systems.

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 systems other than IUCLID 6 which can generate this format.

 

Examples of Poison Centre Notifications

Initial notification: This example IUCLID dossier is for a product containing a mixture in mixture (MiM), covering multiple markets and different languages.

The corresponding notification preview (730 KB | .pdf), generated by the guided dossier preparation tool, is also provided.

Update of initial notification: This dossier contains additional information compared to the initial submission, it is an update of the first example above.

The corresponding notification preview (192 KB | .pdf).

This dossier is for an update due to a significant change of composition, it is an update of the first example above.

The corresponding notification preview (192 KB | .pdf).

Note: the PCN examples, provided in i6z format are compatible with the release of IUCLID 6.3 and 6.4, respectively published in October 2018 and 2019 on the IUCLID 6 website.

 

PCN format version history

Version 1 of the format was published in April 2018 followed by a pilot project run by ECHA in conjunction with stakeholders. If you are working with a previous version of IUCLID, the two earlier versions of the PCN format are available for download.

PCN format picklists: April 2019 version Excel format (106 KB | .xlsx) and April 2019 version XML format (1,995 KB | .xml)

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