Formato de notificação dos centros antivenenos
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.
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.
- Version 1 of the format was published in April 2018 and followed by a pilot project run by ECHA in conjunction with stakeholders.
- In April 2019, version 1.1 of the format is published and can be used for the submission of notifications via the ECHA Submission portal provided by ECHA.
- In October 2019, version 2.0 of the format is published, introducing particularly the last changes to the CLP regulation relevant to the reporting of the Classification and Labelling information.
To help with the IT implementation of this format, the following is available:
- PCN format: 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. The validation rules applied on top of the IUCLID format and the picklist elements used are also provided as a separate annexes.
- Download Part A – Preparing a PCN dossier
- PCN Validation rules annex (362 KB | .pdf)
- PCN format annex - Picklists
- April 2019 version Excel format (106 KB | .xlsx) and XML format (1,995 KB | .xml)
- October 2019 Excel format (321 KB | .xlsx) and XML format (2,138 KB | .xml)
- Note that the list of picklist values contains most of IUCLID phrases, including (but not only) the ones relevant for PCN. If needed, you can download the XML schema corresponding to the XML picklist files published above: XML schema (1KB | .xsd)
- 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.
- Download Part B – Developers’ guide to the IUCLID format (1,259 KB | .pdf)
- Examples of Poison Centre Notifications are provided below:
- Notification example, IUCLID dossier in v.1.1 of the format (114 KB | .i6z), version 2.0 of the format (118 KB | .i6z). This example is for an initial notification 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 IUCLID PCN wizard, is also provided.
- Notification update (v1.1 of the format) of the first example above (452 KB | .i6z), version 2.0 of the format (455 KB | .i6z). This dossier contains additional information compared to the initial submission. Corresponding notification preview (192 KB | .pdf).
- Notification update (v1.1 of the format) of the first example above (448 KB | .i6z), version 2.0 of the format (451 KB | .i6z). This dossier is for an update due to a significant change of composition. 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.