ECHA has released the Poison Centres Notification (PCN) format for submitting information on hazardous mixtures to the Member State appointed bodies.
The PCN format structures the information submitted to the Member State appointed bodies. The format has been organised based on the information and data requirements laid out in Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation. The information on hazardous mixtures classified for health or physical hazards is submitted to appointed bodies at national level. When ECHA’s central notification portal is developed submission through this portal will also be possible.
The information includes product identification (including a new label element – the unique formula identifier – UFI), hazard identification, composition and toxicological information.
This harmonisation ensures that the information available to medical personnel in poisoning incidents is consistent across the EU. It also allows importers and downstream users in different Member States to use the same submission or submission format for Member States.
The PCN format is compatible with IUCLID, a software that is developed at OECD level and promotes the harmonisation of information on chemicals. IUCLID is already used to record and maintain chemical information under REACH, CLP and the Biocidal Products Regulation (BPR).
To facilitate the implementation of IT solutions for this format, the following documentsare available on the Poison Centres website:
- PCN format: the format is available as a set of XML schema definition files (XSDs). There is also a data model that shows all relevant fields and their interconnections.
- Preparing a PCN dossier – Part A: this provides a technical background and offers a practical guide to industry on how to encode, prepare and complete a dossier that is compliant with the PCN format.
- Developers’ guide to IUCLID format – Part B: this explains the structure of the IUCLID file so that developers can build other systems than IUCLID 6, which can generate this format.
- Examples of PCN files are also provided for both single and group notifications.
Poison centres play an important role in ensuring the safe use of chemicals and formulating preventive and curative measures for poisoning incidents. They provide medical advice to general consumers and physicians on health emergencies arising from exposure to hazardous chemicals or to other toxic agents. On average, poison centres in the EU answer 600 000 calls for support each year. Roughly half of the cases are related to accidental exposures involving children. Under Article 45 of the CLP Regulation, economic operators placing certain hazardous mixtures on the market have to provide information to national appointed bodies. This information is used by poison centres.