Are you ready for EU Poison Centre Notification Format?


Consumers and workers come into daily contact with hazardous chemicals, and although they are expected to be used according to safe-use instructions, unintentional exposure may happen: ingestion, skin contact, inhalation, etc. In those cases, emergency professionals need rapid product identification, information about the chemicals contained and its hazardous properties, all these in order to facilitate the identification of the correct treatment and to avoid further damage.

And this is exactly what a poison centre does: it provides medical advice to citizens and healthcare professionals on health emergencies arising from exposure to hazardous chemicals or to other toxic agents; such as medicines, plants, bites and stings. Poison centres in the EU answer calls for support daily and around the clock.

On 22 March 2017, the Regulation (EU) nº 2017/542 was published, adding the Annex VIII, about the harmonised information relating to emergency health response. According to the ECHA, “It’s about harmonisation, and harmonisation brings synergies and efficiencies”. It was designed to regulate all hazardous mixture notifications (mixtures classified with health and/or physical hazards) within the EU, and established two new concepts related to chemical safety:

  • A harmonised information format file: a common format file which will gradually replace the current national requirements in force.
  • A Unique Formula Identifier (UFI): a unique code for each product which will be added on the label.

This new system, although efficient and beneficial in the long term, also implies a new complex notification process for companies, which will have to notify their products in the official language of each country in which they are marketed, pay different national taxes, etc. Providing harmonized information will certainty improve emergency health response, but the number of notifications is expected to significantly increase, and the producers and manufacturers who have started to work with the new system have already experience workability issues such us:

  • Insufficient time prior to deadline to assimilate notification tools.
  • Regular product variations that will lead to multiple and frequent changes of UFI for the same product.
  • Problems working with the ECHA Submission portal: navigation is complicated, too many clicks; it is not always directly clear if you made a wrong input, since validation is only available at the end of the process; notification via Guided Dossier Preparation took approx. 2 – 3 hours for a single product.

To overcome these inefficiencies and for the harmonized notification system to be truly useful for society, but also viable for companies, experts believe that there is a need for managed automation that minimizes the impact of:

  • Tens of thousands of products to be notified.
  • Frequent formulation changes. Partly own initiative, partly by raw material suppliers or driven by legislation changes.
  • Not feasible to do notifications & updates manually. Notifications must be generated in bulk.
  • Automation requires standardization. The solution must work for thousands of notifications at a time.

Time is running out, since the new harmonized notification process shall apply from 1 January 2021, after its publication in the Official Journal of the European Union. That is why we have updated CHEMETER, a reliable SDS authoring software which provides you with country specific legislation, up-to-date regulatory information, continuous new features development and professional assistance. It is also a friendly modular software which accommodates each company’s needs considering the country, sector and the aim of the company. It creates an extended range of documents; such as SDS, e-SDS, labels, dangerous goods documents and sector specific paperwork. It is one of the highest implemented software solutions worldwide, and now in addition, we have updated it to provide it with an additional module that issues automatic notifications in a few minutes.

The new module is specially designed to help users to comply with new poison Centre Notification Requirements for Hazardous Mixtures in the EU. It automatically creates PCN dossiers for harmonised notifications. Just in a few minutes, users will get the file with all the necessary documentation: automatic UFI code generation, toxicological information, complete chemical composition, etc. It is a simplified process, which indicates step by step in a simple way the data that the user needs to complete it. In a few clicks, users will get the file to notify all products.  It is a significant time saver compared to the 2 or 3 hours it would take to generate the Poison Center Notification (PCN) format for a single product using the official portal.

You can get more information about CHEMETER and all Siam services on our website https://www.siam-it.com/en/.