By | October 26, 2020

ARTICLE 45 OF THE EUROPEAN UNION’S classification, labelling and packaging of substances and mixtures regulation, commonly referred to as CLP, requires that member states appoint a body to collect information for emergency health response. Under this requirement, countries set up their own organizations and requirements for collecting and maintaining data. From a business perspective, the issue with this was that each member state had a different set of requirements and methods for submission. This was recognized as a major concern within the EU, and the European Commission took upon the task of determining how this could be resolved.

Deadlines for submission begin on:
▸ Jan. 1, 2020, for consumer use
▸ Jan. 1, 2021, for professional use
▸ Jan. 1, 2024, for industrial use


In March of 2017, Annex VIII of the CLP was published. This annex defined the harmonized elements that should be included in a Poison Centers Notification. Under this requirement, all member states are required to use this harmonized version of the PCN. In addition, the European Chemicals Agency (ECHA) will provide a portal for businesses to submit this information, making the process for notifying the poison center much more streamlined than it had been in the past.


Sphera’s Take

“The Annex VIII requirements are an improvement over the old system since will now be a single set of requirements for all EU countries. However, this does not mean that it is simple. There are many issues that have businesses concerned about being able to comply with the requirements of the regulation, and there are now calls for a postponement of the first deadline. Companies need to protect themselves by ensuring that they are educating themselves on the requirements and participating in forums where their voices and concerns can be heard.”