Recently, the European Chemicals Agency (ECHA) postponed the first deadline for the new Poison Centres Notification (PCN). In response to this coming mandate for European agencies, Carrie Decatur, Sphera’s senior regulatory analyst, led a webinar to explore the regulation, explain its purpose and offer insight into businesses’ responsibilities.
According to the PCN website, “The CARACAL (expert group on CLP) has agreed unanimously to the European Commission’s proposed changes to Annex VIII to CLP. The Commission is now proceeding with adopting a delegated act, which will, among other things, postpone the first compliance date for harmonized reporting to poison centres, for mixtures intended for consumer use, from 1 January 2020 to 1 January 2021.”
The postponement was not unexpected, but the extra time allows organizations to better educate themselves and prepare for the upcoming PCN regulations.
What’s the Big Deal About PCN?
First, we must ask: Why do we have poison centers? Simply put, because sometimes there are exposures that we do not expect, and in those emergency situations, medical providers need to be able to access information quickly. To be effective, centers need product information and a standardized format to identify substances and access data in urgent moments when it’s needed most.
The European Chemicals Agency (ECHA) solved this problem with Annex VIII to the classification, labelling and packaging of substances and mixtures (CLP) and the Unique Formula Identifier (UFI) as well as implementing a harmonized format for dossier submissions for chemicals. In Sphera’s recent webinar, Decatur explored the UFI and requirements, including product categories and four types of submission: standard, limited, group and voluntary.
What Else?
Decatur stated in the webinar that it is critical to understand that once an organization has submitted the information, the work is not finished. Companies must keep their submission up to date, and they are required to update the submission according to certain criteria.
You can view the webinar on-demand here and check out Sphera’s PCN e-book to learn more about Poison Centres Notifications and how to better understand the substances in your products while making safer, smarter decisions about PCN.