The Backstory
Under Article 45 of Regulation EC 1272/2008 (Classification, Labelling and Packaging), manufacturers and importers placing certain hazardous mixtures on the market in a Member State (MS) of the European Economic Area (EEA) must provide information to the appointed body of that MS. This information is ultimately used by poison centers to advise consumers and physicians on proper response following a poisoning incident. The official MS appointed body and contact information must be listed in Section 1.4 of the Safety Data Sheet (SDS).
What’s Changing
In April 2017, Commission Regulation (EU) 2017/542 entered into force, creating a harmonized list of information to be notified to appointed bodies and poison centers; this list of required information was subsequently adopted as a new annex to EC 1272/2008, called “Annex VIII.” Importantly, these requirements do not become compulsory, however, until January 1, 2020.
Not only has the list of requirements been made available in Annex VIII of the CLP regulation, but there is now another new requirement that manufacturers and importers must notify each respective appointed body using a consistent XML format referred to as a Poison Center Notification (PCN)—version 1 of which was just released on April 30, 2018. Although notifiers must currently notify each individual MS appointed body separately, as applicable, eventually, it will be possible to submit the PCN through a single centralized ECHA portal, once development is complete.
Implications
If you’re a manufacturer or importer placing hazardous mixtures on the market in the EEA, you now have less than two years to begin adapting to and using the new PCN format for your official poison center notifications. What’s more, since the SDS must include the contact information for the relevant MS’s official appointed body in Section 1.4, those wishing to use a single SDS approach for all of EEA, must list each appointed body, for each ship-to MS. In other words, if your product is being shipped to Germany, France, and Denmark, then the appointed body for each must be listed, else a separate SDS (one specific for each ship-to country) must be created.
If you have questions regarding these updates or any other regulatory update, get in touch with our compliance experts.
