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Regulatory
Posted By:
Trace One
Annex VIII: what does it bring to the table?
According to article 45 of CLP Regulation, importers and downstream users who place hazardous mixtures in the market should submit relevant information in the event of emergency health response to designated appointed bodies. The Annex VIII to the same regulation defines the content and the harmonized transmission procedure for all Member States.
From its original implementation back in April 2019, the official ECHA Portal and its implementation among the EU and EEA Member States has been updated many times, connecting an ever-greater number of National appointed bodies to the harmonized notification system related to the emergency response.
The latest decisions of the Member States regarding their implementation of Annex VIII are collected and kept updated in the Overview of Member States decisions, available in the PCN section of the ECHA website.
Overview of the Member States decisions: what’s the situation?
As of September 2022, all Member States except Bulgaria and Slovakia are ready to accept notification via the ECHA submission portal.
Belgium, France, Germany, Latvia, Luxembourg and Portugal have confirmed the coexistence of the national submission system with the ECHA Submission portal as an alternative way to forward notifications, with some other countries (such as Austria, Ireland and Italy) which have officially adopted the ECHA portal but chose to keep the national submission system active for industrial mixtures. All other Members States chose to adopt only the official ECHA portal.
While the accepted language situation is varied (with all countries except Austria, Bulgaria, Cyprus, Czech Rep., French, Greece, Hungarian, Liechtenstein, Poland, Romania, Slovakia and Slovenia accepting notifications at least in English, with Finland requiring both Finnish and Swedish), the cost-related situation for notification is much more well defined, with only Belgium, Hungary and Italy foreseeing fees.
Finally, for placing on the market mixtures notified via the ECHA Submission portal in Belgium, France, Germany, Italy, Luxembourg and Spain, duty holders must await confirmation of the receipt of the dossier from the Member State’s appointed body, while for all other countries (except Bulgaria) passing the automated validation checks at portal level will suffice.
As a reminder, the implementation of Annex VIII’s requirements may vary for each Member State (e.g., Italy requiring the notification for non-hazardous detergents). Consultation with the specific National Appointed Body is recommended.
For more information regarding this topic, please consult the following links: