With Covid-19, ECHA takes exceptional measures regarding REACH Authorisation dossiers
Just like any other regulatory area, applications for authorisation are impacted by the Covid-19 pandemic. For this reason, Medtech Europe contacted ECHA explaining the situation of several companies and their need to update their dossiers.
ECHA, in return, is trying to come into contact with the companies involved in applications for authorisation for OPE and NPE substances (Octylphenol Ethoxylate and Nonylphenol Ethoxylate), such as Triton X-100 used by both the pharmaceutical and in vitro diagnostic industries. The goal is twofold:
- ECHA is contacting companies which have submitted an authorisation dossier for one of these substances currently being reviewed by ECHA: these companies may have the possibility to add uses to their dossiers.
- Companies which have not yet submitted an authorisation dossier but see their tonnage increase with the current context are also invited to get in touch with ECHA.
With this reaction and the exceptional measures taken, ECHA is showing its implication in the fight against Covid-19 in any area it can have an action on. The dossiers are of course studied on a case-by-case basis and may eventually be paused for the time needed to their update.
REACH Authorisation, a usually rigid process
The REACH Authorisation targets substances banned by Annex XIV of REACH Regulation. It allows companies to extend their use of a substance which will be banned in the European Union. It requires a long preparation and a deep knowledge of the issue at stake.The process is usually well established and particularly unbending.The measures taken by ECHA are exceptional and are the reflection of the health crisis urgency.
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