The dossier was submitted for a high-tonnage registration of dimethyl ether. Following the ECHA compliance check, the European Commission has adopted an implementing decision on dimethyl ether. According to the decision the lead registrant and co-registrants must submit an update of the registration dossier to ECHA within 36 months from the date of the implementing decision. It is a request that the updated dossier includes reproductive toxicity studies.
The decision ends a discussion between registrants and authorities which has been ongoing since 2017.
For more details, download the Commission adoption here.
It is a comprehensive task to conduct reproductive toxicity studies. Accordingly, the implementing decision is a clear indication of the responsibility to comply with the regulatory requirements.
For more information on registration dossiers, please contact:
Poul Bo Larsen
pbl@dhigroup.com
Tel +45 4516 9478
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