16 June 2023

Update on ECHA draft decision on ethanol (EC 200-578-6)

At the end of last year ECHA issued a draft decision on the test proposal submitted by the Association to conduct a long-term toxicity test in daphnia. In this draft decision, ECHA agreed with the need to perform this test, but also concluded that a new long-term toxicity test in fish was also required. The Association submitted a response to the draft decision explaining in detail why we considered that a new vertebrate animal study was not required and that using a weight-of-evidence approach combining existing studies and QSAR data it was possible to conclude that no long-term effects would be seen in fish at a limit concentration of 100 mg/L.

ECHA seems to have reacted positively to this and, in an unusual move, they have offered to allow us to update the dossier with a switch to a weight-of-evidence approach for this end point using the arguments and the additional data in our response, and they will take this information into account before they make their final decision.  We have agreed to accept the offer and will update the dossier by the deadline of 31st August.  We will advise of any further developments.