ECHA final decision on REACH registration dossier ethanol

On 11 September, ECHA notified registrants of the ethanol substance at Annex IX and X levels (i.e. > 100 t/y) of a Decision on a test proposal that the Association had filed back in 2022, proposing to perform a long-term toxicity study on daphnids. Annex VII and Annex VIII registrants were likely not notified as this is an Annex IX endpoint. The deadline to submit the additional information is 17 December 2026.

 Some background

ECHA had issued a draft decision in response to the test proposal in December 2022 requesting, additionally to the proposed long-term daphnia study, the performance of a long-term fish toxicity test. The Association objected to this decision, to which ECHA proposed to update the information in the dossier to reflect the argumentation; this was done in August 2023. The final decision does not include the request to perform the long-term fish toxicity test, therefore the justification put forward by the Association was sufficient to convince ECHA.

 What does this mean for registrants?

Registrants do not need to take any action in response to the letter from ECHA. The Association will take care of communicating with ECHA the acceptance of the decision, commissioning the study and submitting the results in an update of the Lead registration dossier before the deadline.

 Will there be additional costs to registrants?

Registrants will not need to make additional contributions at this point in order to comply with this decision. The cost of the test was included in the budget of the Association for 2024, and will be covered from available funds.

 We will keep registrants periodically informed of the developments, including at the next General Assembly of the association on 28 November. In the meantime, feel free to get in touch with the Secretariat if you have further questions.