Ethanol lead dossier update August 2024

 

The Lead Registrant of the substance ethanol submitted an update of the lead registration dossier on 22 August 2024. The submission passed checks and validations on 30 August. Registrants should have been notified of this change via REACH-IT.

The dossier has been updated for two reasons:

1. To include additional supporting published literature that the Executive Committee believe is relevant for the ethanol REACH registration dossier.  This is information identified from our annual searches.  The new information does not change any hazard conclusions and requires no actions from members.

2. To accommodate changes made to the ECETOC TRA exposure modelling tool v3.2 (as now implemented in Chesar) which reduces the predicted exposures and RCRs for a small number of PROC codes. This has affected most of the industrial and professional worker exposure scenarios – for ethanol, all those using PROCs 8a and PROC 10, which is all exposure scenarios except the three covering ethanol manufacture. For contributing scenarios using these PROC codes, either the inhalation exposure prediction (PROC 10) or the dermal exposure prediction (PROC 8a) is now more conservative.  As a consequence of these changes, for PROC 10 for professional workers we have revised and increased the risk management measure; exposure scenarios for consumer uses are not affected. The exposure scenarios for members that incorporate these changes are now available on the members area of the website (login required). Whilst members do not have to update their REACH registrations as a result of these changes (the CSR is now jointly submitted by the lead registrant), we suggest to revise your extended Safety Data Sheets, particularly to incorporate the revised risk management measures.

If you are unable to login to the members area of the website, please get in contact with the secretariat.

A response from ECHA on the draft decision (that triggered a dossier update in January 2024) following feedback provided by the Association is still pending. We will keep registrants informed as we receive feedback from ECHA.