Frequently asked questions
Please find below a set of frequently asked questions together with corresponding answers, grouped in the following topics:
Registration dossier and CSR
1. I received a notification from REACH-IT that the Lead Registrant has updated the Lead Registrant Dossier. Do I need to update my individual registration?
The last update of the ethanol dossier was submitted to ECHA in August 2024. The dossier has been updated to include additional supporting published literature relevant for the ethanol registration dossier, and to make changes to the exposure assessment related to ECETOC TRA (see here for more information.
A IUCLID template and step-by-step guidance document to perform the update is available to registrants on the Members Area (login required).
We recommend to all registrants to check and voluntarily update their dossiers at least once every 3 years, to keep tonnage information up to date and to ensure that only relevant uses are included along with use mapping codes that match those included in the lead registrant CSR.
2. Do I need to submit a CSR individually?
In the updated dossier accepted by ECHA on June 2022, a harmonized CSR was submitted by the Lead Registrant on behald of all registrants. If the uses intended to be covered by your registration dossier are included, there is no need to submit an own CSR.
Prior to this update, the CSR was incorrectly mentioned as being submitted by the Lead Registrant on behalf of all co-registrants and in theory all registrants were required to submit their own CSR, for which the Association provided a CSR template. This is no longer required since the last dossier update.
A PDF version of the CSR is available on the Members Area of our website (login required).
3. I missed an update. Is the information provided in the last update also included in the current update?
Yes it is. Each update builds on the previous one so if a co-registrant has missed an update, they can jump to the current one without any consequence.
4. Are the documents of the association IUCLID6 compatible?
We have issued IUCLID6 compatible documents since November 2016.
5. I downloaded the template IUCLID file to my computer and unzipped it. It is full of lots of files of the type .i6d. What do I do with these?
IUCLID 6 export files with the file type .i6z are actually zip files. (IUCID 5 files were similar with the type .i5z) Unfortunately, sometimes Windows recognises the file type and renames it from .i6z to .zip during the download process. If this happens, do not open the zip file. Simply rename it back from a .zip file to the type .i6z and IUCLID 6 will then recognise it as a valid IUCLID export file and allow you to import it into your IUCLID application.
6. Is the Guidance on Safe Use (GoSU) provided by the Lead Registrant?
Yes, the Guidance on Safe Use is provided by the Lead Registrant in the jointly submitted dossier; you can also find it in the Members Area (login required).
SIP and analytical information
1. What analytical tests are required by individual registrants to meet the analytical data requirements?
Please refer to the analytical guidance documents provided by the Consortium in the member's area of the website (login required).
2. Are the values for the substance identity profile referred to percentage in volume or mass percentage?
They refer to mass percentage (% w/w). The reason is that the SIP is based around the impact of classification changes triggered by the impurities and the classification thresholds in the CLP regulation 1272/2008 are by mass percentage.
Biocides
1. Can I use the ethanol REACH dossier for registration under the Biocidal Products Regulation?
Due to our agreements with the data owners, our REACH dossier cannot be used for registration under the BPR. If you are interested in using ethanol for biocidal purposes or marketing it for that purpose, you can contact one of the two existing biocides Consortia for further information on the process. Below the contact details for both consortia:
ASD Consortium Alcohol
Chairman: Dr. Michael Wilz
Tel.: +49 (0) 5 21 / 30 37 – 310
E-Mail: m.wilz@stockmeier.de
URL: http://asd-consortium.com/
The Alcohol Task Force
Secretary: Dr. Matthias Hintzpeter
Tel.: +49 (0)170 739 1680
E-mail: matthias.hintzpeter@outlook.de
URL: http://alcohol-task-force.com/
UK-REACH
1. Is registration under UK-REACH being covered?
The Association intends to prepare and submit a dossier for ethanol under UK-REACH under the same circumstances as the REACH registration in the EU. In the meantime, we recommend that you sign up to the UK-REACH mailing list to stay informed.
2. What is the timeline for submission of the Lead Registrant dossier under UK-REACH?
The UK DEFRA ran a public consultation on the UK-REACH deadlines and implementation, resulting on the postponement of the original UK-REACH deadlines by 3 years, to 27 October 2026, 27 October 2028 and 27 October 2030 depending on tonnage band and hazard profile.
The legislation necessary to give effect to these changes entered the UK Parliament on 20 April 2023 and is expected to come into force in the summer of 2023.
Awaiting these developments, the Association suspended the work on the preparation of the ethanol UK-REACH Lead Registrant dossier until there is clarity on the timelines and data requirements. More information will follow in due course.
3. Where can I find more information on UK-REACH?
Please refer to the HSE REACH page.
KKDIK (Türkiye REACH)
Registration of ethanol under the Türkiye REACH Legislation (KKDIK) will not be prepared by the Association, but the consortium is willling to share the data for the preparation of individual dossiers. The Association is currently looking into how to facilitate this for the registration deadlines that are most likely to be postponed to end of 2025.
Companies interested in registering ethanol or the associated substances vinasses and fusel oil under KKDIK are recommended to sign up for a dedicated KKDIK mailing list to stay informed when more information is available.