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 Lead Registrant has submitted an update to the Lead Registrant Dossier that was accepted by ECHA on 29 June 2022. This update contains an updated harmonized CSR submitted by the LR on behalf of all registrants covering a number of identified uses, as well as new studies from literature and a test proposal for a daphnia chronic test. Given the updated CSR, co-registrants need to submit their own updated company dossier within 12 months of the acceptance date to indicate that they rely on the joint CSR. Therefore, the deadline for submission of own dossiers is 29 June 2023.
A new IUCLID template and step-by-step guidance document to perform the update is currently being validated, and will be made available to registrants on the Members Area in September 2022.
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.
In case you need to have access to information included in the CSR (for example, Exposure Assessment details) to prepare your own documentation (for example, extended SDS), please get in contact with the secretariat to request a copy of the CSR.
3. I missed an update. Is the information provided in the last update also includid 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.
SIP and analytical information
6. 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).
7. 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.
8. 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
9. 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, and that you ensure that relevant UK-based legal entities submits a grandfathering notification by 1 May 2021 or a Downstream User Import Notification (DUIN) by 27 October 2021 to HSE.