Frequently asked questions
Please find below a set of frequently asked questions together with corresponding answers:
1. I received a notification that the Lead Registrant has updated the Lead Registrant Dossier. Do I need to update my individual registration?
The Lead Registrant has performed one major update to the Lead Registrant Dossier beginning of 2016 and there has been a change in legal entity for the Lead Registrant end of July 2016. If you have updated your dossier using our new documents in May 2016 or later, there is no need to update your registration.
A new step-by-step guidance document is currently being prepared to explain the steps to take when updating your Dossier.
2. 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
3. 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).
4. Do I need to submit a CSR individually?
Due to a mistake in the update provided by the lead registrant in 2013, the joint submission shows that both the CSR and the Guidance on Safe Use are submitted jointly. This should NOT be the case as it is intended that only the Guidance on Safe Use is submitted jointly. Indeed, the lead company CSR only covers ethanol use in fuel, so anyone not submitting their own CSR would not have other uses covered by their registration. Therefore we ask that all registrants submit their own CSR to ensure that their registration is fully compliant! In the near future, the consortium is looking to harmonize the CSR so that it can be submitted by the lead registrant on behalf of all the members.
5. Are the documents of the association IUCLID6 compatible?
We have issued IUCLID6 compatible documents in November 2016. Adjusted guidance documents will be created in the near future.
6. Are the values for the substance identity profile referred to percentage in volume or mass percentage?
They refer to mass percentage. 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.
7. 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.
8. I missed the update in 2018. Is the information provided in the 2018 update also includid in the 2019 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.
9. Why are the waste-stage Exposure Scenarios in the CSR not included in the translations?
According to REACH, registrants are required to carry out an exposure assessment for the whole life cycle of a substance, including the waste step. In the case of Ethanol, this was done by integrating all of the conservatively assumed amounts that go from each use into the three main methods of disposal: incineration, landfill and recycling. These assessments are included into the CSRs to show the complete life cycle for a supply chain. However, they are not required to be included in the extended data sheet; they do not represent the situation of an individual user and they do not need to be provided to any actor downstream. For the same reason, regional level exposure assessments are not included in the SDS exposure scenarios and they are only incorporated into the CSR. So there are no translated versions of these – they are just a part of the CSR.
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.