Ethanol

The Ethanol REACH Association (EtOH-REACH) prepared and manages the REACH registration dossier of the substance ethanol (EC 200-578-6, CAS 64-17-5).

The REACH Registration dossier includes a Chemical Safety Report (CSR) submitted by the Lead Registrant on behalf of co-registrants that covers the uses of ethanol described in this document.

Registering ethanol under REACH

There are two ways of obtaining the information necessary for the registration of ethanol under REACH:

  1. membership of EtOH-REACH
  2. the Letter of Access option

Option 1. EtOH-REACH Membership

Legal entities can apply for membership of the EtOH-REACH association by completing the following document: Membership Registration Form.

As soon as we have received the registration, we will send the legal entity an invoice for the membership fee. Only upon payment of this fee will the legal entity become an official member of EtOH-REACH.

Membership of EtOH-REACH will grant you:

  • the ‘right to refer’ to the Lead Registrant dossier for the sole purpose of making its REACH-registration for that substance. The lead registrant has jointly submitted the IUCLID dossier chapters 2, 4, 5, 6, and 7 plus the Guidance on Safe Use;
  • the ‘token’ that enables the legal entity to join the Joint Submission in ECHA's REACH-IT;
  • a Chemical Safety report (CSR) including details of the agreed classification and labeling and all identified uses for the substance according to what is known by the Association;
  • a prepopulated IUCLID template of the individual parts of the Dossier to prepare your own submission.

Once you have paid your invoice, you can ask the Secretariat for the token and joint submission name. To speed up the procedure, it is recommended that you send proof of payment to the Secretariat.

You will receive credentials to access the Members Area of the EtOH-REACH website, where you can download the pre-populated IUCLID template, view the instructions on how to use these documents and how to complete your individual registration.

Option 2. Letter of Access

The Ethanol REACH Association [EtOH-REACH] has made the Letter of Access available for purchase for non-members of EtOH-REACH who intend to register ethanol.

A. The Letter of Access grants:

The Letter of Access grants your legal entity the right to refer to the technical parts of the Registration of the Lead Registrant as a co-Registrant for the purposes of Joint Submission. The Letter of Access does not involve granting ownership of any data or studies produced or obtained by the Association, and it does not allow your company access to view or to use these data/studies.

B. If a company purchases a Letter of Access, it receives from EtOH-REACH:

  • a Letter of Access document confirming that the legal entity has the ‘right to refer’ to the Lead Registrant dossier for the sole purpose of making its REACH-registration for that substance. The lead registrant has submitted jointly the IUCLID dossier chapters 2, 4, 5, 6 and 7 plus the Guidance on Safe Use;
  • the ‘token’ that enables the legal entity to ‘join the Joint-Submission’ in ECHA REACH-IT;
  • a Chemical Safety report (CSR) including details of the agreed classification and labeling and all identified uses for the substance according to what is known by the Association;

Your legal entity will remain responsible for completing aspects of your registration not covered by the Letter of Access.

C. How to get a Letter of Access:

EtOH-REACH has created a Letter of Access order form (Appendix II) and Letter of Access agreement (Appendix III). A legal entity can buy a Letter of Access according to the following instructions:

  1. Legal entity sends a completed and signed Letter of Access agreement and a completed Letter of Access order form to the Secretariat of EtOH-REACH by e-mail.
  2. After a signed copy of the Letter of Access agreement and the completed Letter of Access order form has been received by EtOH-REACH, EtOH-REACH will issue an invoice to Legal Entity by e-mail.
  3. After full payment of the invoice is received by EtOH-REACH, EtOH-REACH will send Legal Entity by e-mail: (i) the Letter of Access document; (ii) credentials to access the Members Area of the Association website to get access to the registration template documents; (iii) the ‘token’ to join the Joint Submission for ethanol in the ECHA REACH-IT system (if the token has expired before your legal entity submits its co-registration, EtOH-REACH will provide a new token).

D. How to use the Letter of Access:

  1. Legal Entity confirms its membership of the Joint Submission for ethanol in REACH-IT using the ‘token’ provided by EtOH-REACH;
  2. Legal Entity prepares its registration dossier using IUCLID6 using a template and following the instructions provided in a guidance document in the Members Area of the website;
  3. Legal Entity submits its registration dossier via REACH-IT.

E. Costs of the Letter of Access

EtOH-REACH considers that all the costs incurred to date in preparing these technical elements of the registration for ethanol and a provision for future costs associated with this work by the Association should be considered in calculating the costs of the Letter of Access. This includes all technical costs relating to the data/studies, exposure assessments, and dossier preparation as well as the management costs relating to the preparation of data-sharing agreements and managing communications (e.g. questionnaires to the SIEFs). 

On this basis, it has been decided to set the fee for a Letter of Access as the same as membership of EtOH-REACH:

Ethanol substance tonnage LoA/Membership fee
<100 tonnes per year €420 + €250 handling fee*
Between 100 and 1000 tonnes per year €1400 + €250 handling fee*
>1000 tonnes per year €14000 + €250 handling fee*

 

*This price is valid until 31 December 2022. After this date, the fee for the Letter of Access and Membership will be recalculated.


Important Notes

  1. Letter of Access and Membership must be purchased on a per Legal Entity basis.
  2. An Only Representative or a Third-Party Representative is required to purchase a Letter of Access for each Legal Entity it represents that wishes to register ethanol under REACH.

Finally, please note that in addition to EtOH-REACH Membership or the Letter of Access fee, the registrant will have to pay a registration fee to ECHA. For more information on this fee, please see the ECHA website.

Documents

Uses covered by the CSR

Membership

Letter Of Access

Apply online (Letter of Access/Membership)

Please note: if you want to apply for a Letter of Access, have the filled out Letter of Access agreement document ready.