Q&A LoAs and co-registration


How long does it take to complete the LoA purchase process?

It takes between 3 to 4 weeks minimum to complete the LoA purchasing process. Although Arcadis is providing its best efforts to speed up the process as much as possible, it is also important that the correct information is provided at the beginning of the process and that the various steps are executed in time by the LoA-purchaser. The above indicated period only starts once the LoA purchaser has verified that his substance has the same sameness as the one of the Lead Dossier (see the Substance Identification Profile (SIP) in the substance-section of the website http://www.rare-earth-consortium.eu/substances).

Itemisation of LoA-costs

The itemisation of LoA cost per substance/tonnage band is available upon request for companies having purchased a LoA. Please allow three weeks for handling your request.
To obtain the cost itemization, please contact rare-earth-consortium@arcadis.com with the name of the substance and the tonnage band.

Note: If you did not purchase a LoA yet, you will need to sign a Non-Disclosure Agreement first.

Yearly documentation

Regulation (EU) 2016/9 stipulates that yearly documentation about the LoA cost and their evolution must be made available.
The yearly documentation is only available on demand and to companies having purchased a LoA.
The yearly documentation is usually available in April. For example, the yearly documentation for 2018 will be ready by April 2019.
If you wish to receive the yearly documentation, please contact rare-earth-consortium@arcadis.com with the name of the substance and tonnage band. Please allow a minimum of 3 weeks for handling your request.

The Rare Earth Consortium is aware of the issues linked to BREXIT, especially when the Lead Registrant is a company located in the UK.
The Rare Earth Consortium will take appropriate actions in due time to ensure continuity of the registrations for the substances covered by the consortium and to avoid disruptions of the supply chains. The actions undertaken will be subject to a communication to the respective SIEFs.

Further information can be found on the ECHA webpage dedicated to the topic: https://echa.europa.eu/uk-withdrawal-from-the-eu

How to upgrade my tonnage band?

If you have already purchased a LoA for a substance in a specific tonnage band and you need to update your registration dossier to a higher tonnage band, please contact rare-earth-consortium@arcadis.com and provide the necessary information.
An amendment to the current LoA Agreement will be prepared.
You will have to pay the difference in LoA-cost between the previous and new tonnage band.
The other steps of the procedure are identical as for the purchase of a LoA.

What should I prepare before buying a LoA?

• Gathering all information necessary to demonstrate the sameness with the substance used to build the Lead dossier (please use the SIP for that purpose - The Substance Identification Profile or SIP is available on the REC website, under each substance). You will need to check that the concentrations of main constituent/impurities are within the ranges proposed by the lead registrant. The analytical methods for concentration determination are suggested in the SIP itself.

• Gather information about your uses to check whether they are covered by the Lead dossier. If not, you will have to include them in your co-registration anyway.
• Make sure the company size of your company as currently indicated in your REACH IT account is up to date before submitting.
• Create a co-registration file using the IUCLID software, either by downloading the IUCLID software locally or by using IUCLID Cloud (https://echa.europa.eu/support/dossier-submission-tools/echa-cloud-services). Please refer to the ECHA website for more information.

What is the procedure to buy a LoA?

• Check the sameness of your substance with the SIP. You can start this procedure before buying the LoA.
• Contact us by email at rare-earth-consortium@arcadis.com with the following pieces of information:
o Name of the legal entity
o Contact name
o Registration intention: Full/Intermediate
o Tonnage band
o Address (of the legal entity registering the substance)
o Invoicing address (if different)
o VAT number
o If we need to mention a P O Number (Purchase Order Number) on the LoA-invoice, please forward it to us.
• Arcadis will prepare a specific LoA Agreement for your substance/tonnage band/Legal Entity and will send it to your attention
• You sign the LoA Agreement and return it to Arcadis (a signed pdf is accepted)
• Arcadis issues the invoice related to the LoA
• After reception of the payment in full, Arcadis will send you the LoA package and token for you to complete your registration.

Can I review the LoA agreement and provide you with my comments before finalization and signature?
No. The Consortium is implementing the principle of fairness, transparency and non-discrimination. Therefore, the LoA Agreement cannot be modified, and the same template is used for all co-registrants. ARCADIS will provide you with a finalized version of the LoA agreement.

I am now producing/importing more tonnage of my substance and I need to update my tonnage band to a higher one. Should I buy another LoA?
In case you need to update your tonnage band to a higher one, contact us and we will generate an amendment to the current LoA agreement. You will be asked to pay the difference of price between the LoA-price of your current tonnage band and the one of the higher tonnage band. Please note that in case you produce/import less, you will not be refunded of the difference.

Do we need a paper version of the signed LoA Agreement?
Our policy is “let’s go digital”, i.e. we are happy with a signed pdf version. However, if you prefer an original signed version, inform us and we will make sure you receive a duly signed paper version. 

Do I have to pay a fee to ECHA on top of the LoA price?
Yes, you must pay a registration fee to ECHA. The fee depends on your tonnage band and the size of your company and other parameters.
After submission, ECHA will send you an invoice for the corresponding ECHA Fee (monitor closely your REACH-IT account).

Reference: COMMISSION IMPLEMENTING REGULATION (EU) 2015/864 of 4 June 2015 amending Regulation (EC) No 340/2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L139, 05.06.2015; p1.

What is the content of the LoA package I will receive together with the token?
The LoA package will contain:
• The CSR for Annex VIII to  annex X dossiers
• The GoSu (Guidance on safe use) (for registration as an Annex VII and VIII under REACH)
• The name of the Joint Submission
• The token.
• The expiry date of the token
Please kindly note you will not receive the IUCLID file. Buying a LoA allows you to refer to the Lead dossier, but without ownership rights. Therefore, you don't receive the IUCLID dossier itself.

I receive a generic CSR with my LoA package. Do I have to modify or complete it?
In the provided CSR in the LoA package, both CSR part A and B are contained within the same document. This should be indicated when adding the document to the IUCLID file of your co-registration.
1. Adapt the CSR word-file as follows:
Before adding the CSR word document to your co-registration file, please first adapt the company specific sections marked in yellow. When doing this, you have the possibility to also adapt the identified uses within the CSR (should your company have other uses then those indicated in the Lead dossier). 
2. Please indicate under “Type of CSR” the option “own CSR initially prepared jointly within the consortium”
3. Please indicate under “CSR contains” all three options. For non-classified substances, sections 9 and 10 are included in the CSR but are empty.
4. Attach the finalized CSR word file under “Chemical Safety Report (CSR)”
Additional info on the CSR can be provided by your company in this record as well, however this is not an obligation. 
How to complete the sameness section of my co-registration dossier?
The co-registrant has the duty to complete this section by demonstrating that its substance is the same as the one used for building the Lead Dossier.  Please use the SIP (Substance Identification Profile) to do so. The SIP is available on the REC website under each substance section. Follow the ECHA guidance for more information.

My use(s) is/are not covered by the CSR included in the LoA package: what should I do?
Please use the CSR provided in the LoA package to adapt it accordingly by including you use(s).

Will it be possible to buy LoAs after May 2018?
Yes. First-time manufacturers and importers having registration duties can still buy a LoA after May 2018.

What should I do if the registration dossier is updated after I purchased a LoA and submitted my co-registration?
If some action from your side is required, you will be informed by a communication from the consortium. Please kindly note that not all updates of the dossier requires some changes in your co-registration file.

How is the reimbursement mechanism working?
When several companies are registering the same substance, a Joint Submission is created and LoAs are made available for sale to the SIEF participants. The price of the LoA is derived considering the tonnage bands and the number of co-registrants in the Joint Submission.
When the Joint submission is created, not all costs pertaining to the registration dossier are known. The initial number of co-registrants is also estimated. Therefore, the price of the LoA is derived in two different steps:
• The initial LoA prices: is based on the actual past costs, an estimation of the future costs and an initial estimation of the number of co-registrants, all per tonnage bands. This is the price you pay when buying a LoA.
• The final price of the LoA will be derived when all costs are known, when the actual number of co-registrants is known.  The final price is not expected to be derived before the end of the 12 years period of data protection under REACH.
If the final price of the LoA is lower than the initial price, each co-registrant is entitled to a reimbursement (depending of the tonnage band).
If the final price of the LoA is higher than the initial price, each co-registrant will have to pay an additional amount. Please note that the consortium has the right to invoice you an additional amount at any time after the purchase of the LoA should the expected future costs exceed the provisions embedded in the initial price of the LoA. 
Further details are provided in the LoA Agreement.

When can I expect a reimbursement?
When you buy a LoA falling under the new regulation on data sharing (EU) 2016/9, i.e. after January 2016, the cost of the LoA you pay (per tonnage band) is the initial cost of the LoA. This initial cost of the LoA is calculated considering a few assumptions:
• The expected dossier costs (including some provisions for future costs due to spontaneous updates (when new information is available) or within a framework like MISA, evaluation by the authorities, etc.)
• The expected number of registrants per tonnage band.

The data protection period under REACH is 12 years after submission of the studies. The final calculation of the costs of the LoA (considering the total actual costs and the actual number of registrants) can only be done after the end of the data protection period. If the final costs of the LoA (per tonnage band) are lower than the initial ones, the LoA purchasers are entitled to a reimbursement (under the conditions indicated in the LoA Agreement).
It should be noted here that any new data submitted after the first submission of the lead registration dossier also bears a 12 years data protection period. Let’s take an example: the lead registration dossier of a substance was submitted for the first time in 2010. For the data submitted at that time, the end of the data protection period is 2010+12=2022.  However, if a new data was submitted in 2020, the data protection period for that data only ends in 2020+12=2032.

In other words, for such dossier submitted for the first time in 2010, only a partial final calculation of the LoA costs can be performed in 2022.
How the final partial calculation of the LoA will be implemented (and consequently when the reimbursement if any will take place) is not decided yet. In any case, not before the end of the 12 years data protection under REACH. 

A technical point: please be aware that companies registering a substance as a TII under SCC below 1000t/y are not participating in the cost sharing model (although these companies are visible on the ECHA dissemination website). The number of co-registrants on the ECHA dissemination website is not providing an actual view of the number of co-registrants having purchased a LoA subject to the cost-sharing model.

Can I join the REC Consortium?
Please note that the Rare Earth Consortium does not consider any further application for membership for the time being.
The consortium was originally formed in order to gather potential registrants of rare earth compounds and discuss the testing strategy and cost sharing between the different actors in the dossier preparation. The consortium agreement foresees a clause indicating that no membership application will be handled in the six-month period prior to a Reach deadline (and we are currently in this six-month period) because the members want to devote all their attention on the dossiers to be submitted against the REACH deadline. 
Please kindly note you don't have to become member of the consortium to buy a letter of access to the substances registered by the members of the consortium. We will therefore ask you to buy a LoA for your substances of interest.