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REACH Full Registration Dossier Service

Preparing full REACH registration dossiers


You don’t want to be a lead registrant but maybe you have no choice?

I can help you with the decision, what may be your tasks.

Being a lead registrant is not an easy task, this is probably why in many SIEFs the lead registrant has not been appointed yet.

At the following link you can see if there is already a lead registrant in your SIEF:
http://echa.europa.eu/web/guest/information-on-chemicals/registered-substances

What should I do if there is no lead registrant in the SIEF related to my activity/company?


On REACH-IT you can look up the email addresses of all SIEF members and you can contact them directly. You can also find out on REACH-IT whether any of the companies has started to organize something in one of the SIEFs. The main point is, you should find out as soon as possible if there is already a lead registrant, as choosing one cannot be avoided, it is usually a common interest.

If your company is a European producer, and it seems that none wants to take the role of the lead registrant, you must immediately report this to your management as it can happened that your company must take this role as long as no other firm is involved in the production of that particular substance. Being the lead registrant means significant financial expenditures, which the company management must plan well in advance.

What additional tasks and expenses should you expect as a lead registrant?



The lead registrant has two main tasks. One of them is to reduce the number of tests and have them completed in a way that it is still compliant with REACH requirements and the full dossier can be submitted. The other task is to communicate with SIEF members regarding the dossier submission, using the help of a SIEF facilitator. The communication is possible via email or other free web surfaces developed for SIEFs, depending on the number of SIEF members.

Gathering the necessary tests



The most simple is if the SIEF members are in possession of the necessary tests, in this case they only need to agree about the division of the data and the costs.



ECHA warned that clock is ticking. What is the rush?



For the lead registrants it is important to submit the full dossier, because until this is not done, the rest of members can also not submit their mini registration dossier.



What is the process of the REACH registration?



The REACH registration dossier should be prepared through the IUCLID 5 and REACH-IT programs. There are two kinds of registration: individual submission and joint submission. Individual submission is only possible if the company is able to give a reasonable justification to ECHA, otherwise joint submission is required, which is also cheaper than the individual submission.

In case of a joint submission the SIEF members choose a lead-registrant, who would be responsible for preparing the “full” registration dossier. First, the lead-registrant must submit the registration dossier. The rest of the SIEF members can submit their „mini” registration dossier after the lead registrant submission.

The REACH “mini” registration dossier should be prepared by all SIEF members, despite the fact that the lead registrant submitted a “full” dossier about the same chemical substance. When the lead-registrant prepared the “full” dossier, the SIEF member who paid for the tests will receive a “token” number. With this “token” number the SIEF member is able to certify that he is allowed to use the toxicological tests of the lead registrant.

From this process you can see that the submission date of the “mini” registration dossier depends on the submission date of the lead-registrant, since the mini dossier can only be submitted after the lead-registrant submitted the “full” dossier. If a company in a pre-SIEF has volunteered to be the “facilitator”, this does not mean that this company is the lead registrant. Lead registrants are theoretically chosen by the SIEF members.

It is common in many pre-SIEFs that a few companies form a consortium for easier cooperation. One independent consultant keeps in contact with the members of the consortium (who are competitors) in order to avoid the accusations of cartell formation. The consortium can deal with several substances. It is not compulsory to participate in the consortium.

The lead registrant is required to ensure access for all SIEF members to the “token” number, if the company has paid, when the lead registrant hands to the SIEF member a “Letter of Access”.

Assume that your Company must become the lead registrant, as none took the role in the SIEF and you want to produce the given substance.

What costs can you expect?



The cost of the full toxicological test of a substance is approximately Eur 2 million. This depends on the substance and the selected lab. This cost will be divided among the SIEF members. It is possible to reduce the cost using the read-across, QSAR method. This is the cost which you should expect in the first round, as not all tests must be paid immediately, only the tests listed in Appendix 7 and 8.

As a lead registrant, you have significant influence on the costs. You must make your calculations so being a lead registrant does not result in financial loss!

What are the specific costs after all?



1.The costs of the toxicological tests proportionally divided among the SIEF members
Toxicological costs must be divided in a fair, transparent, non-discriminative manner among the SIEF members. Of course the lead registrant can charge the other SIEF members for the costs of its added work.
2.If there is a consortium, the costs of the consortium
3.Expenditures paid to the REACH consultants
4.Expenditures paid to the European Chemical Agency

Fees payable to the European Chemical Agency, ECHA, in Euro:



Size of Enterprise Fee for substances in the range of 1-10 tonnes Fee for substances in the range of 10-100 tonnes Fee for substances in the range of 100-1000 tonnes Fee for substances above 1000 tonnes Fee for intermediates
Large enterprise
individual submission 1600 4300 11500 31000 1600
joint submission 1200 3225 8625 23250 1200
Medium enterprise
individual submission 1120 3010 8050 21700 1120
joint submission 840 2258 6038 16275 840
Small enterprise
individual submission 640 1720 4600 12400 640
joint submission 480 1290 3450 9300 480
Micro enterprise
individual submission 160 430 1150 3100 160
joint submission 120 323 863 2325 120

If you decide to be a lead registrant and you need a REACH consultant, I can offer the following services:


reach szolgáltatásRegular communication with pre-SIEF members in the required webpage of the SIEF
reach szolgáltatásClarifying and arranging analytical examinations in order to identify the substance, the additives and impurities, communicating about the sameness of the substance with the pre-SIEF members, as necessary
reach szolgáltatásIdentifying “dormant” registrants
reach szolgáltatásRegular communication with active SIEF members
reach szolgáltatásIf the SIEF members have toxicological data available, checking them according to the Klimisch score and making recommendation for which one should be used for the dossier
reach szolgáltatásIf the client has toxicological data available, checking them according to Klimisch-score
reach szolgáltatásDoing the literature research from current data bases in order to reduce the number of tests
reach szolgáltatásChecking read-across and QSAR methods with a qualified toxicologist in order to reduce the number of tests
reach szolgáltatásBuying toxicological tests from data holders if possible
reach szolgáltatásPreparing the list of and arranging the toxicological tests required in a GLP laboratory (Annex IX and X require a testing proposal by 2010 and not a full test)
reach szolgáltatásCalculating the individual fees which should be paid to the lead-registrant by SIEF members
reach szolgáltatásArranging the payment to the European Chemical Agency (ECHA)
reach szolgáltatásPreparing the “full” registration dossier in IUCLID 5 program
reach szolgáltatásSubmitting the “full” registration dossier through REACH-IT to ECHA
reach szolgáltatásMaking the “token” number available for SIEF members who paid the fee
reach szolgáltatásOf course the specific services which your company needs must be discussed in person, since selecting the appropriate REACH consultant is a big responsibility!

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