If you manufacture or import your substances between 1 and 100 tonnes a year, you are directly concerned by REACH and have to elaborate and submit your registration dossier before 2018. Click
to find out more about registration.
Once a substance has been pre-registered, co-declarants join a Data Sharing and Substance Information Exchange Forum (SIEF). One of the objectives of the SIEF is to limit animal testing while encouraging manufacturers and importers of substances to share costs.
A Letter of Access (LoA) is a document that grants you the right to refer to the Lead Registrant’s (LR’s) registration dossier.
IUCLID (International Uniform Chemical Information Database) is a free software developed by ECHA and the OECD in 2007. The software plays a central role in the IT environments of all organisations that have to cope with the data submission requirements of REACH.
Member Registrants (MRs) have to submit dossiers with the specific information of their company and substance (for instance the substance profile, the substance use and the production volume). Member Registrants are not obliged to submit information that has already been presented in the Lead Registrant’s dossier.
Members of a SIEF have to appoint a Lead Registrant (LR) who will act on behalf of them. The Lead Registrant has to prepare the principal dossier of the joint submission gathering data on the substance and its uses: physiochemical, toxicological and eco-toxicological properties.
CHESAR (Chemical Safety Assessment and Reporting Tool) is an application developed by ECHA to help companies carry out their chemical safety assessments and prepare their chemical safety reports and exposure scenarios for communication in the supply chain.
REACH-IT is the central IT system that supports companies and ECHA to securely submit, process and manage data and dossiers. The platform provides a secure communication channel between both parties to help them coordinate the processing and evaluation of data and dossiers.
The first two waves of registration have shown that the process is quite long and can take more time than primarily expected. EcoMundo would like to present the 7 key steps to successfully create your registration dossier.
has made a short video for this step:
1° The SIEF is empty: When a substance is completely new on the market, it occurs frequently that no other registrant has joined the SIEF yet. In that situation, you may decide whether you would like to present a joint submission or an individual one. If you decide to opt for a joint submission, you can appoint yourself as Lead Registrant. It is highly recommended to opt for a joint submission in order to anticipate the arrival of other registrants in the SIEF. Warning! Whether you decide to present a joint or an individual submission, you will have to prepare the same number of documents and data.
2° A Lead Registrant has already been appointed: If SIEF members have already appointed a Lead Registrant; you have to get in contact with him/her in order to sign the SIEF agreement. Signing the SIEF agreement will give you the right to purchase the Letter of Access which gives you access to the information of the principal dossier. Once you have paid the Letter of Access fees, the Lead Registrant will send you by email both the joint submission dossier references and the token (for your information, the token is a password). These pieces of information will allow you to enter the joint submission on the REACH-IT platform.
3° The SIEF is dormant: A SIEF is declared to be dormant when registrants have joined the SIEF but have not appointed any Lead Registrant. In this situation, you may wait for the election of a Lead Registrant or designate yourself as the Lead Registrant. If you decide to apply for the Lead Registrant role, you have to send a survey to the member registrants with all the information concerning your election. Once you have their approval, you create a joint submission on the REACH-IT platform and declare yourself as Lead Registrant. Thus, ECHA will receive a notification of your status as Lead Registrant.
Considering the fact that the Lead Registrant acts on behalf of other registrants, he/she has a specific role in the registration process.
Although being Lead Registrant is time consuming, it will give you a considerable advantage on the long run: since you are in charge of the SIEF, you will be able to complete your registration faster. Furthermore, being Lead Registrant will also give you the opportunity to conduct the toxicological and eco-toxicological tests according to your criteria. Thus, you can create the Substance Identification Profile (SIP) and make sure that the tests concern your substance and its classification. All these factors may give you a strategic advantage over other companies that are part of the same SIEF.
As the Member Registrant purchases his/her access to the common part through the Letter of Access, he/she has some different roles in the joint submission.
If you are the Lead Registrant, you have to submit your dossier as soon as possible in order to give some time to the Member Registrants to join your SIEF. The deadline set by ECHA is March 2018.
If you are a Member Registrant, the deadline set by ECHA is the 31st of May of 2018 (at 23:59).
For the late pre-registration, the deadline is the 31st of May of 2017. After this date, you will have to consider the inquiry process.
There are different types of costs related to the REACH registration process: the common part fees, the individual part fees and the ECHA fees.
The fees related to the common and individual part of the dossier can vary according to your situation and role in the SIEF (Lead Registrant or Member Registrant).
The ECHA fees vary according to the tonnage of your substance and the size of your company.
Ecomundo tip : If you are an SME, please bear in mind that the European Commission grants discount percentages according to the size of your structure as follows:
if you want to read our article about the costs and fees of the registration dossier.
Registering your substance is a long and complex process that requires several steps. It is important to establish a submission strategy that fits the specificity of your situation. Whether you choose to be Lead Registrant or Member Registrant, managing or joining a SIEF takes time. Thus, it is often better to use the services of specialized providers who can act on your behalf. The provider can give you some guidance on your strategic issues; can find laboratories to run the analytical tests and complete/submit your IUCLID 6 dossier.