Preparing to form a new SIEF
For each substance you have pre-registered, a pre-SIEF page was set up in REACH-IT. In the pre-SIEF page, you will find the contact information of the other companies that have pre-registered with the same substance identifier (e.g. EC number).
You need to contact each other to see who will register and if your substances are the same.
Once you establish that you have the same substance, you have formed a substance information exchange forum (SIEF). It is a specific cooperation for REACH registration, organised by the co-registrants, and usually formalised in an agreement.
In the SIEF, you will share the data you have on your substance with your co-registrants, share costs and prepare the joint registration.
The steps below explain how to go from your pre-registration to preparing to form a new SIEF.
REACH-IT is the IT tool you have to use for submitting information to ECHA, including pre-registrations and registrations.
You can access REACH-IT from ECHA's homepage. You log in with your user ID and password. If you are not yet a user, you can sign up.
You can find your pre-registrations in REACH-IT through ‘Menu > Search > Pre-registrations and pre-SIEFs’.
Verify that you have a pre-registration for each substance you need to register. If you miss a pre-registration, then check what to do from the questions and answers below.
Remember that your pre-registrations are not only your starting point for getting in contact with your co-registrants, they also give you the right to be on the European market without a registration until your registration deadline.
Since you will need to register jointly, it is important that your contact information is up-to-date so that your co-registrants can reach you.
Each pre-registration contains contact information, normally of a person in your company or a third party representative (TPR). This contact information (name and email) is available to all who have pre-registered the substance in the pre-SIEF page of REACH-IT.
Decide if you want to keep the current contact in your pre-registration or change it, and verify that the contact information is up-to-date for each substance you intend to register.
You can access the contact information of other companies that pre-registered your substance through REACH-IT. Go to ‘Menu > Search > Pre-registrations and pre-SIEFs’ in the REACH-IT menu. You can also download the full list.
You will need to contact your co-registrants by email outside REACH-IT. Not everyone listed in the pre-SIEF page will register (for example, because of changes in the portfolio or company strategy) and the response rate may be low.
You will need to be active to register your substance. There are different ways:
- Activate your co-registrants
If the substance is critical to your business, take the initiative to start the discussions. This way you can make sure that the substance is registered by the deadline.
You can indicate you willingness to start-up the SIEF formation by clicking the ‘Become facilitator’ button in REACH-IT.
As the facilitator, you can indicate in the pre-SIEF page how you want to start the discussions. You will most likely need to organise some meetings or web conferences.
- Respond to your co-registrants If you are not taking the initiative, then respond when you are contacted by the SIEF Formation Facilitator (SFF) or a co-registrant – even if you have not yet decided whether to register or not.
- Keep track of your substances
It is possible that for some substances no one will initiate the cooperation. In this case, you should contact the co-registrants yourself to find out if you will be the only registrant for this substance. If so, you need to reserve enough time to prepare the registration on your own.
For establishing substance sameness, all co-registrants need to have determined the name of their substance according to the Guidance for identification and naming of substances under REACH and CLP (see also phase 1: Know your portfolio).
If the name is the same, then the substances are considered the same.
If you have concerns about confidential business information (CBI) when discussing substance sameness, read the questions and answers below.
Once you agree that your substances are the same, a SIEF is formed. You can start working together to share data and register jointly (see phase 3: Get organised with your co-registrants).
Participants of the SIEF should collectively apply the principles of the Guidance for identification and naming of substances under REACH and CLP to define the boundaries of the substance corresponding to the data that they will submit jointly. This is known as the substance identity profile (SIP) and will need to be reported in the lead registrant’s registration dossier. Guidance on the SIP is included in Appendix III of the Guidance for identification and naming of substances under REACH and CLP.
There are two formally separate roles in the SIEF: the lead registrant and – if any – the member registrants. However, all co-registrants are responsible for the schedule and progress of the work, the content of the joint parts of the registration and the content of their own parts of the registration.
The SIEF elects the lead registrant. The lead registrant will have to submit the joint registration through REACH-IT first, before the members can submit their own registrations. The lead registrant also has to distribute the security token numbers to the members, so they can join the joint registration (see phase 6: Submit your registration dossier).
For all other tasks, you need to decide with your co-registrants on how you work together. In practice this means deciding on who does what and whether or not to outsource certain tasks. The agreement is usually documented, for example in a SIEF agreement or a consortium agreement.
The agreement should cover the different activities that SIEF participants have to perform to register (see phases 3, 4, 5 and 6) and keep the registration up-to-date (see phase 7). These activities include for example the following administrative, technical and content-related work:
- SIEF administration: establishing contact points for communication within and outside the SIEF, organising the way the invoices and payments are dealt with, developing reimbursement schemes and keeping records.
- Preparing the content of the dossier: collecting existing data, generating new data, discussing data quality, agreeing what data will be submitted jointly, negotiating data-sharing costs, performing chemical safety assessments, deriving the classification, and preparing the chemical safety report.
- Preparing the IUCLID dossier and submitting it: creating the joint registration dossier in IUCLID, submitting the dossier to ECHA and following up the invoice and messages in REACH-IT.
Checking if a substance has been registered
Logging in to REACH-IT
Finding your pre-registrations and pre-SIEF
- What should I do if I made a mistake in the substance I pre-registered?
- What do I do when I start manufacturing or importing of a phase-in substance?
Establishing substance sameness