Working together with your co-registrants
As a potential registrant, you can face two situations:
- If no registration has yet been submitted, you need to get organised with other potential co-registrants and prepare the joint registration. If you are the only registrant for a substance, you need to proceed on your own.
- If a joint registration already exists, you need to contact the registrants and agree to join them.
If no registration for your substance yet exists you have to agree with your co-registrants how to work and communicate within your substance information exchange forum (SIEF). SIEF members must share available scientific data and decide how to fill data gaps. You need to discuss the relevance, reliability and adequacy of the data available. This takes time and has to be done before preparing and submitting the registration dossier. Finally, you need to agree on cost sharing.
If your substance is already registered it is likely that the preparatory work has already been done. You need to contact the lead registrant to become a member of the joint submission after agreeing on data and cost sharing.
Under REACH, the costs need to be shared in a fair, transparent and non-discriminatory way. Data sharing is designed to share the actual costs related to registration, not to generate profit for any party. SIEF members must reach an agreement on how to share the cost of data and the cost of SIEF administration.
Support from ECHA
As a last resort, if you cannot agree on data and cost sharing with your co-registrants, ECHA can assess your case. This may, under certain conditions, result in a right to refer to the relevant data. The data sharing dispute procedure is free of charge and can be managed without legal support.
More in this section
REACH 2018 phases
- Guidance on data sharing [PDF]
- SIEF, data sharing and joint submission [PDF]
- Data sharing in brief[PDF]
- Joining an existing SIEF [PDF] [EN]
- Typical cost elements in data-sharing negotiations [PDF]
- Checklist to hire a consultant [PDF] [EN]
- Fair, transparent and non-discriminatory cost sharing in SIEFs[PDF] [EN]
- Commission Implementing Regulation on joint submission of data and data sharing(EurLex)
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