Lead Registrant? New regulation on joint submission and data sharing
The new regulation on joint submission and data sharing that entered into force on the 26th of January, 2016, with the aim ” to promote good management practices and ensure the efficient implementation of the agreements”, brings new challenges for both, current and future REACH lead registrants.
This regulation also gives to ECHA the instruction to make sure that all the registrants of the same substance are part of one joint registration. However, as the regulation applies to all the agreements concluded before and after its entry into force, consortia members and lead registrants are highly advised to review the existing data sharing and consortia agreements to ensure compliance with the new duties, and make the necessary amendments, if needed.
Moreover, as expressed at ECHA’s site, this regulation requires registrants:
- “To estimate the number of potential registrants for substance and future additional information requirements, and take this into consideration when agreeing on the cost-sharing model;
- To set-up a reimbursement mechanism as part of the cost-sharing model. This mechanism should consider potential future registrants and registration requirements, and include a method of reimbursement to each co-registrant once a new regitrant joins the agreement.”
Are you a REACH lead registrant? Need help to understand your duties with the new regulation? Contact us!