A new implementing regulation adopted by the European Commission defines more clearly the rules to be included in data sharing agreements within substance information exchange forums (SIEFs) in accordance with the REACH Regulation. The regulation is applicable as of 26 January 2016.
The regulation sets rules to ensure that potential registrants joining a SIEF are given the right to request a breakdown of the study and administrative costs that make up the price for the joint registration and registrants are only required to share the costs of information they need to submit to the ECHA.
In addition, the regulation requires registrants to estimate the number of potential registrants for a substance and future additional information requirements, and take these into account when agreeing on the cost-sharing model and 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 registrant joins the agreement.
The regulation also gives ECHA the mandate to make sure that all registrants of the same substance are part of one joint registration. The new REACH-IT, to be launched in late spring 2016, will not allow registrations to be submitted outside of joint submissions. Although some opt-out provisions are still possible.
For information on how REACH may impact on your business, contact JSC on email@example.com or call Sam Wright on +44 (0)1423 520245.
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