A new Regulation now requires all data sharing agreements to include detailed costs information on the data to be shared. The aim is to clarify the REACH requirement that registrants and/or potential registrants make every effort to ensure that the cost of data sharing for registration purposes is fair, transparent and non-discriminatory. The changes are designed to ensure the efficient functioning of data sharing agreements and promote good management practices.
The additional requirements were introduced by Commission Implementing Regulation 2016/9 on joint submission of data and data sharing in accordance with REACH, which came into effect on 26 January 2016. The requirements apply to both new and existing data sharing agreements. The parties to an existing agreement can, by unanimous agreement, waive certain requirements as between each other. However, this doesn’t bind a new potential registrant of the substance to which the agreement relates.
What are the key changes?
A data sharing agreement must now:
- itemise the data to be shared. This must include the cost of each data item, and explain how it meets the REACH information requirements;
- itemise and justify any relevant management costs associated with the data sharing agreement and/or registration; and
- have a cost sharing model which includes a reimbursement mechanism.
Where a data sharing agreement already exists parties can unanimously waive the obligation to include 1 and 2 above and a reimbursement mechanism.
The reimbursement mechanism should take into account the possibility of future registrants joining the data sharing agreement at a later stage, through a method of proportional reimbursement. It should also take into account the possibility of future additional registration requirements for the substance. In addition it should consider the economic viability of reimbursement where the costs involved are higher than the amount to be reimbursed.
If a cost sharing model cannot be agreed each participant will pay an equal share of the costs associated with the data required. Reimbursement will still occur as though the mechanism had been agreed.
Where registrants have shared information and submitted it jointly, any further costs in relation to the operation of the data sharing agreement should be documented annually. This documentation must be kept for a minimum of 12 years following the latest submission of a study. It must be made available, free of charge, upon the request of any party to the data sharing agreement.
A further provision of the Implementing Regulation reinforces the fundamental principle of REACH of “one substance, one registration”. It enables ECHA (the European Chemicals Agency) to ensure that all registrants of the same substance are part of the same REACH registration. It does, however, remain possible for a registrant to submit certain information separately for reasons including disproportionate cost and confidentiality concerns.
A practical consequence of the Implementing Regulation is that it may increase data sharing disputes under REACH as what is, and is not, “fair, transparent and non-discriminatory” is now more clearly defined. When settling such a dispute, ECHA will take into account the parties’ compliance with the Implementing Regulation. It is also likely to increase administrative costs.
Parties to new data sharing agreements should include the provisions required by the Implementing Regulation. Because the changes also impact existing agreements, data holders/lead registrants should consider getting a unanimous waiver in place now. One advantage would be to prevent an existing party to an agreement challenging a lack of itemised data if his tonnage band increases at some point in the future and he needs access to more data. However, any future registrant will not be bound by this waiver.
But how will the unanimous waiver work in practice? Where there are individual data sharing agreements between parties to a joint registration does a unanimous waiver require a unilateral agreement between all parties (i.e. the lead registrant and all co-registrants)? Alternatively will a waiver between the parties to each individual agreement be sufficient (i.e. the lead registrant and each co-registrant individually)? In practice where there are a large number of parties to a data sharing agreement obtaining a unanimous waiver may be administratively impossible.
Another practical consideration is how ECHA will enforce the “one substance, one registration” rule where there are already two or more joint submissions. How will this impact individual data sharing agreements relevant to these joint submissions? ECHA is to update its IT tools and related guidance to reflect the Implementing Regulation. It is hoped this will provide answers to some of the outstanding questions.
It pays to be mindful of these changes now in advance of the 2018 final registration deadline. A policy to minimise future time and cost through reviewing and amending/obtaining unanimous waivers for existing agreements should be considered. Any policy should also ensure future agreements include the required provisions and reflect the ECHA guidance once released.