By Lisa R. Burchi and Lisa M. Campbell
On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union. The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a “fair, transparent, and non-discriminatory manner” associated with the sharing and joint submission of information and also the costs relating to a registrant’s obligation to share information in accordance with REACH.
Many of the requirements set forth in the Regulation may be already in place in existing Substance Information Exchange Forums’ (SIEF) data-sharing agreements. Nevertheless, the Commission found based on information collected following the 2010 and 2013 REACH registration deadlines that “data sharing and joint submission have not been used to their full potential, their implementation falling short of expectations.” The Commission found that these problems were “especially prejudicial to small and medium size enterprises.” The requirements set forth apply prospectively as well as retroactively, meaning that all companies that are parties to REACH data-sharing agreements are affected by this new Regulation.
The Regulation seeks to “promote good management practices” and “ensure the efficient functioning of agreements” related to data sharing. The requirements set forth in the Regulation are intended to further the OSOR principle, ensure transparency and fairness in data-sharing agreements, and end excessive charges. The Regulation furthers its goals of promoting transparency and fairness by ensuring that a cost-sharing model and reimbursement mechanism are in place when future registrants provide additional compensation and by eliminating concerns that potential registrants pay for studies that are not required of them under REACH.
The Regulation will enter into force on January 26, 2016. All agreements to be executed after this date must be in compliance with these new requirements. More information can be found in The Acta Group’s (Acta®) memo REACH: EU Publishes Regulation Regarding REACH Joint Submission of Data and Data Sharing.