REACH data-sharing principles clarified
A new implementing regulation adopted by the European Commission defines more clearly what the terms ‘fair, transparent and non-discriminatory' mean for data sharing in the REACH Regulation. It also gives ECHA the mandate to make sure that all registrants of the same substance are part of one joint registration. The regulation is applicable as of 26 January 2016.
Helsinki, 7 January 2016 – The regulation sets rules to make sure that the data-sharing agreements in substance information exchange forums (SIEFs) are clear and comprehensive. 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.
Registrants are only required to share the costs of information they need to submit to the Agency. Therefore, they need to clarify how the data they share satisfies the relevant information requirements. They do not, for example, need to pay for data that goes beyond the requirements for their tonnage band.
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;
- 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.
One substance, one registration
ECHA will have a stronger role in getting companies to submit a joint registration when there are multiple registrants for the same substance. The new REACH-IT, to be launched in late spring 2016, will not allow registrations outside of joint submissions.
While all registrants of the same substance must belong to the joint registration, in some cases, registrants can still submit their own data. For example, if there are disagreements about the selection of data, an opt-out for those data points is possible. This still means that all registrants of the same substance remain part of the joint registration.
ECHA will update its IT tools, related guidance documents and other support material to reflect the changes. The Directors' Contact Group (DCG) will revise its recommendations taking into account the Implementing Regulation.
The Implementing Regulation on joint submission of data and data-sharing was published in the Official Journal on 6 January and enters into force on 26 January 2016.
- Registrants of the same substance must be part of the same registration, News alert 25 January 2016
- Official Journal, 6 January 2016
- Know your rights when negotiating for data, ECHA Newsletter 4/2015