REACH 2018: Work together to share data and its costs
The requirement to share data between companies registering the same substance is one of the fundamental aspects of the REACH Regulation. By doing this, registrants can reduce the costs and avoid unnecessary testing, especially on vertebrate animals.
Helsinki, 1 March 2016 – An important step towards successful REACH registration is getting organised with your co-registrants. How this is done depends on whether the substance is already registered or not. Setting up the cooperation is the third phase of the REACH Roadmap for 2018.
If no registration for the substance exists, co-registrants have to set up a new substance information exchange forum (SIEF)*. This means, among other things, agreeing on practical ways of working together, sharing available scientific data and deciding how to fill data gaps before preparing and submitting a joint registration dossier. Companies also need to share the costs in a fair, transparent and non-discriminatory way between the members of the SIEF.
If the substance is already registered, it is likely that the preparatory work has been done and new registrants can contact the SIEF to become part of the joint submission. They will have to negotiate to get access to the data they need and take part in sharing the costs.
Registrants should avoid new tests by making full use of alternatives to animal testing. They should also be aware that ECHA will not accept registrations where data has obviously not been shared. As for data available outside the SIEF, ownership must be respected and compensated for.
Practical advice for new SIEFs and for negotiating with existing registrants is now available on ECHA's website.
A webinar on the third phase of the REACH 2018 Roadmap will take place on Wednesday 2 March at 11:00 (Helsinki time). It will give companies an understanding of the tasks that the SIEF needs to carry out to prepare a registration dossier. It will also explain what fair, transparent and non-discriminatory data and cost sharing mean in the context of REACH and the new Implementing Regulation on the joint submission of data and data sharing. Participants will have the opportunity to ask questions from ECHA's experts.
*A SIEF is a specific group that registrants and pre-registrants of the same substance are part of. They share data for the REACH registration in the SIEF.
The last REACH registration deadline will be on 31 May 2018. This deadline concerns companies that manufacture or import chemical substances in low volumes, between 1-100 tonnes per year.
ECHA's REACH 2018 Roadmap splits the registration into seven phases and describes the milestones of each phase and support that the Agency plans to give to registrants.
Companies should start their preparations early enough. ECHA's REACH 2018 web pages serve as a one-stop-shop for all material to help companies prepare.