Participation in cost sharing
According to Implementing Regulation (EU) 2016/9, costs have to be shared in a fair, transparent and non-discriminatory way between all co-registrants of the same substance.
The price is made up of costs related to tests (study costs) and costs related to administrative work (non-study costs). The individual proportion of the costs depends on how many co-registrants share the data. It makes a significant difference if the costs are shared between 2 or 200 registrants.
The number of co-registrants who share the costs are not definitely clear while an ongoing negotiation. This means that the calculation of the price is based on the currently known number of potential registrants.
The reimbursement scheme makes sure that the costs are equally shared. Each time a new potential registrant buys access to the data, the overall costs for each co-registrant will decrease. REACH is a living process with frequently changes of assumptions which lead to periodically re-calculations of the prices.
The reimbursement scheme will be started earliest in 2022, as soon as the protection period of the studies is over. Future costs are already included and will be part of the reimbursement if it is foreseen that they will not occur in the future.
Test costs
The test costs regarding the requirements of REACH Annexes VII – X are divided into related classes 1 to 4 that correspond to tonnage bands 1-10 t/y, 10-100 t/y, 100-1.000 t/y and > 1.000 t/y.
The information includes necessary endpoint studies and regarding reports, waiver, endpoint summaries and the CSR from the related REACH Annexes. The cost breakdown registers all costs related to tests (study costs) and to administrative work (non-study costs). As well, it shows the price in relation to the information you require for your registration, which are divided into classes related to REACH Annexes (tonnage ranges).
Administrative costs
Administrative costs are running costs of the entire lifetime of the project. The single positions can roughly be broken down into “strategy” until submission of the lead dossier and “running project costs” starting from the submission of the lead dossier.
LTU
A License to Use (LtU) allows registrants of Charcoal, coconut shell EC#271-974-4 to refer to relevant test data of the lead dossier of Charcoal EC#240-383-3 in different tonnage bands. These costs are shared between all registrants that refer to the data.
Please continue with topic “Procedure of the registration”.