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News @en


Mar 2016

REACH: Reimbursement systems mandatory for Letter of Access (LoA)

On 01, Mar 2016 | In News @en | By Alisa Maier

Flakons_quadr_pixelio.dePublishing the implementing regulation 2016/9 of January 5, the EU Commission has laid down strict rules on joint submission of data and cost-sharing in conjunction with REACH registration.

REACH regulation requires the cost-sharing to be handled in a fair, transparent and non-discriminatory way – these nonspecific requirements have often lead to misunderstanding and disputes in the past: costs have not been broken down into details, no reimbursement was planned although, at same time, charging of follow-up costs was established, deeper insight of Dossier was not allowed, and much more.

As laid down in the new implementation regulation, all agreements within a SIEF (Substance Information Exchange Forum) have to incorporate the following rules:

  • Detailed break down of jointly used data including individual data costs as well as details how data complies with requests for registration. (Data-costs)
  • Detailed break down and justification for administrative costs
  • Cost-sharing model including a reimbursement system

Existing agreements can be kept, however only if parties agree unanimously. A party, joining an existing agreement, e.g. for registration period 2018, can insist on the break down of costs as well as installation of a reimbursement system.

In the past, LoA (Letter of Access) costs have often been calculated at a rough estimate, e.g. on basis of number of expected Co-registrants. Now, costs have to be disclosed and, following a yearly check, to be reimbursed in case. e.g more registrants join the Agreement.

1cc supports consortia and lead registrants breaking-down and surveilling the costs of a joint registration as well as handling and administration of letter of access and installation and handling of reimbursement systems.