REACH Update: SIEF Tasks and Registration Requirements

By: Annelie Struessmann, PhD, CONUSBAT

Posted: June 10, 2009

Substance Information Exchange Forums (SIEFs) are operational and critical for data-sharing and the subsequent preparation of joint registration dossiers. A SIEF is established when companies have agreed that their substance is the same. The time remaining to fulfill the tasks for a SIEF is short, especially for registrants needing to submit for the deadline of Dec. 1, 2010. According to the European Chemicals Agency (ECHA), this deadline accounts for more than 55,000 SIEFs, while 146,000 substances have been preregistered.¹

Steps to take before registration include the following, and must be completed at least  two months before the respective registration deadline due to registration approval specifics:^1,2

▪ Identification of SIEF formation facilitator (SFF)
▪ Agreement on the sameness of the substance
▪ Selection of a lead registrant (LR)
▪ Agreement on operational rules for the SIEF and cost splitting
▪ Compilation and sharing of existing data
▪ Determination of data gaps
▪ Generation of new data; initiation of testing (Annex VII, VIII) or preparation of test proposals (Annexes IX, X)
▪ Preparation of Chemical Safety Report (CSR)
▪ Joint Submission (JS) and payment of the registration fee by the LR
▪ Acceptance of LR dossier by ECHA
▪ Submission of SIEF member dossiers
▪ Payment of registration fee by individual members

Registrants are required to jointly submit information on intrinsic properties of the substance, its classification and labeling, and, if applicable, on testing proposals. Contrary to the SFF, the selection of a LR is a provision of the REACH Regulation. The LR acts with the agreement of the other SIEF members and submits the joint registration dossier to the ECHA. Separately and individually, the other registrants submit  their company-specific, administrative information on the following:

▪ The legal entity identity
▪ The substance identity
▪ Information on manufacture and on use(s) with tonnage
▪ Limited exposure information for quantities of 1-10 tonnes