A Substance Information Exchange Forum (SIEF) aims to help registrants of the same substance to share information about the substance and to avoid duplication of testing.
The main duty of companies that pre-registered substances last year is to form SIEFs and make them operational as soon as possible which is critical for data sharing and the subsequent preparation of joint registration dossiers. The time available for data sharing is limited, especially for those who need to submit their registrations to ECHA before 1 December 2010.
The REACH regulation leaves the management of SIEFs to industry. However, ECHA has published a set of key SIEF principles that shall help companies to organize data sharing.
The concept of pre-SIEFs was not foreseen in the REACH regulation text, but has however been introduced with support from industry in order to facilitate SIEF formation among pre-registrants.
Through the REACH-IT system companies who pre-registered substances with either the same name or chemical identifiers are automatically placed in the same pre-SIEF.
As a next step, companies in each pre-SIEF must decide, based on detailed consideration of the substance identity, whether the substance in question can in fact be regarded as the same. Pre-registrants of the same substance then will form one SIEF.
REACH-IT gives access to the contact information of all other pre-SIEF members.
A SIEF is formed when companies have agreed that their substance is identical. Companies within one SIEF are free to choose how they communicate and organise themselves. ECHA is not involved in discussions between potential registrants and is not responsible for allowing or disallowing the creation of a particular SIEF.
All SIEFS are required to select a Lead Registrant. Besides this general requirement, there are no specific rules as to how the Lead Registrant should be selected. He must act with the agreement of the other assenting registrants and submit the Joint Dossier, which contains information on the intrinsic properties of the substance. The other registrants then only have to submit their company-specific information.
Consortia are a more formal type of co-operation between registrants set up in order to provide practical help with SIEF data-sharing obligations and the preparation of registrations. Consortia are voluntary; there is no obligation under REACH to be part of a consortium. The consortium covering platinum group metals is the Precious Metals and Rhenium Consortium (PMC).
Letters of Access
For companies wishing to refer to a Registration Dossier prepared by the Consortium, a Letter of Access (LoA) can be purchased which implies a legal agreement and a fee.
LoA offer a way to benefit from the work that has been executed by the Precious Metals and Rhenium Consortium: Non-Members of the Consortium can purchase these LoA in order to refer to a Registration Dossier prepared by the Consortium.
Members of the Consortium are legitimately authorised to refer to the dossiers, they do not need to purchase LoA as they have paid their share of the costs throughout the past years of Consortium membership. The main differences between Membership and LoA remain:
Consortium Members pay twice per year, based on agreed annual budget: LoA candidates a unique fee, based on PMC predictions; Members are eligible for reimbursements whereas LoA are not; Members are required to participate in Consortium activities and have voting rights, LoA have no participation obligation and no voting rights.
So far nine LoA have been purchased from the PM Consortium (all for Ag substances). In order to ensure a smooth registration and avoid any risk of inconsistency between Members and Non-Members submissions, the PM Consortium has agreedf to assist LoA purchasers in the same way it is assisting its Members.