• The Pre-SIEF Process under REACH
  • March 5, 2009 | Author: Herb Estreicher
  • Law Firm: Keller and Heckman LLP - Washington Office
  • REACH establishes the Substance Information Exchange Forums ("SIEFs") as a kind of virtual platform to allow companies that have pre-registered a substance to work together on data sharing and the development of a joint dossier in support of the registration of their substances. The first step in the process is the so called "pre-SIEF discussions" where the potential registrants are supposed to agree that they are all dealing with the same substance. Once there is agreement on this point, the SIEF is formed and the members of the SIEF are supposed to go about the collective work needed for registration.

    REACH itself provides no provision for SIEF organization. As envisioned by the European Chemical Agency's ("ECHA") Guidance on Data Sharing (RIP 3.4), one pre-registrant is expected to volunteer to take on the role of SIEF facilitator. Section 4.5.2 of the Guidance specifies that the depth of the involvement of the SIEF facilitator may vary. In any case, that involvement may only be based on the agreement of the other SIEF participants. The main tasks of the SIEF facilitator are as follows:

    1.  Initiate contact

    The Role of SIEF facilitator can be limited to the role of initiator. As the Guidance states, the SIEF facilitator may,

    "play the role of a coordinator and initiate the acting together."

    "For example, the facilitator can contact all Potential Registrants and organize the exchange of information on the identity of the substance. As a second step, when the SIEF is formed, he can propose means of organising exchange of substantial information on the substance."

    2.  Propose organization of work

    The SIEF facilitator may extend its role to that of proposing action for preparing the registration dossier in collaboration with other SIEF participants. As the Guidance further states,

    "Alternatively, the SIEF can already at an early stage agree on a Lead Registrant who might take over the organisation of the information exchange and the preparation of the joint submission. Any other organisation form is equally possible, as REACH does not set any conditions in this respect."

    " The next step may be for the facilitator or designated Lead Registrant to make proposals related to any or all of the possible following steps:

    • The form of co-operation between the parties and possible internal rules;
    • Who could perform the necessary technical work (either the Potential Registrants themselves or a contracting Third Party or a combination of both);
    • Scope of the co-operation: whether the co-operation should be limited to the SIEF obligations (data sharing and classification and labelling) or whether it should be extended to cover other objectives;
    • Organization of the exchange of data;
    • Designation of a Lead Registrant (unless this has already been done)."

    3.  Provide management and technical services

    Alternatively, the SIEF facilitator may also propose to do more and provide management and/or technical services for the preparation of the registration dossier. As the Guidance states,

    "In some cases, the tasks that the facilitator or designated Lead Registrant may propose to undertake will be substantial and it might be appropriate for the parties to consider a financial compensation for the resources spent by the facilitator or designated Lead Registrant, beyond the initial contact and proposal, in particular when the facilitator would provide services that otherwise would have to be compensated."

    Irrespective of the precise role played by the SIEF facilitator, it is indeed an important responsibility and must be carried out effectively and efficiently. Theoretically, the SIEF facilitator should be a representative of a company with a major stake in the market for the substance. Only a major market player is positioned to initiate effective and efficient action as it has a greater interest in, and information about, the substance.

    Surprisingly, in a number of cases, it is not a major market player that is volunteering as SIEF facilitator. Rather, it appears that consulting and testing firms acting in the guise of only representatives for undisclosed clients are taking the initiative to serve as SIEF facilitators. Indeed, in some cases, consulting and testing firms are competing with well established consortia for the position of SIEF facilitator.

    In our view, it would be advisable for the major European producers to take control of the process. At the end of the day, all of industry will benefit from the sweat equity of the major producers and there is adequate provision in REACH for this effort to be appropriately reimbursed by other operators. Relegating these tasks to consulting and testing firms that sign up as SIEF facilitators may lead to disastrous results.