Update on SIEF Formation Facilitator Role

Companies that have properly pre-registered under the REACH Regulation still face some immediate challenges as the so-called Substance Information Exchange Forums (SIEFs) are being formed.

First, some pre-registrants are being approached by multiple entities offering to act as SIEF Formation Facilitators (SFFs). While many of them are legitimate industry participants, others are “service providers” that have a profit motive and dubious links to the industry. It is important that pre-registrants properly assess these SFFs to determine which one will actually assist in achieving a cost-effective registration.

Second, for some substances pre-registrants have received no contact whatsoever. In these circumstances pre-registrants must ensure that someone organises the pre-registrants to develop the necessary registration dossier for their substance.

The European Chemicals Agency (ECHA) and the European Commission have provided little guidance to assist companies at this implementation phase of REACH. So what must pre-registrants do to manage this process?

Choosing Among Facilitators

Opportunistic Facilitation of SIEFs

Some pre-registrants have been approached via e-mail by companies claiming to be acting as the SFF, but have actually pre-registered and joined the pre-SIEF primarily for the purposes of selling their services to further their own commercial purposes. In some instances, such companies offer to sell management or communication services and are encouraging the pre-registrants to use specific paid-for SIEF platforms. In other cases, the companies are claiming to provide a broad range of services for subscribers based on a fee schedule, many of which are confusing and do not include the costs of data development or prepayment of the registration dossier. There even have been reports of companies misinforming pre-registrants of their legal obligations in order to make them feel obliged to sign up to their services or specific IT platforms for SIEFs. The pre-registrants should be alert as in many cases such companies promoting SFF services do not disclose their involvement with the substance and may not even be legitimate pre-registrants.

Legitimate Actions by SFFs

The REACH Regulation does not define the role of the SFF. Nevertheless, due to recent complaints involving potential SFFs such as those described above, ECHA has published a document outlining the key SIEF principles and clarifying the role of the SFF. ECHA specifies, that:

  • The SFF is responsible for initiating and conducting discussions after pre-registration and assisting the exchange of data which helps to facilitate the completion of the registration dossier for that substance.
  • Any pre-registrant of the substance in the SIEF may volunteer via REACH-IT to be the SFF.
  • The SFF has no management role beyond facilitating discussions and no legal basis for forcing other pre-SIEF participants to co-operate with them.
  • The SFF cannot demand information or fees for their services unless mutually agreed.

Pre-registrants should also note that neither the REACH Regulation nor any guidance documents require members of any SIEF to participate in a specific IT data-sharing platform. Participation in a platform is entirely voluntary. Participants in a SIEF are free to organise themselves as they see fit to carry out their obligations under REACH.

Steps to Take when Approached by a SFF

In light of these recent pre-SIEF developments, companies should be cautious when approached by pre-registrants offering to act as the SFF. Before completing any surveys received from the SFF or paying any fees, your company should:

  • Make sure that the company claiming to be the SFF is a legitimate pre-registrant in your SIEF (such as manufacturers, importers or Only Representatives of a non-EU manufacturer for the substance your company pre-registered).
  • Try to seek clarification as to whether that company has a legitimate interest in the data collection for your substance (i.e. a desire to provide a meaningful contribution to developing data for the Registration Dossier or that it actually holds any relevant data).
  • If fees are being requested by the company claiming to be the SFF, clarify the basis for these fees and whether they will include the generation of the data studies and the preparation of the registration dossier.
  • Request information on the SFF’s plan or programme for developing the data and what data already exists.
  • Find out if there is an industry-sponsored consortium set up for your substance that could provide practical help with SIEF data-sharing obligations.

What if your Company has Not Been Approached by a SFF?

If your company has not been contacted by a pre-registrant volunteering to be the SFF, your company should promptly contact other pre-registrants of your substance to determine whether anyone in your pre-SIEF has already undertaken the development of the necessary data and studies required to complete the registration dossier. If such a company can be identified, you should inquire whether this includes the necessary data for your tonnage and under what terms the data will be made available. It is important to assess early on whether any data is missing for the completion of the registration dossier and how it will be developed. If no company or consortium is willing to develop the data needed for the registration dossier then the members of the pre-SIEF need to engage in an urgent dialogue to determine how they will proceed and who will take responsibility for developing the required information.