Data sharing in SIEFs: first experiences and a guide

CW Briefing, May 2009

*THIS IS A REVISED VERSION OF THE ARTICLE FIRST PUBLISHED IN CHEMICAL WATCH EUROPEAN BUSINESS BRIEFING MAY 2009*

At this moment many companies are going through their first experiences of substance information exchange fora (SIEFs). In some cases this process moves smoothly, but in many others the process has turned out to be quite different to that anticipated. Experts from Dutch chemicals consultancy Royal Haskoning offer their first impressions and a guide to making progress quickly.

There have been many complaints about SIEFs that have not started at all, or SIEFs where the activity is limited to the communication of the CEFIC standard inquiry letters. As the exchange of information on substances and data is new for most companies, it is not a surprise that companies competing on the market are experiencing difficulties to start up the process of data sharing & joint submissions.

In some cases, however, SIEFs are functioning and the REACH registration process has been started. This is mainly the case where a consortium is in place, when companies have well established working relations or where the SIEF facilitator has a clear interest in an efficient registration process.

The slow start in many SIEFs is attributable to the absence of a SIEF Formation Facilitator (SFF), lack of interest in taking the lead by any of the pre-registrants, or the presence of a small company or consultant as SFF. In the last scenario neither the consultant nor the company has an interest in an efficient process and perhaps not even a direct interest in the registration of the substance. An additional problem, in our experience, is the SFF's lack of REACH knowledge.

When the SIEF functions appropriately, substance sameness discussions and data sharing have been started as the first stages of the registration process. In problematic SIEFs nothing happens and many companies are being frustrated by this. This mainly concerns companies that are not willing to take the lead, but have a clear interest in a smooth registration process. These willing companies are looking for possibilities to open the discussions without taking the lead (a possibility would be hiring an independent party to organise a one day face to face meeting of SIEF members to kick-off the process).

When your company is in this sort of situation and is involved in an inactive SIEF, you can take action starting from your own data. We recommend a number of steps to be taken. These steps are no different to those that are necessary in well functioning SIEFs.

Phase I

  • Make sure you have all information on your substance (purity/impurity profile) and use the guidance for substance identification to establish the identity;

  • Gather test data which you own or have the right to use (legitimate possession or right to refer);

  • Consider initiating or joining cooperative body, e.g. a consortium or sector group;

  • Consider which endpoints you need to cover for your registration dossier depending on your tonnage band;

  • Identify your data gaps and consider whether you need test data to fill the data gap or whether you can waive tests based on the possibilities as outlined in Column 2 of Annex VII-X or those as described in Annex XI;

Phase II

  • Try to get your SIEF to move by pressure on the SFF or try to initiate an initial meeting;

  • Request missing vertebrate test data from other SIEF participants (this can be done on an individual basis if necessary). All pre-registrants in the SIEF are legally obliged to respond and to share their data on a fair and transparent basis;

  • Gather at minimum the data for Annex VII and VIII (when your tonnage band is 1-10 tonnes, Annex VII data is sufficient);

  • Prioritise the work to gather the needed data and put highest priority to the 28-day and reprotox study data (necessary for Annex VIII)

  • Try to waive data;

  • Prepare your registration dossier (this is not a joint dossier, but vertebrate test data are shared with other SIEF members);

  • This procedure is not an opt-out from the SIEF.

It is clear that the procedure described in phase II is not the ideal situation. Preparing a individual registration is much more expensive than a joint registration. However, by entering the first two steps of phase II, you might succeed in getting some people in the SIEF to join you in your effort. The main risk of taking this approach is that you might end-up as lead-registrant. But on the other hand, what are your alternatives if you face the 2010 registration?