SIEF Participation
An important aspect of REACH is the sharing of data between registrants. For both 'phase-in' and 'non-phase-in' substances, data collected through vertebrate animal testing must be shared, in exchange for payment.
In order to facilitate data sharing, Substance Information Exchange Forums (SIEFs) have been created to allow manufacturers and importers of the same 'phase-in' substances to share existing data and agree on the generation of new test data.
The aims of SIEFs are to:
- prevent duplicate testing, especially testing on vertebrate animals
- facilitate data sharing for the purposes of Registration.
- agree on the classification and labelling of the substance
When a SIEF has shared and assessed the available data, it must prepare a joint submission for the parts of the registration dossier that are common to all. The Lead Registrant for the substance will submit the joint submission on behalf of the other registrants. Compensation for sharing data is agreed among the SIEF members.
Key roles within a SIEF are as follows:
- contact details;
- Lead Registrant – prepares and submits the joint submission on behalf of, and with the agreement of, the other registrants. They are typically the company most involved in the substance;
- SIEF Formation Facilitator – a volunteer who initiates discussions and facilitates the exchange of information within the SIEF;
- Consortia – a more organised and formal type of co-operation. A consortium is voluntary and may not contain all members of your SIEF. They may be formed to prepare one or more parts of the joint submission, or to work across several joint submissions for different substances;
- Third Party Representative – in cases where manufacturers, importers or downstream users wish to remain anonymous but still retain full legal responsibility for complying with REACH, a third party representative can be nominated to be the main point of contact for both the SIEF and ECHA.
An key aspect of REACH involves understanding your roles within a SIEF and fulfilling your obligations for data-sharing.
Need assistance facilitating your SIEF or preparing your joint-registration dossier?
IOM's dedicated REACH team are well placed to assist you in your SIEF participation or to become your third party representative, with our services including:
