SIEF (Substance Information Exchange Forum)
The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. Within REACH, enterprises that manufacture or export more than one tonne of a chemical substance per year would be required to register it in a central database.
To facilitate this, REACH provides the formation of a Substance Information Exchange Forum (SIEF) to share information among Potential Registrants of the same "phase-in" substances, A SIEF is a forum to help registrants who intend to register the same substance. It is there to facilitate data sharing between the companies, hence to avoid duplication of studies (unnecessary testing), and to lead to agreed classification and labeling.
The main objectives of SIEF are
- Facilitate data sharing for the purposes of Registration, thereby avoiding the duplication of studies, and
- Agree on the classification and labelling of the substances concerned where there is a difference in the classification and labelling of the substance between the potential Registrants.
All SIEF Participants shall:
- React to requests for information from other participants
- Provide other participants with existing studies upon request.
Potential Registrants shall:
- Request missing information needed for their registration dossiers from other SIEF participants
- Collectively identify needs for further studies to comply with registration requirements
- Make arrangements to perform the identified studies
- Agree on classification and labeling.
- All SIEF participants must select a Lead Registrant (LR).
- This is a mandatory role laid down by the REACH Regulation.
- The role is not automatically given to the company that facilitated the formation of the SIEF.
- If no-one volunteers, there is a potential default mechanism: the EU manufacturer or importer with the highest capacity for production or import will be the LR.
- All the LRs should inform ECHA of their nomination.
A data holder is any person holding information/data relevant to a phase-in substance and willing to share the data, within a SIEF. They:
- Must respond to any query from potential registrants if they hold the data relating to this query
- Are not entitled to request data.
SIEFs shall remain operational until 1 June 2018
The data sharing in a SIEF must lead to a single joint submission for each substance; thereby avoiding unnecessary animal testing and cost.