A Substance Information Exchange Forum (SIEF) is formed once stakeholders agree that they have pre-registered the ‘same substance’ within the REACH-IT system.
Participation within a SIEF is mandatory under REACH, members of a SIEF have no option to opt out but can, in most instances, decide how actively they wish to participate.
Participation is usually either within the SIEF Leadership Team, Involved, Passive or Dormant. The main purpose of the SIEF is to share information (thereby avoiding the duplication of studies) and to work together to compile, and submit, a joint registration dossier for the registration of the substance. If possible the SIEF members should also agree on the classification and labelling of the substance. A SIEF is composed of all legal entities who have pre-registered the same phase-in substance as well as any early registrants of the same substance. Data holders who wish to share relevant information with the potential registrants can also be members of a SIEF.
How is a SIEF formed?
All legal entities that pre-register a substance under the same substance identifiers within REACH-IT will automatically enter into the pre-SIEF for that substance. The role of the SIEF Facilitator (SFF) is open to the first company wishing to assume the position. The task of the SFF is to instigate substance sameness discussions amongst all pre-registrants. Once pre-registrants are in agreement that the substance they intend to register is the same the SIEF is formed after which time the work in gathering together and generating information for joint registration of that substance can begin. It may be that some SIEFs may need to split or merge after members’ discussions about sameness.
How is a SIEF organised?
It is up to individual legal entities to decide how to organise the SIEFs they are in. ECHA does not oversee the work of the SIEFs. It is assumed that the SFF will help organise the SIEF until a Lead Registrant (LR) is appointed. Most SIEFs have a set of specially designated operating rules for their members to abide by laying out the terms involved with data sharing and joint submission. Although the REACH Regulation does not define how the SIEFs should operate it does stipulate some requirements of SIEF participants to react to requests for information from other participants and to provide other participants with existing studies upon request. Potential registrants shall also request missing information needed for their registration dossiers from other SIEF participants collectively identify needs for further studies to comply with registration requirements and make arrangements to perform the identified studies, and agree on classification and labeling.
Roles and obligations in the SIEF.
Potential registrants are current and potential manufacturers and importers of phase-in substances, whether on their own, in preparations or in articles. For manufacturers and importers who wish to hide their identity from other SIEF members there is the possibility for potential registrants to appoint a Third Party Representative (TPR) to represent them in the SIEF. In this situation the potential registrant nominating a TPR still has full legal responsibility for complying with his obligations under REACH The TPR, however, will carry out all tasks related to data sharing and the avoidance of unnecessary testing. The SIEF may also consist of EU-based Only Representatives (OR) who are able to register a substance for manufacturers based outside of the EU. In this case the Only Representatives are themselves the SIEF members and resume full legal responsibility for complying with their requirements under REACH.
Data Holders, who have expressed their intention to share data via REACH-IT, may also be in a SIEF. As there are no checks in the REACH-IT system, anyone can pre-register. It is therefore possible that a (pre-) SIEF contains members that are not described above.
There are certain obligations placed on all members of a SIEF; they are as follows:
• To react appropriately to information requests from other SIEF participants
• To provide other participants with existing studies on request
There are also obligations placed on the SIEF members who are potential registrants, they are as follows:
• To request missing information from other SIEF members
• To collectively identify the need for further studies to comply with registration requirements
• To make arrangements to perform the identified studies where required
• To agree on classification and labeling of the substance where possible
The different categories of SIEF participant do not share the same duties and rights in the SIEF. Whereas data holders must react to any query from Potential Registrants if they hold data relating to this query, they have no other active role in the SIEF. Data Holders will not decide whether a study is included in the joint submission, nor will they participate in the substance sameness discussions or those related to classification and labelling, these are all requirements of the potential registrants (and their representatives).
Along with the general obligations of potential registrants, the legal entity appointed as Lead Registrant (LR) assumes additional responsibility. The LR is the company that will submit the joint dossier on behalf of the other assenting joint registrants, the LR could be the SFF but does not have to be. In most cases the LR will be a company who is required to submit their registration by the first deadline.
One of the key aims of REACH is to generate information on substances to help industry to manage any potential risks, associated with the use of those substances, effectively. However, REACH stipulates numerous provisions to facilitate the sharing of data between registrants to limit tests on vertebrate animals and to reduce costs to industry as far as possible. Data collected through vertebrate animal testing must be shared, in exchange for payment. Other information on the properties of substances must be shared on the request of a potential registrant.
For phase-in substances, a system is established to help registrants find other registrants with whom they can share data and to get an overview of the studies available (pre-registration). Pre-registrants of the same phase-in substance are required to share existing vertebrate animal test data and they should agree on the generation of new test data within a Substance Information Exchange Forum (SIEF). Data holders, who can submit data for the pre-registered substances published by the Agency by 1 January 2009, will also be part of the SIEF.
When a substance (whether used as such or as an intermediate) is manufactured or imported by more than one company, these companies are required to submit certain information together in a ‘joint submission’ including:
· Data on the hazardous properties of the substance (robust/ study summaries);
· Information on classification and labeling;
· Data waiver arguments for non-testing, and testing proposals, for higher tier studies, where appropriate.
They also have the option to submit the following jointly:
· The Chemical Safety Report
· Guidance on safe use
The participants of a joint submission are the lead registrant and the other assenting potential registrants. During joint submission the lead registrant will first submit his registration dossier, including all of the information to be submitted jointly, he will also specify in his dossier the identities of the other registrants he is submitting the joint part of his file on behalf of. All of the other registrants are required to submit their own individual dossiers, complete with their company specific information, identifying the lead registrant dossier that contains data for the joint submission.
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