In order to minimize of duplicate submission of information, all SIEFs must then select a Lead Registrant (Article 11 (1)). It is the responsibility of SIEF members to agree among themselves the Lead Registrant role; ECHA have no influence on this decision. The Lead Registrant will typically be the company with the most active involvement in that substance and/or they may produce the most or hold most of the data. Only one Lead Registrant can be appointed per substance. The Lead Registrant must act with the agreement of the other registrants and submit the Joint Dossier in IUCLID5. The joint dossier contains:
- Study Summaries and Robust Study Summaries
- Classification and Labelling
- Testing proposals (if required)
- Chemical Safety Report (>10 tonnes per annum; optional)
The other registrants have to submit an individual dossier, with the information required under Article 10 of REACH, with the exception of:
1. Studies and testing proposals
2. classification and labelling information agreed upon
3. Chemical Safety Report (CSR)/ guidance on safe use, when a joint submission has been agreed upon for these items.
There is a mechanism to 'opt-out' of part of the Joint submission under certain circumstances. However, this opt-out does not apply to the data sharing obligations, or to opting out of SIEF membership. The specific criteria to opt-out, in accordance with Article 11 (3) are:
(a) it would be disproportionately costly for him to submit this information jointly; or
(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
(c) he disagrees with the lead registrant on the selection of this information.
However, sufficient justification must be provided and there may be higher subsequent registration costs and ECHA may prioritise opt-out submissions for compliance checks.
Consortia Formation
Consortia are a more formal type of co-operation between registrants set up in order to provide practical help with SIEF data-sharing obligations and the preparation of registrations. Consortia are voluntary entities, unlike SIEFs, and usually entail the signing a consortium agreement or adoption of common rules between relevant parties. Companies in SIEFs may come together in consortia in order to prepare one or several sections of the joint submission dossiser, or to work across several joint submissions for different substances.
