SIEF, Consortium & Letters of Access

What is a SIEF?
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. 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. Each SIEF will be operational until 1 June 2018 (the last registration deadline in REACH).

Further information on the organisation of SIEFs and how to join can be found here

What is a consortium?
A consortium is an efficient form of co-operation for potential registrants of a substance, or group of substances, to fulfil the REACH requirements in time with the consortium agreement providing a legal framework for safeguarding the essential business interests of the participating companies.

The REACH Tin Metal Consortium aims to facilitate data and cost sharing for the purposes of REACH registration. It is a voluntary consortium open to any operator and is not limited to members of ITRI. The full agreement provides conditions and costs of membership, scope of the work, roles of partners and issues related to confidentiality and competition law. It should be noted that neither the text of REACH nor the European Commission define consortium formation rules but industry is expected to ensure that any terms are compatible with competition law; for this reason it is considered essential to have a consortium agreement. Consortia terms are not related to the operation of the SIEF (Substance Information Exchange Forum) determined by the REACH Regulation.

The REACH Tin Metal Consortium is concerned with tin metal only. Its aim has been to obtain or generate as far as is practical the data set required for registrants of tin metal at the highest REACH tonnage band i.e. >1000tpa by December 2010. Data required includes chemical information on substance behaviour as well as effect data to human health and the environment. A risk assessment related to the known uses of tin metal was also completed. While the joint dossier for tin was submitted to the Agency ahead of the first registration deadline, the exact scope of required data cannot be specified until the evaluation period of the Agency has been finalised. Further data may need to be submitted should the Agency so demand.

The consortium agreement has been open for signature since the beginning of October 2007. Individual companies remain responsible for assessing their responsibilities and carrying out registration.

What are the benefits of a consortium?
Membership of a consortium provides legal certainty regarding the co-operation of parties involved, and ways to share costs, and ensures the most efficient use of human and financial resources through industry co-operation. The consortium itself provides leadership within industry regarding the difficult and complex requirements of REACH and offers all operators the opportunity to contribute to the direction of that leadership. Consortium membership also provides a means for choosing the best quality studies, whilst protecting confidential business information.

If you are interested in becoming a member of the tin metal consortium, please contact: [email protected]

Joint Submission of Data and letters of access.
Potential registrants of the same substance are required to submit information jointly at registration. In this way a Lead Registrant of the SIEF will submit a dossier for, and on behalf of, the other SIEF members. This does not alleviate the other registrants from registering their substance; all registrants and manufacturers of substances supplied in quantities of one or more tonnes per year are required to submit a registration dossier to the Agency by the relevant deadline.

Information to be submitted jointly will include data on the hazardous properties of the substance including information on classification and labelling. The CSR can be submitted either jointly or separately.

Information to be submitted individually by each registrant will include substance and registrant identity, information on manufacture and use (and the CSR if not submitted jointly).

A letter of access is required in order to submit a joint registration. The data rights to pure tin metal are held by the tin metal consortium. Letters of access can be obtained by contacting the REACH tin metal secretariat (The International Tin Association) at [email protected]

 

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