A consortium is one of the main elements for data sharing and generation within REACH, the other one being the SIEF. Consortium refers to a more organized and formal type of co-operation between parties (implying either a signed agreement or the adoption of operating rules, or reference to an agreed set of general rules). A consortium is voluntary and may not necessarily regroup all participants to a particular SIEF (Substance Information Exchange Forum), but it can regroup only some of them or participants of more than one SIEF. Consortia remain the primary vehicle for reducing the number of individual submissions received by the agency, encouraging the early sharing of data and identifying data gaps. In addition, they prevent duplication of testing strategies and limit the cost of registration. When forming a consortium, particular care should be taken that it does not become a way to exclude or arbitrarily discriminate against competitors. Hence, consortia preferably should be open, and costs should be divided on the basis of objectively determined criteria. REACH actors can decide to create a consortium at any stage of the REACH process, e.g. before pre-registration, to ease the process of checking the identity and sameness in view of the formation of a SIEF, and afterwards. By either signing the consortium agreement, or accepting operating rules by a decision in a meeting, or deciding to refer to a common agreed set of rules (will be referred to as an agreement or legal contract), participants in the agreement will ‘create the consortium’. No additional formalities will be needed. As a consequence, there is no specific requirement that consortia should be organized by way of the creation of a separate legal entity having legal personality under the legislation of a Member State. Elements of co-operation that may be included in a Consortium
- Organization of the co-operation and thus the consortium;
- Consideration of data (existing data, missing data, new data to be developed);
- Defining of data to be shared;
- Facilitating data-sharing and coordination;
- Data valuation, data evaluation (including identification, data access and collection);
- Facilitating cross-reading between SIEFs;
- Organization to preserve the confidentiality of business information and data;
- Preparation of letter of access to data for non-consortium participants;
- Classification and labelling; and
- Post-SIEFs actions: e.g. joint submission of data, joint registration, and maintaining the life of the consortium even after the joint registration - jointly to follow-up the file until final registration/evaluation, including interacting with ECHA.
- Designation in a SIEF of the Lead Registrant (in cases where the consortium groups all SIEF members);
|