AESGP’s consortium framework allows interested companies to work together on specific ingredient-related topics, within the consumer self care sector, in a structured and legally compliant way. Consortia are typically set up to prepare, generate, or share information needed to support regulatory requirements, such as risk assessments.

Consortia managed by AESGP are self funded by their members. Membership is open throughout the life of the consortium, meaning companies can join later if they make a fair contribution to the costs already incurred.

The consortium framework allows companies to pool resources, avoid duplication of effort, share the financial burden and work collectively on shared regulatory challenges, while keeping the scope of cooperation clearly defined.

A pre-consortium brings companies together to identify data gaps and lay the groundwork for forming a consortium. The pre-consortium is governed by the Memorandum of Understanding that frames the cooperation in that phase before a consortium is established.

Once established, the consortium enables members to collaborate in collecting, sharing, and generating information on a specific ingredient. The consortium is governed by the Consortium Agreement.

Eligible consortium members must meet the Consortium Membership Criteria that will be specified in the Memorandum of Understanding and/or Consortium Agreement.

In general, these criteria will be that consortium members must be at all times:

• a legal entity validly incorporated; and
• a market operator having, throughout the term of the consortium, a vested interest in maintaining the use of the respective ingredient for which the consortium is created, including for example manufacturers, importers, distributors and sellers of consumer healthcare products containing the ingredient as well as manufacturers, importers, distributors and sellers of the ingredient itself.

Consultants cannot directly join AESGP Consortia as members. Membership is open only to legal entities that meet the Consortium Membership Criteria (see question above).

Late Joiners can be admitted to the (pre-)consortium after it has been formed, as long as they meet the necessary membership requirements. Membership remains open for the duration of the (pre-)consortium, provided new members make a fair financial contribution to the costs that have already been incurred.

The incentives for consortium members to join, share their own data within the consortium or generate new data include fostering enhanced collaboration and gaining access to resources, which can lead to improved research outcomes. Sharing or generating data also enables members to reduce costs, as expenses are divided fairly among the consortium members, ensuring a more efficient use of resources. Additionally, members can leverage the consortium’s collective expertise to fulfil regulatory requirements and advance their research objectives.

Initially, each company joining the pre-consortium will be invoiced 1,500 EUR to start the work – cost of immediate collaboration.

For non-AESGP members, a management cost of 3,000 EUR will be invoiced in addition to 1,500 EUR.

Additional funds may be invoiced to all involved parties during the pre-consortium phase, following the formal acceptance of the budget, to cover the costs of an external consultant for literature search, data quality validations, or any other possible external costs.

During the pre consortium stage, members jointly develop the consortium budget which will be approved in the consortium agreement.

It is difficult to estimate the total cost for each company due to several factors, including:

• The cost for each substance depends on the laboratory fees for data generation (if any).
• If a company already possesses relevant data to share, the final cost might be lower, as compensation costs will be reimbursed.
• While the pre-consortium will start with at least three participating companies, additional companies may join (pre-)consortium later, which would reduce costs by spreading them across more members of the consortium.
• The number of data required for given substance is under discussion in pre-consortium and therefore it is not known at an early stage what is going to have to be paid.

Given these uncertainties, it is not possible to provide a precise estimate. However, to get an idea of a cost estimate you may consider reviewing similar data generation costs incurred by companies in the past and assume that the costs will be split between, e.g. five, companies.

If a company is interested in joining a (pre-)consortium as a Late Joiner, it should contact either AESGP at consortia@aesgp.eu or the respective AESGP Project Manager (if known). In turn, further information, depending on the stage of the work, will be provided.