In order to meet the project objectives, a European network was set up involving academic experts in different aspects of the physiological functions relating to health claims, representatives of public interest groups, regulatory experts and the food industry.
Initially, four "Phase One" Individual Theme Groups (ITGs) were set up. ITGs A, B and C focused on three physiological areas, namely Diet-related cardio-vascular disease (A), Bone health and osteoporosis (B) and Physical performance and fitness (C).
ITG A, B and C held three meetings to critically assess the criteria currently used for the assessment of the scientific support for claims related to their themes. More specifically they aimed to:
- collate potential types of claims (not an exhaustive list but suitable examples) from the perspective of the function related to physiological area, to describe the general principles which would be needed to support these claims and to evaluate the rationale of the scientific support;
- develop a list of criteria that would be used to justify these identified claims: what needs to be done for the development and justification of enhanced function and reduction of disease risk claims and how these claims should be supported in terms of basic science;
- assess the usability of the markers (and their validation) used for the scientific substantiation of the claims.
ITG (D) review of existing processes reviewed the current global situation in terms of schemes to regulate claims and other similar systems and concepts which are universally applied. The report from ITG (D) was made available to ITGs A, B and C while they were drafting their reports. As a consequence ITG A, B and C were aware of the global background as they were making the selection of criteria which are appropriate for their particular physiological theme.
Publication I contains the reports of "Phase One" ITGs (A to D) and a first draft set of interim criteria agreed by the First Plenary Meeting.
The draft set of interim criteria as published in Publication I was used by four new "Phase Two" theme groups, concerned with insulin sensitivity and risk of diabetes (E), diet-related cancer (F), mental state and performance (G) and gut health and immunity (H).
Like the "Phase One" ITGs, the "Phase Two" ITGs elaborated, in key areas for the development of enhanced function or reduction of disease risk claims, a "blueprint" for what needs to be done in terms of scientific research and how claims should be justified. The "Phase Two" theme groups will review and test how the interim criteria can be used in the different physiological areas. They then positioned their criteria with the draft set of interim criteria and produced a draft set of wider new criteria as necessary.
A draft set of wider criteria were then be obtained from the Second Plenary Meeting and were published in Publication II together with the reports of ITGs E to H. This technique of reflective practice and continuous improvement broadened and refined the set of criteria and ensured that many possible methods for the scientific substantiation of claims were considered. This enabled the final PASSCLAIM Consensus Document to contain consensus criteria derived from a very broad basis and ensured its wide applicability.
The Consensus Group then used the outcome of the ITG and Plenary Meetings (Publication I and II) to propose draft consensus criteria for the scientific substantiation of claims. These were agreed by the Third Plenary Meeting and published in the PASSCLAIM Consensus Document, Publication III. The consensus criteria were widely disseminated among the scientific, industrial, regulatory and consumer communities.