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Demonstrating single and multiple functions attributable to foods or specific food components is a challenge. The International Life Sciences Institute Europe co-ordinated EU concerted actions, Functional Food Science in Europe (FUFOSE) and the Process for the Assessment of Scientific Support for Claims on Food (PASSCLAIM), respectively, addressed the soundness of the evidence and its coherence with a mechanistic schema comprising valid markers of exposure, intermediate and final outcomes and the quality and integrity of the evidence overall. Demonstrating causality often relies on randomized controlled trials (RCTs). However, in public health and biomedical science there is concern about the suitability of RCTs as sole standards of evidence-based approaches. Alternative and complementary approaches using updated Hill's viewpoints for appraising the evidence can be used in conjunction with evidence-based mechanistic reasoning and the quality criteria proposed in FUFOSE and PASSCLAIM to design studies and to assemble evidence exploring single or multiple benefits from food components and foods. [ABSTRACT FROM AUTHOR]

The article focuses on the proposal of the European Union Concerted Action regarding the nature of functional food science in Europe within the context of evidence based nutrition. It was suggested that a food could be considered as functional if it showed an ability to affect beneficially target functions of the body in a manner relevant to an improved state of health or reduction of risk of disease.

The first Committee on Nutrition (CoN) was founded in 1974. Two years later nutrition (N) was added to the society's name, which then became ESPGAN. The Committee systematised compositional and quality criteria for breast milk substitutes and food for special medical purposes, the first of many examples on how recommendations and comments published by the Committees on Nutrition (CsoN) were adopted by the European Economic Community, later the European Union and also influenced the World Health Organization/Food and Agriculture Organization of the United Nations Codex standards. A second CoN focusing on preterm infants was established in 1979 and its recommendations on nutrition of these infants were widely implemented. The third and standing CoN, established 1986, started to organise high-quality symposia at the annual meetings appreciating the need to enhance the expertise in nutritional research. From 1991 the CoN has organised Summer Schools in paediatric nutrition for young colleagues further emphasising its educational interest and more recently an annual, more specialised Nutrition Masterclass. Successively the interest of the CoN has expanded to other areas, such as highlighting dilemmas and uncertainties in the field of nutrition including the design, choice of outcomes and statistical analysis of trials in infant nutrition. The work of the CsoN have had great impact on paediatric nutrition and the committee will continue its important role by writing commentaries and systematic reviews and revising guidelines when required to inform and stimulate discussion among colleagues as well as stimulate training in paediatric nutrition by organising workshops and scientific meetings, training courses, and other approaches, and by interaction with other expert groups.

The concerted action "The process for the assessment of the scientific support for claims on foods", PASSCLAIM, proposed criteria that could provide an international yardstick for the harmonised transparent assessment of evidence submitted to support a claim for a food or food component. The evidence would be systematically appraised against specific criteria: namely, (1) a characterisation of the food or food component to which the claimed effect is attributed; (2) human data, primarily from intervention studies that represent the target populations for the claim; (3) a dose response relationship; (4) evidence allowing for confounders such as lifestyle, consumption patterns, background diet and food matrix etc.; (5) an appropriate duration for the study; (6) a measure of compliance; (7) adequate statistical power to test the hypothesis. Validated and quality assured markers of intermediate or final outcomes could be used when ideal endpoints are not easily accessible for measurement as long as their relationship to the development of the principal outcome relevant to the claim is well characterised and substantiated. The overall coherence and totality of published and unpublished evidence should be considered in the process. Assessments for substantiation claims need expert judgement, weighting of the strength of the claim, and intelligent use of the criteria applied on an individual basis with respect both to gaps in the knowledge and to any need for new knowledge and data.