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A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance

  • Alison M. Gallagher (a1), Gert W. Meijer (a2), David P. Richardson (a3), Virginie Rondeau (a4), Maria Skarp (a5), Marianne Stasse-Wolthuis (a6), Guy C. Tweedie (a7) and Renger Witkamp (a8) (a9)
  • DOI: http://dx.doi.org/10.1017/S0007114511003618
  • Published online: 01 December 2011
Abstract

Diet is well known to have beneficial health properties that extend beyond traditionally accepted nutritional effects. The approach involved in elucidating these beneficial physiological effects is becoming more important, as reflected by increasing research being undertaken. With growing consumer awareness of foods and food constituents and their relationship to health, the key questions for regulators, scientists and the food industry continue to relate to: (1) how consumers could be protected and have confidence that the health claims on foods are well supported by the evidence; (2) how research on physiological effects of food (constituents) and their health benefits could be stimulated and supported; (3) how research findings could be used in the development of innovative new food products. The objectives of this paper are to provide a set of recommendations on the substantiation of health claims for foods, to develop further guidance on the choice of validated markers (or marker patterns) and what effects are considered to be beneficial to the health of the general public (or specific target groups). Finally, the case for developing a standardised approach for assessing the totality of the available scientific data and weighing the evidence is proposed.

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Corresponding author
Correspondence: ILSI Europe a.i.s.b.l., Avenue E. Mounier 83, Box 6, 1200 Brussels, Belgium, fax +32 2 762 00 44, email: publications@ilsieurope.be
Linked references
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This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

16EFSA (2010) Guidance on human health risk-benefit assessment of food. EFSA J 8, 1673. http://www.efsa.europa.eu/en/scdocs/doc/1673.pdf (accessed October 2010).

17EFSA Panel on Dietetic Products, Nutrition and Allergies (2011) General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA J 9, 2135. Published online:http://www.efsa.europa.eu/en/efsajournal/doc/2135.pdf (accessed June 2011).

18J Blumberg , RP Heaney , M Huncharek , (2010) Evidence-based criteria in the nutritional context. Nutr Rev 68, 478484.

22NIH Definition Working Group (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69, 8995.

23EFSA Panel on Dietetic Products, Nutrition and Allergies (2011) Guidance on the scientific requirements for health claims related to gut and immune function. EFSA J 9, 1984. Published online:http://www.efsa.europa.eu/en/efsajournal/doc/1984.pdf (accessed June 2011).

24EJ Irvine , WE Whitehead , WD Chey , (2006) Design of treatment trials for functional gastrointestinal disorders. Gastroenterol 130, 15381551.

26EFSA Panel on Dietetic Products, Nutrition and Allergies (2009) Frequently Asked Questions (FAQ) related to the assessment of Article 14 and 13.5 health claims applications on request of EFSA. EFSA J 7, 1339(8 pp.).

31EFSA (2010) Scientific opinion on establishing food-based dietary guidelines. EFSA J 8, 1460. http://www.efsa.europa.eu/en/scdocs/doc/1460.pdf (accessed October 2010).

32A Mente , L de Koning , H Shannon , (2009) A systematic review of the evidence supporting a causal link between dietary factors and coronary heart disease. Arch Intern Med 169, 659669.

33DP Richardson , T Affertsholt , N-G Asp , (2003) PASSCLAIM – synthesis and review of existing processes. Eur J Nutr 42, 96111.

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