British Journal of Nutrition

Full Papers

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

Alison M. Gallaghera1, Gert W. Meijera2, David P. Richardsona3, Virginie Rondeaua4, Maria Skarpa5, Marianne Stasse-Wolthuisa6, Guy C. Tweediea7 and Renger Witkampa8a9

a1 Northern Ireland Centre for Food and Health, School of Biomedical Sciences, University of Ulster, Coleraine BT52 1SA, UK

a2 Unilever R&D, Olivier van Noortlaan 120, 3133 AT Vlaardingen, The Netherlands

a3 DPR Nutrition Limited, 34 Grimwade Avenue, Croydon, Surrey CR0 5DG, UK

a4 Division of Biostatistics, Unité 897, Institut National de la Santé et de la Recherche Médicale, University Victor Segalen of Bordeaux 2, Bordeaux F-33076, France

a5 ILSI Europe, Avenue E. Mounier 83, Box 6, 1200 Brussels, Belgium

a6 Stasse Consultancy, Udenhout, The Netherlands

a7 Danone Spain, Calle Corcega 590, Barcelona, Spain

a8 Division of Human Nutrition, Wageningen University, Bomenweg 2, 6703 HD, Wageningen, The Netherlands

a9 TNO Quality of Life, Utrechtseweg 48, Zeist, The Netherlands


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.

(Received December 01 2010)

(Revised April 12 2011)

(Accepted May 15 2011)


c1 Correspondence: ILSI Europe a.i.s.b.l., Avenue E. Mounier 83, Box 6, 1200 Brussels, Belgium, fax +32 2 762 00 44, email:


Abbreviations: EFSA, European Food Safety Authority; FDA, Food and Drug Administration; ILSI, International Life Sciences Institute; PASSCLAIM, Process for the Assessment of Scientific Support for CLAIMs on foods; RCT, randomised controlled trials