Abstract
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 The overall coherence and totality of published and unpublished evidence should be considered in the process.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.
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References
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Acknowledgments
This article was commissioned by the Functional Foods Task Force of the European branch of the International Life Sciences Institute (ILSI Europe). Industry members of this task force are Ajinomoto Europe, Barilla G. & F. Fratelli, Bayer CropScience BioScience, Beverage Partners Worldwide, Cadbury, Coca-Cola Europe, Colloïdes Naturels International, CSM, Danisco, Danone, Dow Europe, DSM, FieslandCampina, Frutarom, International Nutrition Company—INC, Kellogg Europe, Kraft Foods, La Morella Nuts, Mars, Martek Biosciences Corporation, McNeil Nutritionals, Monsanto, Naturex, Nestlé, PepsiCo International, Procter & Gamble, Raisio Group, Red Bull, Raffinerie Tirlemontoise—ORAFTI, Südzucker/BENEO Group, Syral, Tate & Lyle, Ülker Bisküvi, Unilever, Soremartec Italia—Ferrero Group, Valio, Wild Flavors, Wimm-Bill-Dann Foods, Wrigley and Yakult Europe. For further information about ILSI Europe, please email info@ilsieurope.be or call +32-2-7710014. The opinions expressed herein are those of the authors and do not necessarily represent the views of ILSI Europe.
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On behalf of the EU PASSCLAIM concerted action.
Please direct all correspondence to: ILSI Europe a.i.s.b.l, Avenue E. Mounier 83, Box 6, 1200 Brussels, Belgium. E-mail: publications@ilsieurope.be
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Aggett, P.J. The Process for the Assessment of Scientific Support for Claims on Food. Eur J Nutr 48 (Suppl 1), 23–26 (2009). https://doi.org/10.1007/s00394-009-0072-4
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DOI: https://doi.org/10.1007/s00394-009-0072-4