The Process for the Assessment of Scientific Support for Claims on Food
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 The overall coherence and totality of published and unpublished evidence should be considered in the process.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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The process of scientifically assessing health claims in the EU was particularly influenced by the results of the PASS-CLAIM project where a consensus on the criteria was first established.
“The process of scientifically assessing health claims in the EU was particularly influenced by the results of the PASS-CLAIM project where a consensus on the criteria was first established (Aggett, 2009;Aggett et al., 2005).”
From Comparison of requirements for using health claims on foods in the European Union, the USA, Canada, and Australia/New Zealand (2021) · cites this paper as Aggett, 2009
Cites
Scientific Concepts of Functional Foods in Europe Consensus Document
(1999) · British Journal Of Nutrition · doi:10.1017/s0007114599000471 · Cited by 1,134 · see citing works
PASSCLAIM1?Gut health and immunity
Cummings, J. H., Antoine, J.-M., Azpiroz, F., Bourdet-Sicard, R., Brandtzaeg, P., Calder, P. C., Gibson, G. R., Guarner, F., Isolauri, E., Pannemans, D., et al. (2004) · European Journal of Nutrition · doi:10.1007/s00394-004-1205-4 · Cited by 324 · see citing works
Passclaim*: Consensus on Criteria
Aggett, P. J., Antoine, J.-M., Asp, N.-G., Bellisle, F., Contor, L., Cummings, J. H., Howlett, J., Müller, D. J. G., Persin, C., Pijls, L. T. J., et al. (2005) · European Journal of Nutrition · doi:10.1007/s00394-005-1104-3 · Cited by 157 · see citing works
Self-citationKrapels, I. P. C., van Rooij, I. A. L. M., Ocké, M. C., van Cleef, B. A. G. L., Kuijpers‐Jagtman, A. M., & Steegers‐Theunissen, R. P. M. (2004) · European Journal of Nutrition · doi:10.1007/s00394-004-0433-y · Cited by 93 · see citing works
PASSCLAIM - Diet-related cardiovascular disease
Mensink, R. P., Aro, A., Hond, E. D., German, J. B., Griffin, B. A., ten Meer, H.-U., Mutanen, M. L., Pannemans, D. L. E., & Stahl, W. (2003) · European Journal of Nutrition · doi:10.1007/s00394-003-1102-2 · Cited by 72 · see citing works
PASSCLAIM, Process for the Assessment of Scientific Support for Claims on Foods
Aggett, P. J., Antonine, J., Asp, N., & Bellisle, F. (2005) · European Journal of Nutrition · doi:10.1007/s00394-005-1101-6 · Cited by 71 · see citing works
Self-citationPASSCLAIM - Synthesis and review of existing processes
Richardson, D. P., Affertsholt, T., Asp, N., Bruce, �., Grossklaus, R., Howlett, J., Pannemans, D. L. E., Ross, R., Verhagen, H., & Viechtbauer, V. (2003) · European Journal of Nutrition · doi:10.1007/s00394-003-1105-z · Cited by 66 · see citing works
PASSCLAIM1?Body weight regulation, insulin sensitivity and diabetes risk
Riccardi, G., Aggett, P. J., Brighenti, F., Delzenne, N. M., Frayn, K. N., Nieuwenhuizen, A. G., Pannemans, D. L. E., Theis, S., Tuijtelaars, S., & Vessby, B. O. (2004) · European Journal of Nutrition · doi:10.1007/s00394-004-1202-7 · Cited by 57 · see citing works
Self-citationPASSCLAIM - Physical performance and fitness
Saris, W. H. M., Antoine, J., Brouns, F. J. P. H., Fogelholm, M., Gleeson, M., Hespel, P., Jeukendrup, A. E., Maughan, R., Pannemans, D. L. E., & Štich, V. (2003) · European Journal of Nutrition · doi:10.1007/s00394-003-1104-0 · Cited by 53 · see citing works
PASSCLAIM1—Diet-related cancer
Rafter, J., Govers, M., Martel, P., Pannemans, D., Pool-Zobel, B., Rechkemmer, G., Rowland, I., Tuijtelaars, S., & Loo, J. V. V. (2004) · European Journal of Nutrition · doi:10.1007/s00394-004-1203-6 · Cited by 52 · see citing works
PASSCLAIM - Bone health and osteoporosis
Prentice, A., Bonjour, J., Branca, F., Cooper, C. C., Flynn, A., Garabédian, M., M�ller, D., Pannemans, D. L. E., & Weber, P. (2003) · European Journal of Nutrition · doi:10.1007/s00394-003-1103-1 · Cited by 47 · see citing works
PASSCLAIM1—Mental state and performance
Westenhöfer, J., Bellisle, F., Blundell, J. E., de Vries, J., Edwards, D., Kallus, W., Milon, H., Pannemans, D. L. E., Tuijtelaars, S., & Tuorila, H. (2004) · European Journal of Nutrition · doi:10.1007/s00394-004-1204-5 · Cited by 41 · see citing works
PASSCLAIM, PROCESS FOR THE ASSESSMENT OF SCIENTIFIC SUPPORT FOR CLAIMS ON FOODS
(2004) · European Journal of Nutrition · doi:10.1007/s00394-004-1208-1 · Cited by 31 · see citing works
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EFSA Panel on Dietetic Products, N. A. A. (. (2011) · EFSA Journal · doi:10.2903/j.efsa.2011.2170 · Cited by 102 · see citing works
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Lalor, F., & Wall, P. G. (2011) · British Food Journal · doi:10.1108/00070701111105358 · Cited by 62 · see citing works
Verhagen, H., Aruoma, O. I., van Delft, J. H. M., Dragsted, L. O., Ferguson, L. R., Knasmüller, S., Pool-Zobel, B. L., Poulsen, H. E., Williamson, G., & Yannai, S. (2003) · Food and Chemical Toxicology · doi:10.1016/s0278-6915(03)00025-5 · Cited by 57 · see citing works
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Verhagen, H., Coolen, S. A. J., Duchateau, G. S. M. J. E., Hamer, M., Kyle, J., & Rechner, A. R. (2004) · Mutation research. Fundamental and molecular mechanisms of mutagenesis · doi:10.1016/j.mrfmmm.2004.01.013 · Cited by 33 · see citing works
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Díaz, C. G., Gil‐González, D., & Álvarez‐Dardet, C. (2018) · Journal of Food Science · doi:10.1111/1750-3841.14359 · Cited by 20 · see citing works
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Development of food groupings to guide dietary advice for people with diabetes
Gillen, L. J., & Tapsell, L. C. (2006) · Nutrition & Dietetics · doi:10.1111/j.1747-0080.2006.00043.x · Cited by 19 · see citing works
Herrero-Barbudo, C., Soldevilla, B., Pérez-Sacristán, B., Blanco-Navarro, I., Herrera, M., Granado‐Lorencio, F., & Domínguez, G. (2013) · PLoS ONE · doi:10.1371/journal.pone.0074135 · Cited by 16 · see citing works
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Martirosyan, D. M., & Liufu, J. (2020) · Functional Foods in Health and Disease · doi:10.31989/ffhd.v10i8.729 · Cited by 15 · see citing works
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van Dam, Y. K., & van Trijp, J. C. M. (2007) · Elsevier eBooks · doi:10.1533/9781845692506.2.153 · Cited by 14 · see citing works
Health Risks and Adverse Reactions to Functional Foods
Ameratunga, R., Crooks, C., Simmons, G., & Woon, S. (2014) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2012.751895 · Cited by 14 · see citing works
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Korthals, M., & Komduur, R. (2009) · Journal of Agricultural and Environmental Ethics · doi:10.1007/s10806-009-9223-0 · Cited by 14 · see citing works
Functional foods: An Australian perspective
Tapsell, L. C. (2008) · Nutrition & Dietetics · doi:10.1111/j.1747-0080.2008.00256.x · Cited by 14 · see citing works
Safety impact—the risk/benefits of functional foods
Pascal, G. (2009) · European Journal of Nutrition · doi:10.1007/s00394-009-0074-2 · Cited by 13 · see citing works
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Alli, S. M. A. (2013) · Journal of Drug Delivery and Therapeutics · doi:10.22270/jddt.v3i5.600 · Cited by 11 · see citing works
Allégations nutritionnelles et de santé pour les produits alimentaires : quel avenir ?
Laplace, J.-P. (2006) · Bulletin de l Académie Nationale de Médecine · doi:10.1016/s0001-4079(19)33167-x · Cited by 7 · see citing works
Jm, M. (2012) · PubMed · Cited by 6 · see citing works
Redécouverte des propriétés fonctionnelles de l’aliment : fondements scientifiques généraux
Pascal, G., Mareschi, J.-P., Contor, L., & Antoine, J. (2006) · Cahiers de Nutrition et de Diététique · doi:10.1016/s0007-9960(06)70606-x · Cited by 6 · see citing works
Wood, J. (2013) · The Atrium (University of Guelph) · Cited by 5 · see citing works
The Political Space between Words and Things: Health Claims as Referential Displacement
Hendrickx, K. (2018) · Science as Culture · doi:10.1080/09505431.2018.1557629 · Cited by 2 · see citing works
Gillen, L. J. (2005) · Research Online (University of Wollongong) · Cited by 2 · see citing works
Study on Varying Salt Level and Storage Time on Physico-Chemical and Sensory Quality of Beef Nugget
Talukder, M., Hashem, M., Rahman, S. M. E., Islam, M., Hossain, M., Ali, M., Azad, M., & Luna, R. (2014) · Progressive Agriculture · doi:10.3329/pa.v24i1-2.19280 · Cited by 1 · see citing works
Effect of Salt and Storage Temperature on Beef Sausage Quality
Luna, R., Hashem, M., Ali, M., Hossain, M., Talukder, M., & Islam, M. S. (2013) · Progressive Agriculture · doi:10.3329/pa.v23i1-2.16561 · Cited by 1 · see citing works
Hendrickx, K. (2023) · Health, technology and society · doi:10.1007/978-981-99-4950-2_6 · Cited by 1 · see citing works
Rafter, J. J. (2007) · Elsevier eBooks · doi:10.1533/9781845693107.3.277
Démonstration scientifique des fonctions des aliments associées à la santé
Pascal, G., Mareschi, J.-P., Contor, L., & Antoine, J. (2008) · Cahiers de Nutrition et de Diététique · doi:10.1016/s0007-9960(08)70277-3
Vidal‐Carou, M. C. (2008) · FMC - Formación Médica Continuada en Atención Primaria · doi:10.1016/s1134-2072(08)70846-6
Pilates: efecte sobre la composició corporal i les variables antropomètriques
Vaquero‐Cristóbal, R., Alacid, F., Esparza-Ros, F., Muyor, J. M., & López-Miñarro, P. Á. (2014)
Fonksiyonel Özellik Sağlayan Doğal Bileşenlerin Et Ürünlerinde Kullanımı
İlter, I., & Kaymak‐Ertekin, F. (2020) · Turkish Journal of Agriculture - Food Science and Technology · doi:10.24925/turjaf.v8i6.1297-1307.3321
Vitamins and Minerals in Pregnancy Nutrition: Objections Management
Орлова, С. В., Никитина, Е. А., Balashova, N. V., Грибакин, С. Г., & Pigareva, Y. A. (2023) · Medical alphabet · doi:10.33667/2078-5631-2023-8-29-35
Suomalainen, T. (2009) · UTUPub (University of Turku)
- Authors
- Aggett, P. J.
- Affiliations
- University of Lancashire (GB)
- Corresponding author
- Aggett, Peter J.
- ORCID
- Aggett, Peter J.
- Venue
- European Journal of Nutrition
- Published
- 2009-11-25
- Volume
- 48
- Issue
- S1
- Pages
- 23-26
- ISSN
- 1436-6207 (ISSN-L)
- 1436-6215
- OpenAlex
- W2090326426
- Cited by
- 53
- References
- 13
- Citations by year
- 2023: 2 · 2021: 2 · 2020: 2 · 2019: 1 · 2018: 2 · 2017: 1 · 2016: 3 · 2014: 4 · 2013: 4 · 2012: 3
- FWCI
- 5.03
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- European Journal of Nutrition (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Consumer Attitudes and Food Labeling
- Life Sciences › Agricultural and Biological Sciences › Food Science › Nutrition, Health, and Society Studies
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutrition and Health Studies
- Keywords
- food claims, intervention research, dose-response relationship, confounding, study duration, adherence measurement, statistical power, expert opinion, food components
- MeSH terms
- Data Interpretation, Statistical, Dose-Response Relationship, Drug, Europe, Food Labeling, Humans, Legislation, Food, Life Style, Public Health, Biomarkers, Evidence-Based Medicine, Functional Food, Food, Organic
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