Scientific substantiation of health claims in the EU

Abstract

EU legislation on nutrition and health claims made on foods (Regulation (EC) No. 1924 specifies that health claims should be only authorised for use in the Community after a scientific assessment of the highest possible standard is carried out by the European Food Safety Authority (EFSA). This paper focuses on the scientific substantiation of health claims within the context of the EU Regulation. The evaluation of the substantiation of health claims is carried out by the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA). The EFSA has published extensive guidance to assist applicants in the preparation of applications for authorisations of health claims. This guidance summarises the general principles applied by the NDA Panel in the evaluation of health claims, including the scientific criteria for substantiation, as well as the scientific requirements for the substantiation of specific health claims. To date, the EFSA NDA Panel has concluded that a wide range of health claims has been substantiated. These include claims for many well-established functions of nutrients, as well as beneficial effects of foods and food constituents on a range of body functions. In addition, claims have been substantiated on the role of nutrients in growth and development of children and on the effects of nutrients and food constituents on reduction of risk factors for disease. EFSA evaluations and guidance have made an important contribution to the understanding of the scientific substantiation of health claims which will help to set new directions for research and will guide future innovation.

Scientific Evidence on Functional Food and Its Commercial Communication: A Review of Legislation in Europe and the USA

“…Out of the 38 studies selected for review, 60.5% (n = 23) analyzed the EFSA (Aggett, 2007(Aggett, , 2009(Aggett, , 2012Asp & Bryngelsson, 2008;Biesalski, Aggett, & Anton, 2011;Buttriss, 2010;Buttriss & Benelam, 2010;Coppens, 2009Coppens, , 2010Flynn, 2011;Gilsenan, 2011;Gorny, 2012;Kardinaal, Mennen, & Hendriks, 2009;Lalor & Wall, 2012;Mitchell, Aggett, Richardson, Stowell, 2011;O'Connor, 2011;Reuterswärd, 2007;Richardson, 2012;Vero & Gasbarrini, 2012;Walter, 2009;Pravst, 2012;Meisterernst & Haber, 2007;Gallagher, Meijer, & Richardson, 2011); a total of 23.7% (n = 9) analyzed the FDA (Aggett, Hathcock, & Jukes, 2012;Ellwood et al, 2010;FDA, 2009;Guzelian & Guzelian, 2008;Hasler, 2008;Kuhn, 2008;Lupton, 2009;Schneeman, 2007Schneeman, , 2010 and 15.8% (n = 6) were comparative analyses of both agencies (Binns, 2008;Jovicic et al, 2011;Lalor & Wall, 2011;Martin, 2010;Moors, 2012;Verhagen, Vos, Franch, Heinonen, & van Loveren, 2010). Of the authors whose articles were selected for review, only four were somewhat affiliated with the agencies they analyzed …”

Health Claims and Methodological Controversy in Nutrition Science

“…Current practice corroborates this: EFSA demands data from human intervention trials and the establishment of a cause–effect relationship in order to issue a positive opinion to an applicant . Additional evidence can be provided by other types of studies (like in vivo or in vitro trials), but this kind of evidence under no circumstances will be considered decisive …”

¿Bueno para la salud? Un análisis de los requisitos de sustanciación científica en la regulación europea de las declaraciones de salud

“…Esa comisión se encarga de redactar las recomendaciones para los solicitantes y establecer los criterios científicos que se aplican en las evaluaciones. 9,10 La regulación NHCR afecta a todas las aseveraciones de efectos sobre la salud que puedan contener las etiquetas de los envases de los alimentos o suplementos alimentarios, pero también a las que se usen en la publicidad u otras presentaciones públicas de esos alimentos. La regulación exige que las declaraciones de salud sean comprensibles para el consumidor promedio (del que se supone que tiene un nivel de información razonable y que es medianamente observador y prudente).…”