Regulatory Environment and Claims – Limits and Opportunities

Abstract

During the past decade, the use of claims became more and more important in many countries in relation to the increased awareness of consumer about the link between foods and health, offering to industry a valuable opportunity to differentiate and valorize their products and to promote innovation. However, more and more stringent regulations are developed, all based on the general principles adopted by the Codex Alimentarius Commission. In addition to the different regulatory processes and administrative requirements according to the country, the high level (and cost) of scientific substantiation of claims, the constraints introduced by nutrient profiles and the poor knowledge of the impact on consumer depending on the cultural contexts may limit these opportunities or, at least complicate their use. All these issues are briefly analyzed, highlighting some striking convergences and differences between countries.

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

“…Only one specific aspect of regulation (evidence required to substantiate a health claim) was reviewed here and this research cannot be considered to be comprehensive. However, according to Martin (), there is a lack of comparative studies on regulatory agency requirements on scientific substantiation of health claims. Moreover, future lines of research should consider the purpose of legislation and consider the following issues: What is the objective of the legislation?…”

Assessment and Management of Health Claims in Europe 9 Years after the Adoption of the Regulation

“…Though the scientific assessment should theoretically provide similar results throughout the world, indeed the precise regulatory context leads sometimes to different outcomes (2). A first example is given by the absence of the possibility to define "qualified claims" (i.e.…”