Legislation- A-Z Guide 2021 S.I. nutrition (particularly the concept of control group) and entail a significant cost in the development of clinical studies to achieve results that meet the requirements of the panel. The possibility of protecting pro- prietary data and using the claim exclusi- vely for 5 years is not necessarily sufficient in the face of these economic constraints. This has two major consequences: (1) The inappropriate use of clinical studies from the literature in the scientific subs- tantiation of the claim. The analysis pres- ented in the previous section shows that this choice is not a winning option in the majority of cases. Indeed, sometimes it only takes two or three relevant studies to validate an allegation (this was the case for example to validate the role of lycopene on platelet aggregation), but the use of non- targeted studies only delays the inevitable; (2) The decreasing number of dossiers filed with EFSA and a significant number of “redundancies”. For example, about 30 successful cases dealt with products and health effects that had already been validated as part of a generic health claim 035 (Article 13.1). An example is on the role of beta-glucans and cholesterol modulation. A dozen other dossiers are repetitions, sometimes with a variation of matrix, of claims that have already been accepted following dossiers on Art 13.5 or Art 14. This is particularly the case for phytoste- rols and cholesterol reduction or the link between glucose and energy metabolism. The analysis of these files by the NDA panel is often restricted to a reference to previous dossiers. This perceived hete- rogeneity in the treatment of health claims dossiers by the NDA panel was also noted in the context of the study of generic files (Art 13.1) where some published opinions would not strictly follow EFSA’s instruc- tions on the level of detail requested. In particular, some opinions did not present all the elements evaluated for a specific file (product characterization, confusion about the level of confidence for the pro- posed function, variable analysis of the scientific evidence of the cause-and- effect relationship). As a result, other studies have shown a distrust of industry in the broken promise of the Nutrition and Health Claims Regulation. News on Functional & Health Ingredients \ Special Issue \ A - Z Health Ingredients 2021 \ ■