H.S. Guide A-Z 2021 - Réglementation failures in the expertise of dossiers. There is the case if the claim relates to a mixture is therefore an essential need for scien- or proposing a particular dosage, matrix tific support in the assembly of evidence, or form of the active ingredient. This is in the selection of studies relevant to the the major cause of non-compliance with claim, and on the need for complex pro- the clinical studies selected in the files. ducts to set up proprietary clinical studies. It is therefore advisable to limit studies Of the 1969 clinical intervention studies from the literature to those investigating described and analyzed in the various a product comparable to that of the claim; published opinions, 58.8% were rejected (2) A primary marker or inappropriate sta- by the panel as irrelevant to support the tistical analyses are the second leading proposed claim (FIGURE 2). The reasons cause of non-compliance in clinical are diverse but can be summed up in 4 studies. Following the first wave of eva- categories and pragmatic answers can luations and the high rate of negative opi- limit these selection errors: nions, EFSA published between 2010 and (1) The product tested in the selected cli- 2012 a number of guidance documents nical studies may not match the claim. This including preferential markers but also 030 FIGURE 3: Graphic representation of cluster analysis of the relationship between the type of claim and the causes of rejection of intervention studies Analysis by the RStudio software and projection of individuals on axes 1 and 2. Profiles 1 to 3 are described in the main document ■ / A - Z Ingrédients Santé 2021 / Hors-Série / L’Actualité des Ingrédients Fonctionnels & Santé