Legislation- A-Z Guide 2021 S.I. those that would not be relevant. Instruc- dietary supplements to create a placebo tions on the duration of treatment are also product, a study of a more complex func- included. These documents also contain tional food should demonstrate the effort information on what type of protocol or to include a control group as relevant as marker would not be considered relevant; possible. (3) For an error on the target popula- The multidimensional analyses (FIGURE 3) tion it is advisable to fully include the allowed us to define three profiles of general population by avoiding gender scientific files: biases. The age of inclusion must also Profile (1) represents very good clinical correspond to the target (adult or child) studies (no rejection of intervention of the claim. Finally, since a health claim studies included in the files, for wha- does not allow for a therapeutic action, tever reason) for ingredient-related dos- it is not advisable to include a popula- siers and disease risk reduction claims tion with a particular pathology. However, (Article 14); it is accepted to target populations with Profile (2) shows studies rejected on the somewhat extreme characteristics of tar- basis of poor quality of clinical protocol geted physiological function in order to but for which the product generally cor- clinically and statistically demonstrate a responds and for functional claims files beneficial effect of the product; (Art 13.5) concerning dietary supplements; (4) To overcome an inappropriate design, Finally, profile (3) shows studies rejected it is usually sufficient to verify that the on the basis of multiple errors related study includes a control group or a double to the four criteria described above for blinded randomization for the distribution dossiers targeting child development of the products under study. While it is and growth claims (Art 14) and for more easy for claims targeting ingredients or complex products. Some studies would 031 News on Functional & Health Ingredients \ Special Issue \ A - Z Health Ingredients 2021 \ ■