H.S. Guide A-Z 2021 - Réglementation on innovative data (Art 13.5), remaining independent criteria: (1) the characteri- in the majority compared to opinions on zation of the product, (2) the relevance children’s development and health or of the proposed claim to human health, disease risk reduction (Art 14). Similarly, and (3) the quality of clinical studies to the success rate by type of claim remains support the health effects to prove a broadly similar with 17.3% (compared to cause-and-effect relationship. Looking at 18.5%) for innovative functional claims, the 38 files published over the 2016-2020 while favorable opinions are 34.7% and period, not a single dossier was rejected 45.3%, respectively for risk reduction on an insufficient characterization of the claims and those for children (compared product concerned (compared to 8.9% to 40.5% and 42.7%). If, however, we at the end of 2015). This implies a much consider only the opinions published in stronger technical record and considera- the last 5 years, there is 100% positive (4 tion of EFSA’s recommendations on the of 4) opinions for child growth and health composition of the dossier. Similarly, only claims, 11.1% (3 of 27) for innovative 7.9% call for effects that are not consi- functional claims but 0% (0 out of 7) for dered relevant to demonstrate a health disease risk reduction claims, showing a benefit (compared to 12.8% at the end of heterogeneous quality of dossiers over 2015). For each of the three files involved, time. We will go on to analyze various the petitioner did not provide a satisfac- elements to explain this situation. tory response to the panel members to demonstrate that the proposed effect was Scientific evidence clearly defined, unique, and beneficial to that is not suitable the health of the general population. This Although the numbers have changed little decline in problems related to the first in the last 5 years, the reasons for these two criteria confirms, however, that the 028 many refusals are different. As a reminder, quality and relevance of scientific evi- the files are evaluated according to three dence remain by far the major reasons for FIGURE 2: Analysis of proposed articles as part of the scientific validation file of the cause-and-effect relationship and causes of rejections for clinical intervention studies All included articles were cited as part of the various published opinions and clinical studies were described and discussed by the panel ■ / A - Z Ingrédients Santé 2021 / Hors-Série / L’Actualité des Ingrédients Fonctionnels & Santé