One more rejection for a health claim related to isolated soy protein and the reduction in plasma cholesterol

After two rejections pursuant to article 13(1) and 14, EFSA has recently provided a negative opinion on a health claim related to the reduction in LDL-cholesterol and the consumption of isolated soy protein. As it is often the case, this rejection is explained by an insufficient scientific substantiation. However, the applicant has provided a dossier supported by 23 randomized and controlled intervention trials. Moreover, these studies were associated to a meta-analysis prepared specifically for this application, and to several supportive studies (intervention studies, meta-analyses, reviews, mechanistic studies).

Nevertheless, the experts have considered that 4 of the 23 trials could not be considered as pertinent due to inadequate experimental methodologies (mainly low quality of statistical analysis). Among the 19 remaining studies, only four studies have shown a reduction in LDL-cholesterol, whereas all the other trials did not conclude to a significant effect of isolated soy protein. Surprisingly, the meta-analyses provided by the applicant have not been considered as pertinent by the NDA panel, and have been rejected for the substantiation of the intended claim due to low methodologies.

Thus, the soy proteins manufacturers cannot still communicate in Europe about the cholesterol-lowering effect of their product, despite that several countries (US, Japan, Brazil for instance) have accepted similar claims.

Data Solution

The most efficient DATA Solution to create your products in the 28 European Member States


The artificial intelligence solution for regulatory review & labelling. Enter your formula and start the analysis!