EFSA’s opinion recognizes that monacolin K in Sylvan Bio red yeast rice is sufficiently characterized. The maintenance of normal blood LDL-cholesterol concentrations has been also acknowledged by EFSA as a beneficial physiological effect. However, the main factor that made this achievement possible is the proven efficacy of Sylvan Bio’s red yeast rice to lower LDL-cholesterol levels in blood, as clearly highlighted by two proprietary clinical trials. These studies, conducted in a population accepted by EFSA (i.e. non-treated hypercholesterolemic subjects), have shown a significant reduction in LDL-cholesterol levels after at least 12 weeks of consumption of Sylvan Bio’s Red yeast rice.
The ingredient, distributed in Europe by Gee Lawson, is the 13th winner of a positive opinion under article 13.5, and joins the other accepted applications, which only represent 16% of all submitted dossiers. This success is a result of Nutraveris’s great experience in Health Claims applications, and confirms the leadership of the consultancy as an expert of EU’s scientific issues on nutrition and health products. Nutraveris consultants realized a pre-assessment of the acceptability of the application, and made sure that the dossier had all chances to succeed before submitting it to authorities, leading to the deposit of only the dossier with a great chance of success. When pre-assessments lead to the conclusion that chances of success of success are low due to insufficient scientific substantiation, Nutraveris supports its clients to build and carry-out new clinical studies, in perfect agreement with EFSA’s requirements.
The positive opinion won by Sylvan Bio brings a new proof to the relevance of Nutraveris’s approach when working on Health Claims applications.