EFSA rejects two new 13.5 claims on ‘transit’ and ‘vaginal moisture’
The European regulatory authority’s panel on Dietetic Products, Nutrition and Allergies (NDA) the applications from French firm Vivatech and Swiss-based Nutrilinks.
Vivatech had applied to EFSA claiming that its Transitech food supplement “improves transit and durably regulates it,” while Nutrilinks had asked EFSA to provide a scientific opinion on a health claim related to its Femilub supplement for the maintenance of vaginal moisture.
However EFSA's NDA panel rejected both claims, stating that Vivatech’s ‘Transitech’ had not been sufficiently characterised in the dossier, and that Nutrilinks had provided no human intervention studies for its food supplement ‘Femilub’.
“No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim,” said EFSA. “A cause and effect relationship has not been established between the consumption of “Femilub” and maintenance of vaginal moisture.”
The Transitech supplement was said to contain “dried parts of Rheum palmatum L. and/or Rheum officinale Baillon and/or their hybrids standardised for hydroxyanthracene derivatives, of Althaea officinalis L., of Rosa centifolia L., ofOcimum basilicum L., of Coriandrum sativum L., dried juice of Cynara scolymus L. standardised for cynarine, Saccharomyces cerevisiae subsp. cerevisiae UVAFERM SC,Bifidobacterium longum R0175 and Lactobacillus helveticus R0052.”
In response to the application the NDA panel said it considered the information provided by Vivatech to be “insufficient to establish that Saccharomyces cerevisiae subsp. cerevisiaeUVAFERM SC was sufficiently characterised.”
“The Panel considers that if in a combination of several microorganisms and/or ingredients one microorganism or ingredient used in the combination is not sufficiently characterised, then the combination is considered to be not sufficiently characterised,” EFSA added.
