Scientific Opinion on the substantiation of a health claim related to “Transitech®” and “improves transit and durably regulates it” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Vivatech submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to “Transitech®” and “improves transit and durably regulates it”. The food that is the subject of the health claim is “Transitech®”, a food supplement which contains 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., of Ocimum 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. The information provided was insufficient to establish that Saccharomyces cerevisiae subsp. cerevisiae UVAFERM 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. The food, “Transitech®”, which is the subject of the claim, is not sufficiently characterised. The Panel concludes that a cause and effect relationship cannot be established between the consumption of “Transitech®” and “improves transit and durably regulates it”.