Scientific Opinion on the substantiation of a health claim related to Monurelle® and reduction of bacterial colonisation of the urinary tract by the inhibition of the adhesion of P‐fimbriated E.coli to uroepithelial cells pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract

Following an application from Zambon B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, 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 Monurelle® and reduction of bacterial colonisation of the urinary tract by the inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells. The food that is the subject of the health claim, Monurelle®, which is a combination of 120 mg cranberry (Vaccinium macrocarpon) extract (including 36 mg proanthocyanidins) and 60 mg of ascorbic acid, is sufficiently characterised. The claimed effect proposed by the applicant is reduction of E.coli adhesion to uroepithelial cells. The Panel considers that reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells is a beneficial physiological effect. Several health claim applications on cranberry products standardised by their proanthocyanidin content have already been evaluated by EFSA with an unfavourable outcome. The Panel notes that no studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of Monurelle® and reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells.