Scientific Opinion on the substantiation of a health claim related to a Uroval® and urinary tract infection pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Valosun A.S. submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Czech Republic, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to cranberry extract and D-mannose contained in the food supplement Uroval^® and urinary tract infections. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panel considers that the food, the cranberry extract and D-mannose containing food supplement Uroval^®, which is the subject of the health claim, is sufficiently characterised. The claimed effect is “prevent adhesion of bacteria to the cell surface, a risk factor for urinary tract infections.” The target population indicated by the applicant is those suffering from acute and / or chronic urinary infections. The Panel considers that reducing the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract is beneficial to human health. The Panel notes the poor quality of the references provided and that none of the references were related to a combination of a cranberry extract and D-mannose equivalent to Uroval®. The Panel considers that no scientific conclusion can be drawn from the references for the substantiation of the claim.

The Panel concludes that a cause and effect relationship has not been established between the consumption of the cranberry extract and D-mannose containing food supplement Uroval® and the reduction of the risk of urinary tract infection by inhibiting the adhesion of certain bacteria in the urinary tract.