Following an application from Naturex SA, submitted pursuant to Article 13(5) of Regulation (EC) 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 Pacran® and defence against bacterial pathogens in the lower urinary tract. The food that is the subject of the claim is Pacran®. The Panel considers that the food, Pacran®, which is the subject of the claim is sufficiently characterised in relation to the claimed effect. The Panel considers that defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect. One human study from which conclusions could be drawn for the scientific substantiation of the claim showed no effect of Pacran® on defence against bacterial pathogens in the lower urinary tract. The Panel concludes that a cause and effect relationship has not been established between the consumption of Pacran® and defence against bacterial pathogens in the lower urinary tract. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application includes a request for the protection of proprietary data.The food that is the subject of the health claim is Pacran®, which contains cranberry powder obtained from the blend of whole North American cranberries (Vaccinium macrocarpon, syn. V. macrocarpon Aiton or V. macrocarpon L). The applicant claims that proanthocyanidins (PACs) are the main food constituent in the Pacran® which are responsible for the claimed effect. The Panel considers that the food, Pacran®, which is the subject of the health claim is sufficiently characterised in relation to the claimed effect.The claimed effect proposed by the applicant is "helps to inhibit the adhesion of P-fimbriated Escherichia coli to the urinary tract cells". The target population proposed by the applicant is "sexually active women with a history of UTIs". The Panel considers that the claimed effect refers to defence against bacterial pathogens in the lower urinary tract in healthy women without signs or symptoms of a urinary tract infection (UTI) and does not include the treatment of UTI. The Panel considers that defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect.The applicant identified four studies as pertinent to the claim: two human intervention studies and two ex vivo studies. The Panel considers that no conclusions can be drawn from one of the human studies for the scientific substantiation of the claim and that the second human study had design limitations but did not show an effect of Pacran® on defence against bacterial pathogens in the lower urinary tract.In addition, the applicant provided two studies on the ex vivo anti-adherence properties of urine from subjects consuming Pacran® on uropathogenic E. coli strains as being pertinent to the claim. The Panel considers that these studies do not provide evidence that an...