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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

EFSA Journal 2009; 7(12):1421[8 pp.]. doi:10.2903/j.efsa.2009.1421
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen Acknowledgment The Panel wishes to thank the members of the Working Group on Claims for the preparation of this opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Valosun A.S. Question number: EFSA-Q-2009-00600 Adopted: 04 December 2009 Published: 21 December 2009 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

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.

© European Food Safety Authority,2009

Summary

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 food that is the subject of the health claim is the cranberry extract and D-mannose containing food supplement Uroval®. According to a conformity declaration, one tablet, coated with a polymer film agent, a hydroxyl-propylmethylcelullose, contains 300 mg of D(+)-mannose and 100 mg of cranberry extract with 10% proanthocyanidins. 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 (mostly E. coli) 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 tract infections. The Panel notes that bacterial adherence precedes an infection and therefore inhibition of bacterial adhesion might result in a reduction for the risk of symptomatic urinary tract infections with bacteriuria ≥105 cfu/mL. 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 applicant identified eight references as being pertinent to the claim. 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.

Keywords

Cranberry, proanthocyanidins, PAC, D-Mannose, bacterial adhesion, urinary tract infection