• Open Access

Scientific Opinion on the substantiation of a health claim related to “Lactobacillus plantarum TENSIA® in the semi-hard Edam-type ‘heart cheese’ of Harmony™” and maintenance of normal blood pressure pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Authors

  • EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)


  • Panel members: Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.
  • Correspondence: nda@efsa.europa.eu
  • Acknowledgement: The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Sean (J.J.) Strain, Inge Tetens, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.
  • Adoption date: 18 September 2014
  • Published date: 1 October 2014
  • Question number: EFSA-Q-2014-00097
  • On request from: Member State - Estonia

Abstract

Following an application from E-piim production Ltd, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Estonia, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to “Lactobacillus plantarum TENSIA® in the semi-hard Edam-type “heart cheese” of Harmony™” and maintenance of normal blood pressure (BP). The food constituent L. plantarum TENSIA®, which is the subject of the health claim, is sufficiently characterised. The Panel considers that the maintenance of normal blood pressure is a beneficial physiological effect. The applicant provided 47 references which did not address the effects of L. plantarum TENSIA® on BP. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim. Two human randomised, double-blind, placebo-controlled, intervention studies investigated the effect on BP of L. plantarum TENSIA® consumed in Edam-type cheese for three and eight weeks. In weighing the evidence, the Panel took into account that only one human intervention study with important methodological limitations showed a BP-lowering effect of L. plantarum TENSIA® consumed in the Edam-type “heart cheese” of Harmony™ when consumed daily for eight weeks, and that no evidence was provided for a mechanism by which L. plantarum TENSIA® in the Edam-type “heart cheese” of Harmony™ could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus plantarum TENSIA®in the semi-hard Edam-type “heart cheese” of Harmony™ and maintenance of normal blood pressure.

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