Symbiosal® and lowering of blood pressure and reduced risk of hypertension: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Dominique Turck, Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Anders Sjödin, Martin Stern, Daniel Tomé, Henk Van Loveren, Marco VincetiPeter Willatts, Ambroise Martin, Sean (J. J.). Strain, Alfonso Siani

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Abstract

Following an application from Han-Biotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, 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 Symbiosal® , lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal® , which is the subject of the health claim, and the food, table salt, which Symbiosal® should replace, are sufficiently characterised. Lowering of blood pressure is a beneficial physiological effect. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with some methodological limitations showed an effect of Symbiosal® on blood pressure in the context of a self-selected diet with a maximum of 3 g/day added salt. The Panel also took into account that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study, that no evidence was provided in support of a mechanism by which Symbiosal® could induce a decrease in blood pressure upon oral consumption as compared to table salt in vivo in humans, and the low biological plausibility of the effect observed in the human intervention study. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal® and lowering of blood pressure.

Original languageEnglish
Article numbere05364
Pages (from-to)1-13
Number of pages13
JournalEFSA Journal
Volume16
Issue number7
Early online date25 Jul 2018
DOIs
Publication statusPublished - Jul 2018

Keywords

  • blood pressure
  • chitosan
  • health claim
  • hypertension
  • Symbiosal

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    EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel), Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., Heinonen, M., Hirsch-Ernst, K. I., Mangelsdorf, I., McArdle, H. J., Naska, A., Neuhäuser-Berthold, M., Nowicka, G., Pentieva, K., Sanz, Y., Sjödin, A., Stern, M., Tomé, D., Van Loveren, H., ... Siani, A. (2018). Symbiosal® and lowering of blood pressure and reduced risk of hypertension: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006. EFSA Journal, 16(7), 1-13. [e05364]. https://doi.org/10.2903/j.efsa.2018.5364