TY - JOUR

T1 - Scientific Opinion on the substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

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

AU - Tetens, Inge

AU - Sjödin, Anders Mikael

PY - 2015

Y1 - 2015

N2 - Following an application from Han-Asiabiotech 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® and 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 for people who want to lower their blood pressure. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with methodological limitations showed a decrease in blood pressure when Symbiosal® was consumed instead of table salt for eight weeks in the context of a salt-restricted diet, but 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 and that no evidence was provided for a mechanism by which the food could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal® instead of table salt and lowering of blood pressure.

AB - Following an application from Han-Asiabiotech 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® and 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 for people who want to lower their blood pressure. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with methodological limitations showed a decrease in blood pressure when Symbiosal® was consumed instead of table salt for eight weeks in the context of a salt-restricted diet, but 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 and that no evidence was provided for a mechanism by which the food could exert the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal® instead of table salt and lowering of blood pressure.

KW - Faculty of Science

KW - Symbiosal®

KW - Chitosan

KW - Sodium chloride

KW - Blood pressure

KW - Hypertension

KW - Health claims

U2 - 10.2903/j.efsa.2015.4147

DO - 10.2903/j.efsa.2015.4147

M3 - Journal article

VL - 13

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 7

M1 - 4147

ER -