Documents made available by the Authority reveal that while the food/constituent of the product was sufficiently characterised, a cause and effect relationship between Symbiosal and lowering of blood pressure “could not be established”.
“The claimed effect proposed by the applicant is ‘lowers the rising of blood pressure when used as a replacement of traditional table salt. The rising of blood pressure is a risk factor for hypertension’,” EFSA ruled.
The target population proposed by the applicant, Han‐Biotech were subjects presenting prehypertension systolic blood pressure (SBP) of 130 to 139 mmHg and/or diastolic blood pressure (DBP) of 80 to 89 mmHg, as well as subjects presenting recently discovered mild to moderate hypertension.
The decision was made despite the inclusion of four human studies of which the Panel considered one human study to have methodological limitations.
This study demonstrated a decrease in SBP and DBP when 3 grams (g) of Symbiosal per day was consumed instead of added table salt for eight weeks.
EFSA’s Dietetic Products, Nutrition and Allergies (NDA) Panel also considered the animal studies included did not support the results of the human study concluding that overall, no evidence had been provided in support of Symbiosal’s mechanism.
What is Symbiosal?
Symbiosal is produced by mixing sea salt (97%) with chitosan (3%), following a patented manufacturing process. Chitosan itself is a is a polysaccharide produced from chitin derived from crab shells.
Han‐Biotech claimed that chitosan “acts as a chelator of the Cl− and therefore decreases its hypertensive effect.
“It forms a complex with anion Cl− which is stable enough to partially limit its digestive absorption.
“Decreased amounts of Cl− within the plasma serum prevents stimulation of the angiotensin converting enzyme (ACE) receptors.”
The Panel rejected this suggestion, noting that the studies provided did not establish that Symbiosal bound Cl− in the gut, or that upon oral administration, Symbiosal had an ACE inhibitory activity through this or other mechanisms.
Disappointing conclusion
The decision is a disappointing end to France-based Han-Biotech and its application, which was received by EFSA on January of this year.
The scientific evaluation procedure that started in the following month was then followed up in March by a list of questions, submitted by the Panel to Han-Biotech to provide additional information to accompany the application.
The scientific evaluation was suspended on 26/03/2017 and restarted on 19/04/2018, in compliance with Article 16(1) of Regulation (EC) No 1924/2006.
In April 2018, EFSA received the applicant's reply. Last month, the NDA Panel, having evaluated the data, adopted its final opinion on the scientific evidence related to Symbiosal's health claim.