Scientific Opinion on the substantiation of health claims related to sodium
bicarbonate and maintenance of normal blood pressure (ID 1404) pursuant
to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Sodium bicarbonate
blood pressure
health claims
1. Charakterystyka żywności / składnika
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Utrzymanie prawidłowego ciśnienia krwi
The food constituent that is the subject of the health claim is sodium bicarbonate.
Sodium bicarbonate is also known as baking soda or bicarbonate of soda (chemically NaHCO3). Sodium bicarbonate is authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to sodium bicarbonate naturally present in foods and added to foods.
The Panel considers that the food constituent, sodium bicarbonate, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Utrzymanie prawidłowego ciśnienia krwi
The claimed effect is “blood pressure reduction”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to maintenance of normal blood pressure.
Blood pressure is the pressure (force per unit area) exerted by circulating blood on the walls of blood vessels. Elevated blood pressure, by convention above 140 mmHg (systolic) and/or 90 mmHg (diastolic), may compromise the normal arterial and cardiac function.
The Panel considers that maintenance of normal blood pressure is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego ciśnienia krwi
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Utrzymanie prawidłowego ciśnienia krwi
Among the references provided for the scientific substantiation of the claim one was not available to the Panel after every reasonable effort had been made to retrieve it and another reported on a human
study which investigated a health outcome (sodium excretion in patients with chronic renal failure) other than the claimed effect The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A placebo-controlled, cross-over intervention study investigated the effects of consuming three litres per day of a sodium bicarbonate-containing mineral water for seven days vs. a control solution containing equimolar amounts of sodium chloride salt on blood pressure and electrolyte excretion in 10 mildly hypertensive and 10 normotensive subjects (Luft et al., 1990). No power calculations were performed. Data analyses were presented for mildly hypertensive and normotensive subjects separately. The Panel notes that this study was not properly controlled for blood pressure analyses as no between-treatment comparison was provided for this variable. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of sodium bicarbonate and maintenance of normal blood pressure.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, sodium bicarbonate, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “blood pressure reduction”. The target population is assumed to be the general population. Maintenance of normal blood pressure is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of sodium bicarbonate and maintenance of normal blood pressure.
