Scientific Opinion on the substantiation of health claims related to foods
with reduced amounts of sodium and maintenance of normal blood
pressure (ID 336, 705, 1148, 1178, 1185, 1420) 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
blood pressure
health claims
1. Charakterystyka żywności / składnika
The food constituents that are the subjects of the health claim are “sodium/salt”, “low sodium/salt and/or increased potassium”, “food reduced/low in/free of sodium/salt and/or increased potassium”, “breads with salt content of <0.7 %”, and “natural berries/sodium”.
A claim on potassium and maintenance of normal blood pressure has been already evaluated with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010).
From the information provided, the Panel assumes that the food constituent that is the subject of the health claim is sodium, which should be reduced in foods in order to obtain the claimed effect.
Sodium is a well recognised nutrient and is measurable in foods by established methods.
Sodium is naturally present in foods as a normal constituent at a low level. It is also added to foods, mainly as sodium chloride (commonly known as salt) during processing, cooking and immediately prior to consumption, but also as sodium nitrate, sodium phosphate or sodium glutamate. Sodium is authorised for addition to foods (Annex I of the Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to sodium naturally present in foods and added to foods.
The Panel considers that the food constituent, sodium, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Spożycie dużej ilości sodu podnosi ciśnienie krwi; spożycie produktów o niskiej lub bardzo niskiej zawartość sodu pomaga utrzymać prawidłowe ciśnienie krwi
The claimed effects are “effects on blood pressure”, “heart health”, “blood pressure, heart health”, and “cardiovascular system”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel notes that the claimed effect relates to the 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 140 mmHg (systolic) and/or 90 mmHg (diastolic), may compromise the normal function of the arteries.
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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Spożycie dużej ilości sodu podnosi ciśnienie krwi; spożycie produktów o niskiej lub bardzo niskiej zawartość sodu pomaga utrzymać prawidłowe ciśnienie krwi
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is good consensus on the effect of sodium intake on blood pressure in normotensive and hypertensive human subjects. This evidence comes from large-scale prospective cohort studies, and from a number of well controlled intervention studies and meta-analysis of randomised controlled trials (Geleijnse et al., 2003; He and MacGregor, 2003; He et al., 2009; IoM, 2005; SCF, 1993; WHO, 2006). Whereas sodium intake generally shows an association (and potassium intake an inverse association) with blood pressure values and/or the risk of hypertension, the sodium/potassium ratio appears to be a stronger predictor of blood pressure than the intake of either electrolyte alone (IoM, 2005).
European and American professional associations recommend decreasing dietary sodium intakes for the prevention and management of human hypertension (Appel et al., 2006; Lichtenstein et al., 2006; Mancia et al., 2007), and biologically plausible mechanisms for this effect have been proposed.
The Panel concludes that a cause and effect relationship has been established between high dietary sodium intakes and increased blood pressure, and that the reduction of dietary sodium intake helps to maintain a normal blood pressure.
4. Uwagi do zaproponowanego brzmienia oświadczenia
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Spożycie dużej ilości sodu podnosi ciśnienie krwi; spożycie produktów o niskiej lub bardzo niskiej zawartość sodu pomaga utrzymać prawidłowe ciśnienie krwi
The Panel considers that the following wording reflects the scientific evidence: “High sodium intakes increase blood pressure; consumption of foods low or very low in sodium helps to maintain normal blood pressure.”
5. Warunki i możliwe ograniczenia stosowania oświadczenia
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Spożycie dużej ilości sodu podnosi ciśnienie krwi; spożycie produktów o niskiej lub bardzo niskiej zawartość sodu pomaga utrzymać prawidłowe ciśnienie krwi
To establish conditions of use, sodium/salt nutrition claims as per Annex of Regulation (EC) No 1924/2006 should be considered. The target population is the general population.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, sodium, which is the subject of the health claims, is sufficiently characterised.
The claimed effects are “effects on blood pressure”, “heart health”, “blood pressure, heart health”, and “cardiovascular system”. 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 been established between high dietary sodium intakes and increased blood pressure, and that the reduction of dietary sodium intakes helps to maintain a normal blood pressure.
The following wording reflects the scientific evidence: “High sodium intakes increase blood pressure; consumption of foods low or very low in sodium helps to maintain normal blood pressure.”
To establish conditions of use, sodium/salt nutrition claims as per Annex of Regulation (EC) No 1924/2006 should be considered. The target population is the general population.