ID 331 -
Węglany i wodorowęglany sodu i potasu
PL: Węglany i wodorowęglany sodu i potasu
EN: Carbonate/bicarbonate as salts of Ca, Mg, Na, K (mineral waters/hydrogencarbonate (bicarbonate))
Pdf: carbonate
1. Charakterystyka żywności / składnika
The food constituents that are the subject of the health claim are “carbonate/bicarbonate as salts of Ca, Mg, Na, K” and “mineral waters/hydrogencarbonate (bicarbonate)”.
In the context of the information provided, the Panel assumes that the food constituents that are the subject of the health claim are carbonate and bicarbonate salts of calcium, magnesium, sodium and potassium.
A claim on calcium (including carbonate and bicarbonate salts of calcium) and maintenance of normal bone, and a claim on magnesium (including carbonate and bicarbonate salts of magnesium) and maintenance of normal bone, have already been assessed with favourable outcomes (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009, 2010).
This opinion refers to the carbonate and bicarbonate salts of sodium and potassium.
The carbonate salts of potassium and sodium, and the bicarbonate salts, potassium bicarbonate and sodium bicarbonate, are all soluble in water and occur naturally in mineral waters.
Potassium carbonate (E501), sodium carbonate (E500) and the respective bicarbonates are authorised for addition to foods for technological purposes. They are also authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/20066, Annex II of Directive 2002/46/EC7 and Regulation (EC) No 1333/20088). This evaluation applies to carbonates and bicarbonates of potassium and sodium naturally present in foods, and those forms authorised for addition to foods and for use in food supplements (Annex II of the Regulation (EC) No 1925/2006, Annex II of Directive 2002/46/EC, and Regulation (EC) No 1333/2008).
The Panel considers that the food constituents, carbonate and bicarbonate salts of sodium and potassium, which are the subject of the health claim, are sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effects are “acid/base balance and bone health” and “bone density/bone health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the maintenance of normal bone by maintaining acid-base balance.
The Panel considers that maintenance of normal bone is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie prawidłowego stanu kości
Among the references provided for the scientific substantiation of the claim were narrative reviews on, for example, acid-base homeostasis and dietary potential renal acid load (PRAL) on various chronic diseases, including osteoporosis, or on the influence of dietary PRAL and/or net endogenous acid production (NEAP) on urine pH and renal excretion of minerals, acids and/or bases, which did not include original data that could be used for the scientific substantiation of the claim. A number of references referred to food constituents (e.g. dietary acid load and composition of the whole diet), other than the carbonate and bicarbonate salts of sodium and potassium and/or reported on health outcomes (e.g. back pain, rheumatoid arthritis, physical performance and cancer) other than bone mineral density. Four references were not available to the Panel after every effort was made to retrieve them. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Six references reported on human intervention studies which addressed the effects of short-term interventions with (potassium or sodium) bicarbonate on mineral balance (calcium and phosphorus), acid-base status, acid excretion, markers of bone resorption and/or formation, cortisol, free insulin- like growth factor 1 (IGF-1), parathormone (PTH), 1,25(OH)2 vitamin D, or thyroid hormones (Burckhardt, 2006; Frassetto et al., 2005; Frassetto et al., 2000; Lutz, 1984; Maurer et al., 2003; Sebastian et al., 1994). The Panel notes that none of these studies addressed the effects of (potassium or sodium) bicarbonate on measures of bone mass or bone mineral density. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of carbonate or bicarbonate salts of sodium or potassium and maintenance of normal bone.
Warunki i możliwe ograniczenia stosowania oświadczenia
Appropriate warning needed for K to be determined (to be determined) Must at least be a source of mineral/s as per annex to regulation 1924/2006
