Its Scientific Panel on Additives and Nutrient Sources added to Food (ANS) found no issue with calcium acetate, calcium pyruvate, calcium succinate, magnesium pyruvate, magnesium succinate and potassium malate.
The positive safety opinions mean the nutrients can be added to the positive list of permitted nutrients that forms part of the 2002 Food Supplements Directive (FSD).
The applications for approval were submitted by the UK Health Food Manufacturers Association (HFMA), German firm, Fresenius Medical Care Deutschland GmbH and UK company, BioCare Ltd.
“…human and animal studies indicate that magnesium and calcium are readily absorbed from orally ingested soluble organic salts,” ANS said.
“The Panel expects the bioavailability of calcium from the less soluble pyruvate and succinate salt sources to be comparable to that of readily soluble salts, given that the absorption of calcium from the gastrointestinal tract is primarily determined by food components, especially organic acids. Similarly, potassium from potassium malate is readily absorbed from the gastrointestinal tract.”
The ANS noted that while no data was provided on the metabolic fate of the nutrients, succinate, pyruvate, acetate and malate are, “normal constituents of the body with well documented biochemical fates”.
Safety data included daily doses of 13-25g calcium pyruvate that show no adverse effect for six weeks in hyperlipidaemic subjects as well as, “Studies that have investigated the effect of calcium pyruvate supplementation during physical training, on body fat and metabolic responses to exercise”.
Only in one case were, “adverse changes in serum lipid composition … documented”.
The HFMA suggested levels of 800mg calcium succinate or calcium pyruvate per day and Fresenius Medical Care proposed 110mg or 167mg for calcium acetate.
For these nutrients a total Tolerable Upper Intake Level (UL) defined by EFSA’s predecessor, the Scientific Committee on Food (SCF), is 2500 mg/day. For magnesium, the UL is 250 mg/day.
There is no UL for potassium but EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) noted, “long-term supplementary intake of up to 3g/day, in addition to intake from food, has been shown not to have an adverse effect in adults.”
BioCare proposed adding 350mg of potassium malate to food supplements. When other sources are considered, the maximum intake would be 1.5 g/day.
“Combined intake of succinate and pyruvate salts from the proposed sources of calcium and magnesium would increase the exposure to these anions to 3.2 and 5.2 g/day, respectively. No adverse effects have been reported for the proposed use levels for succinate, acetate and malate.”
The opinion can be found here.