Scientific Documents
Magnesium aspartate, potassium aspartate, magnesium potassium aspartate, calcium aspartate, zinc aspartate, and copper aspartate as sources for magnesium, potassium, calcium, zinc, and copper added for nutritional purposes to food supplements - Scientific Panel on Food Additives and Nutrient Sources added to food (ANS)
Question number: EFSA-Q-2005-129 , EFSA-Q-2006-260 , EFSA-Q-2005-215 , EFSA-Q-2005-101 , EFSA-Q-2006-253 , EFSA-Q-2006-294 , EFSA-Q-2005-109 , EFSA-Q-2006-282 , EFSA-Q-2006-283 , EFSA-Q-2006-284 , EFSA-Q-2006-285 , EFSA-Q-2006-305 , EFSA-Q-2006-254 , EFSA-Q-2005-161 , EFSA-Q-2006-259Adopted: 27 November 2008
Summary (26 KB)
Opinion (125 KB)
Summary
Following a request from the European Commission to the European Food Safety Authority (EFSA), the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion on the safety of magnesium aspartate, potassium aspartate, magnesium potassium aspartate, calcium aspartate, zinc aspartate, and copper aspartate added for nutritional purposes as sources of magnesium, potassium, calcium, zinc and copper in food supplements and on the bioavailability of magnesium, potassium, calcium, zinc and copper from these sources.
The present opinion deals only with the safety of magnesium aspartate, potassium aspartate, magnesium potassium aspartate, calcium aspartate, zinc aspartate, and copper aspartate as sources for magnesium, potassium, calcium, zinc, and copper, and with the bioavailability of the nutrient cations from these sources. The safety of magnesium, calcium, zinc, potassium and copper themselves, in terms of amounts that may be consumed, is outside the remit of this Panel.
The information on bioavailability provided to the Panel from the sourcess considered in this opinion allows one to conclude that calcium, magnesium, potassium and copper are bioavailable from these sources, with the exception of magnesium aspartate complex. In view of the reported information on the insolubility of the magnesium aspartate complex, the Panel could not consider the magnesium aspartate complex as bioavailable and thus could not evaluate exposure to aspartate arising from its consumption as a food supplement. In the case of zinc aspartate it is assumed that its reported solubility in diluted hydrochloric acid will allow its dissociation and absorption in the stomach. However, it was not clear to the Panel if further absorption could take place in the intestine considering its reported insolubility in water.
The Panel considers that the individual or combined use of zinc and copper aspartates as sources of zinc and copper, at the proposed use levels, are not of safety concern. However, the individual use of calcium, magnesium and potassium aspartates as food supplements, at the proposed use levels, could be of safety concern because the margins of safety towards a no observable adverse effect level (NOAEL) from a 90-day rat study are considered too low.
Furthermore, based on the cumulative exposure estimates arising from use of a multi-mineral combination, the Panel considers that the proposed use levels could be of safety concern given that the margin of safety between the estimated exposure and the NOAEL in the 90-day rat study is too low. Furthermore the estimated exposure would be above the levels reported to induce amino acid imbalance in intervention trials, taking into consideration aspartate exposure from the diet.
The Panel notes that according to Commission Regulation (EC) No 629/2008 the maximum levels of lead, mercury and cadmium in food supplements as sold should be 3 mg/kg, 0.1 mg/kg and 1 mg/kg, respectively.
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