EFSA cannot approve calcium form in supplements
After a request from the European Commission, EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS) found insufficient data to determine the safety of the nutrient at typical doses across the 27-member state EU bloc.
The ANS stated: “The petitioner selected sodium phosphinate as reference substance, but only reported data on the acute toxicity in rats and mice. Further toxicity data on phosphinate were not provided. The Panel concludes that due to the lack of toxicological data on phosphinate, the safety of calcium phosphinate as a source of calcium cannot be assessed.”
The petioner was German company, Honeywell Specialty Chemicals Seelze GmbH, which submitted its dossier in July, 2005.
The verdict means the nutrient cannot be added to the EU Food Supplemnts Directive positive list of nutrient s that can be used in food supplements across the EU.
“The present opinion deals only with the safety of calcium phosphinate as a source of calcium and the bioavailability of calcium from this source,” ANS stated. “The safety of calcium itself, in terms of amounts that may be consumed, is outside the remit of this Panel. Calcium phosphinate should be used according to the petitioner as a mineral supplement in a liquid and a solid form for oral administration.”
It noted bioavailability was likely to be similar to other soluble sources.
“Based on the proposed daily supplementation of up to 2500mg/day for the use of calcium phosphinate in liquid and solid form, the Panel calculated an exposure to 589mg calcium/day and 1911mg phosphinate/day, the latter corresponding to 32mg phosphinate/kg body weight/day for a 60 kg person,” ANS added.
Calcium ascorbate, magnesium ascorbate and zinc ascorbate were all deemed safe by EFSA recently.
