Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to Calcium ascorbate with a content of threonate for use as a source of vitamin C in food supplements

doi:10.2903/j.efsa.2007.491
  EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC) Panel Members Fernando Aguilar, Herman Autrup, Sue Barlow, Laurence Castle, Riccardo Crebelli, Wolfgang Dekant, Karl-Heinz Engel, Natalie Gontard, David Gott, Sandro Grilli, Rainer Gürtler, John Chr. Larsen, Catherine Leclercq, Jean-Charles Leblanc, F. Xavier Malcata, Wim Mennes, Maria Rosaria Milana, Iona Pratt, Ivonne Rietjens, Paul Tobback, Fidel Toldrá.
Type: Opinion of the Scientific Committee/Scientific Panel Question number: EFSA-Q-2005-044 Adopted: 17 April 2007 Published: 29 May 2007 Last updated: 29 May 2007. This version replaces the previous one/s.
Abstract

No abstract available

Summary

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked to advice on the safety and bioavailability of the substance calcium ascorbate with a content of threonate, when used as a source of vitamin C in food supplements.

 
The present opinion deals only with the safety and bioavailability of the particular source of vitamin C, calcium ascorbate with a content of threonate, to be used as a nutritional substance in food supplements. The safety of vitamin C itself, in terms of the amounts that may be consumed, is outside the remit of this Panel and has previously been evaluated by EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies and by the Scientific Committee for Food (SCF).
 
Calcium ascorbate with a content of threonate is a product consisting of the calcium salt of L-ascorbic acid (vitamin C) and less than 2% of L-threonic acid along with calcium carbonate and water.
 
The bioavailability of vitamin C from calcium ascorbate with a content of threonate is comparable to that of ascorbic acid.
 
The toxicity studies and mutagenicity tests with calcium ascorbate with a content of threonate, with calcium threonate or L-threonic acid, hemicalcium salt indicate that the compounds are of low toxicity and are not mutagenic. Data on carcinogenicity, long-term studies, reproductive and developmental toxicity of calcium ascorbate with a content of threonate were not presented. Such toxicity studies are not needed in the light of the dissociation of calcium ascorbate with a content of threonate to substances which are physiologically present in the body (ascorbate, threonate, calcium) and considering that the safety of ascorbic acid (and its calcium and sodium salts), and calcium was previously evaluated.
 
The intended conditions of use of calcium ascorbate with a content of threonate correspond to those of other approved sources of vitamin C. The additional exposure to calcium and threonate through use of supplements with calcium ascorbate with a content of threonate does not represent a cause of safety concern.
 
The Panel noted that threonate is a normal metabolite in the body and concluded that the use of calcium ascorbate containing up to 2% threonate as a source of vitamin C in food supplements is not of safety concern.
Keywords

Calcium ascorbate with a content of threonate; Calcium ascorbate; calcium threonate; calcium ascorbate/threonate, vitamin C, L-ascorbic acid, L-threonic acid, CAS Registry Number. 5743-28-2