In a scientific opinion published this week, the group’s Scientific Panel on Food Additives and Nutrient Sources (ANS) found the substance to be a bioavailable form of calcium, and to pose no safety concerns.
The evaluation came at the request of the European Commission, which had received a petition from the UK-based supplement firm Biocalth to consider the addition of calcium L-threonate to Annex II of Directive 2002/46/EC of the European Parliament and of the Council relating to food substances.
The panel noted that threonate is a normal constituent of the body, typically arising from the catabolism of ascorbic acid.
“Human and animal studies indicate that calcium from calcium L-threonate is absorbed. In animal studies, the bioavailability of calcium from this source was comparable to or higher than from other sources of calcium,” states the opinion.
The tolerable upper intake level for calcium from all sources is currently set at 2500mg per day by the Scientific Committee on Food (SCF).
The petitioner proposed use levels of 2-4 tablets per person per day of calcium L-threonate, with each tablet providing 100 mg calcium and 675 mg threonate.
EFSA found that the exposure to calcium through the use and at the use levels of calcium L-threonate proposed by the petitioner, may lead to exposures of 200-400 mg calcium per person per day, which would not represent a safety concern.
EFSA’s panel examined available science on the substance, which found that it has no adverse effects in animal studies at doses as high as 40g/kg bw in mice or 32g/kg bw in rats.
Studies have also shown that L-threonate is not genotoxic, which indicates that no carcinogenicity studies were necessary.
Reproductive and developmental toxicity studies in mice also indicated that calcium L-threonate in doses up to 6 g/kg bw per day has no adverse effect on the fertility and the developing fetus, and did not cause maternal toxicity, said EFSA.
“The Panel concludes that calcium is bioavailable from calcium L-threonate and that the use of calcium L-threonate as a source of calcium in food supplements for the uses and at the use levels proposed by the petitioner is not of safety concern,” it wrote.
Other forms of calcium recently backed by EFSA include calcium sulphate and calcium ascorbate with threonate.
The agency only last month backed an earlier Scientific Committee on Food (SCF) opinion concluding calcium sulphate can be safely used as a calcium source in food supplements.
And last year, it concluded the use of calcium ascorbate with threonate in food supplements is comparable in bioavailability to ascorbic acid as a vitamin C source, and does not pose health threats in the doses used.