Malic acid and its salts: what the regulators concluded
EFSA evaluated malic acid and its sodium, potassium and calcium salts as food additives and set a group acceptable daily intake of 30 mg per kilogram of body weight per day. At the levels used in food, exposure for the general population was well within this figure. A 2024 EFSA call for data signals that a formal re-evaluation of the whole malic acid and malates group is underway, consistent with the rolling EU programme reviewing all permitted additives.
EFSA set a group ADI of 30 mg/kg body weight per day for malic acid and its sodium, potassium and calcium salts (E296, E350, E351, E352), concluding that exposure from food use did not raise a concern for the general population.
2013Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
EFSA issued a call for data on malic acid and malates (E296, E350, E351, E352) as part of the systematic re-evaluation of all EU-permitted food additives, meaning the existing approval is being reviewed but no new adverse signal triggered the process.
2024RegulatoryEFSA call for data on malic acid and malates
Di-calcium malate as a novel food source of calcium
A related compound, di-calcium malate, was assessed separately by EFSA in 2018 as a novel food ingredient and as a supplemental calcium source. EFSA concluded it was not harmful at the proposed use levels. This opinion is distinct from the food additive assessment but reinforces the view that calcium malate compounds do not carry a toxicological signal at realistic intakes.
EFSA evaluated di-calcium malate used as a novel food ingredient and as a calcium source in food supplements, total diet replacement products and foods for special medical purposes, concluding it raised no grounds to restrict it at the proposed use levels.
2018Regulatory reviewEFSA Journal, evaluation of di-calcium malate as a novel food ingredient