Safety of trimagnesium dicitrate anhydrous (TMDC) to be used as a food additive in food supplements in solid and chewable forms

Abstract The present scientific opinion deals with the safety of trimagnesium dicitrate anhydrous (TMDC) when used as a stabiliser and anticaking agent in food supplements in solid and chewable forms. TMDC is a magnesium salt of citric acid in the anhydrous form. Following oral ingestion, TMDC is expected to fully and readily dissociate into magnesium and citrate ions. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the ‘Guidance for submission for food additive evaluations’; however, this was considered to be justified by the Panel given that both magnesium and citrate are natural constituents of the diet and also the human body. Exposure estimates to TMDC from its proposed use were calculated for both typical and maximum use levels alongside the resulting intake of magnesium and citrate. At the proposed typical level, the intake of magnesium resulting from the use of TMDC would be below the tolerable upper level (UL) of 250 mg/day for supplemental magnesium. In the worst case scenario of high‐level intakes of TMDC when used at the maximum proposed use level of 120,000 mg/kg, the maximum estimated intake of magnesium would be 311 mg/day per day in the elderly and 389 mg/day in adults, in both cases above the UL. The Panel noted that the intake of both magnesium and citrate resulting from the proposed use and use levels of TMDC appears to be within the normal dietary intake in the general population. The Panel concluded that there was no safety concern from the proposed typical use levels of TMDC as a stabiliser and anticaking agent in food supplements, whereas at the proposed maximum use levels, the resulting exposure to magnesium in adults and the elderly at the high‐level would be above the UL.