EFSA’s Food Additives and Nutrient Sources added to Food (ANS) panel looked at the safety of TMDC following an application from German firm RDA Scientific Consultants on behalf of an unnamed client.
TMDC is a magnesium salt of citric acid, which breaks down into magnesium and citrate ions after it is eaten.
How much is too much?
In its opinion the ANS panel said there were no safety concerns under proposed typical use levels of TMDC as a stabiliser and anti-caking agent in food supplements.
When consumed at these levels, it was likely magnesium intakes would still fall below the tolerable upper level (UL) of 250 mg/day for added magnesium.
However looking at the “worst case scenario” of maximum intakes of TMDC, magnesium intake would be 311 mg per day for the elderly and 389 mg per day for younger adults.
In both cases this is above the UL and close to the lowest-observed-adverse-effect level (LOAEL) of 360–365 mg of magnesium per day set by EFSA’s predecessor the Scientific Committee for Food (SCF).
Levels above this were linked to mild diarrhoea in some adults.
Recommendation to risk managers
All additives must be approved as safe before being used in foods and food supplements in the EU.
Under these EU rules, in July 2015 the European Commission asked EFSA to look at the TMDC application.
In its recommendations, the EFSA panel wrote:“In the case of TMDC being used as a food additive in food supplements containing a source of magnesium, the total amount of magnesium that could be consumed at a single eating occasion should be below the UL of 250 mg/day.
“Therefore, risk managers may wish to consider whether consumption advice and recommended maximum daily dose of the TMDC being used as a food additive in food supplements should be provided to the consumers.”
Managing director of RDA Scientific Consultants Marion Gebhart told us EFSA's systematic approach of taking into account exposure from all sources was "justified".
She said she did not think EFSA's points on maximum intakes would present an obstacle on the road to approval.