Re‐evaluation of glutamic acid (E 620), sodium glutamate (E 621), potassium glutamate (E 622), calcium glutamate (E 623), ammonium glutamate (E 624) and magnesium glutamate (E 625) as food additives

Abstract

The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of glutamic acid-glutamates (E 620-625) when used as food additives. Glutamate is absorbed in the intestine and it is presystemically metabolised in the gut wall. No adverse effects were observed in the available short-term, subchronic, chronic, reproductive and developmental studies. The only effect observed was increased kidney weight and increased spleen weight; however, the increase in organ weight was not accompanied by adverse histopathological findings and, therefore, the increase in organ weight was not considered as an adverse effect. The Panel considered that glutamic acid-glutamates (E 620-625) did not raise concern with regards to genotoxicity. From a neurodevelopmental toxicity study, a no observed adverse effect level (NOAEL) of 3,200 mg monosodium glutamate/kg body weight (bw) per day could be identified. The Panel assessed the suitability of human data to be used for the derivation of a health-based guidance value. Although effects on humans were identified human data were not suitable due to the lack of dose-response data from which a dose without effect could be identified. Based on the NOAEL of 3,200 mg monosodium glutamate/kg bw per day from the neurodevelopmental toxicity study and applying the default uncertainty factor of 100, the Panel derived a group acceptable daily intake (ADI) of 30 mg/kg bw per day, expressed as glutamic acid, for glutamic acid and glutamates (E 620-625). The Panel noted that the exposure to glutamic acid and glutamates (E 620-625) exceeded not only the proposed ADI, but also doses associated with adverse effects in humans for some population groups.

Review of Glutamate Intake from Both Food Additive and Non-Additive Sources in the European Union

“…Sources of uncertainty identified in the 2017 EFSA ANS Opinion on glutamic acid-glutamates (E620-E625) as food additives [1] will cause similar uncertainties in the present assessment. In particular, the distinction between glutamate naturally present in food, added as a food ad- ditive or present as a nutrient cannot be made using analytical data alone.…”

“…When data on use levels from Appendix E of the ANS Opinion on glutamates [1] were entered into the model average population intakes ranged from 2 mg/kg bw/day (elderly adults in Denmark) to 37 mg/kg bw/day (toddlers in Belgium; Table 5) and high-level intakes ranged up to 82 mg/kg bw/day for toddlers in the UK. Because they are based on the same use levels, the results are very similar to those provided in the ANS Opinion for the non-brand-loyal scenario (Table 6), although different exposure methodologies were applied.…”

“…Data on levels of glutamic acid and glutamates (E620-E625) were taken from Appendix E (concentration levels of glutamic acid-glutamates (E620-E625) used in the exposure scenarios) of the EFSA ANS Opinion [1] re-evaluating the safety of glutamic acidglutamates. The data-set included all food categories where glutamic acid-glutamates (E620-E625) are authorized and where data were available.…”

“…Total free glutamate intake estimates were based on E620-E625 use levels from Appendix E of the ANS Opinion [1] and natural free glutamate levels combined. Average population intakes ranged from 11 mg/kg bw/ day (Danish elderly) to 74 mg/kg bw/day (toddlers in Belgium; Table 7) and high-level intakes ranged to over 110 mg/kg bw/day for toddlers in Bulgaria and other children in Belgium.…”

“…In 2017, the EFSA Panel on Food Additives and Nutrient Sources (ANS) added to Food published a scientific Opinion re-evaluating the safety of glutamic acid-glutamates (E620-E625) when used as food additives [1]. The Opinion concluded that exposure to glutamic acid and glutamates (E620-E625) exceeded not only the proposed accepted daily intake (ADI) (30 mg/kg bw/day), but also doses associated with adverse effects in humans for some population groups.…”