Risk Assessment Paradigm for Glutamate
- PMID: 30508819
- PMCID: PMC6518862
- DOI: 10.1159/000494783
Risk Assessment Paradigm for Glutamate
Abstract
Background: Re-evaluation of the use of glutamic acid and glutamate salts (referred to as glutamate hereafter) by the European Food Safety Authority (EFSA) proposed a group acceptable daily intake (ADI) of 30 mg/kg body weight (bw)/day.
Summary: This ADI is below the normal dietary intake, while even intake of free glutamate by breast-fed babies can be above this ADI. In addition, the pre-natal developmental toxicity study selected by EFSA, has never been used by regulatory authorities worldwide for the safety assessment of glutamate despite it being available for nearly 40 years. Also, the EFSA ignored that toxicokinetic data provide support for eliminating the use of an uncertainty factor for interspecies differences in kinetics. Key Messages: A 3-generation reproductive toxicity study in mice that includes extensive brain histopathology, provides a better point of departure showing no effects up to the highest dose tested of 6,000 mg/kg bw/day. Furthermore, kinetic data support use of a compound-specific uncertainty factor of 25 instead of 100. Thus, an ADI of at least 240 mg/kg bw/day would be indicated. In fact, there is no compelling evidence to indicate that the previous ADI of "not specified" warrants any change.
Keywords: Acceptable daily intake; Glutamate; Macronutrient; Risk assessment.
© 2018 The Author(s) Published by S. Karger AG, Basel.
References
-
- WHO: Principles for the Safety Assessment of Food Additives and Contaminants in Food World Health Organization (WHO)/International Programme on Chemical Safety (IPCS)/United Nations Environment Programme (UNEP) Environmental Health Criteria. 1987;70 http://www.inchem.org/documents/ehc/ehc/ehc70.htm.
-
- EFSA: Scientific Opinion on the re-evaluation of glutamic acid (E 620), sodium glutamate (E 621), potassium glutamate (E622), calcium glutamate (E 623), ammonium glutamate (E 624), and magnesium glutamate (E 625) as food additives (EFSA Panel on Food Additives and Nutrient Sources added to Food/ANS) (Question no EFSA-Q-2011-00577, EFSA-Q-2011-00578, EFSA-Q-2011-00579, EFSA-Q-2011-00580, EFSA-Q-2011-00581, EFSA-Q-2011-0582, adopted: 21 June 2017) EFSA J. 2017;15:4910. https://www.efsa.europa.eu/en/efsajournal/pub/4910.
-
- Vorhees CV, Butcher RE, Brunner RL, Sobotka TJ. A developmental test battery for neurobehavioral toxicity in rats: a preliminary analysis using MSG calcium carrageenan, and hydroxyurea. Toxicol Appl Pharmacol. 1979;50:267–282. - PubMed
-
- SCF: Reports of the Scientific Committee for Food. Twenty-fifth series. First series of food additives of various technological functions Opinion expressed on 18 May 1990. Published by the Commission of The European Communities Directorate-General Telecommunications, Information Industries and Innovation L-2920 Luxembourg. EUR 13416. 1991 Available at: http://aei.pitt.edu/40834/1/25th_food.pdf.
-
- JECFA: Miscellaneous food additives L-Glutamic acid and its ammonium, calcium, magnesium, monosodium, and potassium salts; in JECFA: Evaluation of Certain Food Additives and Contaminants. Geneva, 31st Meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), February 16–25, 1987. World Health Organization (WHO), Food and Agriculture Organization of the United Nations (FAO) WHO Technical Report Series. 1987;759:29–31. http://whqlibdoc.who.int/trs/WHO_TRS_759.pdf.
