Risk Assessment Paradigm for Glutamate

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 eve...

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Bibliographic Details
Published in:Annals of nutrition and metabolism 2018-01, Vol.73 (Suppl 5), p.53-64
Main Authors: Roberts, Ashley, Lynch, Barry, Rietjens, Ivonne M.C.M.
Format: Article
Language:English
Subjects:
Acceptable daily intake
Amino acids
Animals
Body weight
Breast
Breast feeding
Diet
Dietary intake
Dosage
Food Additives - administration & dosage
Food Additives - toxicity
Food intake
Food safety
Glutamate
Glutamic acid
Glutamic Acid - administration & dosage
Glutamic Acid - toxicity
Health risk assessment
Histopathology
Humans
Infants
Macronutrient
Mice
No-Observed-Adverse-Effect Level
Rats
Regulatory agencies
Review
Review Article
Risk Assessment
Safety
Safety and security measures
Salts
Toxicity
Toxicokinetics
Uncertainty
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Summary: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.
ISSN:0250-6807
1421-9697
DOI:10.1159/000494783