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Safety evaluation of the food enzyme protein-glutamine γ-glutamyltransferase from the non-genetically modified Streptomyces mobaraensis strain AE-BTG

Efsa Journal. European Food Safety Authority +

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December 4, 2024

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December 4, 2024

View abstract on PubMed

Summary

This summary is machine-generated.

The food enzyme protein-glutamine γ-glutamyltransferase is safe for use in food manufacturing, with no genotoxicity or systemic toxicity concerns identified. However, potential allergic reactions cannot be ruled out due to manufacturing processes.

Area Of Science

  • Food Science
  • Enzymology
  • Toxicology

Background

  • Protein-glutamine γ-glutamyltransferase (EC 2.3.2.13) is a food enzyme produced by *S. mobaraensis* AE-BTG.
  • The enzyme is intended for use in nine food manufacturing processes.
  • The production organism's viable cells were absent in the final food enzyme product.

Purpose Of The Study

  • To assess the safety of protein-glutamine γ-glutamyltransferase for use in food manufacturing.
  • To evaluate potential risks associated with dietary exposure to the food enzyme.
  • To determine the toxicological profile and allergenic potential of the enzyme.

Main Methods

  • Estimation of dietary exposure to the food enzyme's total organic solids (TOS).
  • Genotoxicity testing to evaluate DNA damage potential.
  • A 90-day repeated dose oral toxicity study in rats.
  • Amino acid sequence homology search for known allergens.

Main Results

  • Estimated dietary exposure was up to 0.398 mg TOS/kg body weight (bw) per day.
  • Genotoxicity tests showed no safety concerns.
  • A no observed adverse effect level (NOAEL) of 538 mg TOS/kg bw per day was established in rats, yielding a margin of exposure of at least 1351.
  • No homology to known allergens was found, but the risk of allergic reactions could not be excluded due to manufacturing ingredients.

Conclusions

  • The food enzyme protein-glutamine γ-glutamyltransferase does not present safety concerns regarding genotoxicity or systemic toxicity under intended use.
  • A significant margin of exposure was calculated, indicating a low risk from toxicity.
  • While no direct allergenic match was found, the potential for allergic reactions remains a consideration.

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