Safety evaluation of the food enzyme fructan β-fructosidase from the genetically modified Trichoderma reesei strain AR-577

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Summary

This summary is machine-generated.

The food enzyme fructan β-fructosidase, produced using genetically modified Trichoderma reesei, is safe for use in cereal processing. Safety assessments, including toxicity and allergenicity studies, confirm no safety concerns for consumers.

Area Of Science

  • Food Science and Technology
  • Biotechnology
  • Enzymology

Background

  • Fructan β-fructosidase (EC 3.2.1.80) is a food enzyme produced by genetically modified Trichoderma reesei AR-577.
  • The enzyme is intended for use in processing cereals and grains for baked and non-baked products.

Purpose Of The Study

  • To assess the safety of fructan β-fructosidase for use in food production.
  • To evaluate potential risks associated with dietary exposure to the food enzyme.

Main Methods

  • Genotoxicity testing was performed.
  • A 90-day oral toxicity study in rats was conducted.
  • Allergenicity assessment involved homology searches and consideration of manufacturing processes.

Main Results

  • Genotoxicity tests showed no safety concerns.
  • The no observed adverse effect level (NOAEL) was determined to be 1000 mg TOS/kg bw/day, yielding a margin of exposure of at least 5495.
  • No homology to known allergens was found, and the risk of allergic reactions was considered low.

Conclusions

  • The food enzyme fructan β-fructosidase does not raise safety concerns under the intended conditions of use.
  • The manufacturing process ensures the enzyme is free from viable cells and DNA of the production organism.
  • While the risk of allergic reactions is low, it cannot be entirely excluded due to the use of an allergen-source material in manufacturing.