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Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Komagataella phaffii strain DSM 34125

Efsa Journal. European Food Safety Authority +

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July 15, 2025

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July 15, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

This study assessed a food enzyme, triacylglycerol lipase, produced using genetically modified yeast. The enzyme showed no safety concerns for use in food manufacturing, with low allergy risk.

Area Of Science

  • Food Science
  • Biotechnology
  • Enzymology

Background

  • Triacylglycerol lipase (EC 3.1.1.3) is a food enzyme produced by the genetically modified Komagataella phaffii strain DSM 34125.
  • The production organism's genetic modifications were evaluated and found to pose no safety concerns.

Purpose Of The Study

  • To evaluate the safety of the food enzyme triacylglycerol lipase for use in food manufacturing.
  • To assess potential risks associated with dietary exposure to the enzyme.

Main Methods

  • Assessment of genetic modifications in the production strain.
  • Evaluation of the manufacturing process for contaminants (viable cells, DNA).
  • Estimation of dietary exposure levels and assessment of allergenic potential.

Main Results

  • The food enzyme was free from viable production cells and DNA.
  • Estimated dietary exposure was up to 0.039 mg TOS/kg bw/day.
  • No homology was found between the enzyme's amino acid sequence and known allergens, indicating a low risk of allergic reactions.

Conclusions

  • The food enzyme triacylglycerol lipase does not raise safety concerns under the intended conditions of use.
  • The manufacturing process and lack of allergenic homology support the enzyme's safety profile.
  • Further toxicity testing was deemed unnecessary based on the qualified presumption of safety of the production strain.

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