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Safety evaluation of an extension of use of the food enzyme pectinesterase from the genetically modified Trichoderma reesei strain RF6201

Efsa Journal. European Food Safety Authority +

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May 13, 2025

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May 13, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

The food enzyme pectinesterase, produced by genetically modified Trichoderma reesei, is safe for expanded use in seven food processes. New evaluations confirm no safety concerns for consumers, with a high margin of exposure.

Area Of Science

  • Food enzyme safety assessment
  • Genetically modified microorganisms in food production
  • Toxicology and risk assessment

Background

  • Pectinesterase (EC 3.1.1.11) is a food enzyme produced using the genetically modified Trichoderma reesei strain RF6201.
  • Previous safety evaluations by EFSA concluded no safety concerns for five intended food manufacturing processes.

Purpose Of The Study

  • To update the safety evaluation of pectinesterase for an expanded use in a total of seven food manufacturing processes.
  • To assess the safety of pectinesterase under revised intended conditions of use based on new data.

Main Methods

  • Dietary exposure estimation for pectinesterase-total organic solids (TOS) in four specific food manufacturing processes.
  • Calculation of the margin of exposure (MOE) by comparing estimated dietary exposure to the previously established no observed adverse effect level (NOAEL).

Main Results

  • Estimated dietary exposure to pectinesterase-TOS was up to 0.488 mg TOS/kg body weight per day in European populations.
  • A margin of exposure of at least 2049 was derived, based on the NOAEL of 1000 mg TOS/kg body weight per day.
  • The updated safety evaluation incorporated new data and confirmed previous findings.

Conclusions

  • The food enzyme pectinesterase does not give rise to safety concerns under the revised intended conditions of use.
  • The expanded use of pectinesterase in seven food manufacturing processes is considered safe for consumers.
  • The updated risk assessment supports the continued safe use of this food enzyme.

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