Safety evaluation of an extension of use of a food enzyme containing endo-polygalacturonase, pectinesterase, pectin lyase and non-reducing end α-l-arabinofuranosidase activities from the non-genetically modified Aspergillus niger strain PEC

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Summary

This summary is machine-generated.

This food enzyme, produced by Aspergillus niger, has four activities and was found safe for expanded use in seven food processes. The margin of exposure was at least 333, indicating no safety concerns.

Area Of Science

  • Food Science
  • Enzymology
  • Toxicology

Background

  • A food enzyme produced by Aspergillus niger with four declared activities (endo-polygalacturonase, pectinesterase, pectin lyase, and α-l-arabinofuranosidase) was previously evaluated.
  • EFSA concluded in a prior assessment that the enzyme was safe for use in three food manufacturing processes.

Purpose Of The Study

  • To update the safety evaluation of the food enzyme for an expanded use in a total of seven food manufacturing processes.
  • To assess potential risks associated with increased dietary exposure to the enzyme's total organic solids (TOS).

Main Methods

  • Dietary exposure to food enzyme-TOS was estimated for six food manufacturing processes, excluding one where TOS are removed.
  • Calculated dietary exposure levels were compared to the previously established no observed adverse effect level (NOAEL).

Main Results

  • The estimated dietary exposure to food enzyme-TOS was up to 0.612 mg TOS/kg body weight per day in European populations.
  • A margin of exposure (MOE) of at least 333 was derived when comparing the estimated exposure to the NOAEL of 204 mg TOS/kg body weight per day.
  • The enzyme has four declared activities: endo-polygalacturonase (EC 3.2.1.15), pectinesterase (EC 3.1.1.11), pectin lyase (EC 4.2.2.10), and non-reducing end α-l-arabinofuranosidase (EC 3.2.1.55).

Conclusions

  • The updated safety assessment, considering new data and the revised MOE, indicates no safety concerns for the food enzyme under the expanded intended conditions of use.
  • The food enzyme produced by Aspergillus niger strain PEC is safe for use in seven food manufacturing processes.