Safety evaluation of an extension of use of the food enzyme mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain AE-HCM

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Summary

This summary is machine-generated.

The food enzyme mannan endo-1,4-β-mannosidase, produced by Aspergillus niger, is safe for use in 13 food processes. Dietary exposure estimates show a margin of exposure of at least 1242, indicating no safety concerns.

Area Of Science

  • Food science and technology
  • Enzymology
  • Toxicology

Background

  • Mannan endo-1,4-β-mannosidase (EC 3.2.1.78) from Aspergillus niger strain AE-HCM was previously evaluated for safety.
  • EFSA concluded no safety concerns for its use in three food manufacturing processes.
  • The applicant sought to extend its use to ten additional processes.

Purpose Of The Study

  • To update the safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase.
  • To assess its safety for use in a total of 13 food manufacturing processes.
  • To evaluate potential risks associated with extended use.

Main Methods

  • Dietary exposure assessment for food enzyme-total organic solids (TOS) in 12 processes where TOS are not carried over.
  • Calculation of dietary exposure up to 0.586 mg TOS/kg body weight (bw) per day.
  • Derivation of the margin of exposure (MOE) by comparing exposure levels with the no observed adverse effect level (728 mg TOS/kg bw per day).

Main Results

  • Dietary exposure was estimated to be up to 0.586 mg TOS/kg bw per day.
  • A margin of exposure (MOE) of at least 1242 was derived.
  • The updated evaluation considered new data and previous findings.

Conclusions

  • The food enzyme mannan endo-1,4-β-mannosidase does not give rise to safety concerns.
  • This conclusion applies to the revised intended conditions of use across 13 food manufacturing processes.
  • The updated safety assessment supports the expanded application of the enzyme.