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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View abstract on PubMed
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.
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