Safety evaluation of an extension of use of the food enzyme oryzin from the non-genetically modified Aspergillus ochraceus strain AE-P
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Summary
This summary is machine-generated.The food enzyme orzyin, produced by Aspergillus ochraceus, is safe for expanded use in food manufacturing. Updated safety evaluations confirm no concerns at revised usage levels, ensuring consumer protection.
Area Of Science
- Food enzyme safety assessment
- Microbiology
- Toxicology
Background
- Oryzin (EC 3.4.21.63) is a food enzyme derived from Aspergillus ochraceus.
- Previous safety evaluations by EFSA found no safety concerns for nine food manufacturing processes.
- The applicant sought to extend its use to an additional process, withdraw two, and revise usage levels.
Purpose Of The Study
- To update the safety evaluation of the food enzyme orzyin.
- To assess the safety of orzyin under revised intended conditions of use.
- To evaluate expanded applications in eight food manufacturing processes.
Main Methods
- Dietary exposure assessment for orzyin-total organic solids (TOS).
- Calculation of margin of exposure (MOE) using established no observed adverse effect levels (NOAEL).
- Review of previous safety data and updated usage information.
Main Results
- Estimated dietary exposure to orzyin-TOS is up to 0.354 mg TOS/kg body weight per day.
- A margin of exposure (MOE) of at least 5260 was derived.
- The NOAEL from the previous evaluation was 1862 mg TOS/kg body weight per day.
Conclusions
- The food enzyme orzyin does not give rise to safety concerns under the revised intended conditions of use.
- Updated safety evaluation supports the expanded application of orzyin in food manufacturing.
- EFSA's assessment confirms the safety of orzyin for consumers.
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