# Protease From Aspergillus Flavus (E1101)

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**Safety rating:** UNKNOWN
**E-number:** E1101
**CAS number:** 977017-31-4
**Category:** flavoring
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-04

## Summary

Protease from Aspergillus flavus is an enzyme derived from the fungus Aspergillus flavus that breaks down proteins in food. It functions as a flavor enhancer, processing aid, and stabilizer in food manufacturing, helping to develop flavors and improve texture in various food products.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | approved |
| Canada | approved |
| Australia | approved |
| Japan | approved |
| South Korea | approved |
| Brazil | approved |
| China | approved |
| India | approved |

## Detailed analysis

## What is Protease From Aspergillus Flavus?

Protease from Aspergillus flavus (CAS Number: 977017-31-4) is an enzyme produced by the fungus Aspergillus flavus. Proteases are naturally occurring enzymes that catalyze the breakdown of proteins into smaller peptides and amino acids. This particular protease is used in food manufacturing as a processing aid and flavoring agent, where it facilitates protein hydrolysis to enhance taste, aroma, and texture development.

## Common Uses

This protease enzyme is employed in various food manufacturing applications:

- **Meat Processing**: Used to tenderize meat products and develop umami flavors through protein breakdown
- **Cheese and Dairy**: Aids in flavor development and texture modification in cheese production
- **Baked Goods**: Assists in dough conditioning and development of complex flavors during fermentation
- **Protein Hydrolysates**: Used to create flavor-enhancing protein hydrolysates for soups, broths, and savory applications
- **Fermented Foods**: Supports flavor development in fermented products like soy sauce and other condiments

As a processing aid, the enzyme performs its function during manufacturing and may be inactivated or removed before the final product reaches consumers.

## Safety Assessment

Protease from Aspergillus flavus has not been formally approved by the FDA as a Generally Recognized As Safe (GRAS) additive. However, the lack of GRAS status does not necessarily indicate a safety concern. The enzyme has generated zero reported adverse events in FDA databases and has been involved in zero product recalls, suggesting it has not caused documented safety issues in the food supply.

Important considerations for enzyme safety include:

- **Protein Degradation**: As an enzyme, protease breaks down proteins but does not alter the fundamental chemical composition of foods in ways that would create new toxins
- **Thermal Inactivation**: Most proteases are inactivated by heat processing, which may occur during or after food manufacturing
- **Allergenic Potential**: While the source organism (Aspergillus flavus) is a common fungus, the purified enzyme product is distinct from the whole organism. Individuals with mold allergies should exercise caution, though sensitization to specific enzymes is rare
- **Enzyme Purity**: Commercial enzyme preparations vary in purity and may contain trace components from the production process

## Regulatory Status

The regulatory landscape for this ingredient varies globally:

- **United States**: Not listed as GRAS; may be used in foods only if approved by FDA or under specific regulatory provisions
- **European Union**: Enzyme use in foods is regulated under EC Regulation 1332/2008. Individual enzymes require assessment and approval for specific food applications
- **Other Jurisdictions**: Japan, Canada, and other countries maintain their own enzyme approval lists

The fact that this protease has not received formal GRAS status in the U.S. may reflect that it is either not commonly used, that approval processes have not been completed, or that it is used only in limited applications.

## Key Studies

Scientific literature on proteases from Aspergillus species demonstrates:

- Proteases from Aspergillus fungi are well-characterized enzymes with known enzymatic properties and mechanisms
- Studies confirm their effectiveness in protein hydrolysis and flavor development in food matrices
- Safety profiles of food-grade enzymes generally show they do not present toxicological concerns when used at typical food processing levels
- No peer-reviewed literature documents adverse health effects from food products containing Aspergillus flavus protease at normal consumption levels

The absence of reported adverse events and recalls in FDA databases aligns with the general safety profile of enzymatic processing aids used in food manufacturing.

## Brands using Protease From Aspergillus Flavus

- Garden of Life (2 products)
- Bloom (1 product)
- Dukes (1 product)
- Terra Kai organics (1 product)
- Triscuit (1 product)
- Wheat Thins (1 product)
- zena greens (1 product)

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Protease From Aspergillus Flavus (E1101) — Safety, regulation, and evidence." https://additivefacts.com/additives/protease-from-aspergillus-flavus. Accessed 2026-05-20.