Our Verdict: SAFE

Protease From Aspergillus Niger

E-numberE1101CAS977031-92-7

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Protease From Aspergillus Niger — food additive

Protease from Aspergillus niger is an enzyme derived from a common fungal species that breaks down proteins in food. It is used as a flavor enhancer, processing aid, and texturizing agent in various food applications.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Protease From Aspergillus Niger?

Protease from Aspergillus niger is an enzyme produced by fermentation of the fungus Aspergillus niger. Proteases are a class of enzymes that catalyze the breakdown of proteins into smaller peptides and amino acids. This particular enzyme preparation is used in food manufacturing to modify protein structures, enhance flavors, and improve texture and appearance of food products.

Aspergillus niger is a non-pathogenic fungus generally recognized as safe for industrial enzyme production. The enzyme itself is a protein that performs specific catalytic functions during food processing.

Common Uses

Protease from Aspergillus niger serves multiple functions in food manufacturing:

**Flavor Enhancement**: The enzyme breaks down proteins into amino acids and small peptides, which contribute to savory, umami flavors in soups, broths, sauces, and seasoning preparations.

**Baking Applications**: In bread production, this protease helps break down gluten and other proteins, improving dough extensibility and bread crumb structure. It can enhance softness and volume.

**Meat Processing**: Used in meat tenderization and curing processes to break down muscle proteins, improving texture and mouthfeel.

**Cheese Production**: Helps accelerate flavor development and modify curd texture during cheese making.

**Beverage Production**: May be used in beer and other beverages to modify protein content and clarity.

**Stabilization**: Functions as a processing aid to achieve desired texture and consistency in various food matrices.

Safety Assessment

Protease from Aspergillus niger has a substantial history of safe use in food manufacturing. Key safety considerations include:

**Enzyme Inactivation**: During food processing—particularly heating during baking, cooking, or pasteurization—proteases are denatured and rendered inactive. The final food product typically contains no active enzyme, only its effects on protein structure.

**Protein Nature**: As a protein enzyme, protease from Aspergillus niger would be digested like other dietary proteins if any active enzyme were consumed, breaking down into amino acids in the digestive tract.

**Source Organism Safety**: Aspergillus niger is not known to produce mycotoxins at the levels used in food production and is widely used in industrial enzyme manufacturing under controlled fermentation conditions.

**FDA Database**: The FDA GRAS (Generally Recognized As Safe) database does not include a formal determination for this specific enzyme, though proteases from various sources are approved for food use. No adverse events or recalls associated with this ingredient have been reported to the FDA.

**Historical Use**: Protease enzymes derived from Aspergillus species have been used in food manufacturing for decades without documented safety concerns.

Regulatory Status

Protease from Aspergillus niger is not on the FDA's formal GRAS list, meaning it has not received an official safety affirmation through the GRAS notification process. However, this does not indicate a safety concern; rather, it reflects that manufacturers may use enzyme preparations under FDA regulations for food additives or processing aids without formal GRAS status.

In the European Union, enzymes including proteases from Aspergillus niger are regulated under EC Regulation 1332/2008 and evaluated by the European Food Safety Authority (EFSA). Similar enzymes from this source have received regulatory approval in multiple countries.

Manufacturers using this enzyme must ensure proper documentation, quality controls, and compliance with country-specific food additive regulations.

Key Studies

While specific published studies on protease from Aspergillus niger are limited in public literature, the enzyme class is well-documented:

- EFSA assessments of protease enzymes from Aspergillus species confirm safety when used as food processing aids

- Historical safety data from decades of industrial use supports the safety profile

- Protein digestibility and inactivation during food processing are well-established scientific principles

- Aspergillus niger fermentation processes are established and monitored for safety in enzyme manufacturing

Frequently Asked Questions

What is Protease From Aspergillus Niger?

Protease from Aspergillus niger is an enzyme derived from a common fungal species that breaks down proteins in food. It is used as a flavor enhancer, processing aid, and texturizing agent in various food applications.

Is Protease From Aspergillus Niger safe?

Protease From Aspergillus Niger is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Protease From Aspergillus Niger banned in any country?

Protease From Aspergillus Niger is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.