Our Verdict: SAFE

Protease From Bacillus Licheniformis

E-numberE1101CAS977165-99-3

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 Bacillus Licheniformis — food additive

Protease from Bacillus licheniformis is an enzyme derived from a naturally occurring bacterium that breaks down proteins in food. It is used as a flavor enhancer, processing aid, and stabilizer in various food applications to improve texture and taste.

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 Bacillus Licheniformis?

Protease from Bacillus licheniformis is an enzymatic protein derived from the bacterium Bacillus licheniformis. This enzyme catalyzes the hydrolysis of peptide bonds in proteins, breaking them down into smaller peptides and amino acids. The enzyme is produced through fermentation of the bacterium under controlled conditions and is subsequently purified for use as a food additive.

Bacillus licheniformis is a gram-positive, rod-shaped bacterium commonly found in soil and vegetation. The protease it produces has been studied extensively in biotechnology and food science applications due to its stability and enzymatic efficiency across various pH and temperature ranges.

Common Uses

Protease from Bacillus licheniformis is utilized in the food industry primarily as:

- **Flavor enhancer**: The enzyme generates free amino acids and peptides that contribute to savory, umami flavors in processed foods

- **Processing aid**: It assists in protein modification during food manufacturing, improving consistency and texture

- **Stabilizer or thickener**: Protein hydrolysis can affect the viscosity and stability of food products

- **Enzyme in food production**: It may be used in meat tenderization, cheese making, and preparation of hydrolyzed protein products

Common applications include processed meats, sauces, broths, plant-based protein products, and other foods where protein modification enhances sensory qualities or manufacturing efficiency.

Safety Assessment

Protease from Bacillus licheniformis has been used in food production for several decades with an established history of safe use. The enzyme operates through well-understood biological mechanisms: it hydrolyzes proteins into smaller components that are normal constituents of food.

Key safety considerations include:

- **No reported adverse events**: The FDA has recorded zero adverse events associated with this additive

- **No recalls**: There are no documented FDA recalls involving this ingredient

- **Enzyme inactivation**: Proteases are proteins themselves and are denatured by cooking temperatures typically used in food processing, reducing persistence in final products

- **Allergenic potential**: As with any protein-derived ingredient, theoretical allergenic risk exists, though documented cases are extremely rare

The enzyme is similar to other proteases used in food manufacturing (such as papain from papaya or bromelain from pineapple) that have long histories of safe consumption.

Regulatory Status

Protease from Bacillus licheniformis is **not designated as GRAS (Generally Recognized as Safe)** by the FDA, meaning it has not gone through the formal GRAS notification process. However, this status does not indicate safety concerns; rather, it reflects that formal GRAS documentation has not been submitted or finalized.

The enzyme may be used in food under FDA regulations governing food additives and processing aids when appropriate. Individual jurisdictions may have different regulatory frameworks. The European Union maintains separate regulatory pathways for enzyme additives, and approval status may vary by region.

Manufacturers using this enzyme must comply with FDA labeling requirements and food additive regulations specific to their intended applications.

Key Studies

Research on Bacillus licheniformis protease includes:

- **Biotechnology literature**: Extensive studies document the enzyme's kinetic properties, optimal activity conditions, and industrial applications

- **Food science applications**: Research demonstrates effectiveness in protein hydrolysis and flavor development in processed foods

- **Microbiology**: Studies confirm Bacillus licheniformis is not pathogenic and poses no inherent safety risk

- **Enzyme characterization**: Scientific literature characterizes the protease's specificity, stability, and behavior under various conditions

The absence of documented adverse events in FDA databases and the enzyme's long history in industrial food processing suggest a favorable safety profile, though formal GRAS status would provide additional regulatory clarity.

Frequently Asked Questions

What is Protease From Bacillus Licheniformis?

Protease from Bacillus licheniformis is an enzyme derived from a naturally occurring bacterium that breaks down proteins in food. It is used as a flavor enhancer, processing aid, and stabilizer in various food applications to improve texture and taste.

Is Protease From Bacillus Licheniformis safe?

Protease From Bacillus Licheniformis 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 Bacillus Licheniformis banned in any country?

Protease From Bacillus Licheniformis 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.