Our Verdict: SAFE

Protease From Aspergillus Oryzae

E-numberE1101CAS977017-33-6

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 Oryzae — food additive

Protease from Aspergillus oryzae is an enzyme derived from the fungus Aspergillus oryzae that breaks down proteins in food. It is used as a flavor enhancer, processing aid, and stabilizer in food manufacturing to improve texture and develop desired tastes.

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 Oryzae?

Protease from Aspergillus oryzae is an enzyme produced by the filamentous fungus Aspergillus oryzae. Proteases are a class of enzymes that catalyze the breakdown of proteins into smaller peptides and amino acids through hydrolysis. This particular enzyme is derived from a microorganism long used in food fermentation, particularly in Asian food production. The enzyme preparation is used in food processing to modify protein structure and enhance flavor development.

Common Uses

Protease from Aspergillus oryzae functions as a processing aid in meat products, dairy applications, and baked goods. In meat processing, it helps tenderize muscle proteins and can improve texture. In cheese and dairy production, it aids in protein hydrolysis during fermentation and aging, contributing to flavor development. The enzyme is also used in brewing and beverage production to clarify products by breaking down proteins that cause cloudiness. Additionally, it serves as a flavor enhancer by generating amino acids and peptides that contribute savory and umami notes to foods. Its stabilizing properties help maintain consistent product texture during shelf storage.

Safety Assessment

Protease from Aspergillus oryzae derives from a microorganism with a long history of safe use in fermented foods, particularly in traditional Japanese food production where Aspergillus oryzae is used to make sake, miso, and soy sauce. The enzyme itself is a protein that is degraded during normal digestive processes. According to FDA records, there have been zero reported adverse events associated with this additive and zero recalls involving its use.

Enzyme preparations used in food processing are generally considered safe when used at appropriate levels because they are inactivated through standard food processing steps such as heating. The protein nature of enzymes means they are subject to denaturation and digestion like any other dietary protein. Enzyme safety assessments typically focus on potential allergenicity and the purity of the enzyme preparation, including absence of microbial contaminants or mycotoxins.

Regulatory Status

Notably, protease from Aspergillus oryzae does not hold FDA GRAS (Generally Recognized As Safe) status. However, the absence of GRAS status does not indicate a safety concern; rather, it reflects regulatory classification decisions. The enzyme may be permitted under other regulatory frameworks or used as a processing aid under FDA regulations that allow certain enzymes in food processing when used in accordance with good manufacturing practices. Enzyme preparations must meet purity specifications and be free from pathogenic microorganisms.

Regulatory approaches to enzyme use vary internationally. Some jurisdictions may classify such enzymes differently or have specific approval processes. Users of this enzyme in food manufacturing should verify current regulatory requirements in their specific markets and ensure compliance with local food additive regulations.

Key Studies

Scientific literature supports the use of fungal proteases in food processing. Research demonstrates that proteases from Aspergillus species effectively hydrolyze food proteins and contribute to flavor compound generation through amino acid and peptide formation. Studies on Aspergillus oryzae itself confirm its long history of safe use and its established role in fermentation food production.

Toxicological data for enzyme preparations derived from Aspergillus oryzae show no significant safety concerns when used as processing aids. The enzyme's protein composition means standard food processing conditions render it biologically inactive. Comprehensive safety reviews of fungal enzyme preparations have not identified specific hazards associated with this class of additives when used appropriately in food manufacturing.

Frequently Asked Questions

What is Protease From Aspergillus Oryzae?

Protease from Aspergillus oryzae is an enzyme derived from the fungus Aspergillus oryzae that breaks down proteins in food. It is used as a flavor enhancer, processing aid, and stabilizer in food manufacturing to improve texture and develop desired tastes.

Is Protease From Aspergillus Oryzae safe?

Protease From Aspergillus Oryzae 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 Oryzae banned in any country?

Protease From Aspergillus Oryzae 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.