Our Verdict: SAFE

Lipase From Aspergillus Oryzae

E-numberE1104CAS977031-68-7

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

Lipase From Aspergillus Oryzae — food additive

Lipase from Aspergillus oryzae is an enzyme derived from a food-grade fungus that breaks down fats during food processing. It functions as a processing aid to improve flavor development, texture, and quality in various food products.

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
Not EvaluatedUK FSA
Canada
Not EvaluatedHealth Canada
Australia
Not EvaluatedFSANZ
Japan
Not EvaluatedMHLW
South Korea
Not EvaluatedMFDS
Brazil
Not EvaluatedANVISA
China
Not EvaluatedNHC / GB 2760
India
Not EvaluatedFSSAI
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 Lipase From Aspergillus Oryzae?

Lipase from Aspergillus oryzae is an enzyme produced by fermentation of the fungus Aspergillus oryzae, a microorganism with a long history of safe use in food fermentation. Lipases are enzymes that catalyze the breakdown of lipids (fats and oils) into fatty acids and glycerol. This fungal lipase is used as a processing aid and enzyme in food manufacturing, where it facilitates the hydrolysis of fats to enhance flavor compounds and improve product characteristics.

Common Uses

Lipase from Aspergillus oryzae is primarily used in cheese production, where controlled fat breakdown contributes to flavor development and texture. It is also employed in baked goods, dairy products, and other processed foods where lipolysis (fat breakdown) enhances sensory qualities. As a processing aid, the enzyme typically does not appear in final products in significant amounts, as it is either removed during processing or becomes inactive. The enzyme is particularly valued in applications where traditional aging or fermentation would be impractical or time-consuming.

Safety Assessment

The safety profile of lipase from Aspergillus oryzae is supported by the established safety of Aspergillus oryzae itself. This fungus has been used safely in food fermentation for centuries, particularly in Asian food production including miso, soy sauce, and sake. Aspergillus oryzae is not known to produce harmful mycotoxins, and it does not cause disease in immunocompetent individuals.

Enzymes used as processing aids are generally recognized as safe when they are produced from approved microorganisms and properly manufactured. The enzyme itself is a protein, which is broken down during digestion like other dietary proteins. According to FDA guidance, enzymes used in food processing are subject to the same safety requirements as other food additives.

The FDA has received zero adverse events reported in connection with lipase from Aspergillus oryzae, and there are no recorded recalls associated with this ingredient. This indicates a strong safety record in commercial food applications.

Regulatory Status

While lipase from Aspergillus oryzae has not received formal FDA GRAS (Generally Recognized As Safe) status, this does not indicate a safety concern. Many enzymes used in food processing operate under FDA approval as food additives or processing aids without GRAS designation. The ingredient has been used commercially in food applications and has been accepted in various food categories by regulatory authorities in multiple countries.

The European Union permits lipase from Aspergillus oryzae in certain food applications under Regulation (EC) 1332/2008 on food enzymes, demonstrating regulatory acceptance in international food markets. The lack of GRAS status may reflect the enzyme's niche use rather than any identified safety issue.

Key Studies

Limited peer-reviewed literature specifically examines lipase from Aspergillus oryzae in isolation, as research on fungal lipases often focuses on broader enzyme classes or fermentation microbiology. However, the extensive history of Aspergillus oryzae use in traditional and industrial food fermentation provides substantial evidence of its safety profile. Studies on lipase enzymes in general demonstrate their efficacy in controlled fat hydrolysis and their rapid inactivation during food processing.

The absence of adverse event reports and regulatory recalls serves as an indicator of real-world safety in commercial food production where this enzyme has been employed.

Frequently Asked Questions

What is Lipase From Aspergillus Oryzae?

Lipase from Aspergillus oryzae is an enzyme derived from a food-grade fungus that breaks down fats during food processing. It functions as a processing aid to improve flavor development, texture, and quality in various food products.

Is Lipase From Aspergillus Oryzae safe?

Lipase 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 Lipase From Aspergillus Oryzae banned in any country?

Lipase 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.