Our Verdict: SAFE

Diastase From Aspergillus Oryzae

CAS9001-19-8

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

Diastase From Aspergillus Oryzae — food additive

Diastase from Aspergillus oryzae is an enzyme preparation derived from the fungus Aspergillus oryzae that breaks down starches into simpler sugars. It is commonly used in food manufacturing as a processing aid to improve fermentation, enhance flavor development, and increase digestibility in baked goods, beverages, and other processed foods.

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
ApprovedUK FSA
Canada
ApprovedHealth Canada
Australia
ApprovedFSANZ
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 Diastase From Aspergillus Oryzae?

Diastase from Aspergillus oryzae is an enzyme complex produced by the filamentous fungus Aspergillus oryzae. The enzyme preparation contains amylase activity, which catalyzes the breakdown of starch molecules into maltose and glucose. This fungal strain has been used safely in traditional fermentation processes for centuries, particularly in Asian food production. The enzyme is produced through fermentation of Aspergillus oryzae under controlled conditions, then isolated and concentrated for use as a food processing aid.

Common Uses

Diastase from Aspergillus oryzae functions primarily as a processing enzyme in the food industry. Its main applications include:

- **Baking**: Improves dough conditioning and fermentation by converting starches to fermentable sugars, enhancing yeast activity and bread volume

- **Brewing and Fermentation**: Facilitates starch breakdown in beer, sake, and other fermented beverages

- **Grain Processing**: Used in the production of malt and grain-based products

- **Dairy Products**: Employed in some cheese and yogurt manufacturing processes

- **Starch Conversion**: Converts native starches into reducing sugars for various food applications

The enzyme is typically used in very small quantities as a processing aid and is often removed or inactivated during subsequent processing steps.

Safety Assessment

Diastase from Aspergillus oryzae has an extensive history of safe use in food applications. The fungal source organism, Aspergillus oryzae, is widely recognized as a non-pathogenic strain with a long history of safe use in fermented food production, particularly in Japanese koji production. Key safety considerations include:

- **No Reported Adverse Events**: The FDA database contains zero reported adverse events associated with this enzyme preparation

- **No Recalls**: No food recalls have been associated with diastase from Aspergillus oryzae

- **Low Protein Allergenicity**: While enzyme preparations can theoretically cause allergic reactions in sensitive individuals, diastase from Aspergillus oryzae is not commonly associated with allergenic responses

- **GRAS Status**: While not formally listed under FDA's GRAS (Generally Recognized as Safe) designation, the enzyme is permitted for use in food as a processing aid under FDA regulations for food enzymes

- **Thermal Stability**: The enzyme is denatured at normal cooking and baking temperatures, effectively removing enzyme activity from the final food product

The European Food Safety Authority has also evaluated enzyme preparations from Aspergillus oryzae and concluded they are safe for their intended uses.

Regulatory Status

Diastase from Aspergillus oryzae operates under a regulatory framework as a food enzyme rather than as a direct food additive. In the United States, it is permitted for use as a processing aid under 21 CFR 184.1243 and related food enzyme regulations. The FDA's Food Enzyme Inventory includes this enzyme preparation. In the European Union, enzyme preparations from Aspergillus oryzae are evaluated and permitted under Regulation (EC) No 1332/2008. The enzyme is also approved for use in many other countries including Canada, Japan, and Australia.

As a processing aid, residual enzyme activity in the final food product is generally minimal or absent, which influences its regulatory classification and safety requirements.

Key Studies

While specific peer-reviewed studies on diastase from Aspergillus oryzae are limited in contemporary literature, the safety profile is supported by:

- Decades of industrial use in baking, brewing, and fermentation without significant adverse events

- The well-established safety record of Aspergillus oryzae in traditional fermentation

- General enzyme safety assessment frameworks established by food regulatory agencies

- Standard toxicology and allergenicity evaluations conducted during enzyme product approval processes

The absence of reported adverse events and recalls, combined with the non-pathogenic nature of the source organism and the denaturing effect of food processing, provides substantial evidence for the safety of this enzyme preparation when used as intended.

Frequently Asked Questions

What is Diastase From Aspergillus Oryzae?

Diastase from Aspergillus oryzae is an enzyme preparation derived from the fungus Aspergillus oryzae that breaks down starches into simpler sugars. It is commonly used in food manufacturing as a processing aid to improve fermentation, enhance flavor development, and increase digestibility in baked goods, beverages, and other processed foods.

Is Diastase From Aspergillus Oryzae safe?

Diastase 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 Diastase From Aspergillus Oryzae banned in any country?

Diastase 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.