# Carbohydrase From Rhizopus Oryzae

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**Safety rating:** UNKNOWN
**CAS number:** 977050-28-4
**Category:** other
**FDA GRAS:** no
**Adverse events (FDA AERS):** 0
**FDA recalls:** 0
**Last updated:** 2026-04-02

## Summary

Carbohydrase from Rhizopus oryzae is an enzyme derived from a fungal source that breaks down carbohydrates during food processing. It functions as a processing aid to improve texture, fermentation efficiency, or other processing outcomes in food manufacturing.

## Regulatory status

| Country | Status |
| --- | --- |
| United States | approved |
| European Union | not_evaluated |
| United Kingdom | not_evaluated |
| Canada | not_evaluated |
| Australia | not_evaluated |
| Japan | not_evaluated |
| South Korea | not_evaluated |
| Brazil | not_evaluated |
| China | not_evaluated |
| India | not_evaluated |

## Detailed analysis

## What is Carbohydrase From Rhizopus Oryzae?

Carbohydrase from Rhizopus oryzae is an enzyme preparation derived from the fungus Rhizopus oryzae (CAS Number: 977050-28-4). Enzymes are biological catalysts that speed up chemical reactions. Carbohydrases are a class of enzymes that break down complex carbohydrates into simpler sugars through hydrolysis. This particular enzyme source has been developed for use in food processing applications where controlled carbohydrate breakdown is desired.

## Common Uses

Carbohydrase enzymes derived from fungal sources like Rhizopus oryzae are utilized in various food manufacturing processes. These enzymes may be employed in baking to improve dough handling and fermentation rates, in brewing and fermentation industries to enhance sugar availability for microorganisms, and in starch processing to modify carbohydrate structures. As a processing aid, the enzyme itself is typically inactivated or removed during processing, and any residual enzyme activity is generally considered minimal in the final food product.

The use of fungal-derived carbohydrases has been common in food manufacturing for decades, with similar enzyme preparations from other fungal sources well-established in the industry.

## Safety Assessment

Carbohydrase from Rhizopus oryzae has not been formally approved by the FDA as a Generally Recognized As Safe (GRAS) ingredient, though it may be used under specific regulatory frameworks in certain jurisdictions. According to FDA records, there have been zero reported adverse events and zero recalls associated with this additive, indicating no documented safety incidents in U.S. food supply.

The safety profile of enzyme preparations depends on several factors: the purity of the enzyme preparation, the complete removal or inactivation of the enzyme during processing, the absence of allergenic or toxic compounds from the source organism, and the intended level of use. Rhizopus oryzae is not known to be a human pathogen or allergen source of concern in the scientific literature.

When enzyme preparations are used as processing aids, they are typically designed to be completely inactivated or removed before the food reaches consumers, which substantially reduces potential exposure.

## Regulatory Status

In the United States, carbohydrase from Rhizopus oryzae does not hold FDA GRAS status. However, this does not automatically mean the ingredient is unsafe; rather, it indicates the enzyme has not completed the GRAS notification process with the FDA. Some enzyme preparations used in food processing operate under food additive regulations or petition-based approvals rather than GRAS designations.

Regulatory status varies internationally. The European Union maintains strict enzyme regulations, and similar carbohydrase preparations from approved fungal sources may be listed in the EU's enzyme inventory (EC 1107/96). Other countries including Canada, Australia, and Japan have their own enzyme approval processes.

Manufacturers intending to use this enzyme preparation should verify its regulatory status in their specific jurisdiction and ensure compliance with local food laws.

## Key Studies

Scientific literature on Rhizopus oryzae-derived enzymes is limited compared to more established enzyme sources. Most supporting data would typically come from manufacturer stability and safety studies, though these are not always published in peer-reviewed journals. Research on related carbohydrase enzymes from fungal sources demonstrates that properly manufactured and controlled enzyme preparations present minimal food safety concerns when used as processing aids.

The absence of reported adverse events and recalls in FDA databases suggests that any current use of this enzyme in the U.S. food supply has not raised safety concerns. However, additional published research characterizing this specific enzyme preparation's properties and safety profile would provide greater transparency.

## Sources

- FDA Substances Added to Food (CFSAN)
- OpenFDA Adverse Event Reporting System (AERS)
- OpenFDA Food Recalls
- EFSA OpenFoodTox
- EU Food Additive Portal

## Citation

Additive Facts. "Carbohydrase From Rhizopus Oryzae — Safety, regulation, and evidence." https://additivefacts.com/additives/carbohydrase-from-rhizopus-oryzae. Accessed 2026-05-12.