Our Verdict: SAFE

Carbohydrase And Cellulase From Aspergillus Niger

CAS977050-27-3

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

Carbohydrase And Cellulase From Aspergillus Niger — food additive

Carbohydrase and cellulase from Aspergillus niger is an enzyme preparation derived from the fungus Aspergillus niger, used as a processing aid to break down carbohydrates and cellulose in food production. It facilitates texture modification and ingredient processing in various food manufacturing applications.

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
ApprovedHealth 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 Carbohydrase and Cellulase From Aspergillus Niger?

Carbohydrase and cellulase from Aspergillus niger is an enzyme preparation produced through fermentation of the fungus Aspergillus niger. This additive contains multiple enzyme activities capable of hydrolyzing carbohydrates and cellulose—complex plant polymers—into simpler sugars and compounds. The preparation is used in food manufacturing as a processing aid, meaning it facilitates food production but is not intended to remain in the final product at significant levels.

Common Uses

This enzyme preparation is employed in several food processing applications:

- **Grain and cereal processing**: Breaking down cell walls to improve ingredient extraction and texture

- **Juice and beverage production**: Clarifying and improving yield from fruit and vegetable sources

- **Baking**: Enhancing dough properties and improving fermentation efficiency

- **Animal feed production**: Increasing digestibility of plant-based feed ingredients

- **Starch processing**: Facilitating conversion and modification of starch-containing materials

As a processing aid, the enzyme catalyzes reactions during manufacturing but is typically inactivated or removed before the final product reaches consumers.

Safety Assessment

Aspergillus niger is widely recognized as a safe source organism for enzyme production. It has been used in industrial enzyme manufacturing for decades and produces the enzyme preparation without generating known mycotoxins or harmful byproducts.

Key safety considerations include:

**Allergenicity**: Enzyme preparations may trigger reactions in individuals with mold sensitivities, though finished food products contain negligible enzyme levels. Direct occupational exposure during manufacturing poses greater concern than consumer exposure.

**Toxicity**: No acute or chronic toxicity has been demonstrated in available studies. The proteins are degraded during normal digestive processes.

**Microbiological safety**: The production organism (Aspergillus niger) does not produce aflatoxins or other mycotoxins. Manufacturing processes include controls to ensure product purity.

**FDA data**: The FDA has received zero adverse event reports associated with this additive and zero product recalls. This 20+ year safety record reflects its established safe use history.

Regulatory Status

This additive is **not listed as GRAS (Generally Recognized as Safe)** by the FDA for direct food use. However, it is regulated and permitted under FDA guidelines for enzyme preparations from approved source organisms when used as processing aids. The distinction is important: processing aids do not require GRAS affirmation if they are removed or inactivated during processing.

The European Food Safety Authority (EFSA) has similarly permitted enzyme preparations from Aspergillus niger in food production, reflecting international scientific consensus on safety.

Use in food is permitted only when:

- Proper manufacturing controls are followed

- The enzyme is inactivated during food processing

- Residual enzyme levels are negligible in final products

Key Studies

Scientific literature supporting safety includes:

- Toxicological studies on Aspergillus niger enzyme preparations showing no systemic toxicity at relevant exposure levels

- Allergenicity assessments indicating low risk from food residues

- Microbiological evaluations confirming absence of mycotoxin production

- Decades of industrial use data without adverse event reports

Research has established that enzyme proteins are hydrolyzed by stomach acid and digestive enzymes, preventing absorption of intact enzyme molecules.

Frequently Asked Questions

What is Carbohydrase And Cellulase From Aspergillus Niger?

Carbohydrase and cellulase from Aspergillus niger is an enzyme preparation derived from the fungus Aspergillus niger, used as a processing aid to break down carbohydrates and cellulose in food production. It facilitates texture modification and ingredient processing in various food manufacturing applications.

Is Carbohydrase And Cellulase From Aspergillus Niger safe?

Carbohydrase And Cellulase From Aspergillus Niger 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 Carbohydrase And Cellulase From Aspergillus Niger banned in any country?

Carbohydrase And Cellulase From Aspergillus Niger 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.