Our Verdict: SAFE

Carbohydrase From Bacillus Subtilis

CAS977031-70-1

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 From Bacillus Subtilis — food additive

Carbohydrase from Bacillus subtilis is an enzyme derived from the bacterium Bacillus subtilis that catalyzes the breakdown of carbohydrates in food processing. It is used in food manufacturing to improve texture, digestibility, and processing efficiency in various food 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
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 Carbohydrase From Bacillus Subtilis?

Carbohydrase from Bacillus subtilis is an enzyme preparation derived from the naturally occurring bacterium Bacillus subtilis. Enzymes are proteins that catalyze biochemical reactions, and carbohydrases specifically break down complex carbohydrates into simpler sugars. This particular enzyme is produced through fermentation of Bacillus subtilis strains and is used as a food additive in industrial food processing.

Enzymes like carbohydrase have been used in food manufacturing for decades. Bacillus subtilis is a non-pathogenic bacterium commonly found in soil and is recognized as safe for various biotechnological applications. The enzyme itself functions as a processing aid to modify carbohydrate structures during food production.

Common Uses

Carbohydrase from Bacillus subtilis is employed in several food manufacturing applications:

- **Baking**: Improves dough handling properties and bread texture by breaking down starches and other carbohydrates

- **Beverage production**: Used in juice and beer manufacturing to enhance clarity and reduce viscosity

- **Starch processing**: Assists in converting starches into fermentable sugars or modified starch products

- **Grain processing**: Facilitates enzyme-based modifications in grain milling and cereal production

- **Sugar refining**: Helps optimize sugar extraction and processing efficiency

The enzyme functions as a processing aid, meaning it may be removed or inactivated during final food preparation, though residual enzyme activity may remain in the finished product.

Safety Assessment

Bacillus subtilis is widely recognized as a safe microorganism in food and pharmaceutical applications. The enzyme derived from this organism has a long history of safe use in food processing across multiple countries.

Key safety considerations:

- **Protein nature**: Like all enzymes, carbohydrase is a protein that is digested in the human gastrointestinal tract

- **FDA adverse events**: Zero reported adverse events associated with this additive in FDA databases

- **Recalls**: No FDA recalls associated with carbohydrase from Bacillus subtilis

- **Allergen potential**: As with all protein-based products, theoretical allergen risk exists for individuals with enzyme sensitivities, though this is rare

- **Microbial safety**: The production organism (Bacillus subtilis) is non-pathogenic and does not produce toxins

Regulatory Status

Carbohydrase from Bacillus subtilis is not listed as Generally Recognized as Safe (GRAS) by the FDA, meaning it has not completed the GRAS notification process. However, this does not indicate safety concerns; rather, it reflects the regulatory classification status.

The enzyme is approved for use in various food applications in multiple jurisdictions:

- **United States**: Permitted as a food additive under FDA regulations for specific food processing applications

- **European Union**: Approved under food enzyme regulations (EC 1332/2008)

- **Other countries**: Approved in Canada, Japan, and other jurisdictions for food processing use

Regulatory approval is based on comprehensive safety assessments conducted by food safety authorities. The lack of GRAS designation does not reflect safety concerns but rather indicates it operates under different regulatory pathways.

Key Studies

Research on Bacillus subtilis-derived enzymes demonstrates consistent safety profiles:

- Studies on enzyme preparations from Bacillus subtilis show rapid protein degradation in simulated gastrointestinal conditions, supporting safety

- Fermentation studies confirm that production strains are free from toxigenic potential

- Food processing applications have been monitored across decades with no emerging safety signals

- The enzyme's specificity for carbohydrate substrates limits off-target biological activity

The absence of reported adverse events in FDA databases, combined with regulatory approval in multiple countries and the well-established safety record of Bacillus subtilis, supports the continued use of this enzyme in food processing applications.

Frequently Asked Questions

What is Carbohydrase From Bacillus Subtilis?

Carbohydrase from Bacillus subtilis is an enzyme derived from the bacterium Bacillus subtilis that catalyzes the breakdown of carbohydrates in food processing. It is used in food manufacturing to improve texture, digestibility, and processing efficiency in various food applications.

Is Carbohydrase From Bacillus Subtilis safe?

Carbohydrase From Bacillus Subtilis 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 From Bacillus Subtilis banned in any country?

Carbohydrase From Bacillus Subtilis 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.