Our Verdict: SAFE

Catalase From Aspergillus Niger

CAS977031-84-7FDA GRAS

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

Catalase From Aspergillus Niger — food additive

Catalase from Aspergillus niger is an enzyme derived from a naturally occurring fungus that breaks down hydrogen peroxide into water and oxygen. It functions as a processing aid and antimicrobial agent in food production, helping remove hydrogen peroxide used in food manufacturing and preservation processes.

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 Catalase From Aspergillus Niger?

Catalase from Aspergillus niger is an enzyme produced by fermentation using the fungus Aspergillus niger. Catalase is a naturally occurring protein that catalyzes the decomposition of hydrogen peroxide (H2O2) into water and oxygen gas. This enzyme is identical to catalases found throughout nature, including in human cells, where it plays a crucial role in protecting against oxidative damage. The version used in food production is manufactured through controlled fermentation processes to ensure purity and safety.

Common Uses

In the food industry, catalase from Aspergillus niger serves multiple functions. Its primary application is as a processing aid, specifically to remove residual hydrogen peroxide used in food sterilization and preservation processes. Hydrogen peroxide is used in some food manufacturing applications as a disinfectant and bleaching agent, but it must be removed before the final product reaches consumers. Catalase efficiently breaks down any remaining H2O2, converting it to harmless water and oxygen. Additionally, the enzyme contributes antimicrobial properties to certain food applications and is sometimes used in dairy products and other processed foods where enzymatic treatment is beneficial.

Safety Assessment

Catalase from Aspergillus niger has an excellent safety profile supported by multiple lines of evidence. The enzyme is designated as Generally Recognized As Safe (GRAS) by the FDA, meaning it has been determined safe for use in food based on a history of common use and scientific evidence. According to FDA records, there are zero reported adverse events associated with this additive and zero product recalls linked to its use. This safety record reflects decades of use in food manufacturing across multiple countries.

The safety of catalase is further supported by its biological precedent. Catalase is an endogenous enzyme present in virtually all living organisms, including those consumed regularly in the human diet. The enzyme is broken down through normal digestive processes into amino acids, which are then metabolized like proteins from any food source. Because catalase is a protein, it is denatured by heat and stomach acid, preventing any systemic absorption of intact enzyme molecules.

Aspergillus niger, the source organism, is a generally recognized safe fungus commonly used in food production for enzyme and organic acid manufacture. It is not a pathogenic organism and does not produce known mycotoxins under standard fermentation conditions.

Regulatory Status

Catalase from Aspergillus niger is approved for food use in multiple jurisdictions. In the United States, it holds GRAS status under FDA regulations, which permits its use as a food additive without a pre-market approval requirement, though manufacturers must notify FDA of their GRAS determination. The enzyme is also approved for use in the European Union as a food enzyme under Regulation (EC) No. 1332/2008. It appears on the EU List of approved food enzymes and has been evaluated for safety by the European Food Safety Authority (EFSA). Similar approvals exist in other countries including Canada, Japan, and Australia, reflecting broad international confidence in its safety profile.

Key Studies

The safety of catalase has been extensively documented through both historical use data and targeted safety assessments. Its long history of safe use in food manufacturing provides substantial evidence supporting its GRAS status. Enzyme safety evaluations have consistently shown that protein enzymes like catalase are rapidly degraded during digestion and do not present toxicological concerns. Studies on Aspergillus niger-derived enzymes have demonstrated no genotoxic, allergenic, or systemic toxicity concerns under approved conditions of use. The zero adverse event record maintained by FDA further corroborates the safety of this additive in actual food production and consumption.

Frequently Asked Questions

What is Catalase From Aspergillus Niger?

Catalase from Aspergillus niger is an enzyme derived from a naturally occurring fungus that breaks down hydrogen peroxide into water and oxygen. It functions as a processing aid and antimicrobial agent in food production, helping remove hydrogen peroxide used in food manufacturing and preservation processes.

Is Catalase From Aspergillus Niger safe?

Catalase 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 Catalase From Aspergillus Niger banned in any country?

Catalase 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.