Our Verdict: SAFE

Catalase From Penicillium Notatum

CAS977090-05-3FDA 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 Penicillium Notatum — food additive

Catalase from Penicillium notatum is an enzyme derived from a fungal strain that breaks down hydrogen peroxide into water and oxygen. It functions as a processing aid and antimicrobial agent in food production, helping remove residual hydrogen peroxide used in food processing.

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 Penicillium Notatum?

Catalase from Penicillium notatum is an enzyme derived from the fungus Penicillium notatum. Catalase is a naturally occurring enzyme found in most living organisms that catalyzes the decomposition of hydrogen peroxide (H₂O₂) into water (H₂O) and oxygen (O₂). The enzyme used as a food additive is produced through fermentation of the Penicillium notatum strain and subsequently purified for food applications.

Common Uses

This enzyme is primarily used in food manufacturing as a processing aid to remove residual hydrogen peroxide. Hydrogen peroxide is commonly used in food processing for bleaching, disinfection, and sterilization purposes—particularly in dairy processing, juice production, and starch manufacturing. After these processes, catalase is added to break down any remaining hydrogen peroxide into harmless water and oxygen, ensuring the final food product does not contain dangerous peroxide residues.

The enzyme also serves antimicrobial functions by contributing to food preservation processes. It may be used in conjunction with other processing techniques to support food safety during manufacturing.

Safety Assessment

Catalase from Penicillium notatum has received Generally Recognized as Safe (GRAS) status from the FDA, indicating that the agency has concluded it is safe for its intended use in food. The enzyme has an excellent safety record, with zero reported adverse events and zero FDA recalls associated with this additive. This reflects both the inherent safety of the enzyme and its appropriate use in food manufacturing at specified levels.

As an enzyme, catalase is a protein that is broken down by digestive enzymes in the human gastrointestinal tract, similar to other dietary proteins. The end products of catalase decomposition are the same amino acids found in normal protein metabolism, making systemic absorption of intact enzyme unlikely. The hydrogen peroxide that catalase breaks down is completely eliminated through this enzymatic reaction, leaving only water and oxygen as byproducts.

The source organism, Penicillium notatum, has a long history of safe use in food and pharmaceutical applications. This fungal strain was first identified as the source of penicillin and has been extensively studied over decades.

Regulatory Status

Catalase from Penicillium notatum is affirmed as GRAS by the FDA under 21 CFR 184.1645. This regulatory status means the enzyme may be used as a food additive without pre-market approval, provided it is used in accordance with good manufacturing practice and within specified functional purposes.

The enzyme is recognized in international food safety frameworks and is approved for use in food manufacturing in multiple jurisdictions. Its GRAS status is based on scientific evaluation of safety data and the enzyme's long history of safe use in food production.

Key Studies

The GRAS determination for catalase from Penicillium notatum was based on comprehensive safety evaluations. These assessments considered the source organism's safety history, the enzyme's function and specificity, potential toxicity, and allergenicity. The enzyme's well-characterized mechanism of action—simple decomposition of hydrogen peroxide into harmless components—supports its safety profile.

Literature on catalase enzymes generally demonstrates their safety across numerous applications. The enzyme's rapid and complete breakdown of hydrogen peroxide, combined with the protein nature of the enzyme itself, presents minimal food safety concerns when used as directed in food manufacturing processes.

Frequently Asked Questions

What is Catalase From Penicillium Notatum?

Catalase from Penicillium notatum is an enzyme derived from a fungal strain that breaks down hydrogen peroxide into water and oxygen. It functions as a processing aid and antimicrobial agent in food production, helping remove residual hydrogen peroxide used in food processing.

Is Catalase From Penicillium Notatum safe?

Catalase From Penicillium Notatum 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 Penicillium Notatum banned in any country?

Catalase From Penicillium Notatum 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.