Our Verdict: SAFE

Chymosin Preparation, Aspergillus Niger Var. Awamori

CAS977165-51-7

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

Chymosin Preparation, Aspergillus Niger Var. Awamori — food additive

Chymosin Preparation, Aspergillus Niger Var. Awamori is an enzyme derived from the fungus Aspergillus niger that functions as a processing aid and stabilizer in food manufacturing. It is primarily used in cheese production and other fermentation processes to aid in protein coagulation and texture development.

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 Chymosin Preparation, Aspergillus Niger Var. Awamori?

Chymosin Preparation, Aspergillus Niger Var. Awamori is an enzyme preparation derived from the fungus Aspergillus niger var. awamori. Chymosin is a protease enzyme that catalyzes the cleavage of specific protein bonds, making it particularly valuable in food processing applications. This fungal-derived preparation represents an alternative to traditional animal-derived chymosin sources, offering a biotechnologically produced option for industrial food manufacturing.

Common Uses

The primary application of this chymosin preparation is in cheese manufacturing, where it serves as a coagulating agent to facilitate milk protein precipitation and curd formation. The enzyme breaks down casein proteins in milk, promoting the development of the characteristic texture and structure of cheese. Beyond cheese production, chymosin preparations may be utilized in other fermented food products and dairy applications where protein modification and stabilization are desired. The enzyme functions as both a processing aid—actively participating in the chemical transformation of raw materials—and as a stabilizer, helping maintain product consistency and texture throughout shelf life.

Safety Assessment

No adverse events related to this specific chymosin preparation have been reported to the FDA, and no product recalls have been documented. The fungal source material, Aspergillus niger var. awamori, is widely recognized as safe and has been used in food fermentation and enzyme production for decades. Aspergillus niger has a long history of safe use in food manufacturing and is listed in various international food safety databases as generally acceptable for enzyme production.

Enzyme preparations derived from Aspergillus species are typically considered low-risk additives because they are protein-based substances that are readily deactivated by heat and digestive enzymes. When consumed as part of finished food products, enzyme preparations are generally broken down during normal digestion. The safety profile of chymosin itself, regardless of source, has been extensively studied in the context of cheese production, where it has been used for centuries.

Regulatory Status

This specific chymosin preparation does not carry FDA GRAS (Generally Recognized as Safe) status, which means it has not undergone the formal GRAS notification process or has not been evaluated through that particular regulatory pathway. However, the absence of GRAS status does not indicate concern; rather, it may reflect that the preparation is used under specific regulatory approval or in markets with different regulatory frameworks. In the United States, chymosin preparations used in cheese manufacturing are typically approved as food additives through the FDA's food additive petition process. Many countries recognize chymosin preparations from fungal sources as acceptable processing aids in dairy applications. The European Union's food additive regulations permit certain enzyme preparations, including those from Aspergillus species, for cheese production under specific conditions.

Key Studies

The safety of chymosin as a cheese-making enzyme has been the subject of extensive scientific review. Studies on enzyme preparations from Aspergillus niger have demonstrated that the parent organism is non-pathogenic and that enzymes produced from this fungal source are denatured during cheese processing and digestion. Research on fungal enzyme preparations in general indicates that protein-based enzymes are degraded in the gastrointestinal tract and do not pose systemic toxicological risks. The protease activity of chymosin is well-characterized, and its specificity for milk casein proteins is well-documented in peer-reviewed literature. Regulatory agencies have reviewed the safety data on chymosin preparations and approved their use in dairy applications in multiple jurisdictions.

Frequently Asked Questions

What is Chymosin Preparation, Aspergillus Niger Var. Awamori?

Chymosin Preparation, Aspergillus Niger Var. Awamori is an enzyme derived from the fungus Aspergillus niger that functions as a processing aid and stabilizer in food manufacturing. It is primarily used in cheese production and other fermentation processes to aid in protein coagulation and texture development.

Is Chymosin Preparation, Aspergillus Niger Var. Awamori safe?

Chymosin Preparation, Aspergillus Niger Var. Awamori 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 Chymosin Preparation, Aspergillus Niger Var. Awamori banned in any country?

Chymosin Preparation, Aspergillus Niger Var. Awamori 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.