Our Verdict: RATING UNKNOWN

Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland)

CAS977017-74-5

Insufficient data to assign a rating

We do not have enough regulatory data to assign a safety rating to this additive at this time.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland) โ€” food additive

Milk clotting enzyme from Bacillus cereus is a protease enzyme derived from the bacterium Bacillus cereus that facilitates milk coagulation in cheese production. It functions as a substitute for traditional animal-derived rennet in the cheese-making process.

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 Milk Clotting Enzyme From Bacillus Cereus?

Milk clotting enzyme from Bacillus cereus (Bacillus cereus protease) is an enzymatic preparation produced by fermentation of the bacterium Bacillus cereus. This enzyme catalyzes the hydrolysis of specific peptide bonds in milk proteins, primarily casein, causing milk to coagulate and form curdsโ€”an essential step in cheese production. The enzyme is extracted and purified from the bacterial culture for use as a food processing aid.

Common Uses

This enzyme is primarily used in cheese manufacturing as a milk-clotting agent, serving a similar function to traditional animal rennet derived from calf stomach linings. It can be used in various cheese types including hard, semi-hard, and soft varieties. The enzyme helps standardize cheese production, as it provides consistent clotting performance regardless of seasonal variations that affect animal-derived rennet. Additionally, it addresses religious and dietary restrictions for consumers seeking non-animal alternatives to traditional rennet.

Safety Assessment

Backillus cereus is a gram-positive, spore-forming bacterium that occurs naturally in soil and various food environments. While some strains of Bacillus cereus are known pathogenic strains capable of producing enterotoxins, the enzyme preparation used in food production is derived from carefully controlled fermentation processes and subsequently purified. The final enzyme product consists of purified protein rather than intact bacterial cells.

The purified enzyme itself has not been associated with adverse events according to FDA records. No food recalls linked to this additive have been documented in FDA databases. The enzyme functions as a protease, breaking down proteins into smaller components, and is typically inactivated during cheese processing and aging, reducing potential concerns about bioactivity in final products.

Historically, Bacillus-derived enzymes have been employed in food processing for decades. Their use in fermentation and enzymatic processes is well-established in food manufacturing. The safety profile depends substantially on the manufacturing controls, source strain selection, and purification methods employed to ensure the enzyme preparation contains only the desired protease without contaminating bacterial cells or toxins.

Regulatory Status

This additive has not received FDA GRAS (Generally Recognized As Safe) designation in the United States. However, the absence of GRAS status does not indicate the additive is unsafe; rather, it indicates that formal regulatory approval through specific pathways (such as a Food Additive Petition) has not been completed or that it operates under alternative regulatory frameworks.

In the European Union, various milk-clotting enzymes from Bacillus species have been evaluated and approved under specific conditions and purity specifications. The enzyme may be permitted in certain EU member states under established regulations for food enzymes. International regulatory acceptance varies by country and jurisdiction.

Manufacturers using this enzyme in cheese production must comply with applicable regulations in their respective markets and ensure proper documentation of safety and manufacturing controls.

Key Studies

Scientific literature on Bacillus cereus-derived proteases demonstrates their efficacy in milk coagulation. Research indicates these enzymes can effectively substitute for animal rennet in cheese production with comparable clotting times and curd quality. Studies have focused on optimizing enzyme concentration, pH conditions, and temperature for cheese manufacturing.

Microbiological safety studies emphasize the importance of strain selection and manufacturing controls to prevent contamination with pathogenic strains or toxin production. Enzyme purification studies confirm that properly manufactured preparations contain primarily protein enzymes with minimal bacterial cell material. Post-processing analysis of cheeses made with these enzymes shows the enzymatic activity is largely eliminated during fermentation and aging periods, further reducing potential biological activity in finished products.

Frequently Asked Questions

What is Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland)?

Milk clotting enzyme from Bacillus cereus is a protease enzyme derived from the bacterium Bacillus cereus that facilitates milk coagulation in cheese production. It functions as a substitute for traditional animal-derived rennet in the cheese-making process.

Is Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland) safe?

Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland) is currently rated "unknown" 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 Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland) banned in any country?

Milk Clotting Enzyme From Bacillus Cereus (frankland And Frankland) 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.