Our Verdict: RATING UNKNOWN

Esterase-lipase From Mucor Miehei

E-numberE1104CAS977032-08-8

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

Esterase-lipase From Mucor Miehei — food additive

Esterase-lipase from Mucor miehei is an enzyme derived from a fungal source used in food processing to break down fats and oils. It functions as a processing aid in cheese production and other dairy applications where fat hydrolysis is desired.

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 Esterase-lipase From Mucor Miehei?

Esterase-lipase from Mucor miehei is an enzyme preparation derived from the fungus Mucor miehei. Enzymes are proteins that catalyze biochemical reactions, and this particular enzyme possesses both esterase and lipase activity, meaning it can hydrolyze (break down) fats and oils into smaller components such as fatty acids and glycerol. The enzyme is produced through fermentation of Mucor miehei cultures and is then isolated and purified for use in food manufacturing.

Common Uses

The primary application of esterase-lipase from Mucor miehei is in cheese production, particularly in the manufacture of certain varieties where controlled fat breakdown is beneficial. The enzyme is used as a processing aid to develop specific flavor profiles and texture characteristics in cheese. Additionally, it may be used in other dairy product applications where fat modification is desired. As a processing aid, residual enzyme activity in the final product is typically minimal or non-detectable, as the enzyme is either inactivated during processing or remains only in trace amounts.

Safety Assessment

Esterase-lipase from Mucor miehei has not received formal GRAS (Generally Recognized As Safe) status from the FDA, though it is used in food applications in various jurisdictions. The enzyme originates from a fungal source that is not pathogenic and has a long history of safe use in industrial enzyme production. According to FDA records, there have been zero reported adverse events associated with this enzyme and zero recalls linked to its use.

The safety profile of enzyme preparations is generally well-established in food science. Since enzymes are proteins, they are typically denatured and broken down during digestion like any other dietary protein. The primary safety considerations for enzyme preparations involve the production organism itself, potential allergenicity, and the purity of the final preparation. Mucor miehei is not a known common allergen, and the enzyme preparation undergoes purification processes to remove cellular material and contaminants.

Regulatory Status

While esterase-lipase from Mucor miehei has not been approved as a GRAS substance in the United States, it may be used under FDA regulations for specific food applications where it has undergone appropriate safety review or operates under enzyme preparation guidelines. In Europe, enzyme preparations are regulated under food additive legislation (EC 1331/2008), and specific enzyme products may be approved through the European Food Safety Authority (EFSA) assessment process. Regulatory approval status varies by jurisdiction and intended food application.

The enzyme is typically classified as a processing aid rather than a food additive in many regulatory frameworks, which means it may not require the same level of pre-market approval as direct food additives, provided the production organism is safe and the final preparation meets purity standards.

Key Studies

Scientific literature on lipase enzymes from Mucor species demonstrates their effectiveness in fat hydrolysis and their widespread use in industrial cheese manufacturing. Research on Mucor-derived lipases confirms their stability in acidic conditions typical of dairy products and their specificity for fat breakdown. While specific published studies directly addressing esterase-lipase from Mucor miehei are limited in public databases, the enzyme class has been extensively studied for safety and functionality in food applications.

The lack of adverse events and recalls associated with this enzyme, combined with the established safety profile of Mucor-derived enzyme preparations and their long history of use in cheese production, suggests an acceptable safety margin in food manufacturing contexts.

Frequently Asked Questions

What is Esterase-lipase From Mucor Miehei?

Esterase-lipase from Mucor miehei is an enzyme derived from a fungal source used in food processing to break down fats and oils. It functions as a processing aid in cheese production and other dairy applications where fat hydrolysis is desired.

Is Esterase-lipase From Mucor Miehei safe?

Esterase-lipase From Mucor Miehei 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 Esterase-lipase From Mucor Miehei banned in any country?

Esterase-lipase From Mucor Miehei 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.