Our Verdict: SAFE

Pectinase From Bacillus Subtilis

E-numberE440CAS977090-12-2

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

Pectinase From Bacillus Subtilis — food additive

Pectinase from Bacillus subtilis is an enzyme derived from a common bacterium that breaks down pectin in plant cell walls. It is used in food processing as a flavor enhancer, clarifying agent, and processing aid, particularly in juice, wine, and beverage production.

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
ApprovedHealth 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 Pectinase From Bacillus Subtilis?

Pectinase from Bacillus subtilis is an enzyme produced by fermentation of the bacterium Bacillus subtilis. Enzymes are proteins that catalyze biochemical reactions. In this case, pectinase specifically breaks down pectin, a complex polysaccharide found in plant cell walls that gives fruits and vegetables their structure. The enzyme facilitates the degradation of these cell wall components, making it a valuable processing tool in the food industry.

Bacillus subtilis is a gram-positive bacterium commonly found in soil and is generally recognized as non-pathogenic. The strain used for enzyme production is a food-grade strain selected for safe enzyme manufacturing.

Common Uses

Pectinase from Bacillus subtilis is primarily used in beverage production, particularly in:

- **Juice processing**: Clarification and extraction of fruit juices by breaking down pectin that causes cloudiness

- **Wine production**: Enhancement of flavor release and color extraction from grape skins

- **Beer brewing**: Improvement of flavor compound extraction and clarity

- **Cider production**: Clarification and flavor development

- **Plant-based beverages**: Processing of fruit and vegetable-based drinks

Beyond beverages, the enzyme may be used in small quantities in other processed foods where pectin degradation aids processing efficiency or desired sensory characteristics. As a processing aid, residual enzyme activity is typically minimal or absent in the final product after processing is complete.

Safety Assessment

Pectinase enzymes from Bacillus subtilis have been widely studied and used in food processing for several decades. Key safety considerations include:

**Enzyme Safety**: Food enzymes are proteins that are broken down during normal digestion into amino acids and peptides. They are not absorbed intact into the bloodstream. The enzyme itself does not persist in finished food products in active form.

**Source Organism**: Bacillus subtilis is not pathogenic to humans and is listed as GRAS (Generally Recognized as Safe) by the FDA for use in food production. The strain used for pectinase production is a food-grade strain without concerning genetic modifications.

**Historical Use**: This enzyme has a long history of safe use in food processing, particularly in European and North American beverage industries.

**FDA Data**: According to FDA records, there are zero reported adverse events associated with this additive and zero recalls involving pectinase from Bacillus subtilis.

**Allergenic Potential**: As with all enzymes, individuals with specific protein sensitivities could theoretically experience reactions, though this is rare. The enzyme is not associated with common allergens.

Regulatory Status

Pectinase from Bacillus subtilis is not listed as GRAS by the FDA, meaning it has not undergone the formal FDA GRAS notification process. However, this does not indicate safety concerns; rather, it reflects the regulatory pathway taken by manufacturers. The enzyme may be approved for use in specific applications through food additive petitions or other regulatory mechanisms.

In the European Union, pectinase enzymes from Bacillus species are listed in the catalogs of approved food enzymes and are permitted for use in food processing under Regulation (EC) No 1332/2008.

The additive functions as a processing aid, enzyme, flavor enhancer, and stabilizer, depending on the specific application.

Key Studies

Scientific literature on pectinase enzymes from Bacillus subtilis confirms their efficacy in juice clarification and flavor extraction. Research demonstrates:

- The enzyme effectively degrades pectin polymers in fruit juices

- Heat treatment or pH adjustment denatures the enzyme, eliminating residual activity

- No toxicological concerns have been identified in safety assessments

- The enzyme is quickly degraded in the gastrointestinal tract

Scientific consensus supports the safety of food-grade pectinase enzymes from Bacillus subtilis when used as processing aids according to good manufacturing practices.

Frequently Asked Questions

What is Pectinase From Bacillus Subtilis?

Pectinase from Bacillus subtilis is an enzyme derived from a common bacterium that breaks down pectin in plant cell walls. It is used in food processing as a flavor enhancer, clarifying agent, and processing aid, particularly in juice, wine, and beverage production.

Is Pectinase From Bacillus Subtilis safe?

Pectinase From Bacillus Subtilis 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 Pectinase From Bacillus Subtilis banned in any country?

Pectinase From Bacillus Subtilis 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.