Our Verdict: RATING UNKNOWN

Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant

CAS977164-02-5

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

Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant โ€” food additive

Alpha-acetolactate decarboxylase is a recombinant enzyme derived from Bacillus subtilis that catalyzes the breakdown of alpha-acetolactate in beer production. It is used primarily in brewing to reduce diacetyl formation and improve beer flavor stability.

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 Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant?

Alpha-acetolactate decarboxylase (AALD) is an enzyme produced through recombinant DNA technology using Bacillus subtilis as the production organism. The enzyme catalyzes the conversion of alpha-acetolactate to acetoin, effectively bypassing the natural pathway that would otherwise produce diacetylโ€”an undesirable compound in beer that creates a butter or butterscotch off-flavor. This recombinant enzyme preparation is a biotechnology-derived food additive used to improve beer quality during fermentation.

Common Uses

Alpha-acetolactate decarboxylase is primarily used in beer brewing to accelerate the maturation process and reduce unwanted flavor compounds. During yeast fermentation, alpha-acetolactate naturally forms as a metabolic byproduct. Without intervention, this compound is slowly converted to diacetyl, which requires extended aging periods (days to weeks) for the yeast to gradually metabolize it. By introducing this enzyme, brewers can dramatically shorten this maturation phase while simultaneously reducing diacetyl levels, resulting in faster production timelines and more consistent product quality. The enzyme is added directly to fermenting beer in controlled amounts and remains active only during the fermentation period.

Safety Assessment

The safety profile of this enzyme preparation is supported by several factors. Bacillus subtilis is considered a non-pathogenic organism with a long history of safe use in food fermentation. The recombinant enzyme is a protein that is denatured and degraded during normal digestion, similar to all dietary proteins. No adverse events have been reported to the FDA related to this additive, and there are no recorded recalls associated with its use. The enzyme does not persist in the final product in significant quantities, as it is either inactivated during subsequent processing steps (such as pasteurization) or degraded naturally. Allergenicity studies have not identified this enzyme as a common allergen, though individuals with severe sensitivities to Bacillus-derived proteins should exercise caution. The fermentation conditions and heat treatment in beer production further ensure that any residual enzyme activity is eliminated.

Regulatory Status

This enzyme preparation does not currently hold GRAS (Generally Recognized as Safe) status from the FDA, though it may be used in certain brewing applications under specific regulatory pathways. In the European Union, enzyme preparations are subject to regulation under EC Regulation 1332/2008, which requires safety assessment before approval. The enzyme has been used in commercial brewing operations in various jurisdictions where it has been approved through established biotechnology review processes. Regulatory status varies by country, and brewers should verify local regulations before use. The lack of GRAS status does not indicate a safety concern but rather reflects the classification process and regulatory history of this particular additive.

Key Studies

Research on alpha-acetolactate decarboxylase has focused on its efficacy in reducing diacetyl formation and its fate during beer processing. Studies demonstrate that the enzyme effectively catalyzes the decarboxylation of alpha-acetolactate when applied at appropriate stages of fermentation, with most enzyme activity ceasing by the end of the fermentation period. Thermal stability studies show that the enzyme is denatured at temperatures well below typical beer pasteurization conditions (typically 60-75ยฐC), ensuring no active enzyme remains in the finished product. Toxicological evaluations of the enzyme preparation, conducted according to standard protocols for food-grade enzymes, have not identified safety concerns at food-use levels.

Frequently Asked Questions

What is Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant?

Alpha-acetolactate decarboxylase is a recombinant enzyme derived from Bacillus subtilis that catalyzes the breakdown of alpha-acetolactate in beer production. It is used primarily in brewing to reduce diacetyl formation and improve beer flavor stability.

Is Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant safe?

Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant 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 Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant banned in any country?

Alpha-acetolactate Decarboxylase Enzyme Preparation From Bacillus Subtilis Recombinant 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.