ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT
ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT is a genetically derived enzyme used as a processing aid in the brewing and fermentation of alcoholic beverages.
What It Is
ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT is an enzyme preparation used in food processing, derived through recombinant DNA techniques from a strain of the bacterium Bacillus subtilis that has been modified to contain a gene coding for the enzyme alpha-acetolactate decarboxylase. It falls into the category of food processing enzymes, which are specialized protein catalysts that accelerate specific biochemical reactions during the manufacturing or transformation of foods without being part of the final food product in significant amounts. Enzyme preparations like this one are technically classified based on the specific catalytic activity they perform; in this case, decarboxylation of alpha-acetolactate into acetoin. In scientific terms, the active component of this additive is an enzyme known as alpha-acetolactate decarboxylase (often abbreviated as ALDC). This enzyme catalyzes the conversion of alpha-acetolactate, a metabolic intermediate formed during fermentation, into acetoin, a neutral compound, thereby bypassing the formation of diacetyl, a compound associated with off-flavors in fermented beverages. The preparation is derived from a genetically engineered Bacillus subtilis strain that has been modified to express the decarboxylase gene from another microbe, Bacillus brevis, allowing for high-level production of the enzyme during fermentation. This additive is used as a processing aid rather than a food ingredient; the intended function is to modify a biochemical pathway during beverage fermentation processes. It is listed and defined in regulatory frameworks such as the United States Code of Federal Regulations, which specify the conditions under which such enzyme preparations may be used in food production.
How It Is Made
The manufacturing of ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT typically involves fermentation biotechnology processes. A genetically modified strain of Bacillus subtilis is cultivated under controlled conditions in a suitable growth medium. The Bacillus subtilis host is nonpathogenic and non-toxigenic, meaning it does not produce known toxins or cause disease, which is an important consideration in food enzyme production. During production, the genetically modified bacteria secrete the alpha-acetolactate decarboxylase enzyme into the fermentation broth. Following the fermentation stage, the broth is subjected to a series of separation and purification steps to remove cellular debris and concentrate the enzyme. These steps may include filtration, centrifugation, and other standard processing techniques. The resulting enzyme-rich preparation is then stabilized, often with approved food-grade stabilizers or additives, to maintain enzyme activity during storage and use. Because this additive is derived through recombinant DNA techniques, stringent quality control checks are used to ensure the production strain does not persist in the final enzyme preparation. Manufacturers must comply with specifications such as those outlined in the Food Chemicals Codex for enzyme preparations used in food processing. These specifications help define purity criteria, activity assays, and acceptable limits for contaminants. The final product is typically formulated in a form that retains catalytic activity and can be reliably incorporated into industrial brewing and fermentation operations. This general process description is representative of commercial enzyme production; however, specific proprietary details about individual manufacturers’ cultivation conditions, fermentation media, and downstream processing methods are not public and can vary between producers.
Why It Is Used In Food
Enzyme preparations like ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT are used in food and beverage production to improve process efficiency and product quality. In brewing and the fermentation of distilled spirits, the spontaneous formation of diacetyl, a compound with a buttery flavor, can lead to off-flavors that require extended maturation periods to naturally reduce. The addition of this enzyme preparation accelerates the conversion of alpha-acetolactate directly into acetoin, bypassing the diacetyl stage and reducing the need for extended aging or conditioning time. This allows producers to achieve desired flavor profiles more efficiently. As a processing aid, the enzyme is added in the minimum amount necessary to achieve its catalytic effect. It is not intended to remain in significant quantities in the final consumer product, but rather to facilitate specific biochemical changes during processing. The use of such enzyme preparations can improve production throughput, reduce processing times, and help maintain consistent sensory attributes in final products. Enzymes such as alpha-acetolactate decarboxylase are favored in industrial settings because they are specific in action, operate under mild conditions, and generally do not introduce undesirable components into the food matrix. These factors make enzyme technology attractive for industrial-scale fermentation processes where uniformity, efficiency, and product quality are priorities.
Adi Example Calculation
To illustrate how ADI might be conceptualized for a food additive typically assigned a numerical value, consider an example where an additive has a hypothetical ADI of X milligrams per kilogram of body weight per day. For a 70 kilogram adult, the lifetime daily intake at the ADI would be 70 x X milligrams. This calculation provides an upper bound estimate of the amount that could be consumed daily without appreciable health risk, based on available safety data. In the case of ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT, the ADI has been designated as "not specified," meaning that a specific numeric ADI value was not deemed necessary. However, if one were to conceptually consider how intake estimates might be evaluated, regulators would look at the levels used in food production, residual amounts in final products, and consumption patterns across populations. By estimating the total potential intake from all relevant sources and comparing it with toxicological data, authorities assess whether exposure could approach levels of concern. With enzyme preparations expressed as proteins that break down in digestion and with limited residual presence, typical dietary exposures are far below levels that would raise safety issues.
Safety And Health Research
The safety evaluation of ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT has been considered by regulatory authorities and expert committees in the context of its use as a processing aid. In the United States, the authorization under 21 CFR 173.115 reflects FDA’s review of evidence demonstrating that the enzyme preparation can be produced under conditions that limit contaminants and that it can be used safely in specific food production applications. Importantly, regulatory evaluation of enzyme preparations focuses on ensuring that the production organism is nonpathogenic and non-toxigenic, that the genetic modification does not introduce harmful elements, and that the final preparation complies with established purity and identity specifications. (联邦公报) The Joint FAO/WHO Expert Committee on Food Additives (JECFA) evaluated alpha-acetolactate decarboxylase from Bacillus brevis expressed in Bacillus subtilis and designated an ADI "not specified," which is a classification used when the available data indicate that no safety concern exists at levels of intake arising from its intended use. This designation typically arises from toxicological evaluations that may include assessments of acute toxicity, genetic toxicology, subchronic studies, and other relevant data. An "ADI not specified" reflects a finding that dietary exposure under conditions of intended use is unlikely to pose a health risk. From a scientific standpoint, enzyme preparations used as processing aids generally exhibit low toxicity because they are proteins that are degraded during digestion and do not introduce bioactive small molecules at levels that would contribute to systemic toxicity. Additionally, the source organism Bacillus subtilis is widely regarded as safe in food enzyme applications and has a long history of use in industrial enzyme production contexts. Animal and in vitro studies relevant to the safety of alpha-acetolactate decarboxylase have not identified specific hazards at expected exposure levels when used according to regulatory provisions. Overall, the available safety data and regulatory decisions support the conclusion that this enzyme preparation, when produced and used according to authorized conditions, does not present safety concerns for consumers through its role as a processing aid.
Regulatory Status Worldwide
In the United States, ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT is referenced in the Code of Federal Regulations under 21 CFR 173.115, which permits the safe use of this enzyme preparation under specified conditions. The regulation defines the source organism and production parameters, including that the enzyme preparation is derived from a genetically modified Bacillus subtilis strain that expresses the alpha-acetolactate decarboxylase gene from Bacillus brevis. It further outlines that the enzyme may be stabilized with approved agents and must meet specifications for enzyme preparations as defined in recognized compendia. This regulatory citation reflects that the enzyme preparation is an approved enzyme food additive for use as a processing aid in the production of alcoholic malt beverages and distilled liquors under the conditions set out in the regulation. The citation 21 CFR 173.115 provides assurance that the additive has been evaluated and authorized by the U.S. Food and Drug Administration for these uses. (联邦公报) Internationally, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) has evaluated alpha-acetolactate decarboxylase from Bacillus brevis expressed in Bacillus subtilis and established that an acceptable daily intake (ADI) was "not specified," indicating that, when used according to good manufacturing practice, the enzyme preparation does not raise safety concerns at expected levels of exposure. Such an ADI designation by JECFA is often interpreted by regulatory bodies to mean that a formal numeric limit is not necessary based on available safety data. (FAOHome) In other regulatory frameworks, enzyme preparations used as processing aids may be subject to specific listing, specification, and purity requirements. These vary by region and may involve distinct evaluations by food safety authorities or adherence to compendial specifications such as those found in the FAO/WHO Combined Compendium of Food Additive Specifications.
Taste And Functional Properties
The primary function of ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT is catalytic rather than sensory. As an enzyme, it does not contribute a distinct taste to foods in the way that flavoring agents do. Instead, its action influences the sensory attributes of fermentative beverages by steering the biochemical conversion pathways that occur during fermentation. Specifically, by accelerating the decarboxylation of alpha-acetolactate to acetoin, it reduces the formation of diacetyl, a compound associated with undesirable buttery or butterscotch off-flavors when present above sensory thresholds. The functional behavior of enzyme preparations like this one is influenced by factors such as temperature, pH, and the composition of the fermentation medium. In brewing applications, for example, the enzyme must remain active within the typical temperature and pH ranges encountered during fermentation. Enzymes such as alpha-acetolactate decarboxylase are proteins that exhibit catalytic activity at moderate temperatures; activity generally declines outside the optimal range. Stability of the enzyme preparation is achieved through formulation and stabilization during manufacturing to ensure that sufficient activity is maintained when introduced into industrial fermentation settings. Because the enzyme is not consumed as a substrate itself and is used in small quantities, it typically does not impart recognizable tastes or functional effects unrelated to its catalytic role. Its utility is entirely in modifying metabolic pathways that influence the levels of specific metabolites, such as diacetyl, that can impact sensory perceptions in beverages.
Acceptable Daily Intake Explained
Acceptable daily intake (ADI) is a regulatory concept used to describe the estimated amount of a food additive that can be consumed daily over a lifetime without appreciable health risk. It is often expressed on a body weight basis and derived from toxicological studies with safety factors applied. In the case of ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT, JECFA has designated an ADI "not specified," which means that, based on the available toxicological and exposure data, the enzyme preparation can be used as intended without the need to establish a numerical ADI limit. This classification is typically applied to substances for which the committee considers there is no safety concern at levels resulting from its use as a processing aid. An "ADI not specified" does not imply that any amount is acceptable under all circumstances, but rather that typical dietary exposure through the intended use is sufficiently low and supported by data indicating low toxicity. In practical terms, enzyme preparations used at technologically necessary levels during food processing do not result in significant residual amounts in the final food product. As proteins, they are generally digested into amino acids in the human gastrointestinal tract and do not persist as active enzymes in the body. Consumers should understand that the ADI concept is a conservative regulatory tool designed to protect public health and that an "ADI not specified" designation by JECFA reflects a high degree of confidence in the safety of the additive when used appropriately in food manufacturing.
Comparison With Similar Additives
ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT can be compared with other enzyme preparations used in food processing to illustrate differences in function and application. For example, proteases are a class of enzymes that hydrolyze peptide bonds and are widely used in cheese production, meat tenderization, and protein hydrolysis processes. Unlike alpha-acetolactate decarboxylase, which targets a specific intermediate in fermentation pathways, proteases act on a broad range of peptide substrates and influence texture and flavor through protein breakdown. Another category of food enzymes includes amylases, which catalyze the breakdown of starch into simpler sugars. These enzymes are used in baking and brewing to enhance fermentable sugar availability. In contrast to alpha-acetolactate decarboxylase’s role in modulating flavor compound formation, amylases primarily influence carbohydrate metabolism during processing. Lactase, an enzyme that hydrolyzes lactose into glucose and galactose, is another processing enzyme that, when added to dairy products, reduces lactose content to aid digestion for lactose-intolerant individuals. While lactase’s function has a direct connection to consumer digestion attributes, alpha-acetolactate decarboxylase’s role is specific to improving processing outcomes and sensory attributes in fermented beverages. These comparisons highlight that different enzyme preparations have distinct catalytic activities tailored to specific technological objectives in food production. The regulatory evaluation of each enzyme considers its source, production process, intended function, and safety profile within the context of its use.
Common Food Applications Narrative
ALPHA-ACETOLACTATE DECARBOXYLASE ENZYME PREPARATION FROM BACILLUS SUBTILIS RECOMBINANT finds its primary application in the production of fermented beverages, particularly alcoholic products such as beer and distilled spirits. In traditional brewing processes, diacetyl can accumulate during fermentation and contribute undesirable buttery off-flavors that require a maturation period for natural reduction. By introducing this enzyme preparation into the process, brewers can accelerate the conversion of alpha-acetolactate to acetoin, thereby reducing the formation of diacetyl and lessening the need for prolonged conditioning time. This catalytic adjustment supports more efficient and consistent production practices. The enzyme is used as an aid in various fermentation steps, especially where controlling flavor formation and fermentation kinetics is important. Its use can be of particular interest in larger-scale operations where throughput and flavor consistency are critical considerations. In this context, the enzyme acts during the fermentation stage and is not a consumable ingredient in the final product but rather a technological agent that enhances the manufacturing process. Beyond alcoholic beverage production, enzyme preparations with similar catalytic profiles may also be explored for their potential to modulate specific biochemical pathways in other fermented foods. However, the predominant and well-documented use of this specific recombinant enzyme preparation is in the brewing and fermentation industry, where it helps producers achieve desired sensory outcomes more reliably and efficiently.
Safety & Regulations
FDA
- Approved: True
- Regulation: 21 CFR 173.115
EFSA
- Notes: No specific EFSA evaluation located for this enzyme preparation.
JECFA
- Notes: JECFA designated an ADI not specified but did not provide a numeric value or year on the available record.
- Adi Display: ADI not specified
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