CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS

CAS: 977082-97-5 ENZYME

CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS is an enzyme preparation used in food processing. It is derived from fermentation of Bacillus subtilis and combines carbohydrase and protease activities to help break down carbohydrates and proteins in food ingredients.

What It Is

CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS is a food enzyme preparation that combines carbohydrase activities, which catalyze the hydrolysis of certain carbohydrate bonds, with protease activities, which catalyze the breakdown of proteins into smaller peptides. These enzyme functions assist in specific biochemical reactions during food processing. This preparation is produced from strains of the bacterium Bacillus subtilis and is identified in regulatory inventories such as the U.S. Food and Drug Administration Substances Added to Food (formerly EAFUS) where it is listed with CAS Registry Number 977082-97-5. The mixture enables the targeted breakdown of macromolecules in food systems and is typically used for its catalytic activity rather than as a nutrient or flavoring agent. The designation "enzyme" reflects its role as a biological catalyst, not a source of dietary protein or carbohydrate. Enzyme preparations like this one are classified separately from direct nutrients or additives that contribute to flavor or nutrition.

How It Is Made

The enzyme preparation CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS is manufactured through controlled fermentation of selected, nonpathogenic strains of the microorganism Bacillus subtilis. During production, the organism is grown in nutrient media under conditions that promote the expression and secretion of carbohydrase and protease enzymes. After fermentation, the culture is processed to separate and purify the enzyme mixture from the cells and fermentation medium. Downstream processing typically includes filtration, concentration, and drying to yield a stable powdered enzyme preparation suitable for use in food processing. Because the manufacturing process involves biological fermentation rather than chemical synthesis, the final preparation can vary in specific activity based on production strain, fermentation conditions, and purification steps. Regulatory specifications for enzyme preparations such as this focus on microbial strain history, absence of toxic substances, and adherence to good manufacturing practices to ensure consistent safety and functionality in food applications. General specifications described in codified additive monographs help processors ensure quality and consistency across production batches. The technical function of this mixture arises directly from the combination of enzymatic activities produced by the organism during fermentation.

Why It Is Used In Food

CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS is used in food manufacturing to catalyze the breakdown of complex carbohydrates and proteins into simpler components. The carbohydrase component helps cleave carbohydrate polymers into smaller sugars or oligosaccharides, while the protease component hydrolyzes peptide bonds in proteins to yield smaller peptides and amino acids. This dual enzymatic activity can be useful in processes where simultaneous modification of both carbohydrate and protein fractions is desired, such as in the production of starch syrups, clarification of beverages, or preparation of protein hydrolysates. Although specific use levels are governed by good manufacturing practice rather than regulatory limits, the catalytic functions of these enzymes support process efficiency, product consistency, and ingredient transformation without materially altering final product composition beyond intended modifications. Enzyme preparations are typically applied during processing steps where targeted biochemical reactions improve extractability, digestibility, or functional properties of raw materials. The choice to use a combined carbohydrase/protease mixture reflects a desire to streamline processing by harnessing multiple catalytic activities in one ingredient rather than separate enzyme additions.

Adi Example Calculation

Because a formal numeric ADI value is described by JECFA as "not limited", an illustrative calculation is not applicable for this specific ingredient. In general, ADI calculations for food additives involve dividing a no-observed-adverse-effect level (NOAEL) from toxicological studies by a conservative safety factor to derive a value expressed in milligrams per kilogram of body weight per day. For ingredients with an ADI described as not limited, this reflects a determination that, within the range of typical exposures from use in food processing, there is no evidence from relevant toxicological data indicating that intake at those levels would pose appreciable risk.

Safety And Health Research

Mixed enzyme preparations derived from Bacillus subtilis have been evaluated by organizations such as JECFA, which determined that a preparation of mixed microbial carbohydrase and protease from Bacillus subtilis did not raise toxicological concerns and assigned an Acceptable Daily Intake described as "not limited" on the basis of available data. Toxicological studies d in historical evaluations include information on acute and subacute effects of enzyme preparations, and these data supported the conclusion that enzyme preparations of this type do not exhibit significant toxicological hazards at levels typically encountered in food processing. Research on food enzyme safety generally emphasizes the history of safe use of Bacillus subtilis strains in fermentation and enzyme production, the nonpathogenic nature of the production strains, and the absence of viable production organisms or harmful metabolites in purified enzyme preparations. Safety assessments for food enzymes consider potential allergenicity, microbial strain characteristics, and manufacturing controls to ensure that the preparation does not introduce hazards into food products.

Regulatory Status Worldwide

In the United States, CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS is listed in the FDA Substances Added to Food inventory (formerly EAFUS) as a technical enzyme preparation used in food processing, indicating recognition for use based on historical safety and expert evaluation rather than a specific numeric regulatory limit. This inventory listing reflects that enzyme preparations derived from nonpathogenic microorganisms can be used under conditions of good manufacturing practice. In the U.S. Code of Federal Regulations, enzyme preparations similar to this one are subject to general provisions that permit use as direct food ingredients when produced in accordance with safety criteria and accepted manufacturing practices. According to the Joint FAO/WHO Expert Committee on Food Additives (JECFA), mixed microbial carbohydrase and protease preparations from Bacillus subtilis were evaluated in 1971 and assigned an Acceptable Daily Intake described as "not limited", meaning that no specific quantitative intake limit was established because of low toxicity and the nature of enzyme proteins. Use is nevertheless expected to be limited by good manufacturing practice. Regulatory frameworks outside the U.S. similarly consider enzyme preparations on a case-by-case basis, often requiring safety dossiers for approval within specific jurisdictions and subjecting them to evaluation by food safety authorities before inclusion in positive lists for food use.

Taste And Functional Properties

As an enzyme preparation, CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS does not contribute taste in the way that flavoring agents or sweeteners do. Its primary influence on sensory attributes comes indirectly through its catalytic action on substrate components during processing: breakdown of complex carbohydrates can yield simpler sugars that may contribute subtle sweetness, while protein hydrolysis can influence texture or solubility in ways that affect mouthfeel. These effects are secondary to its catalytic function and depend on the food matrix and process conditions. Functionally, the enzyme mixture is active under a range of processing conditions typical of food manufacturing, although specific activity will vary with temperature, pH, and substrate availability. Enzymes generally display temperature and pH optima that reflect their microbial origin, and their activity in a given food application is governed by how closely process conditions match those optima. The mixture is soluble in aqueous environments, where the enzymatic reactions take place, and is generally inactivated by high heat or extremes of pH encountered in later stages of food processing.

Acceptable Daily Intake Explained

The concept of Acceptable Daily Intake (ADI) refers to an estimate of the amount of a food additive that can be ingested daily over a lifetime without appreciable health risk, based on available toxicological data and safety factors. For enzyme preparations such as CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS, a formal numerical ADI value is not established because JECFA characterized the ADI as "not limited", indicating that the available safety data did not suggest a level of concern at dietary exposures realistically encountered through food processing. However, the lack of a numeric ADI should not be interpreted as an unrestricted recommendation to consume large amounts; rather, enzyme preparations are used at levels sufficient to achieve their functional purpose in manufacturing, and their presence in finished products is minimized by good manufacturing practices.

Comparison With Similar Additives

CARBOHYDRASE AND PROTEASE, MIXTURE, FROM BACILLUS SUBTILIS can be compared with other enzyme preparations used in food processing, such as carbohydrase enzymes derived from Aspergillus species, which primarily target carbohydrate polymers like starch, and protease preparations from other microbial sources that focus solely on protein hydrolysis. Mixed enzyme preparations combine catalytic functions in a single ingredient, which can simplify formulation and processing compared to using separate enzymes sequentially. Compared to single-function enzymes, mixtures may provide broader substrate modification but require careful control to avoid over-hydrolysis or unintended effects in the food system. In contrast to some chemically synthesized additives that provide sensory effects (e.g., sweeteners or flavor enhancers), enzyme preparations function by facilitating biochemical changes in the food matrix.

Common Food Applications Narrative

Enzyme preparations with combined carbohydrase and protease activities are used across a variety of food manufacturing contexts where targeted breakdown of carbohydrates and proteins is desired. For example, in the production of starch-derived ingredients, carbohydrase activity can help depolymerize starch into simpler sugar units to improve process yields or modify functional properties. In beverage processing, such enzymes can assist with clarification by reducing macromolecular complexes that cause haze. Protein hydrolysates produced with protease activity may serve as functional ingredients in formulations for flavor enhancement, texture modification, or nutritional adjustments. Bakery product manufacturers sometimes use enzyme additives to improve dough handling or crumb structure by selectively modifying flour components. These enzyme functions are chosen based on specific processing goals rather than for direct flavor contributions, and their use is governed by good manufacturing practices to achieve consistent processing outcomes.

Safety & Regulations

FDA

  • Notes: FDA listing in EAFUS indicates recognition of use based on historical safety, but specific CFR section for this exact ingredient could not be verified.

EFSA

  • Notes: No EFSA evaluation specific to this mixed enzyme preparation found in authoritative lists.

JECFA

  • Year: 1971
  • Notes: JECFA assigned an ADI described as not limited based on evaluation but numerical ADI mg per kg not specified in the referenced monograph.
  • Adi Display: Not limited

Sources

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