TTB received petitions for the following adjuncts that contained sufficient evidence for us to approve their use in the production of beer and cereal beverages (as defined in 27 CFR Part 25) for sale to consumers. All brewers may use these adjuncts in the production of beer when they are used as outlined below and in accordance with good brewing practices.
Calcium pantothenate is a common supplemental form of pantothenic acid, commonly referred to as vitamin B. Calcium pantothenate is often used in dietary supplements due to its greater stability as a salt than pantothenic acid, which allows for better absorption. We note that pantothenic acid is naturally present in malted grain and there is no method currently available to differentiate this natural compound from the synthetic equivalent, calcium pantothenate. Therefore, laboratory analysis of samples was not performed since it would not have supplied useful data. We provide that the use of calcium pantothenate is safe for human consumption and that it is appropriate in the production and processing of beer (and cereal beverages).
We approve the use of calcium pantothenate as an appropriate material for brewery production under 27 CFR part 25 with no limitation other than current good manufacturing practice, as provided by the FDA (21 CFR 184.1212).
TTB provides that the use of dimethyl dicarbonate (DMDC) is appropriate for use in beer (and cereal beverages). DMDC is used or intended for use as a microbial control agent under normal circumstances of bottling, canning, or other forms of final packaging, where the viable microbial load has been reduced to 500 microorganisms per milliliter or less by current good manufacturing practices such as heat treatment, filtration, or other technologies prior to the use of DMDC.
Hop Extract and Sunflower Lecithin Antifoaming Products
We approve the use of two antifoaming products made with water, hop extract, and sunflower lecithin that are intended for use as a processing aid to control foaming in the fermentation tank during the brewing of beer based on our review of the manufacturer's submitted data and our subsequent laboratory analyses of product samples submitted. The results of analyses on the submitted samples showed no significant differences in the contents between the samples treated with the materials and the samples not treated. We also note that the Food and Drug Administration considers plant-derived lecithin as GRAS under 21 CFR 184.1400 and hops as GRAS under 21 CFR 182.20.
We approve the hop extract and sunflower lecithin antifoaming agents for use in the production of beer and cereal beverages (as defined in 27 CFR part 25) for sale to consumers when it is used in accordance with good brewing practice and in accordance with the manufacturer's guidelines.
To use this treating material, brewers should:
- Add it to the fermentation tank during fermentation; and
- Use at a dose rate of 5 to 50 g/hl.
We approve this polymer used to remove heavy metal ions, primarily iron and copper, during the filtration process of beer production. The components of this polymer are polyvinylpolypyrrolidone (PVPP) and polyvinylimadazole (PVI). This cross-linked, insoluble powder, which is slightly hygroscopic terpolymer, binds heavy metals that are present in alcohol beverages. PVPP is listed as an approved material in the Adjunct Reference Manual, maintained by the Beer Institute, as well as in TTB regulations at 27 CFR 24.246. PVI is a polymer related to the approved PVPP. We also note that the Food and Drug Administration (FDA) found no significant impact in response to the food contact notification of this material. Additionally, we conducted an analysis of beer treated with this material and found that it does not alter the characteristics of the product and that heavy metals are reduced in the final product when it is used. Therefore, on March 27, 2007, we concluded that this treating material does not alter the characteristics of the product and it is appropriate for use in the production of beer.
To use this treating material, brewers should:
- add it directly to the alcohol beverage during the maturation process at levels not exceeding 80 grams per 100 liters of beverage, and
- limit its use to a single application.
We approve this extruded physical blend of polyvinylpolypyrrolidone (PVPP) and polystyrene (PS) as an adjunct treating material in beer production. It is used in the same manner as diatomaceous earth as a filtering system for a dose tank. The results of analyses on samples submitted showed no significant differences in the contents between the sample treated with the material and the sample not so treated.
Specifically, no toxic metals were introduced into the product as a result of its use. Additionally, organoleptic evaluations (odor and taste) revealed the samples to be indistinguishable and that the odor and taste of beer was unchanged. We also note that the FDA found no significant impact in response to the food contact notification. Therefore, on December 19, 2007, we concluded that this treating material does not alter the characteristics of the product and it is appropriate for use in the production of beer.
To use this treating material, brewers should:
- use it as a filtering agent with a similar application as diatomaceous earth;
- not exceed common use levels in the range of 80 -150 grams per 100 liters, depending on the characteristics of the beer; and
- only regenerate for reuse in accordance to the manufacturer’s guidelines.
ALDC ENZYME PREPARATION
TTB has formally approved an ALDC enzyme preparation containing acetolactate decarboxylase produced by B. licheniformis carrying an acetolactate decarboxylase gene from B. brevis for use as a processing aid in the production of beer and cereal beverages. The manufacturer of the enzyme provides that the enzyme preparation prevents the formation of diacetyl during fermentation without influencing the flavor profile of the final beer. The ALDC enzyme preparation may be used by brewers in the processing of beer up to levels of 0.133 mg TOS/L of fermented wort, as specified in FDA's GRAS Notice No. GRN 000587.
β-GLUCANASE AND XYLANASE ENZYME PREPARATION
TTB has approved a mixed β-glucanase and xylanase enzyme preparation derived from a non-pathogenic and nontoxigenic strain of Humicola insolens as a processing aid for wort production. Brewers may use the mixed enzyme preparation in the mashing phase of the wort production process to ensure efficient breakdown of β-glucans, pentosans, and other gums. The manufacturer of the enzyme provides that the product will increase the wort and beer filtration rate and avoid haze.
We note that the Food and Drug Administration (FDA) responded to the manufacturer of the mixed enzyme preparation on September 21, 2006. The FDA’s response provided that the agency had no questions regarding the manufacturer’s conclusion that mixed β-glucanase and xylanase enzyme preparation is generally recognized as safe (GRAS) under the intended conditions of use (GRAS Notice No. GRN 000195).
To use this enzyme preparation, brewers should use:
- the minimum level necessary to achieve the desired effect, not to exceed 150-300 grams of the mixed enzyme preparation per ton of total raw materials
- in accordance with good manufacturing practices.
Lipase is a mixed enzyme preparation derived from Aspergillus oryzae carrying a gene encoding lipase from Thermomyces lanuginosus. The enzyme preparation is used during the mashing phase of wort production to ensure sufficient breakdown of the cell wall materials, protein, starches, and fats of grains that are unmalted. Based on our review of submitted data pertaining to the use of the lipase enzyme preparation and our subsequent laboratory analyses of the product samples submitted, consistent with ATF Procedure 95-1, TTB approves the lipase enzyme preparation for use in the production of beer and cereal beverages (as defined in 27 CFR part 25) for sale to consumers when it is used in accordance with good brewing practice and in accordance with the manufacturer’s guidelines. The recommended dosage of the mixed enzyme preparation is stated as 1.2 kg to 2.5 kg per metric ton of total raw grain, depending on the brewer’s mashing routine.
Please note that TTB does not have authority to approve labeling of brewery products that are made exclusively from grains that are unmalted. The TTB regulation at 27 CFR 7.10 requires, in part, that malt beverages be “…made by the alcoholic fermentation of an infusion or decoction, or combination of both, in potable brewing water, of malted barley with hops…”. In cases where a brewery product (other than saké and similar products) fails to meet the definition of a malt beverage, the product is subject to ingredient and other labeling requirements administered by the U.S. Food and Drug Administration (FDA). For more information on this subject, please see TTB Ruling 2008-3, Classification of Brewed Products as “Beer” Under the Internal Revenue Code of 1986 and as “Malt Beverages” Under the Federal Alcohol Administration Act.
Lysozyme, which is described as an enzyme that is isolated from the whites of eggs, has the ability to lyse, or cause dissolution of, the cell walls of gram-positive bacteria. In 1993, the Food and Drug Administration (FDA) issued an advisory opinion, which stated that it was “currently unaware of any safety or health concerns for the general population with regard to the use of lysozyme in wine. Essentially, the use in question consists of adding a chemically unmodified major protein component (lysozyme) of one common food (eggs) to another common food (wine).” In 1997, TTB’s predecessor agency approved the use of lysozyme as a treating material to stabilize wines from malolactic acid bacterial degradation. In 2007, TTB added lysozyme to the list of enzymatic activity materials authorized for use in wine production in 27 CFR 24.246. Analysis by TTB of beer treated with this material revealed that it does not alter the characteristics of the product. Organoleptic (odor and taste) tests indicated that there was a slight difference in taste between the two samples. However, taste tests revealed a preference for the sample treated with lysozyme. We do not believe that there is any reason to conclude that the result reached with regard to the use of lysozyme in wine production would not have relevance to the production of beer. Additionally, studies have shown that lysozyme added to finished beer at 100 ppm was an effective alternative in sterilizing yeast and eliminating contaminating bacteria. Therefore, on September 12, 2008, we concluded that lysozyme is appropriate for use in the production of beer. To use this treating material, brewers should:
- not exceed 500 milligrams per liter.
PULLULANASE ENZYME PREPARATION
TTB has formally approved a pullulanase enzyme preparation produced in B. licheniformis carrying a modified synthetic gene from B. deramificans and B. acidopulluyticus as a processing aid in the production of beer and cereal beverages. The manufacturer provides that the pullulanase enzyme preparation is used as a processing aid that converts starches or dextrins into fermentable sugars during the mashing or fermentation stages of the production of beer and cereal beverages, particularly for low calorie or light beer products. The manufacturer's recommended dosage is at a maximum level of 129 milligrams total organic solids (mg TOS) per kilogram (kg) starch raw material, as specified in FDA's GRAS Notice No. GRN 000645.
How to Petition TTB to Approve a New Adjunct
To petition TTB regarding new additions to this online list, brewers must follow the process outlined in ATF Procedure 95-1. TTB may remove adjuncts from this list if persuasive evidence is subsequently provided that the material should not be used in beer.