Wine and Juice Treating Materials and Processes for Domestic Wine Production | TTB: Alcohol and Tobacco Tax Trade Bureau

The following information addresses the regulatory requirements for wine and juice treating materials and processes. These regulations and those pertaining to the production of wine can be found in part 24 of Title 27 of the Code of Federal Regulations (27 CFR part 24).

TTB statutory authority.

TTB has been delegated authority under 26 U.S.C. Chapter 51 of the Internal Revenue Code of 1986 (IRC) to promulgate regulations pertaining to wine. The statutory provisions under which TTB promulgates such regulations include Section 5382 of the IRC (26 U.S.C. 5382). Section 5382 of the IRC provides that proper cellar treatment of natural wine constitutes those practices and procedures that produce a finished product acceptable in good commercial practice as prescribed by regulation. Section 5382 also authorizes the promulgation of regulations setting forth limitations on the preparation and use of methods and materials for clarifying, stabilizing, preserving, fermenting, and correcting wine and juice.

The regulations promulgated under the IRC regarding wine treating materials and processes can be found in 27 CFR 24.246, 24.248 , 24.249, and 24.250.

Regulations on authorized wine and juice treating materials and processes.

As provided in § 24.246, wine and juice treating materials are used in the process of filtering, clarifying, or purifying wine and may remove cloudiness, precipitation, and undesirable odors and flavors.

The addition of any substance foreign to wine which changes the character of the wine, or the abstraction of ingredients which will change its character, to the extent inconsistent with good commercial practice, is not permitted on bonded wine premises.
The Assistant Administrator, Headquarters Operations, may cancel or amend the approval for use of a material or process in the production, cellar treatment, or finishing of wine and juice when the specified use or limitation of any material in the table is determined to be unacceptable for use in foods and beverages by the U.S. Food and Drug Administration (FDA).

The materials listed in the table at the end of § 24.246 are approved as being consistent with good commercial practice in the production, cellar treatment, or finishing of wine, and where applicable in the treatment of juice, within the general limitations provided in § 24.246 and the limitations listed in the table.

As provided in § 24.248, any process which changes the character of the wine to the extent inconsistent with good commercial practice is not permitted on bonded wine premises.

The processes listed in the table at the end of § 24.248 are approved as being consistent with good commercial practice for use by proprietors in the production, cellar treatment, or finishing of wine and juice within the limitations specified in that section.

Approval of treating materials and processes not listed in § 24.246 and § 24.248.

TTB may administratively approve the use of treating materials and processes not listed in the regulations under two regulatory authorities:

As an experiment under § 24.249; and
For continual use (acceptable in good commercial practice) under § 24.250.

Experimentation with new treating material or process.

In accordance with the requirements in § 24.249, and with prior approval from TTB, proprietors may conduct experimentations with a treating material or process in a manner that will not jeopardize the revenue, conflict with wine operations, or be contrary to law.

Prior to conducting an experiment, the proprietor must file an application with the Director, Regulations and Rulings Division (RRD).

The application must set forth, in detail, the experimentation to be conducted and indicate the facilities and equipment to be used. You may submit your application electronically using this Contact RRD Form.

The experimentation cannot be conducted until the Director, RRD has:

Determined that the experimentation will not jeopardize the revenue;
Determined that the experimentation does not conflict with wine operations;
Determined that the experimentation is not contrary to law; and
Approved the application.

If approved, the:

Experimentation must be conducted separately from wine operations; and
Proprietor must keep records of the kind and quantity of materials received and used, and the volume of wine treated and the manner by which disposed.

TTB maintains the authority to apply more conditions to specific requests to protect the revenue and to ensure that the experimentation does not place an administrative burden on the Government.

You can view the application requirements and standards regarding approval of the experimental use of a new treating material or process in § 24.249.

Continual use of a wine treating material or process (acceptable in good commercial practice).

Consistent with §§ 24.246 and 24.248, TTB may approve use of wine treating materials and processes that are determined to be acceptable in good commercial practice. In general, good commercial practice includes addressing the reasonable technological or practical need to enhance the keeping, stability, or other qualities of the wine, and achieving the winemaker's desired effect without creating an erroneous impression about the character and composition of the wine. Generally, TTB considers approval of continual use only after several experiments have been conducted with the same method or process.

Applications for such approval must be submitted in accordance with the requirements set forth in § 24.250. In general, § 24.250 requires that the application shows that the proposed material or process is a cellar treatment consistent with good commercial practice; § 24.250 further requires that the application provide:

The name and description of the material or process;
The purpose, manner, and extent to which the material or process is to be used together with any technical bulletin or other pertinent information relative to the material or process;
A sample, if a proposed material;
Documentary evidence of the FDA's approval of the material for its intended purpose in the amounts proposed for the particular treatment contemplated;
The test results of any laboratory scale pilot study conducted by the winemaker in testing the material and an evaluation of the product and of the treatment including the results of tests of the shelf life of the treated wine;
A tabulation of pertinent information derived from the testing program conducted by the chemical manufacturer demonstrating the function of the material or process;
A list of all chemicals used in compounding the treating material and the quantity of each component;
The recommended maximum and minimum amounts, if any, of the material proposed to be used in the treatment and a statement as to the volume of water required, if any, to facilitate the addition of the material or operation of the process; and
Two 750-milliliter samples representative of the wine before and after treatment.

Information of a confidential or proprietary nature to the manufacturer or supplier of the treating material or process may be forwarded by the manufacturer or supplier to TTB.

You can view the application requirements and standards for approval of new treating materials or processes in § 24.250.You can view the application requirements and standards for approval of new treating materials or processes in § 24.250. Send the application electronically using this Contact RRD Form.

Conditions and limitations on continual use approvals.

Approvals for continual use of a treating material or process, made under § 24.250, are subject to the following conditions and limitations:

Use for Domestic Wine. These approvals only apply to wines distributed domestically and do not imply the acceptability of wines so treated in foreign markets. Accordingly, if you wish to export the treated wine, you should check with each destination country to ensure that this is an acceptable treatment for wines sold there.
Generally Recognized as Safe (GRAS) Determination. TTB relies on and consults with FDA with regard to the use and acceptability of materials used in the production of wine. FDA has the authority to qualify substances as GRAS for addition to food products. TTB has the authority to rescind the use of any material if the FDA finds that a material is no longer accepted as safe for addition to foods.
Subsequent Rulemaking. TTB will propose changes to the list of approved wine treating materials and processes in the TTB regulations at §§ 24.246 – 24.248 based on letter requests we have approved under § 24.250, including those listed in the tables below. Proposed changes to the regulations will be published as a Notice of Proposed Rulemaking in the Federal Register. In our rulemaking, we will identify the evidence that we relied on when we approved the letter requests and any conditions and limitations that we imposed on those approvals. We will request public comments on whether these materials and processes should be listed in §§ 24.246 – 24.248 and whether the conditions and limitations are appropriate. After considering the comments, we will publish a final rule that either adds the treatments or processes to the regulations or concludes that their use is not consistent with good commercial practice. The final rule may also determine additional information is needed through subsequent notice and comment. The final rule action will supersede the prior continual use approvals under § 24.250, and this webpage will be updated to reflect any changes.*

Wine and juice treating materials and processes that have been administratively approved for continual use.

The following lists wine and juice treating materials and processes that TTB has approved as acceptable in good commercial practice under our authority in § 24.250, pending the outcome of rulemaking. As a result of this administrative approval, industry members do not need to apply to TTB to use these treatments, provided any listed limitations are met.

MATERIALS FOR THE TREATMENT OF WINE AND JUICE ADMINISTRATIVELY APPROVED FOR CONTINUAL USE PENDING THE OUTCOME OF RULEMAKING

(See § 24.246 for materials authorized under TTB regulations, including those authorized in T.D. TTB-185, published and effective August 24, 2022)

Materials and use	Reference or limitation	TTB notes
Beta-glucosidase enzyme preparation: To aid in fining and the removal of off flavors in wine and juice.	The beta-glucosidase enzyme preparation must be derived from Aspergillus niger. The amount used must not exceed 0.363 g/L (36.3 g/hL). GRAS Notice No. 000750.	Preliminary conclusion, as of July 18, 2023, allowing the use of beta-glucosidase derived from Aspergillus niger.
Biotin: Fermentation aid to facilitate fermentation of juice and wine	The amount used must not exceed that of good commercial practice only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize the use of biotin at a rate not to exceed 25 ppb (25 ng/mL). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*
Calcium Pantothenate: Fermentation aid to facilitate fermentation of juice and wine.	The amount used must not exceed that of good commercial practice only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize use at a rate not to exceed 1.5 ppm (1.5 mg/L). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*
Chitin-glucan: To clarify and to stabilize wine.	Chitin-glucan must be derived from Aspergillus niger. The amount used must not exceed 500g/hL of wine. GRAS Notice No. GRN 000412.	Preliminary conclusion, as of September 22, 2022, allowing use of chitin-glucan derived from Aspergillus niger.
Chitosan: To remove spoilage organisms such as Brettanomyces from wine, and for clarification, fining, and removing off flavors from wine and juice.	The Chitosan must be derived from Aspergillus niger. The amount used must not exceed 500 grams per 100 liters of wine. GRAS Notice No. GRN 000397.	TTB regulations authorize the use of chitosan to remove spoilage organisms such as Brettanomyces at a rate not to exceed 0.04 pounds per 1 gallon (500 g/100 L) of wine. TTB has also made the preliminary conclusion, as of March 17, 2022, of allowing the use of chitosan to remove off flavors.
Copper sulfate: To remove hydrogen sulfide and/or mercaptans from wine	The quantity of copper sulfate added (calculated as copper) must not exceed 6 parts copper per million parts of wine (6.0 mg/L). The residual level of copper in the finished wine must not exceed 1 part per million (1 mg/L). 21 CFR 184.1261 (GRAS).	Preliminary conclusion, as of May 7, 2018, allowing increase of the residual level of copper from 0.5 parts per million (0.5 mg/L) to 1 part per million (1 mg/L). TTB regulations at § 24.246, as amended August 24, 2022, state that the residual level of copper in the finished wine must not exceed 0.5 parts per million (0.5 mg/L). TTB continues to allow, through this administrative approval under § 24.250, the residual level of copper in the finished wine not to exceed 1 part per million (1 mg/L) pending additional rulemaking.
Folic Acid: Fermentation aid to facilitate fermentation of juice and wine.	The amount used must not exceed that of good commercial practice, only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize use at a rate not to exceed 100 ppb (100 ng/mL). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*
Inositol (myo-inositol): Fermentation aid to facilitate fermentation of juice and wine.	The amount used must not exceed that of good commercial practice, only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize use at a rate not to exceed 2 ppm (2 mg/L). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*
Magnesium Sulfate: Fermentation aid to facilitate fermentation of juice and wine.	The amount used must not exceed that of good commercial practice, only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize use at a rate not to exceed 15 ppm (15 mg/L). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*
Molecularly-imprinted adsorbent resins (molecularly-imprinted polymers or MIPs): For repeated use in the removal of target molecules such as off flavors or aromas, including but not limited to phenolic compounds associated with smoke taint/impact due to exposure from wildfire smoke.	The molecularly imprinted adsorbent resins must comply with 21 CFR §177.2420 paragraphs a, b, and d. Extractives testing under §177.2420 paragraph c is not required because MIP that achieves the intended technical effect will have a high food-contact surface to mass ratio implying the extractives specifications will be met.	Preliminary conclusion as of February 28, 2024.
Niacin: Fermentation aid to facilitate fermentation of juice and wine.	The amount used must not exceed that of good commercial practice, only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize use at a rate not to exceed 1 ppm (1 mg/L). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*
Pea protein: Fining agent and to remove off flavors from wine and juice.	The amount used must not exceed 0.5 g/L (50 g/hL). GRAS Notice No. GRN 000182.	Preliminary conclusion, as of March 17, 2022, allowing the use of pea protein.
Potassium Polyaspartate: To stabilize wine by preventing tartrate crystal precipitation.	The amount used must not exceed 100mg/L of wine. GRAS Notice No. GRN 000770.	Preliminary conclusion, as of February 7, 2020, allowing use of potassium polyaspartate.
Pyridoxine (pyridoxine hydrochloride): Fermentation aid to facilitate the fermentation of juice and wine.	The amount used must not exceed that of good commercial practice, only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining yeast nutrient in the wine would be de minimis.	TTB regulations at § 24.246, as amended August 24, 2022, authorize use at a rate not to exceed 150 ppb (150 ng/mL). TTB continues to allow, through this administrative approval under § 24.250, use at a rate not to exceed that of good commercial practice pending additional rulemaking on such a use rate.*

* As explained in T.D. TTB 185, published and effective August 24, 2022, TTB intends to engage in additional rulemaking regarding fermentation aids (yeast nutrients). In the interim, TTB will continue to allow, under an administrative approval pending rulemaking, the use of biotin, calcium pantothenate, folic acid, inositol, magnesium sulfate, niacin, and pyridoxine hydrochloride at levels consistent with good commercial practice, only for the purpose of providing nutrients to the yeast, and not to fortify the wine, where the level of any remaining nutrient in the wine would be de minimis.

PROCESSES FOR THE TREATMENT OF WINE, JUICE, AND DISTILLING MATERIAL ADMINISTRATIVELY APPROVED FOR CONTINUAL USE PENDING THE OUTCOME OF RULEMAKING

(See § 24.248 for processes authorized under TTB regulations, including those authorized in T.D. TTB-185, published and effective August 24, 2022)

Process and Use	Reference or limitation	TTB Notes
Electrodialysis: To aid in the removal of tartrates, and to adjust the pH.	This process must not alter the vinous character of the wine.	Electrodialysis to aid in the removal of tartrates is approved at 27 CFR 24.248. Preliminary conclusion allowing the use of electrodialysis to adjust the pH of wine and juice, as of March 24, 2023.
Spinning Cone Column: To reduce the ethyl alcohol content of wine and to remove off flavors in wine	Use shall not alter vinous character. For standard wine, the same amount of essence must be added back to any lot of wine as was originally removed. Water separated from alcohol during processing may be recovered by refluxing in a closed continuous system and returning it to the wine. The addition of water other than that originally present in the wine prior to processing, will render standard wine "other than standard."	TTB regulations at § 24.248, as amended, August 24, 2022, authorize the use of the spinning cone column process, but does not authorize the addition of the original water that was removed through the use of the process back to the wine, with the resulting wine to be considered standard wine. TTB continues to allow, through this administrative approval under § 24.250, the use of reflux distillation to separate the water from neutral alcohol removed during spinning cone column process and return of the water back to the reduced alcohol wine in a continuous process.