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Wine and Juice Treating Materials and Processes for Domestic Wine Production

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.

The application should be mailed to:

Director, Regulations and Rulings Division
Alcohol and Tobacco Tax and Trade Bureau
1310 G Street, NW., Box 12
Washington, DC 20005

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 .

The application should be mailed to:

Director, Regulations and Rulings Division
Alcohol and Tobacco Tax and Trade Bureau
1310 G Street, NW., Box 12
Washington, DC 20005

Conditions and limitations on continual use approvals.

Approvals 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 §§ 24.246 – 24.248 based on letter requests we have approved under § 24.250 by publishing 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. That final rule action will supersede the prior continual use approvals under § 24.250 .

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

The following wine and juice treating materials and processes have been approved as acceptable in good commercial practice under our authority in § 24.250, but have not been subject to subsequent rulemaking:

MATERIALS AUTHORIZED FOR THE TREATMENT OF WINE AND JUICE

Materials and use	Reference or limitation	TTB notes
Acacia (gum arabic): To clarify and to stabilize wine.	The amount used shall not exceed 16 lbs/1000 gals (1.92 g/L) of wine. 21 CFR 184.1330 (GRAS).	Preliminary conclusion allowing increase from 2 lbs/1000 gals 3/1/2011.
Biotin: Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 182.8159 (GRAS).	Preliminary conclusion allowing use of biotin 8/1/2011.
Calcium Pantothenate: Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 184.1212 (GRAS).	Preliminary conclusion allowing use of calcium pantothenate 6/29/2011.
Carboxymethyl cellulose: To stabilize wine by preventing tartrate precipitation.	The amount used must not exceed 0.8% of the wine. 21 CFR 182.1745 (GRAS).	Preliminary conclusion allowing use of carboxymethyl cellulose 4/16/2012.
Chitosan: To remove spoilage organisms such as Brettanomyces from wine.	The Chitosan must be derived from Aspergillus niger. The amount used must not exceed 10 grams per 100 liters of wine. GRAS Notice No. GRN 000397.	Preliminary conclusion allowing use of Chitosan 1/23/13.
Enzymatic activity Cellulase (beta-glucanase): To clarify and filter wine.	The enzyme activity must be derived from Tricoderma longibrachiatum or Tricoderma harzianum. The amount used must not exceed 300 ppm. 21 CFR 184.1250 (GRAS) and GRAS Notice No. GRN 000149.	Preliminary conclusion allowing use of beta-glucanase derived from Tricoderma harzianum 8/25/2010.
Folic Acid: Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 172.345 (GRAS).	Preliminary conclusion allowing use of folic acid 6/29/2011.
Inositol (myo-inositol): Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 184.1370 (GRAS).	Preliminary conclusion allowing use of Inositol (myo-inositol) 8/1/2011.
Magnesium Sulfate: Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 184.1443 (GRAS).	Preliminary conclusion allowing use of magnesium sulfate 6/29/2011.
Mannoprotein: To stabilize wine from the precipitation of potassium bitartrate crystals.	The amount used must not exceed 50-400 milligrams per liter (mg/L). GRAS Notice No. GRN 000284.	Preliminary conclusion allowing use of mannoprotein 10/31/2011.
Niacin: Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 184.1530 (GRAS).	Preliminary conclusion allowing use of niacin 6/29/2011.
Polyvinyl-polypyr-rolidone (PVPP)/ polyvinylimadazole (PVI) polymer: To remove heavy metal ions and sulfides from wine.	The amount used to treat the wine must not exceed 80 grams per 100 liters of wine. 21 CFR 173.50 and FDA FCN No. 320.	Preliminary conclusion allowing use 8/25/2010.
Pyridoxine (pyridoxine hydrochloride): Yeast nutrient before and during fermentation.	The amount used must not exceed that of good commercial practice. 21 CFR 184.1676 (GRAS).	Preliminary conclusion allowing use of pyridoxine (pyridoxine hydrochloride) 8/1/2011.
Synthetic (L(+)) Tartaric Acid: to correct natural acid deficiencies in grape juice/wine and to reduce the pH of grape juice/wine where ameliorating material is used in the production of grape wine.	Use as prescribed in 27 CFR 24.182 and 24.192. FDA GRAS Notice GRN 000187 (GRAS).	Preliminary conclusion allowing use of synthetic (L(+)) tartaric acid, 12/20/2011.

PROCESSES AUTHORIZED FOR THE TREATMENT OF WINE, JUICE, AND DISTILLING MATERIAL

Process and Use	Reference or limitation	TTB Notes
Reverse osmosis in combination with osmotic transport: To reduce ethyl alcohol content in wine.	See reference and limitation for each process in 27 CFR 24.248. The two processes may be used in combination.	Preliminary conclusion allowing use in combination 8/25/2010.
Ultrafiltration: To separate red juice into low color and high color fractions.	Permeable membranes that are selective for molecules greater than 500 and not less than 25,000 molecular weight with transmembrane pressures less than 200 psi. Shall not alter vinous character.	Preliminary conclusion allowing use 4/16/2012.