[Code of Federal Regulations] [Title 27, Volume 1] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 27CFR24.246] [Page 574-577] TITLE 27--ALCOHOL, TOBACCO PRODUCTS AND FIREARMS CHAPTER I--BUREAU OF ALCOHOL, TOBACCO AND FIREARMS, DEPARTMENT OF THE TREASURY PART 24--WINE--Table of Contents Subpart L--Storage, Treatment and Finishing of Wine Sec. 24.246 Materials authorized for the treatment of wine and juice. (a) Wine. Materials used in the process of filtering, clarifying, or purifying wine may remove cloudiness, precipitation, and undesirable odors and flavors, but 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 materials listed in this section 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 of this section: Provided, That: (1) When the specified use or limitation of any material on this list is determined to be unacceptable by the U.S. Food and Drug Administration, the appropriate ATF officer may cancel or amend the approval for use of the material in the production, cellar treatment, or finishing of wine; and (2) Where water is added to facilitate the solution or dispersal of a material, the volume of water added, whether the material is used singly or in combination with other water based treating materials, may not total more than one percent of the volume of the treated wine, juice, or both wine and juice, from which such wine is produced. (b) Formula wine. In addition to the material listed in this section, other material may be used in formula wine if approved for such use. [[Page 575]] Materials Authorized for Treatment of Wine and Juice ------------------------------------------------------------------------ Materials and use Reference or limitation ------------------------------------------------------------------------ Acacia (gum arabic): To clarify and The amount used shall not exceed 2 to stabilize wine. lbs/1000 gals. (0.24 g/L of wine. 21 CFR 184.1330 (GRAS) *See footnote below. Activated carbon: To assist precipitation during 27 CFR 24.176. GRAS per FDA fermentation. advisory opinion dated 1/26/79. To clarify and to purify wine.. The amount used to clarify and purify wine shall be included in the total amount of activated carbon used to remove excessive color in wine. 27 CFR 24.241 and 24.242 (GRAS). To remove color in wine and/or The amount used to treat the wine, juice from which the wine was including the juice from which the produced. wine was produced, shall not exceed 25 lbs/1000 gal. (3.0 g/L). If the amount necessary exceeds this limit, a notice is required pursuant to 27 CFR 24.242 (GRAS). Albumen (egg white): Fining agent May be prepared in a light brine 1 for wine. oz. (28.35 grams) potassium chloride, 2 lbs (907.2 grams) egg white, 1 gal. (3.785 L) of water. Usage not to exceed 1.5 gals. of solution per 1,000 gals. of wine. (GRAS). Alumino-silicates (hydrated) e.g., 21 CFR Secs. 182.2727, 182.2729, Bentonite (Wyoming clay) and 184.1155 (GRAS) and 186.1256. GRAS Kaolin: To clarify and to per FDA advisory opinion dated stabilize wine or juice. July 26, 1985. Ammonium phosphate (mono- and di The amount used shall not exceed 8 basic): Yeast nutrient in wine lbs. per 1000 gals. (0.96 g/L) of production and to start secondary wine. 21 CFR 184.1141 (GRAS). fermentation in the production of sparkling wines. Ascorbic acid iso-ascorbic acid May be added to grapes, other fruit (erythorbic acid): To prevent (including berries), and other oxidation of color and flavor primary wine making materials, or components of juice and wine. to the juice of such materials, or to the wine, within limitations which do not alter the class or type of the wine. 21 CFR 182.3013 and 182.3041 (GRAS). Calcium carbonate (with or without calcium salts of tartaric and malic acids): To reduce the excess natural The natural or fixed acids shall acids in high acid wine, and not be reduced below 5 g/L. 21 CFR in juice prior to or during 184.1069 and 184.1099, and fermentation.. 184.1191 (GRAS). A fining agent for cold The amount used shall not exceed 30 stabilization.. lbs/1000 gals. (3.59 g/L) of wine. Calcium sulfate (gypsum): To lower The sulfate content of the finished pH in sherry wine.. wine shall not exceed 2.0g/L, expressed as potassium sulfate. 27 CFR 24.214. 21 CFR 184.1230 (GRAS). Carbon dioxide (including food 27 CFR 24.245. grade dry ice): To stabilize * * * 21 CFR 184.1240 (GRAS). and to preserve wine. Casein, potassium salt of casein: GRAS per FDA opinions of 02/23/60 To clarify wine. and 08/25/61. 27 CFR 24.243. Citric acid: To correct natural acid 27 CFR 24.182 and 24.192. deficiencies in wine. 21 CFR 182.1033 (GRAS). To stabilize wine other than The amount of citric acid shall not citrus wine. exceed 5.8 lbs/1000 gals. (0.7 g/ L). 27 CFR 24.244. 21 CFR 182.1033 (GRAS). Copper sulfate: To remove hydrogen sulfide and/ The quantity of copper sulfate or mercaptans from wine. added (calculated as copper) shall not exceed 0.5 part copper per million parts of wine (0.5 mg/L) with the residual level of copper not to be in excess of 0.5 part per million (0.5 mg/L). 21 CFR 184.1261 (GRAS). Defoaming agents (polyoxyethylene Defoaming agents which are 100% 40 monostearate, silicon dioxide, active may be used in amounts not dimethylpoly-siloxane, sorbitan exceeding 0.15 lbs/1000 gals. monostearate, glyceryl mono-oleate (0.018 g/L of wine. Defoaming and glyceryl dioleate): To control agents which are 30% active may be foaming, fermentation adjunct. used in amounts not exceeding 0.5 lbs/1000 gals. (0.06 g/L) of wine. Silicon dioxide shall be completely removed by filtration. The amount of silicon remaining in the wine shall not exceed 10 parts per million. 21 CFR 173.340 and 184.1505. Dimethyl dicarbonate: To sterilize and to stabilize Must meet the conditions prescribed wine, dealcoholized wine, and by FDA in 21 CFR 172.133. DMDC may low alcohol wine. be added to wine, dealcoholized wine, and low alcohol wine in a cumulative amount not to exceed 200 parts per million (ppm). Enzymatic activity: Various uses as The enzyme preparation used shall shown below. be prepared from nontoxic and nonpathogenic microorganisms in accordance with good manufacturing practice and be approved for use in food by either FDA regulation or by FDA advisory opinion. Carbohydrase (alpha-Amylase): The amylase enzyme activity shall To convert starches to be derived from Aspergillus niger, fermentable carbohydrates. Aspergillus oryzae, Bacillus subtilis, or barley malt per FDA advisory opinion of 8/18/83 or from Rhizopus oryzae per 21 CFR 173.130 or from Bacillus licheniformis per 21 CFR 184.1027. [[Page 576]] Carbohydrase (beta-Amylase): To The amylase enzyme activity shall convert starches to be derived from barley malt per fermentable carbohydrates. FDA advisory opinion dated 8/18/ 83. Carbohydrase (Glucoamylase, The amylase enzyme activity shall Amylogluco-sidase): To convert be derived from Aspergillus niger starches to fermentable or Aspergillus oryzae per FDA carbohydrates. advisory opinion dated 8/18/83 or from Rhizopus oryzae per 21 CFR 173.130 or from Rhizopus niveus per 21 CFR 173.110. Catalase: To clarify and to The enzyme activity used shall be stabilize wine. derived from Aspergillus niger or bovine liver per FDA advisory opinion dated 8/18/83 (GRAS). Cellulase: To clarify and to The enzyme activity used shall be stabilize wine and to derived from Aspergillus niger per facilitate separation of the FDA advisory opinion dated 8/18/83 juice from the fruit. (GRAS). Glucose oxidase: To clarify and The enzyme activity used shall be to stabilize wine. derived from Aspergillus niger per FDA advisory opinion of 8/18/83 (GRAS). Pectinase: To clarify and to The enzyme activity used shall be stabilize wine and to derived from Aspergillus niger per facilitate separation of juice FDA advisory opinion dated 8/18/83 from the fruit. (GRAS). Protease (general): To reduce The enzyne activity used shall be or to remove heat labile derived from Aspergillus niger or proteins. Bacillus subtilis per FDA advisory opinion dated 08/18/83 or from Bacillus licheniformis per 21 CFR 184.1027 (GRAS). Protease (Bromelin): To reduce The enzyme activity used shall be or to remove heat labile derived from Ananus comosus or proteins. Ananus bracteatus (L) per FDA advisory opinion dated 08/18/83 (GRAS). Protease (Ficin): To reduce or The enzyme activity used shall be to remove heat labile proteins. derived from Ficus spp. per FDA advisory opinion dated 08/18/83 (GRAS). Protease (Papain): To reduce or The enzyme activity used shall be to remove heat labile proteins. deived from Carica papaya (L) per 21 CFR 184.1585 (GRAS). Protease (Pepsin): To reduce or The enzyme actvity used shall be to remove heat labile proteins. derived from porcine or bovine stomachs per FDA advisory opinion dated 08/18/83 (GRAS). Protease (Trypsin): To reduce The enzyme activity used shall be or to remove heat labile derived from porcine or bovine proteins. pancreas per FDA advisory opinion dated 08/18/83 (GRAS). Urease: To reduce levels of The urease enzyme activity shall be naturally occurring urea in derived from Lactobacillus wine to help prevent the fermentum per 21 CFR 184.1924. Use formation of ethyl carbamate. is limited to not more than 200 mg/ L and must be filtered prior to final packaging of the wine. Ethyl maltol: To stabilize wine.... Use authorized at a maximum level of 100mg/L in all standard wines except natural wine produced from Vitis vinifera grapes. FDA advisory opinion dated 12/1/86. Ferrocyanide compounds (sequestered No insoluble or soluble residue in complexes): To remove trace metal excess of 1 part per million shall from wine and to remove remain in the finished wine and objectionable levels of sulfide the basic character of the wine and mercaptans from wine. shall not be changed by such treatment. GRAS per FDA advisory opinion of 06/22/82. Ferrous sulfate: To clarify and to The amount used shall not exeed 3 stabilize wine. ozs./1000 gals. (0.022 g/L) of wine. 21 CFR 184.1315 (GRAS). Fumaric acid: To correct natural acid The fumaric acid content of the deficiencies in grape wine. finished wine shall not exceed 25 lbs/1000 gals (3.0 g/L). 27 CFR 24.182 and 24.192. 21 CFR 172.350. To stabilize wine.............. The fumaric acid content of the finished wine shall not exceed 25 lbs/1000 gals (3.0 g/L). 27 CFR 24.244. 21 CFR 172.350. Gelatin (food grade): To clarify (GRAS). juice or wine. Granular cork: To smooth wine...... The amount used shall not exceed 10 lbs/1000 gals. of wine (1.2 g/L). GRAS per FDA advisory opinion dated 02/25/85. Isinglass: To clarify wine......... GRAS per FDA advisory opinion dated 02/25/85. Lactic acid: To correct natural 27 CFR 24.182 and 24.192. acid deficiencies in grape wine. 21 CFR 184.1061 (GRAS). Malic acid: To correct natural acid 27 CFR 24.182 and 24.192. 21 CFR deficiencies in juice or wine. 184.1069 (GRAS). Malo-lactic bacteria: To stabilize Malo-lactic bacteria of the type grape wine. Leuconostoc oenos may be used in treating wine. GRAS per FDA advisory opinion dated 02/25/85. Maltol: To stabilize wine.......... Use authorized at a maximum level of 250 mg/L in all standard wine except natural wine produced from Vitis vinifera grapes. FDA advisory opinion dated 12/1/86. Milk (pasteurized whole or skim) Fining agent for white grape The amount used shall not exceed wine or sherry. 2.0 liters of pasteurized milk per 1,000 liters of white grape wine or sherry (0.2 percent V/V). Nitrogen gas: To maintain pressure 21 CFR 184.1540 (GRAS). during filtering and bottling or canning of wine and to prevent oxidation of wine. [[Page 577]] Oak chips or particles, uncharred 21 CFR 172.510. and untreated: To smooth wine. Oxygen and compressed air: May be used in juice and wine.. None. Polyvinyl-polypyr-rolidone (PVPP): To clarify and to stabilize The amount used to treat the wine, wine and to remove color from including the juice from which the red or black wine or juice. wine was produced, shall not exceed 60 lbs/1,000 gals. (7.19 g/ L) and shall be removed during filtration. PVPP may be used in a continuous or batch process. The finished wine shall retain vinous character and shall have color of not less than 0.6 Lovibond in a one-half inch cell or not more than 95 percent transmittance per **AOAC Method 11.003-11.004 (14th Ed.). 21 CFR 173.50. Potassium bitartrate: To stabilize The amount used shall not exceed 35 grape wine. lbs/1000 gals. (4.19 g/L) of grape wine. 21 CFR 184.1077 (GRAS). Potassium carbonate and/or potassium bicarbonate To reduce excess natural The natural or fixed acids shall acidity in wine, and in juice not be reduced below 5 parts per prior to or during thousand (5 g/L). 21 CFR 184.1619 fermentation. and 184.1613 (GRAS). Potassium citrate: pH control agent The amount of potassium citrate and sequestrant in treatment of shall not exceed 25 lbs/1000 gals. citrus wines. (3.0 g/L) of finished wine. 27 CFR 24.182. 21 CFR 182.1625 and 182.6625 (GRAS). Potassium meta-bisulfite: To The sulfur dioxide content of the sterilize and to preserve wine. finished wine shall not exceed the limitations prescribed in 27 CFR 4.22. 21 CFR 182.3637 (GRAS). Silica gel (colloidal silicon Use shall not exceed the equivalent dioxide): To clarify wine. of 20 lbs. colloidal silicon dioxide at a 30% concentration per 1000 gals. of wine. (2.4 g/L). Silicon dioxide shall be completely removed by filtration. (GRAS). Sorbic acid and potassium salt of The finished wine shall contain not sorbic acid: To sterilize and to more than 300 milligrams of sorbic preserve wine; to inhibit mold acid per liter of wine. 21 CFR growth and secondary fermentation. 182.3089 and 182.3640 (GRAS). Soy flour (defatted): Yeast The amount used shall not exceed 2 nutrient to facilitate lbs/1000 gals. (0.24 g/L) of wine. fermentation of wine. (GRAS). Sulfur dioxide: To sterilize and to The sulfur dioxide content of the preserve wine. finished wine shall not exceed the limitations prescribed in 27 CFR 4.22(b)(1). 21 CFR 182.3862 (GRAS). Tannin: To adjust tannin content in The residual amount of tannin shall apple juice or in apple wine. not exceed 3.0 g/L, calculated as gallic acid equivalents (GAE). GRAS per FDA advisory opinions dated 4/6/59 and 3/29/60. Total tannin shall not be increased by more than 150 milligrams/liter by the addition of tannic acid (polygalloylglucose). To clarify or to adjust tannin The residual amount of tannin, content of juice or wine calculated in gallic acid (other than apple). equivalents, shall not exceed 0.8 g/L in white wine and 3.0 g/L in red wine. Only tannin which does not impart color may be used in the cellar treatment of juice or wine. GRAS per FDA advisory opinions dated 4/6/59 and 3/29/60. Total tannin shall not be increased by more than 150 milligrams/liter by the addition of tannic acid (poly- galloylglucose). Tartaric acid: To correct natural acid Use as prescribed in 27 CFR 24.182 deficiencies in grape juice/ and 24.192. 21 CFR 184.1099 wine and to reduce the pH of (GRAS). grape juice/wine where ameliorating material is used in the production of grape wine. Thiamine hydrochloride: Yeast The amount used shall not exceed nutrient to facilitate 0.005 lb/1000 gals. (0.6 mg/L) of fermentation of wine. wine or juice. 21 CFR 184.1875 (GRAS). Yeast, autolyzed: Yeast nutrient to 21 CFR 172.896 and 184.1983. GRAS facilitate fermentation in the per FDA advisory opinion of 10/06/ production of grape or fruit wine. 59. Yeast, cell wall/membranes of The amount used shall not exceed 3 autolyzed yeast: To facilitate lbs/1000 gals. (0.36 g/L) of wine fermentation of juice/wine. or juice. (GRAS). ------------------------------------------------------------------------ * GRAS--An acronym for ``generally recognized as safe.'' The term means that the treating material has an FDA listing in Title 21, Code of Federal Regulations, Part 182 or Part 184, or is considered to be generally recognized as safe by advisory opinion issued by the U.S. Food and Drug Administration. ** AOAC--Association of Official Analytical Chemists. *** To stabilize--To prevent or to retard unwanted alteration of chemical and/or physical properties. (Sec. 201, Pub. L. 85-859, 72 Stat. 1383, as amended (26 U.S.C. 5381, 5382, 5385, 5386, and 5387)) [T.D. ATF-299, 55 FR 24989, June 19, 1990, as amended by T.D. ATF-312, 56 FR 31079, July 9, 1991; T.D. ATF-350, 58 FR 52231, Oct. 7, 1993; T.D. ATF-350, 60 FR 38959, July 31, 1995; T.D. ATF-371, 61 FR 21079, May 9, 1996; T.D. ATF-409, 64 FR 13683, Mar. 22, 1999] [[Page 578]]