(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 TTB 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.
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.
Acetaldehyde: For color The amount used must not exceed 300
stabilization of juice prior to ppm, and the finished concentrate
concentration. must have no detectable level of
the material. 21 CFR 182.60
(GRAS).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 Sec. Sec. 182.2727,
Bentonite (Wyoming clay) and 182.2729, 184.1155 (GRAS) and
Kaolin: To clarify and to 186.1256. GRAS per FDA advisory
stabilize wine or juice. opinion dated 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 pantothenate: Yeast The amount used must not exceed 0.1
nutrient to facilitate lb. per 25,000 gallons. 21 CFR
fermentation of apple wine. 184.1212 (GRAS).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 The quantity of copper sulfate
sulfide and/or mercaptans from added (calculated as copper) must
wine. 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
0.5 parts 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.
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.
Carbohydrase (pectinase, The enzyme activity used must be
cellulase, hemicellulase): To derived from Aspergillus
facilitate separation of juice aculeatus. FDA advisory opinion
from the fruit. dated12/19/1996.
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).
Cellulase (beta-glucanase): To The enzyme activity must be derived
clarify and filter wine. from Tricoderma longibrachiatum.
The amount used must not exceed 3
g/hl. 21 CFR 184.1250 (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).
Lysozyme: To stabilize wines The amount used must not exceed 500
from malolactic acid bacterial mg/L. FDA advisory opinion dated
degradation.. 12/15/93.
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 products (pasteurized whole,
skim, or half-and-half):
Fining agent for grape wine or The amount used must not exceed 2.0
sherry. liters of pasteurized milk
products per 1,000 liters (0.2
percent V/V) of wine.
To remove off flavors in wine.. The amount used must not exceed 10
liters of pasteurized milk
products per 1,000 liters (1
percent V/V) of wine.Nitrogen gas: To maintain pressure 21 CFR 184.1540 (GRAS).
during filtering and bottling or
canning of wine and to prevent
oxidation of wine.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 must not exceed the equivalent
dioxide): To clarify wine or juice. of 20 lbs. colloidal silicon
dioxide at a 30% concentration per
1000 gals. of wine. (2.4 g/L).
Silicon dioxide must be completely
removed by filtration. 21 CFR
172.480.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; T.D. TTB-17, 69 FR 67643, Nov. 19, 2004; T.D. TTB-61, 72 FR 51709, Sept. 11, 2007]