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FORMULAS FOR WINES, DISTILLED SPIRITS AND FLAVORS USED IN ALCOHOL BEVERAGES
Proprietors of Bonded Wineries, Bonded Wine Cellars, Beverage Distilled Spirits Plants, Manufacturers of Flavors for Use in Alcohol Beverages and Others Concerned:
Purpose. The purpose of this circular is to clarify and provide information and guidelines for the completion and submission of formulas for:
1. Wines (ATF Form 5120.29) 2. Distilled Spirits (ATF Form 5110.38) 3. Flavors used in alcohol beverages
Background. The processing of each applicant's beverage and nonbeverage formulas can be facilitated by the submission of formulas that are properly completed. In addition to following the guidelines presented in this circular, the instructions on the reverse side of each form must be followed and each item to be completed by the applicant must contain the required information. The listing of the formula ingredients must be as specific and detailed as required by this circular. All ingredients must be approved for food or beverage use by the U.S. Food and Drug Administration (USFDA). Previously submitted formulas are not affected by the requirements of this circular.
This circular is divided into three sections. The first section deals with formulas for beverage products; the second section deals with formulas for flavors used in alcohol beverages; the third section includes examples of wine, distilled spirits and flavor formulas.
Section I. BEVERAGE FORMULAS
1. General information applicable to both wine and distilled spirits product formulas.
Flavor Information
Formulas for wine and distilled spirits products produced with flavors must include specific information on these flavors. A. If the flavor is produced in the U.S., include the following:
1. Name of the flavor
2. Name and address of the flavor manufacturer
3. Manufacturer's product number (if none, so indicate)
4. Drawback formula number (if none, so indicate)
5. Date of approval of nonbeverage formula (Flavor formula approval is not mandatory prior to submission of ATF Form 5120.29 or 5110.38.)
6. Alcohol content of flavor (if nonalcoholic, so indicate)
7. A description of any coloring material contained in the flavor (See Coloring Materials, page 5 of this circular.)
B. If the flavor is produced outside the U.S., include the following: 1. Name of flavor
2. Name and address of flavor manufacturer and domestic affiliate, if any
3. Manufacturer's product number (if none, so indicate)
4. Alcohol content of flavor (if nonalcoholic, so indicate)
5. A description of any coloring material contained in the flavor (See Coloring Materials, page 5 of this circular.)
(See Examples 1 and 2, Section III of this circular for examples of presentation of flavor information.) In addition to including the information specified in A or B on the preceding page on the beverage formula, in the case of flavors produced outside the U.S., and domestically produced flavors for which no nonbeverage formula (ATF Form 5530.5) is filed, the flavor manufacturer must supply ATF with:
1. A statement (on company letterhead) quantitating the ingredients in the flavor (See Example 5, Section III of this circular),
2. An eight ounce sample of the flavor
The statement must include the name and address of the distilled spirits producer or winery purchasing the flavor and, if available, the number of the beverage formula in which the flavor will be used and the name of the beverage product. Forward the sample and statement to:
Bureau of Alcohol, Tobacco and Firearms National Laboratory Center 1401 Research Boulevard Rockville, Maryland 20850 Attn: NBA
The processing of the beverage formula cannot be completed until the flavor sample and statement have been evaluated by ATF.
Flavor Categorization
For labeling purposes ATF categorizes flavors as:
1. All natural
2. Natural and artificial containing not more than 0.1% artificial topnote
3. Natural and artificial containing greater than 0.1% artificial topnote
4. All artificial
(Artificial topnote does not include synthetic vanillin, ethyl vanillin, maltol, or ethyl maltol.) Flavors categorized as 1 or 2 are natural for alcohol beverage labeling purposes. Flavors categorized as 3 or 4 are artificial for alcohol beverage labeling purposes. (Production with an artificial flavor, if permissible, may require labeling as an "Imitation" product or specific label disclosure of the use of an artificial flavor.)
Vanillin, Ethyl Vanillin, Maltol, Ethyl Maltol
If the levels of synthetic vanillin, ethyl vanillin, maltol and/or ethyl maltol in the finished wine or distilled spirit exceed ATF's prescribed limitations, whether added directly or through a flavor or a combination from both sources, the finished alcohol beverage will be viewed as containing an artificial flavor and appropriate labeling will be required.
The specific limitations are:
Vanillin 40 ppm (mg/1)
Ethyl vanillin 16 ppm (mg/1)
Maltol 250 ppm (mg/1)
Ethyl maltol 100 ppm (mg/1) It is important to note that these are individual use limitations. When vanillin and ethyl vanillin are used in combination, the combined use calculated as vanillin may not exceed 40 ppm. Similarly, when maltol and ethyl maltol are used in combination, the combined use calculated as maltol may not exceed 250 ppm. In calculating combined use, ethyl vanillin and ethyl maltol can be multiplied by 2.5 to determine the equivalent amount of vanillin and maltol, respectively.
Examples:
a. Vanillin and ethyl vanillin are added by the distilled spirits producer in the production of a liqueur in the amounts of 20 ppm vanillin and 8 ppm ethyl vanillin.
Determine the combined use of these ingredients as follows:
Vanillin20 ppm
Ethyl vanillin converted to vanillin (8 x 2.5) 20 ppm Total 40 ppm
In this example, even though synthetic vanillin and ethyl vanillin have been added by the producer, the labeling of the product would not be affected since the combined use of the vanillin and ethyl vanillin does not exceed the 40 ppm limitation. b. In the same liqueur, maltol and ethyl maltol are added in the amounts of 125 ppm maltol and 100 ppm ethyl maltol.
Calculate the combined use as follows:
Maltol 125 ppm
Ethyl maltol converted to maltol (100 x 2.5) 250 ppm Total 375 ppm
In this example, the combined use of maltol and ethyl maltol exceeds the 250 ppm limitation. Therefore, if labeled as a liqueur, the product would have to be desig- nated "Imitation Liqueur."
Nonoptional Ingredients
Ingredients that affect products labeled under the Federal Alcohol Administration Act (FAA Act) e.g., coloring material (added directly or through a flavor), artificial flavors, or some limited ingredients, may not be shown as "optional" (or shown as added in a range of "0 - ___ "). Such ingredients may not be added or deleted by rider (for wines) or superseding formula (for distilled spirits).
Coloring Materials
Coloring materials must be specifically identified in formulas. "Certified Color," for example, or "Green Shade #55" are not acceptable. The reference must include the name and number of the certified color such as "FD&C Red 40" or the specific components of a coloring material marketed under a commercial/product name. If a flavor used in the production of the alcohol beverage contains a coloring material, this information must be included with the flavor information on the formula -- "contains FD&C Yellow 5 and caramel color."
Address Information
Submit formula applications for beverage wine and distilled spirits products to:
Bureau of Alcohol, Tobacco and Firearms Product Compliance Branch 1200 Pennsylvania Avenue, NW Washington, DC 20226 2. Specific information regarding Forms 5120.29 and 5110.38
Form 5120.29 Formula and Process for Wine
A. Formulas must be numbered sequentially. (Item 1 of form.)
B. Flavored wines, overameliorated wines (wine produced with sugar and water in excess of the 35% by volume limit prescribed in 27 CFR Part 240) and/or wines produced by authorized but nonstandard processes must be referenced as "Other than Standard Wine" in Item 4 of the form.
C. Item 5 of the form must include the total yield of wine product being produced and the quantity of each ingredient. The yield and ingredient quantities may be stated in ranges, e.g., "yield -- 90-100 gallons," "orange juice concentrate -- 4-8 gallons." The total of the ingredients listed must equal the stated yield. (See calculations for Example 1, Section III of this circular.)
D. Specifically identify the base wine by class and type in accordance with 27 CFR 4.21, and state its alcohol content.
E. Specify the alcohol content of the finished product. This may be stated in a range but must not cross tax categories.
Form 5110.38 - Formula for Distilled Spirits under the Federal Alcohol Administration Act
A. Formulated distilled spirits products not conforming to one of the classes described in 27 CFR 5.22 must be identified as "Distilled Spirits Specialty" in Item 1 of the form.
B. Formulas must be numbered sequentially. (Item 12 of form.) Formula numbers for multiple plant formulas must be preceded by the letter "M." (See Example 2, Section III of this circular.) C. Although quantitative information is not generally required for distilled spirits product formulas, the inclusion of maximum use rates (stated in percent by volume) for flavors is necessary. With this informa- tion, ATF can determine whether there is a usage problem for flavors containing limited ingredients. If the proposed usage is not indicated on the formula, processing is delayed because ATF must return the formula to the applicant to request use levels for any flavors containing limited ingredients.
D. Ingredients that are added by the distilled spirits producer which are subject to USFDA use limitations must be quantitated on the formula. Show the exact amount to be used, the range, or the maximum possible usage, i.e., "use will not exceed ____ ." Examples of such ingredients:
USFDA Regulations Ingredient Limit (21 CFR)
Ester gum100 ppm 172.735 Sodium benzoate1,000 ppm 184.1733 Gum arabic/gum acacia 10,000 ppm 184.1330 Brominated vegetable oil15 ppm 180.30 Propylene glycol50,000 ppm 184.1666
E. If the product contains wine, each wine must be identified as to class and type and alcohol content. For each wine produced under a formula, the formula number, name and address of the wine producer must be included. The percentage of wine (on a proof gallon basis) to be used in the finished product must be specified. (See Example 2, Section III of this circular.)
F. If the product is to be labeled as a blend of different classes and types of distilled spirits (such as "Strawberry Liqueur and Brandy") or distilled spirits and a nonalcoholic component (such as "Coffee Liqueur and Cream") the production of each type of distilled spirit must be clearly shown by the ordering and listing of the ingredients. That is, for the examples stated, the production of the strawberry liqueur must be distinguished from the production of the brandy. (See Example 2, Section III of this circular.) The percentage (on a proof gallon basis) of each class and type of distilled spirit must be included on the formula. If the product is not comprised of substantially equal amounts of each class and type of spirit, the percentages must be indicated on the product label. (Substantially equal means that neither spirit component contributes less than 40% of the total alcohol.) In the case of the "Coffee Liqueur and Cream," the cream must be shown as a separate component of the finished product rather than as an ingredient of the coffee liqueur.
SECTION II. FLAVOR FORMULAS
The manufacturer of any flavor used in an alcohol beverage is required to provide a quantitative formula to the Bureau. These formulations must provide all the information necessary for the proper classification and labeling of finished alcohol beverage products. These flavor formulations may be submitted on ATF Form 5530.5 by those domestic producers who file claims as manufacturers of nonbeverage products. (See Example 3, Section III of this circular.) If the formula does not contain any added taxpaid alcohol the form 5530.5 will be stamped "NO ACTION." (See Example 4, Section III of this circular.) This signifies that the flavor information was received by the Bureau and that the product does not contain any alcohol that is eligible for drawback. All other manufacturers, whether foreign or domestic, should submit their formulas on company letterhead. (See Example 5, Section III of this circular.) A representative eight ounce sample must accompany each formula submission.
All flavor formulas, regardless of the form of submission, must include the following:
1. Name of product and manufacturer's product number
2. Alcohol content
3. Formula number (if submitted on form 5530.5)
4. A quantitative list of ingredients
5. Name and address of alcohol beverage manufacturer purchasing the flavor (if available)
6. A statement that all ingredients used are Generally Recognized as Safe (GRAS) by the
Flavor and Extract Manufacturers's Association (FEMA) and/or approved for use in alcohol beverages by the USFDA
Quantitative Formula
A. Natural flavoring materials approved for use without limitation or restriction by the USFDA must be listed. These ingredients may be grouped by type with the predominant flavoring specified and the total quantity of that grouping stated.
Examples:
1. Strawberry and other fruit juices 2. Orange oil and other citrus oils 3. Orris concrete (21 CFR 172.510) 4. Bergamot oil (21 CFR 182.20)
B. Natural flavorings that are approved for use with limitation or restriction must be specified and quantitated individually. If the ingredient has a restricted use, it must be indicated that this restriction is followed. In addition, the formula must state where the approval for use is found in the USFDA regulations.
Examples:
1. Bitter almond oil (Free from prussic acid, FFPA, 21 CFR 182.20) 2. Wormwood/Artemisia (Thujone free, 21 CFR 172.510) 3. Cinchona extract (6% total alkaloids, 21 CFR 172.510) 4. Oil of rue (21 CFR 184.1699)
C. All artificial flavors (including those considered nature identical) must be listed and quantitated. All ingredients must be approved by the USFDA or be listed as FEMA GRAS. If the flavorings are approved for use without limitation or restriction they may be grouped together as in Example 1 on page 10 with the predominant flavoring by quantity specified. All flavor ingredients with specific limitations or restrictions must be listed separately as in Example 4 at the top of page 10.
Examples:
1. Ethyl acetate and other esters 2. Benzaldehyde (21 CFR 182.60) 3. Cinnamic acid (21 CFR 172.515) 4. Caprylic acid (21 CFR 184.1025)
D. All nonflavor ingredients such as preservatives, acidulants, solvents, etc., must be listed and quantitated separately. The formula must also state where the approval for use is found in the USFDA regulations.
Examples:
1. Tannic acid (21 CFR 184.1097)
2. Propylene glycol (21 CFR 184.1666)
3. Butylated hydroxyanisole (BHA, 21 CFR 172.515)
4. Brominated vegetable oil (BVO, 21 CFR 180.30)
E. The following four ingredients must be specified and quantitated individually because of their special use restrictions. (See page 4 of this circular.)
1. Vanillin 2. Ethyl Vanillin 3. Maltol 4. Ethyl Maltol
A statement confirming the absence of synthetic vanillin, ethyl vanillin, maltol or ethyl maltol is also required.
F. Flavors that are ingredients in the finished flavor formula must be identified by the following:
1. Name of the flavor
2. Name and address of flavor manufacturer
3. Manufacturer's product number (if none, so indicate)
4. Drawback formula number (if none, so indicate)
5. Date of approval of nonbeverage formula
6. Alcohol content of flavor (if nonalcoholic, so indicate)
G. All colors including FD&C certified colors and other colorants exempt from certification (such as caramel, annatto, etc.) must be disclosed. If an ingredient (such as saffron or elderberry extract) can be used as a colorant but also has other functions, the particular function or functions of the ingredient in the product must be stated.
Address Information
Flavor formulas and samples should be sent to:
Bureau of Alcohol, Tobacco and Firearms National Laboratory Center 1401 Research Boulevard Rockville, Maryland 20850 Attn:. NBA
Section III. EXAMPLE FORMULA (FORM) (234 KB) OTHER THAN STANDARD WINE (STRAWBERRY FESTIVAL) FORMULA #1
Before approving this formula ATF determined, in part, that:
1. Each flavor is used within its prescribed limitation.
2. Vanillin and maltol limitations were not exceeded. To determine this ATF calculated as follows:
Vanillin
Berry flavor #3222 contains 720 ppm ethyl vanillin (see Example 3 of this section) and is used at a maximum rate of 7 gallons per 1000 gallons (.7% by volume). Maximum use for this flavor, based on ethyl vanillin content, is 2.22%.
Maltol
a. Strawberry Flavor #3501 contains 25,000 ppm maltol (See Example 5 of this section) and is used at a maximum of 5 gallons per 1000 gallons (.5%).
25,000 x .5%= 125 ppm maltol
b. The producer adds up to 50 ppm ethyl maltol
50 x 2.5 (conversion factor)= 125 ppm maltol Total 250 ppm maltol
Note:
Calculations are based on maximum possible usage.
3. The total of the ingredients equals the stated yield. To determine this ATF calculates as follows:
a. Minimum quantity of wine with maximum quantities of all other ingredients.
588.00 400.00 5.00 7.00 1000.00
b. Maximum quantity of wine with minimum quantities of all other ingredients.
794.00 200.00 2.50 3.50 1000.00
4. The alcohol content of the finished product is correct based on the alcohol content of each component and the total yield. To determine this ATF calculates the gallons of alcohol contributed by each alcoholic component and the resulting amount of alcohol in the finished product. Example 588 gals wine @ 14% alc= 82.3 gals alc
7 gals Berry flavor @ 24% alc = 1.7 gals alc
Total gals alc = 84.0
(Total gallons alcohol) 84 (Total yield) 1000 x 100 = 8.4% alcohol
(FORM) (169 KB)
(FORM) (146 KB)
DISTILLED SPIRITS SPECIALTY (STRAWBERRY AND BRANDY) FORMULA #M-1
Before approving this formula ATF determined, in part, that:
1. Each flavor is used within its prescribed limitation.
2. Vanillin and maltol limitations were not exceeded. To determine this ATF calculated as follows:
Vanillin
a. Berry flavor #3222 contains 720 ppm ethyl vanillin (See Example 3 of this section) and is used at a maximum of 1% by volume
720 x 1% x 2.5 (conversion factor) = 18 ppm vanillin
b. The producer adds up to20 ppm vanillin Total 38 ppm vanillin
Maltol
a. Strawberry flavor #3501 contains 25,000 ppm maltol (See Example 5 of this section) and is used at a maximum of .5% by volume
25,000 x 5%=125 ppm maltol
b. The producer adds up to 50 ppm ethyl maltol
50 x 2.5 (conversion factor) =125 ppm maltol Total 250 ppm maltol
Note:
Calculations are based on maximum usage.
(FORM) (58 KB)
Natural & Artificial Berry Flavor #3222
ATF is able to develop the following information from this flavor formulation:
1. The flavor is natural and artificial with less than 0.1% artificial topnote. (Natural for alcohol beverage labeling purposes.)
2. The flavor does not contain any coloring material.
3. The flavor contains the following limited or restricted ingredients:
Maximum use rate IngredientLevelof the flavor
Ethyl vanillin 720 mg/12.22%
Caprylic acid 120 mg/1 8.33%
Wormwood (Thujone free)
Bitter almond oil (FFPA)
EXAMPLE #5
SPECIAL FLAVORS INC. Marseilles, France
The following quantitative formula is provided for our flavor, Natural and Artificial Strawberry Flavor #3501 (nonalcoholic).
Purchaser: The M Company, Inc. Rural Route 2, Box 50 Posen, Michigan 34905 and 230 W. Pratt Street Baltimore, Maryland 30785
Nat. & Art. Strawberry Flavor #3501
40 lbs. Strawberry juice concentrate and other fruit juices. (All approved for use without limitation or restriction by USFDA)
0.5 lbs. Orange oil and other citrus oils (with 0.5% BHA)
0.2 lbs. Orris Concrete (21 CFR 172.510)
0.1 lbs. Ethyl butyrate and other artificial esters (approved for use without limitation by USFDA or FEMA GRAS)
2.5 lbs. Maltol (21 CFR 172.515)
10 lbs b Cloud Emulsion #65 (3% BVO 21 CFR 180.30, 7.5% Ester Gum 21 CFR 172.735, and citrus oils)
0.1 lbs. Sodium benzoate (21 CFR 184.1733)
Q.S. Strawberry shade (FD&C Red #4 and FD&C Yellow #5)
Q.S. Elderberry Extract (for Color)
100 lbs. Yield (12.0 Gallons)
Alcohol content = 0
This flavor does not contain vanillin, ethyl vanillin or ethyl maltol.
All ingredients used are GRAS by FEMA and/or approved for use in alcohol beverages by the USFDA.
Modifier Flavor #25
ATF is able to develop the following information from this flavor formulation:
1. Intermediate flavor #212 is an all natural flavor with no coloring material added and with no limited ingredients.
2. This flavor is all natural.
3. This flavor contains caramel color.
4. This flavor contains the following limited ingredients:
Maximum use rate Ingredient Level of the flavor
Tannic acid5,991 mg/12.50%
Propylene glycol 100,000 mg/150%
Nat. & Art. Strawberry Flavor #3501
ATF is able to develop the following information from this flavor formulation:
1. It is a natural and artificial flavor with 0.1% artificial topnote. (Natural for alcohol beverage labeling purposes.)
2. The flavor contains the named fruit (strawberry).
3. The flavor contains the following colors: FD&C Red 40, FD&C Yellow 5 and elderberry extract.
4. The flavor contains the following limited or restricted ingredients:
Maximum use rate Ingredient Levelof the flavor
Sodium benzoate 1,000 mg/1 No limit BHAless than 0.5% No limit of the essential oil content
Maltol25,000 mg/11.0%
BVO3,000 mg/10.5%
Ester gum7,500 mg/11.33%
Inquiries. Inquiries concerning this circular should refer to its number and be addressed to: Associate Director (Compliance Operations), Bureau of Alcohol, Tobacco and Firearms, 1200 Pennsylvania Avenue NW, Washington, DC 20226.
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