You should use the Limited Ingredient Calculation Worksheet when you are submitting a formula application for a product containing one or more compounded flavors purchased from a flavor manufactuer.
Many compounded flavors contain ingredients that have limits on their total use, per TTB and FDA requirements. TTB refers to these as limited ingredients or limited components. The Limited Ingredient Calculation Worksheet enables you to determine the total concentration of limited ingredients in your product and should be submitted with your formula to TTB.
It is important to note that not all flavors are compounded flavors—a calculation worksheet is only used for products containing a compounded flavor. Any flavor, cloudifier, or blender that consists of multiple ingredients that are combined to produce a particular taste or appearance, and is purchased from a flavor manufacturer, is considered a compounded flavor and requires review by the TTB Nonbeverage Products Laboratory (NPL). When you purchase a compounded flavor from a flavor producer, please request that they supply you with a Flavor Ingredient Data sheet (FIDS or FID sheet). You will need information about the flavor from the FID sheet in order to complete the worksheet.
Please note that use of this worksheet does not excuse you from your responsibility to ensure compliance with applicable FDA regulations on ingredient safety. Please contact FDA if you have questions about limited ingredients under FDA regulations.
TTB uses information from the Limited Ingredient Calculation Worksheet when we review formulas:
- To verify that your beverage does not contain an excess of the prescribed limits for certain ingredients. Products that contain an excess amount of certain limited ingredients in violation of FDA regulations must be reformulated to avoid violations of FDA requirements.
- To determine whether the product contains an artificial flavor for labeling purposes. There are four artificial flavor materials (vanillin, ethyl vanillin, maltol, and ethyl maltol) that TTB allows to be used at limited levels in alcohol beverages without affecting the labeling of the product.
- To ensure that flavored malt beverages and flavored beer products containing one or more flavors made with alcohol do not exceed regulatory limits for the alcohol added by flavors as set forth in 27 CFR 7.5 and 27 CFR part 25.15
Make sure the worksheet contains the proper information on all compounded flavors used in your product, and upload it in Formulas Online in the Docs/Links tab. If you submit your formula application on paper, send it with TTB Form 5100.51 as an attachment.
Limited Ingredient Calculation Worksheets can calculate total alcohol content and ingredient level based on volume or percentage. When completing a worksheet, select the worksheet that matches how your formula is written. For example, if your formula displays quantities based on the percentage of each ingredient in the finished product, select the percentage based worksheet. If your formula displays the actual quantities of ingredients, rather than the percentage of such ingredients in the finished product, select the volume based worksheet. If you use the volume based worksheet, it is extremely important that your units of measure are all consistent.
You only need to enter the information from the FID sheet for each flavor listed; the worksheet will perform the calculations and display the total values.
Select the volume based example or percentage based example below for step-by-step instructions on how to fill out the Limited Ingredient Calculation Worksheet.
Questions regarding limits, results, or using the formula can be addressed by the formula team at 866-927-2533, option 7.
The volume based worksheet below has been filled in for the compounded flavors present in this example of a fictitious Wine Specialty product.
Step 1: In the Flavor Information table, add the flavor name, TTB Drawback Number, and TTB Company Code for each compounded flavor used in your formula. This information can be found on the FID sheet supplied by the flavor manufacturer. You may abbreviate the flavor name to save space, such as "Nat. Blue" for natural blueberry flavor.
Step 2: The Limited Flavor Components Concentration table appears directly below the Flavor Information table. For each flavor, enter the concentration of each limited component directly from the corresponding FID sheet. The components are listed in parts per million (ppm). Enter all information for each flavor before proceeding to the next column, which represents the next compounded flavor.
In this example, Flavor #1 (Nat. Blue) contains 500 ppm of Ester Gum, 10 ppm of BVO, 1,500 ppm of Gum Arabic, and 28,000 ppm of Propylene Glycol. The other three flavors in this fictitious example product also contain limited ingredients, as reflected below.
The worksheet contains the 11 most commonly used limited flavor components. If the corresponding FID sheet lists other limited component(s) that are present in the flavor, those must be listed as well. Use the blank lines under Acetic Acid to enter the information for each additional component(s) listed on the FID Sheet.
Step 3: In the Volume of Flavor Used column, state the maximum amount of each flavor that will be used in the product. You must use the same unit of measure for each flavor listed (for example, liters or mL or ounces or gallons). In the % Alcohol in Flavor column, enter the alcohol value from the FID sheet.
Step 4: The next piece of information to enter into the worksheet is the total volume of finished product that will be produced. In this example, it is 1,000 gallons (therefore the volume of flavors used are also listed in gallons).
Once the total volume is entered, the spreadsheet performs a calculation in the third column (see above) showing the percentage of the finished beverage that is alcohol contributed by each flavor.
Understanding the Results: In the example below, the red arrow points to the total concentration of each limited component in the finished product, which was calculated automatically by the worksheet based on the information entered for each flavor. If any number in this column is larger than the Limitation column, Yes will appear in the Over Limit? column. In this example, the Wine Specialty product does not exceed any of the limits.
If Yes appears in the Over Limit column of any of the first four lines (Synthetic Vanillin, Ethyl Vanillin, Synthetic Maltol, or Ethyl Maltol), the limit for that component has been exceeded and the flavors convert from a natural status to an artificial status under TTB's labeling policy. This will affect the labeling of the alcohol beverage. We changed the quantity of flavors containing synthetic vanillin present in the following example to illustrate an exceedance of a TTB limit:
The word Yes could also appear in any of the lines below Ethyl Maltol. These components represent the most common FDA limited ingredients, and the total amount of these components in the finished product may not exceed the stated limit. If Yes appears in any of these lines in the Over Limit? column, the product must be reformulated. Please note: For any additional limited components entered after acetic acid, the FDA limits will need to be manually entered and compared with the amount in the product to ensure compliance.
For flavored malt beverage products: If your formula is for a flavored malt beverage or flavored beer product, compare the total percentage of the malt beverage or beer that is alcohol contributed by flavors (or other nonbeverage ingredients) with the appropriate limit stated in 27 CFR 7.5 and 27 CFR part 25.15 to ensure that the formula does not exceed the maximum amount allowed.
Under those regulations, if the malt beverage or beer is not more than 6% alcohol by volume, the flavors and other nonbeverage ingredients containing alcohol may contribute no more than 49% of the overall alcohol content of the finished beer. For example, if the finished malt beverage or beer contains 5.0% alcohol by volume, the product may derive not more than 2.45% alcohol by volume from the addition of flavors and other nonbeverage ingredients containing alcohol. In the case of a malt beverage or beer with an alcohol content of more than 6% by volume, no more than 1.5% of the volume of the finished product may consist of alcohol derived from added flavors and other nonbeverage ingredients containing alcohol.
If the total amount of alcohol contributed by flavors (or other nonbeverage ingredients) exceeds the regulatory limit, the product must be reformulated in order to be classified as a beer or malt beverage. Please click here for more information on flavored malt beverages with flavors containing alcohol.
If your formula states ingredients as a percentage, you should complete the percentage based worksheet rather than the volume based worksheet. The percentage based worksheet below has been filled in for the compounded flavors present in this example of a fictitious Wine Specialty product.
Step 1:
In the Flavor Information table, add the flavor name, TTB Drawback Number, and TTB Company Code for each compounded flavor used in your formula. This information can be found on the FID sheet supplied by the flavor manufacturer. You may abbreviate the flavor name to save space, such as "Nat. Blue" for natural blueberry flavor.
Step 2:
For each flavor, type the percent by volume used in the final product in the top line of the Limited Flavor Components Concentration table, shown in blue. In this example, the Natural Blueberry flavor makes up .13% volume of the final product.
Step 3:
For each flavor, enter the concentration of each limited component directly from the corresponding FID sheet. The components are listed in parts per million (ppm). Enter all information for each flavor before proceeding to the next column, which represents the next compounded flavor.
In this example, Flavor #1 (Nat. Blue) contains 500 ppm of Ester Gum, 10 ppm of BVO, 1,500 ppm of Gum Arabic, and 28,000 ppm of Propylene Glycol. The other three flavors in this fictitious example product also contain limited ingredients, as reflected below
The worksheet contains the 11 most commonly used limited flavor components. If the corresponding FID sheet lists other limited component(s) that are present in the flavor, those must be listed as well. Use the blank lines under Acetic Acid to enter the information for each additional component(s) listed on the FID Sheet.
Step 4:
Enter each flavor's alcohol content into the corresponding box, shown in green. The worksheet will then calculate the percentage of alcohol contributed by the flavor to the final product and the total percentage of alcohol contributed by all flavors.
The black box, Alcohol Content of Finished Product (%), is not part of a calculation and it does not have to be filled in. However, we recommend entering in the alcohol content of the finished product as stated on the product formula so that all information on the alcohol content of your product is available at a glance. This is particularly important for malt beverages with flavor(s) containing alcohol.
Understanding the Results: The worksheet automatically calculates the total concentration of each limited component in the finished product, based on the information entered for each flavor. If any number in the Total column is larger than the Limitation column, Yes will appear in the Over Limit? column. This example Wine Specialty Product does not exceed any of the limits.
If Yes appears in the Over Limit? column of any of the first four lines (Synthetic Vanillin, Ethyl Vanillin, Synthetic Maltol, or Ethyl Maltol), the limit for that component has been exceeded and the flavors convert from a natural status to artificial. We changed the quantity of flavors containing Synthetic Vanillin present in our example Wine Specialty Product to illustrate an exceedance of a TTB limit:
The word Yes could also appear in any of the lines below Ethyl Maltol. These components represent the most common FDA limited ingredients, and the total amount of these components in the finished product may not exceed the stated limit. If Yes appears in any of these lines in the Over Limit? column, the product must be reformulated. Please note: For any additional limited components entered after acetic acid, the FDA limits will need to be manually entered and compared with the amount in the product to ensure compliance.
For flavored malt beverage products: If your formula is for a flavored malt beverage or flavored beer product, compare the total percentage of the malt beverage or beer that is alcohol contributed by flavors (or other nonbeverage ingredients) with the appropriate limit stated in 27 CFR 7.5 and 27 CFR part 25.15 to ensure that the formula does not exceed the maximum amount allowed.
Under those regulations, if the malt beverage or beer is not more than 6% alcohol by volume, the flavors and other nonbeverage ingredients containing alcohol may contribute no more than 49% of the overall alcohol content of the finished beer. For example, if the finished malt beverage or beer contains 5.0% alcohol by volume, the product may derive not more than 2.45% alcohol by volume from the addition of flavors and other nonbeverage ingredients containing alcohol. In the case of a malt beverage or beer with an alcohol content of more than 6% by volume, no more than 1.5% of the volume of the finished product may consist of alcohol derived from added flavors and other nonbeverage ingredients containing alcohol.
If the total amount of alcohol contributed by flavors (or other nonbeverage ingredients) exceeds the regulatory limit, the product must be reformulated in order to be classified as a beer or malt beverage. Please click here for more information on flavored malt beverages with flavors containing alcohol.
You can select a calculation worksheet that best meets your needs from the links below:
- Volume Based, 7 Flavors [XLS file]
- Volume Based, 15 Flavors [XLS file]
- Percentage Based, 7 Flavors [XLS file]
- Percentage Based, 15 Flavors [XLS file]