Limited Ingredient Calculation Worksheet
What is a Limited Ingredient Calculation Worksheet?
A Limited Ingredient Calculation Worksheet is a tool to facilitate the approval of a beverage alcohol formula
containing compounded flavor. It calculates the total amounts of ingredients that have limits on their total use
per TTB and Food and Drug Administration (FDA) requirements.
The worksheet is also useful as a product development tool. By using the worksheet, you can confirm that
new formulas are in compliance with requirements, and determine whether a product will be labeled as artificial, prior to submitting the formula to TTB.
Key Limited Ingredient Calculation Worksheet Topics
You should use the Limited Ingredient Calculation Worksheet when you are submitting a formula application for a product containg a compounded flavor that was 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 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, request that they supply you with a Flavor Ingredient Data Sheet (FIDS) [link to new page]. You will need the FIDS in order to complete the worksheet.
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 are considered adulterated under the FD&C Act and must therefore be reformulated.
- To determine whether the product contains an artificial flavor for labeling purposes due to exceeding TTB's limits for a TTB limited ingredient.
Make sure the worksheet contains the proper information on all compounded flavors used in your product, and upload it in Formulas Online [link] in the Docs/Links tab. If you submit your formula application on paper, send it with TTB Form 5100.51 as an attachment.