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Listing Ingredients in Your Formula
All ingredients used in flavors must be approved for food use by the U.S. Food and Drug Administration (FDA). The FDA lists these ingredients on their web site at:
- Summary of GRAS Notices
- Substances Added to Food (formerly “EAFUS” - FDA’s Everything Added to Food in the United States)
Each ingredient in your formula does not need to be disclosed. TTB allows materials to be grouped together in nonbeverage formulas provided certain rules are met. The advantage of grouping materials together is that subtle changes can be made in the formula without resubmitting to TTB.
The following are examples of materials that may be grouped together:
- Essential oils and absolutes
- Acids
- Flavor chemicals (aldehydes, ketones, esters, alcohols, etc.)
- Fruit juices
In each category, predominant ingredients must be identified and quantified. Here is an example of a properly disclosed grouping of ingredients.
Total formula is 100 lbs
Benzaldehyde (FEMA # 2127, 1.23 lbs)
and other FEMA GRAS natural aldehydes …………………………………… 2.0 lbs
In this example, the class of flavor chemicals, natural aldehydes, is given along with the total weight of the group of ingredients. The predominant flavor chemical, benzaldehyde, is given along with its weight and FEMA number.
A sufficient quantity of ingredients in each category must be disclosed. TTB requires the following disclosure:
- If the grouping represents 10% or less of the total weight of the formula, at least 20% of the group must be identified and quantified.
- If the grouping represents more than 10% of the total weight of the formula, at least 50% of the group must be identified and quantified. In this case, more than one component may need to be identified and quantified to meet the requirement.
This allows TTB to make certain that the product will always be unfit for beverage purposes and provides investigators and auditors a method to determine compliance.
There are some restrictions in materials that can be grouped.
- Products containing ethanol, limited ingredients, and colors must be listed separately.
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- The ethanol content (%v/v) must be provided along with the volume of the component. If the ingredient does not contain ethanol or any limited ingredients, please indicate this on TTB Form 5154.1.
- Limited ingredients must be quantified and colors must be identified. If the ingredient does not contain limited ingredients or colors, please indicate this on the form.
- All FDA limited ingredients must be listed and quantified separately.
- The TTB limited ingredients (artificial vanillin, ethyl vanillin, artificial maltol, and ethyl maltol) must be listed and quantified separately.
To properly group flavor chemicals, it is important to understand naming conventions:
Aldehydes: usually have aldehyde in the name or end with “al.” Examples include benzaldehyde, acetaldehyde, citral, and trans 2-hexenal.
Ketones: usually end with “one.” Examples include furanone, acetophenone, and ß-ionone.
Esters: usually end with “ate.” Examples include ethyl acetate, amyl butyrate, and cinnamyl formate.
Alcohols: usually end with “ol.” Examples include ethanol, citronellol, and geraniol.
(Note: do not group ethanol with other alcohols)
Some Important Tips:
- The predominant ingredient(s) must be disclosed when grouping ingredients.
- While it is not required, including FEMA numbers for flavor chemicals can be useful to the chemist reviewing the formula.
- Make sure any component that makes the product unfit is disclosed.
- Natural and artificial flavor components must be listed separately.
- If grouping under the heading flavor chemicals, the group may contain aldehydes, ketones, esters, alcohols, etc. It cannot contain oils, absolutes, acids, solvents, or juices.
- In some cases, even if the appropriate amount has been disclosed, it still may be necessary to return the formula for more information. Common solvents such as propylene glycol, triethyl citrate, benzyl alcohol, triacetin, and glycerin cannot be grouped together.