Laboratory - Scientific Services Division

Limited Ingredients

Flavoring Substances and Adjuvants Subject to Limitation or Restriction - Flavoring Substances and Adjuvants that are GRAS Only in Certain Situations - TTB Limited Ingredients - Prohibited Ingredients - Coloring Materials

FDA – Center for Food Safety and Nutrition

Flavoring Substances and Adjuvants Subject to Limitation or Restriction (Please note: This table does not include materials used in the wine-making process that may have limitations. Please refer to 27 CFR Part 24.)

This table contains substances commonly or historically seen by TTB in formulations, it is not meant to be an exhaustive list of all substances that have limitations in foods or beverages.  This list does not contain substances which may have labeling requirements.  For questions about limitations for substances not on this list or substances which may have labeling requirements please refer to 21 and 27 CFR or contact FDA.

This list is meant for use in determining whether a limit is exceeded in an alcohol beverage product.  For substances which do not specifically have a limit for alcoholic beverages, the limit for 'All other food categories' is stated (this includes alcoholic beverages).  If the product being formulated is not an alcohol beverage product please refer to 21 CFR for limits in other food categories.

View the list.

 

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Flavoring Substances and Adjuvants that are GRAS Only in Certain Situations

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TTB Limited Ingredients

There are 4 artificial flavor materials that TTB allows to be present at certain levels in alcoholic beverages without affecting the label declaration. If the levels of each of these, or a combination of them, exceed TTB's limitation the alcoholic beverage must be labeled as "imitation." The ingredients and their limits are: vanillin (40 ppm), ethyl vanillin (16 ppm), maltol (250 ppm), and ethyl maltol (100 ppm). Please note that these are individual limitations. When vanillin and ethyl vanillin (or maltol/ethyl maltol) are used in combination, the combined use calculated as vanillin may not exceed 40 ppm. In calculating the combined use, multiply the level of ethyl vanillin by 2.5 and add to the level of vanillin. This is the "total vanillin." The same scenario applies to maltol and ethyl maltol.

Example:

a. Vanillin and ethyl vanillin are added by the distilled spirits producer in the production of a liqueur at a rate of 20 ppm of vanillin and 8 ppm of ethyl vanillin. The "total as vanillin" would be:

20 + (2.5 X 8) = 40 ppm

In this example the producer would not have to label the product as imitation.

b. In another product, the producer adds maltol at the level of 125 ppm and ethyl maltol at 100 ppm. The "total as maltol" would be:

125 + (2.5 X 100) = 375 ppm

In this example the "total as maltol" exceeds the maximum allowed of 250 ppm. Therefore the product would be labeled as imitation.

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Prohibited Ingredients

The Food and Drug Administration is responsible for determining which ingredients are prohibited from being used in food and/or beverage products. The laboratory enforces these restrictions for alcohol containing products.

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Coloring Materials

Many alcohol beverage products contain coloring agents. Coloring agents are added to impart color which is not natural to the product. There are two categories of coloring agents that are used: FDA Certified Colors and Non-certified Colors. Certified colors are synthetic dyes approved by the FDA for use in beverage products. The non-certified colors are natural coloring agents approved for use in alcohol beverages. Below is a list of coloring agents which may be used in beverage products.

Certified Colors

FD&C Blue #1

FD&C Blue #2

FD&C Green #3

FD&C Red #3

FD&C Red #40

FD&C Yellow #5**

FD&C Yellow #6

 

**Must be specifically declared on the beverage label.

Non-Certified Colors

Annatto Extract

Caramel

Carmine (Cochineal Extract)**

Beta Carotene

Elderberry Extract

Grapeskin Extract

Paprika

Saffron

Titanium Dioxide

Turmeric

Beet Extract

 

**Must be specifically declared on the beverage label.

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Page last reviewed: August 21, 2014
Page last updated: December 13, 2016
Maintained by: Scientific Services Division

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