Laboratory - Scientific Services Division

Limited Ingredients

Flavoring Substances and Adjuvants Subject to Limitation or Restriction - Flavoring Substances and Adjuvants that are Used Only in Certain Situations - TTB Limited Ingredients - Prohibited Ingredients - Color Additives

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.

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Flavoring Substances and Adjuvants that are Used 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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Color Additives

Many alcohol beverage products contain color additives. Color additives are added to impart color which is not natural to the product. There are two categories of color additives that are used: Color Additives Exempt from Certification and Color Additives Subject to Certification.  Color Additives Subject to Certification are synthetic dyes approved by the FDA for use in food and beverage products. The Color Additives Exempt from Certification are coloring agents approved for use in food and beverage products.

Below is a list of color additives which may be used in beverage products and/or beverage mixes.  (There may be additional colors that can be used in nonbeverage products listed in 21 CFR part 73 Subpart A.)  Color Additives may not be used to color foods for which standards of identity have been promulgated under section 401 of the Federal Food, Drug, and Cosmetic Act unless added color is authorized by such standards.  Color Additives used must adhere to the identity and specifications stated for that color additive in 21 CFR.

Coloring information should be stated on an alcoholic beverage label in accordance with 27 CFR 5.32 and 5.39.  For information on labeling of alcoholic beverage products that have been treated with wood please see 27 CFR 5.39(c).

Color Additives Subject to Certification     21 CFR part 74 Subpart A

Color

Reference

Limit

Uses and Restrictions

FD&C Blue No. 1

21 CFR 74.101

GMP

FD&C Blue No. 1 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice (GMP).

FD&C Blue No. 2

21 CFR 74.102

GMP

FD&C Blue No. 2 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice (GMP).

FD&C Green No. 3

21 CFR 74.203

GMP

FD&C Green No. 3 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice (GMP).

FD&C Red No. 3

21 CFR 74.303

GMP

FD&C Red No. 3 may be safely used for coloring foods generally (including dietary supplements) in amounts consistent with good manufacturing practice (GMP).

FD&C Red No. 40

21 CFR 74.340

GMP

FD&C Red No. 40 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice (GMP).

FD&C Yellow No. 5**

21 CFR 74.705

GMP

FD&C Yellow No. 5 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice (GMP). 
**Labeling - Must be specifically declared on the alcoholic beverage label.  (27 CFR 5.32 (b)(5))

FD&C Yellow No. 6

21 CFR 74.706

GMP

FD&C Yellow No. 6 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with current good manufacturing practice (GMP).

Color Additives Exempt from Certification     21 CFR part 73 Subpart A

Color

Reference

Limit

Uses and Restrictions

Annatto Extract

21 CFR 73.30

GMP

Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice (GMP).

β-Apo-8'-carotenal

21 CFR 73.90

15 mg/pint of liquid food

β-apo-8′-carotenal may be safely used for coloring foods generally, subject to the following restrictions:

The quantity of β-apo-8′-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food.

Canthaxanthin

21 CFR 73.75

30 mg/pint of liquid food

Canthaxanthin may be safely used for coloring foods generally subject to the following restrictions:

The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food.

Caramel

21 CFR 73.85

GMP

Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice (GMP).

Carrot oil

21 CFR 73.300

GMP

Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice (GMP).

β-Carotene

21 CFR 73.95

GMP

β-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice (GMP).

Cochineal extract**; Carmine**

21 CFR 73.100

GMP

Carmine and cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practice (GMP).  **Labeling - Must be specifically declared on the alcoholic beverage label. (27 CFR 5.32 (b)(6))

Dehydrated beets (beet powder)

21 CFR 73.40

GMP

Dehydrated beets may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice (GMP).

Fruit juiceϮ

21 CFR 73.250

GMP

Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Grape skin extract (enocianina)

21 CFR 73.170

In accordance with 27 CFR Parts 4 & 5

Grape skin extract (enocianina) may be safely used for the coloring of still and carbonated drinks and ades, beverage bases, and alcoholic beverages subject to the following restrictions: 

(1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards. 

(2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR.

Mica-based pearlescent pigments

21 CFR 73.350

0.07 % by weight

Mica-based pearlescent pigments may be safely used as a color additive in food as follows:

In amounts up to 0.07 percent, by weight, in the following:

(A) Distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume.

(B) Cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, and cocktails.

(C) Non-alcoholic cocktail mixes and mixers, such as margarita mix, Bloody Mary mix, and daiquiri mix, but excluding eggnog, tonic water, and beverages that are typically consumed without added alcohol (e.g., fruit juices, fruit juice drinks, and soft drinks).

Paprika

21 CFR 73.340

GMP

Paprika may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Paprika oleoresin

21 CFR 73.345

GMP

Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice (GMP).

Riboflavin

21 CFR 73.450

GMP

Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Saffron

21 CFR 73.500

GMP

Saffron may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Sodium copper chlorophyllin

21 CFR 73.125

0.2% in the dry mix

Sodium copper chlorophyllin may be safely used to color citrus-based dry beverage mixes in an amount not exceeding 0.2 percent in the dry mix.

Spirulina extract

21 CFR 73.530

GMP

Spirulina extract may be safely used for coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts, dessert coatings and toppings, beverage mixes and powders, yogurts, custards, puddings, cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded cereals), and coating formulations applied to dietary supplement tablets and capsules, at levels consistent with good manufacturing practice (GMP).

Titanium dioxide

21 CFR 73.575

1% by weight

Titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions:

The quantity of titanium dioxide does not exceed 1 percent by weight of the food.

Toasted partially defatted cooked cottonseed flour

21 CFR 73.140

GMP

Toasted partially defatted cooked cottonseed flour may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice (GMP).

Tomato lycopene extract; tomato lycopene concentrate

21 CFR 73.585

GMP

Tomato lycopene extract and tomato lycopene concentrate may be safely used for coloring foods generally in amounts consistent with good manufacturing practice (GMP).

Turmeric

21 CFR 73.600

GMP

Turmeric may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Turmeric oleoresin

21 CFR 73.615

GMP

Turmeric oleoresin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Vegetable juiceϮ

21 CFR 73.260

GMP

Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice (GMP).

Ϯ  Please see FDA's draft guidance on Fruit Juice and Vegetable Juice as Color Additives in Food for more information.

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Page last reviewed: August 21, 2014
Page last updated: March 13, 2017
Maintained by: Scientific Services Division

TTB
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