Defining Color Additives in the United States

Color additives are regulated in the United States by the Food and Drug Administration (FDA). The FDA separates
color additives into two groups, Color Additives Exempt from Certification (Exhibit A) and Color Additives Subject
to Certification (Exhibit B). In general terms, the FDA defines color additives as any dye, pigment, or other
substance that can impart color to a food, drug, cosmetic, or the human body.
Understanding color additives in the United States can be confusing due to the method the FDA uses to classify
colors. One reason many people become confused when trying to understand color additives is because they look at
color additives from the same perspective as flavors. Defining or classifying a flavor is quite different from defining
a color additive. While flavors are commonly labeled as natural in the United States, it would be very rare to label a
color as natural for the reasons further explained below. Another cause for confusion regarding color additives
involves the food color regulations of other countries. These regulations can be quite different from the U.S. with
regard to allowed color additives and the labeling of the color additives.
Color additives that are exempt from certification are generally termed natural within the industry, but may also
be referred to as exempt colors in accordance with FDA regulations. The FDA does not allow for the term natural
to be used to describe a color additive minus one exception: The FDA believes a color is natural only if it is
inherently natural to the food holding the color. Despite the FDA regulations, the food industry in the United States
commonly refers to exempt colors as natural colors. A list of common exempt colors can be found in Exhibit A.
Color additives that are subject to certification by the FDA are commonly referred to throughout the food industry as
FD&C colors, artificial colors, or synthetic colors. A list of common FD&C colors can be found in Exhibit B. The
regulations and listings with regard to color additives can be found in Title 21 Parts 70 74 of the U.S.
FDA/CFSAN Code of Federal Regulations.
The FDA has provided guidance on acceptable practices for labeling color additives. Exempt colors are typically
labeled with their given name and a reference to their purpose. For example, vegetable juice (color) would be
typically seen on a label for a product utilizing a vegetable juice to provide color. Other terminology that may be
utilized would include color added, colored with vegetable juice, artificial color added, or artificially
colored. Unlike exempt color additives, the FDA requires certified color additives to be listed on ingredient labels
by name. For example, FD&C Red No. 40 should be identified as such on the label.
Color additives are not subject to the GRAS (generally recognized as safe) exemption. The Federal Food Drug and
Cosmetic Act states that a substance that imparts color is a color additive, and is therefore subject to the FDAs
premarket approval process. The premarket approval process requires a color petition to be filed with the FDA for
consideration of the petitioned color to be listed as an approved color additive. The petition process involves
proving a color additive is safe for its intended use. The safety and suitability of the intended color must be
demonstrated through data as required by the FDA. If and when the FDA is satisfied with the data submitted, they
may approve the color through the addition of a regulation for the petitioned color additive.
While outside of the scope of this paper, it should be noted that color additive regulations around the world are far
from consistent. Certain colors that are permitted for use in Europe or Asia may not be acceptable in the United
States and vice versa. Therefore, it is important to consider international implications regarding color additive
regulations when working on products with international possibilities.

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Exhibit A:
Common Color Additives Approved For Use in Human Food
21 CFR Part 73, Subpart A: Color Additives Exempt From Batch Certification
21 CFR Section
Color Name
EEC#
United States
Comments/Restrictions
73.30
Annatto Extract
E160b
Foods generally
73.40
Dehydrated Beets
E162
Foods generally
73.75
Canthaxanthin
E161g
Foods generally, not to
exceed 30 mg/lb of solid or
semisolid food or per pint of
liquid food
73.85
Caramel
E150a-d
Food generally
73.90
-Apo-8-carotenal
E160e
Foods generally, not to
exceed 15mg/lb solid, 15
mg/pt liquid
73.95
-Carotene
E160a
Foods generally
Cochineal Extract
73.100
E120
Foods generally
Carmine
73.125
Sodium copper
E141
Citrus-based dry mix
chloropyhllin
beverage mixes not to exceed
0.2% in dry mix; extracted
from alfalfa.
73.169
Grape Color Extract
E163
Non-beverage foods
73.170
Grape Skin Extract
E163
Most beverages
73.250
Fruit Juice
Coloring Foodstuff
Foods generally
73.260
Vegetable Juice
Coloring Foodstuff
Foods generally
73.340
Paprika (ground dried
Coloring Foodstuff
Foods generally
pod of mild capsicum
73.345
Paprika Oleoresin
E160c
Food generally
73.450
Riboflavin
E101
Foods generally
73.500
Saffron
E164
Foods generally
73.575
Titanium Dioxide
E171
Foods generally, not to
exceed 1% by weight
73.585
Tomato lycopene
E160
Foods generally
extract; tomato
lycopene concentrate
73.600
Turmeric (ground
Coloring Foodstuff
Foods generally
rhizome of Curcuma
longa L)
73.615
Turmeric Oleoresin
E100
Foods generally

Delivering Innovative Flavor, Color, Ingredient System and

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1261 Pacific Avenue
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www.wildflavors.com

Office Number
Facsimile
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(859)342-3600
(859)342-3610
www.wildflavors.com

Exhibit B:
Common Color Additives Approved For Use in Human Food
21 CFR Part 74, Subpart A: Color Additives Subject to Batch Certification
21 CFR Section
Color Name
EEC#
United States
Comments/Restrictions
74.101
FD&C Blue No. 1
E133
Foods generally
74.102
FD&C Blue No. 2
E132
Foods generally
74.303
FD&C Red No. 3
E127
Food generally
74.340
FD&C Red No. 40
E129
Foods generally
73.705
FD&C Yellow No. 5
E102
Foods generally
73.706
FD&C Yellow No. 6
E110
Foods generally

Delivering Innovative Flavor, Color, Ingredient System and

Process Technology Solutions to the Food and Beverage Industry

WILD Flavors, Inc.

1261 Pacific Avenue
Erlanger, KY 41018 USA
www.wildflavors.com

Office Number
Facsimile
Website

(859)342-3600
(859)342-3610
www.wildflavors.com