The short answer is “No.” Under section 201(s) of the FD&C Act, the GRAS provision applies to
the definition of a food additive. There is no corresponding provision in the definition (in section
201(t) of the FD&C Act) of a color additive.
However, under section 201(t)(1) and 21 CFR 70.3(f), the term color additive means a material
that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or
extracted, isolated, or otherwise derived from a vegetable, animal, mineral, or other source, and
that is capable (alone or through reaction with another substance) of imparting color when
added or applied to a food; except that such term does not include any material which FDA, by
regulation, determines is used (or intended to be used) solely for a purpose or purposes other
than coloring. Under 21 CFR 70.3(g), a material that otherwise meets the definition of color
additive can be exempt from that definition on the basis that it is used or intended to be used
solely for a purpose or purposes other than coloring, as long as the material is used in a way
that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or
consumer acceptability is concerned. Given the construct of section 201(t)(1) of the Act and 21
CFR 70.3(f) and (g), the use of a substance that is capable of imparting color may constitute
use as both a color additive and as a food additive or GRAS substance. For example, beta carotene
is both approved for use as a color additive (21 CFR 73.95) and affirmed as GRAS for
use as a nutrient in human food (21 CFR 184.1245); in some food products, beta-carotene may
be safely and lawfully used for both purposes.
