Food additives and color additives for food use are “food” as defined in section 201(f) of the
FD&C Act (21 U.S.C. 321(f)). Therefore, many food additive and color additive facilities are
required to register because these facilities manufacture/process, pack, or hold food for
consumption in the United States. However, if a food additive is not intended to have a technical
effect in or on the food and meets the definition of a food contact substance in section 409(h)(6)
of the FD&C Act (21 U.S.C. 348(h)(6)), it is excluded from the definition of “food” for purposes
of food facility registration (see 21 CFR 1.227).Consequently, facilities that manufacture food contact substances are not
required to register.
