The term indirect food additive is not defined in the FD&C Act or FDA regulations, but is
generally used to refer to a food contact substance. For the purposes of food facility registration,
the definition of “food” in 21 CFR 1.227 excludes food contact substances, as defined in
section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), but includes food additives (see 21
U.S.C. 321(f)). Consequently, facilities that manufacture chemicals used in the production of
food contact substances are not required to register with FDA. However, if substance X is
intended to have a technical effect in or on the food, it is “food” (i.e., a food additive), as defined
in 21 CFR 1.227 and section 201(f) of the FD&C Act, and the facility that manufactures
substance X must be registered. In addition, if an owner, operator, or agent in charge of a
manufacturing facility for substance X reasonably believes that the substance is reasonably
expected to be directed to food use, the owner, operator, or agent in charge must register the
facility with FDA.
