Food Chemical Codex is a compendium of specifications for food ingredients. It has been issued and revised in several editions and supplements. Several food additive and GRAS regulations incorporate one or more editions of FCC by reference (see 21CFR 170.30 (h) and individual regulations). When incorporated by reference, these specifications are binding and must be met. Where FCC specifications are not explicitly referenced, they are not binding, but serve as a guide for food grade quality consistent with good manufacturing practice.
Food additives are defined in section 201(s) of the Act and may not be used in food unless approved by regulation, codified in 21 CFR Parts 172 and 173. However substances whose use is generally recognized as safe (GRAS) are not food additives (legally), although they may be food ingredients. GRAS substances do not require premarket approval by FDA. Some, but not all, GRAS ingredients are listed in 21CFR Parts 182 and 184. Before concluding that a substance is an unapproved food additive consideration must be given to whether its use may be GRAS, or whether its use was approved by FDA or USDA prior to 1958 (prior sanctioned ingredients which are also exempt from food additive status).
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