Food Contact Substance (FCS)
Section 409 of the FD&C Act defines an FCS as any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.
There is a hierarchy from Food Contact Substance (FCS) through Food Contact Material (FCM) to Food Contact Article (FCA).
- The Food Contact Substance (the subject of an FCN) is a single substance, such as a polymer or an antioxidant in a polymer. As a substance, it is reasonably pure (the Chemist's definition of substance). Even though a polymer may be composed of several monomers, it still has a well-defined composition.
- Food Contact Material (FCM) is made with the FCS and (usually) other substances. It is often (but not necessarily) a mixture, such as an antioxidant in a polymer. The composition may be variable.
- The Food Contact Article is the finished film, bottle, dough hook, tray, or whatever that is formed out of the FCM.
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