Food contact substance is anything that touches food (or touches something that touches food) may be an
Indirect Food Additive. The U.S. FDA requirements regarding the use of Indirect Food Additives are known
as "Food Contact Substance" (FCS) regulations. Examples of FCS products may include:
The U.S. FDA requires that all FCS products are determined safe for their intended use before they are permitted
for sale in the United States. Safety is dictated by the regulatory status of each component that comprises the FCS.
New components and uses of FCS products require premarket notification to the U.S. FDA prior to marketing in
the United States. The determination of how an FCS is regulated depends on its chemical composition. It is the
responsibility of the FCS manufacturer to ensure that food contact materials comply with the specifications and
limitations in all applicable authorizations. The identity, specifications, and limitations of the individual FCS
components are regulated by provisions in the Code of Federal Regulations, the Federal Register, Effective
Food Contact Notifications, Prior Sanctioned Letters, GRAS Notices, Threshold of Regulations Exemptions,
as well as U.S. FDA enforcement actions such as import refusals, import alerts, warning letters, etc.