Answer: A "food-contact substance" defined in Section 409(h)(6) of the act is "any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food."
Notifications are only required for FCSs that are also food additives under Section 201(s) of the act. Thus, FCSs that are prior-sanctioned, generally recognized as safe (GRAS), or not reasonably expected to become a component of food do not require premarket clearance by FDA, as under the old Food Additive Petition process.
For example, a company might determine that a particular compound is not a "food additive" based on extraction studies demonstrating that the substance does not migrate to food under its intended conditions of use. Because the substance is not a "food additive," as that term is defined in Section 201(s) of the act, it does not require premarket clearance by FDA. However, an FCN can be filed for an otherwise unregulated FCS, regardless of whether it is a food additive. FDA properly has accepted FCNs on such materials.
The agency does not intend, however, to accept FCNs on compounds that are already permitted for the use under an applicable regulation (e.g., polymers otherwise listed under Part 177 for the particular use; prior sanctioned compounds under Part 181; or GRAS compounds listed in Parts 182, 184, or 186). Likewise, an FCN is not permitted for the use of a substance that is already covered by a Threshold of Regulation exemption.
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