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Food Contact Substances Flowchart

FDA-flowchartFSCDetermine Component StatusFunctional BarrierApproved Indirect AdditiveGRAS or prior sanctionHousewares exemptionThreshold of RegulationNo Migration DeterminationFood Contact Notification (FCN)GRAS Notice

Food contact substance (FCS)

Food contact substance (FCS) means any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if use of the substance is not intended to have any technical effect in the food. FCSs are regulated as indirect food additives, unless otherwise indicated in the remaining steps in this flow chart. (Direct food additives, color additives, dietary supplements, and pesticide residues are also regulated, but are not addressed in this flow chart.)

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Determine Component Status

In the case of a mixture to be used for food contact, each distinct component of the mixture must be cleared as a food contact substance. Physical blending of different substances is permitted, if all components are cleared by FDA or exempt. FDA does accept FCNs for formulations where all of the components are already authorized for food contact use. These formulation FCNs are submitted on a different form (3479) than for new FCSs or uses of them. Formulation FCNs are not required, but rather are used when the submitter wants verification that all components are cleared for the intended use and the formula is permitted.

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Functional barrier

If a substance is not expected to become a component of food, then it is not a food additive and is not subject to FDA regulations for food additives. Thus, if a substance is not part of the food-contact surface of a package and is separated from the food by a barrier that does not permit migration of the substance to food, then it is not subject to FDA regulation as a food additive. This is an interpretation that arises from court decisions and unpublished FDA positions—it is not clearly stated in FDA regulations or guidance. Caution is necessary when applying the functional barrier doctrine. The evaluation of whether a substance does not make contact with food due to a functional barrier should include full consideration of package structure and potential food-contact exposure scenarios, and should be made in consultation with regulatory/legal experts.

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Approved indirect additive

Consult 21 CFR 174 – 179 to see if the substance is a listed (i.e., permitted) indirect food additive.

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GRAS or prior sanctioned

Consult 21 CFR 182 – 186 to see if use of the component is Generally Recognized as Safe (GRAS). Consult 21 CFR 181 to see if use of the component is listed as Prior Sanctioned (these are substances cleared by FDA prior to 1958).

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Housewares exemption

The legislative history of the FFDCA results in the so-called ''housewares'' exemption for components of dishes, utensils, and other articles used by consumers to prepare or hold food. Because FDA has not issued a binding exemption for housewares (but rather has stated it generally will not enforce FCS requirements for them), many companies that make these products do not use the housewares exemption and instead ensure that their products comply with requirements for FCSs.

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Threshold of Regulation

Consult the listing of Threshold of Regulation Exemption to check if the substance is exempt because it has been shown to result in a very low concentration.

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No Migration Determination

A food packaging substance may be used without prior FDA review when there is a sound basis for concluding that it is not a food additive because it is not reasonably expected to become a component of food under the conditions of its intended use. This is a self-determination that can be made when there is evidence for it based on extraction studies and/or calculations. No migration determinations should be made only by experts who specialize in the testing, calculations, and records to support the determination.

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GRAS Notice

FDA accepts GRAS notifications, which become effective 90 days after they are submitted, unless FDA objects to GRAS status. A GRAS petition needs to show a substance is GRAS based on qualified experts and scientific literature. FDA has a GRAS notification program to review notices and posts an inventory of the notices on its GRAS web page.

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