Food Contact Materials: FDA Pathways, Migration Limits, and Imports

The FDA regulates food contact materials by treating any substance that could migrate from packaging, containers, or processing equipment into food as a food additive, which means it needs premarket clearance before it can be used. The regulations sit primarily in the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations, and they cover four clearance pathways, migration safety limits, good manufacturing practice rules, restrictions on specific chemicals like PFAS and phthalates, separate treatment for recycled plastics, and import controls. Getting any of these wrong exposes a company to product refusals at the border, recalls, and civil penalties that reach into six figures per violation.

What Counts as a Food Contact Material

A food contact material is any surface, container, or packaging component that touches food during manufacturing, processing, or storage. The FDA splits them into two categories, and the split matters for how much scrutiny each faces.

Direct contact materials physically hold or touch the food: plastic wraps, aluminum cans, glass jars, paper wrappers. Indirect contact materials support the production chain without touching the finished food, such as lubricants on processing equipment or gaskets inside beverage dispensers. Both fall under FDA oversight if any substance from the material could reasonably migrate into food. The agency evaluates each material based on its intended conditions of use, not against a single universal standard, because polymers, metals, coatings, paperboard, and glass all behave differently under heat, cold, moisture, and time.

Why Packaging Is Regulated as a Food Additive

The statute that pulls packaging into the food additive framework is 21 U.S.C. § 321(s), which defines a food additive as any substance whose intended use could reasonably result in it becoming a component of food, whether that transfer is deliberate or incidental.¹ A plastic container does not need to visibly dissolve into a beverage for the plastic’s chemical components to qualify.

The definition carves out several exceptions. Substances generally recognized as safe (GRAS) by qualified experts are excluded. So are materials approved by the FDA or USDA before September 6, 1958, called prior-sanctioned substances, which keep their exemption only when used under the original conditions of approval.¹ Pesticide residues, color additives, and new animal drugs are regulated under separate statutory frameworks and fall outside the food additive definition entirely.

The Four Pathways to Legal Use

A substance that qualifies as a food additive cannot legally reach the market until it clears one of several regulatory pathways.² Picking the wrong one wastes months.

Food Contact Notification

The food contact notification (FCN) program is the primary route for new substances. A company submits proprietary safety data for a specific substance and its intended use. The FDA has 120 days to review. If the agency raises no objection within that window, the notification becomes effective and the company can market the product.³

One detail catches companies off guard. An effective FCN applies only to the specific manufacturer or supplier named in the notification. Competitors cannot rely on someone else’s FCN to sell the same substance. Downstream purchasers who buy from the named manufacturer or supplier, however, can rely on that notification to market or use the substance for its approved purpose.⁴

Food Additive Petition

The older route is the food additive petition under 21 U.S.C. § 348. A petitioner asks the FDA to issue a regulation prescribing conditions for safe use. The petition must include the substance’s chemical identity, proposed conditions of use, methods for detecting the substance in food, and full safety investigation reports.⁵ Unlike an FCN, an approved regulation is not proprietary. Once published, any manufacturer can use the substance under the specified conditions. The tradeoff is a review timeline much longer than 120 days.

Threshold of Regulation Exemption

Substances that migrate into food at very low levels can qualify for an exemption under 21 CFR 170.39. If the resulting dietary concentration is at or below 0.5 parts per billion, which corresponds to roughly 1.5 micrograms per person per day, the substance may be exempt from full food additive review.⁶ The substance cannot be a known carcinogen, and the manufacturer has to request the exemption from the FDA rather than self-certify.

GRAS Determinations and Prior Sanctions

Substances with a documented history of safe use may qualify as generally recognized as safe, taking them outside the food additive definition. The FDA looks at whether qualified experts would agree the substance is safe under its intended conditions of use.²

Prior-sanctioned substances sit under a separate exemption. These are materials that received explicit approval from the FDA or USDA before the 1958 Food Additives Amendment. The exemption covers only the specific uses that were originally sanctioned, including specific levels, conditions, and product types. Using a prior-sanctioned substance in a new way requires one of the other pathways.⁷

Migration Limits and Safety Testing

Migration is the transfer of molecules from a container or wrapper into the food itself, and it is the central safety concept. Regulators set limits based on how much of a substance a person can safely consume over a lifetime. The thresholds usually distinguish total migration, the combined weight of all substances transferred, from specific migration limits for individual chemicals of concern. Compliance is measured in parts per billion or parts per million, using laboratory testing and scientific modeling.

Impurities, reaction byproducts, and breakdown products that the manufacturer never intended to include, known as non-intentionally added substances, still have to stay below levels that would compromise food safety. The FDA calculates risk through dietary exposure assessments that account for how much of a given food the average person eats and how much of that food touches the material.

Food Simulants

Because testing migration directly into every possible food is impractical, laboratories use standardized liquids called food simulants that mimic how food categories interact with packaging. The FDA recommends different simulants for different food types:⁸

Aqueous and acidic foods: 10% ethanol, with separate water and 3% acetic acid tests when acid sensitivity is a concern.
Alcoholic beverages: 10% or 50% ethanol, depending on alcohol content.
Fatty foods: food oil such as corn oil, or synthetic triglyceride mixtures. For polymers like polyolefins where oil-based analysis is impractical, 95% ethanol substitutes.

The FDA no longer recommends heptane as a fatty-food simulant because it interacts too aggressively with many polymers and overstates real-world migration.

Good Manufacturing Practice Obligations

Premarket clearance is only the start. Manufacturers must also comply with the good manufacturing practice rule in 21 CFR 174.5, which imposes two core obligations: the quantity of any substance that migrates into food must be no more than reasonably needed to achieve the material’s intended function, and every component must be of a purity suitable for its intended use.⁹ A food contact substance is also not supposed to accomplish any physical or technical effect in the food itself unless a separate regulation permits it.

In practice, companies throughout the supply chain maintain compliance documentation, often called letters of guaranty or statements of compliance, that summarize the legal basis for a material’s safety and any restrictions on its use. Industry treats these documents as essential for due diligence, and major retailers typically require them before accepting products, but their format and retention period come from commercial practice and contracts rather than a single FDA regulation. Supporting evidence usually includes laboratory migration test results and identification of the applicable regulatory authorization, whether an effective FCN, a food additive regulation, a GRAS determination, or a threshold of regulation exemption.

PFAS, Phthalates, and Chemicals Under Restriction

Per- and polyfluoroalkyl substances (PFAS) were once widely used as grease-proofing agents on paper food packaging. That era is effectively over. As of February 2024, the FDA announced that PFAS-containing substances are no longer being sold in the U.S. market for grease-proofing food packaging, following voluntary manufacturer phase-outs and regulatory action. In January 2025, the FDA declared 35 food contact notifications related to PFAS in paper packaging no longer effective.¹⁰

Phthalates are on a different track. The FDA currently authorizes nine phthalates for food contact use: eight as plasticizers and one as a monomer in polymer production. In May 2022, the agency revoked authorizations for 23 additional phthalates after industry demonstrated those uses had been abandoned. The FDA also denied petitions requesting a blanket ban on phthalates as a class, concluding that available evidence did not support grouping all phthalates together or show that the approved uses were unsafe. The agency is still reviewing more than 23,900 public comments submitted in response to a 2022 request for information about dietary exposure and safety data for the eight remaining plasticizer phthalates, and revised assessments could narrow the conditions of approved use.¹¹

Recycled Plastic and Paperboard

Using post-consumer recycled plastic in food packaging requires a separate FDA evaluation because recycling can introduce contaminants that were not present in the virgin material. The FDA reviews each proposed use case by case and issues informal advisory opinions, sometimes called letters of no objection, indicating whether a recycling process produces plastic of suitable purity for food contact.¹²

A manufacturer seeking this evaluation must provide a complete description of the recycling process, source controls ensuring only compliant input material is used, test results demonstrating contaminant removal, and a description of the intended conditions of use including temperature, food type, and duration of contact. The FDA generally expects the process to reduce contaminants to a dietary concentration below 0.5 parts per billion, and migration testing or modeling may also be required.¹²

One exception matters at scale. The FDA no longer evaluates individual recycling processes for recycled PET or PEN, the plastics used in most beverage bottles, after concluding that standard tertiary recycling of these polymers consistently produces material of suitable purity for food contact.¹² Recycled paperboard used in food contact meets a separate rule under 21 CFR 176.260, which restricts the sources of reclaimed fiber and prohibits material that has been used to ship poisonous or hazardous substances.¹³

Importing Food Contact Materials

Products entering the U.S. from foreign sources pass through a dual review involving U.S. Customs and Border Protection and the FDA. CBP receives the entry filing and refers FDA-regulated products to the agency for review.¹⁴ Screening tools weigh a firm’s compliance history and known problems with specific product types.

Prior Notice Timing

Federal law requires prior notice for all food imports, and CBP will not release a food shipment without proof that prior notice has been filed with the FDA.¹⁵ Minimum lead times depend on mode of arrival:

Road: at least 2 hours before arrival at the port.
Rail: at least 4 hours before arrival.
Air: at least 4 hours before arrival.
Sea: at least 8 hours before arrival.

Prior notice can be submitted no earlier than 30 calendar days before anticipated arrival through the Automated Broker Interface, or 15 days through the FDA’s Prior Notice System Interface.¹⁶ Miss the deadline and the shipment is refused admission.

Detention and Import Alerts

If documentation is incomplete or FDA screening flags a concern, the shipment can be detained. Refused articles must be exported within 90 days of the refusal notice, or the Secretary of the Treasury will order their destruction.¹⁷

Repeated violations can land a company on an FDA import alert, placing the firm on a “Red List” for detention without physical examination. Future shipments are held automatically instead of being screened on a risk basis. Getting off an import alert requires the importer to demonstrate that the underlying violation has been corrected, and some alerts require corrective action and formal removal from detention before any shipment will be released.¹⁸ Port storage fees, lost inventory, and disrupted supply chains during that process often cost more than the detained shipment is worth.

Penalties for Violations

Introducing an adulterated food contact material into commerce triggers both criminal and civil enforcement. On the criminal side, a first offense under 21 U.S.C. § 333 carries up to one year of imprisonment, a fine of up to $1,000, or both. A second offense, or a violation involving intent to defraud or mislead, increases the maximum to three years of imprisonment and a $10,000 fine.¹⁹

Civil penalties are far steeper. For 2026, an individual who introduces adulterated food into interstate commerce or fails to comply with a recall order faces a maximum penalty of $99,704 per violation. For entities other than individuals, the maximum reaches $498,517 per violation, with an aggregate cap of $997,034 for all violations adjudicated in a single proceeding.²⁰ These figures are adjusted annually for inflation.

1
Office of the Law Revision Counsel. 21 USC 321 – Definitions; Generally
2
U.S. Food and Drug Administration. How FDA Regulates Substances That Come Into Contact With Food
3
U.S. Food and Drug Administration. About the FCS Review Program
4
U.S. Food and Drug Administration. Inventory of Effective Food Contact Substance (FCS) Notifications
5
Office of the Law Revision Counsel. 21 USC 348 – Food Additives
6
eCFR. 21 CFR 170.39 – Threshold of Regulation for Substances Used in Food-Contact Articles
7
eCFR. 21 CFR Part 181 – Prior-Sanctioned Food Ingredients
8
U.S. Food and Drug Administration. Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations)
9
eCFR. 21 CFR 174.5 – General Provisions Applicable to Indirect Food Additives
10
U.S. Food and Drug Administration. Market Phase-Out of Grease-Proofing Substances Containing PFAS
11
U.S. Food and Drug Administration. Phthalates in Food Packaging and Food Contact Applications
12
U.S. Food and Drug Administration. Recycled Plastics in Food Packaging
13
eCFR. 21 CFR 176.260 – Pulp From Reclaimed Fiber
14
U.S. Food and Drug Administration. FDA Import Process
15
U.S. Customs and Border Protection. Importing Food for Commercial Use (Resale)
16
eCFR. 21 CFR Part 1 Subpart I – Prior Notice of Imported Food
17
Office of the Law Revision Counsel. 21 USC 381 – Imports and Exports
18
U.S. Food and Drug Administration. Industry FAQs for Import Alerts
19
Office of the Law Revision Counsel. 21 USC 333 – Penalties
20
GovInfo. Annual Civil Monetary Penalties Inflation Adjustment