Packaging protects food, preserves its quality, and avoids contamination. If proper control over the inner-side materials in a container or parts of a wrapper that may come in contact with food is not ensured, hazardous materials may leach into food. For this reason, FDA-approved custom packaging food-contact materials play a very critical role in public health and consumer safety.
As the U.S. is the leading market for foodstuffs, its FDA has very strict packaging demands. Consequently, imported food products also have to abide by the FDA regulations concerning food safety, with a view to providing assurance that any substance that migrates from packages into food does not pose any health hazard. These are developed in an effort to avoid chemical migration with the aim of protecting consumers and ensuring trust in the safety of food packaging.
Poorly vetted packaging materials increase the risk of contamination. Substances that are not qualified for contact with food have the potential to leach out toxic or harmful molecules over time, especially with heat, pressure, or even long-term storage. Contamination problems of this nature can lead to product recalls, regulatory actions, and/or even exposure of consumers. Using legally approved constituents of food contact, therefore, is more than a compliance task; it’s a core component of the food safety strategy.
Growing Importance of Food-Safe Packaging
Over the last few decades, consumers have become much more conscious of the possible chemical exposures coming out of packaging. The rise of processed foods, takeout, and single-use packaging has driven demand for food-safe materials. Regulators have called for more transparency about what happens between packaging and food. The result has been a recent spurt of innovative designs that rely on safer plastics, recyclable materials, and barrier layers-but also a corresponding need for strict regulatory review.
Why FDA Regulations Are Stricter for U.S.-Bound Food Items
The FDA regulatory approach calls for a safety evaluation of substances that are used intentionally in food-contact materials. The premarket safety evaluation of food-contact materials under the FD&C Act must provide “reasonable certainty of no harm” from migration into food.
To handle this, the FDA operates a Food Contact Substance Notification program. Manufacturers must submit a notification to the FDA, known as FCN-for review before using the substance in food contact applications.
This review process, in conjunction with post-market surveillance, ensures that all food articles coming into the United States are considered safe.
The Risk of Contamination and Product Recalls
Food safety is compromised if material that comes in contact with food is not correctly approved or tested. Material assurance heads the top of the list of concerns, considering a material’s potential to leach or migrate into food from its packaging. Exceeding the regulatory limits or unexpected leaching/toxic exposure entails dangers related to off-flavors, toxic exposure, and product recalls. Such information is specifically needed by the FDA in order to estimate the risk of exposure while reviewing the FCN.
Recalls, sometimes because of package failure and chemical migration, are extremely expensive-not only financially but in the erosion of consumer trust. Upfront verification that the food-contact substances are approved and safe minimizes the risk of these events.
What are FDA Food-Contact Materials?
Understanding precisely what “food contact materials” are and how these materials are treated under the law in the U.S. is important as a foundation for a deep understanding of regulated packaging.
FDA Definition Under the Federal Food, Drug, & Cosmetic Act
The FDA defines an FCSS as any substance intended for use in materials that contact food, such as packaging, processing equipment, or food containers, if that substance is not intended to have a technical effect in the food itself.
Legally speaking, these fall under Section 409 of the FD&C Act. For use in food-contact applications, such substances must be approved through Food Contact Notification or be generally recognized as safe (GRAS) or meet other regulatory criteria.
What Constitutes a Food Contact Substance (FCS)
An FCS is a single chemical or compound-e.g., a polymer monomer, a stabilizer, colorant, or antioxidant-which is expected to migrate into food in small amounts. These are reviewed on a case-by-case basis through a Food Contact Notification. The notifier is required to submit data showing that migration will not exceed safe limits under the conditions of intended contact.
When a manufacturer submits an FCN, the FDA has 120 days to review it. If the FDA has no objections, the substance may be used in the way described in the submission. However, FCNs are specific to the notifier notification applies only to that manufacturer and its specified conditions of use.
Classes of Food-Contact Packaging Materials
FCMS derived from FCSs are very diverse, and the following list is representative: polymers, coatings, adhesives, paper, and printing inks. The regulatory status of a particular FCM depends upon the status of each migrating FCS in its formulation.
Polymers/plastics: Most packaging films, bottles, or trays are manufactured using FDA-approved polymers.
Coatings: The inside coatings of cans or liners of containers mainly depend on FCS.
Paper & paperboard: Packaging paper is usually treated with additives that provide resistance against grease or moisture.
Adhesives: These are used in multilayer packaging, labels, or laminates.
Colourants/antioxidants: Substances added to materials in order to give colour and/or improve stability.
Examples of Accepted Materials
Common examples of FDA-approved food-contact materials include:
Paper/cardboard with grease-resistant coatings: these are used in pizza boxes or bakery boxes.
There are several types of plastics that exist for different uses under the 21 CFR code, but the three most common are polyethylene-terephthalate or PET, polypropylene or PP, and HDPE or high-density polyethylene.
Internal coatings on either metal cans or on foil with FCSs, which are safe under migration testing
Adhesives and glues in packaging,g laminates, or labels
Antioxidants or stabilizers, which, when added to polymers, extend shelf life without migrating to unsafe levels
The FDA keeps a list of effective Food Contact Substance Notifications, through which one can find what uses have been approved and under what conditions.
The Difference Between Direct vs. Indirect Food Contact Packaging
One basic distinction in how food-packaging is regulated is on the basis of whether such packaging has direct contact with food-or only indirectly, through a barrier or other non-food surface.
What Counts as Direct Contact
Direct-contact packaging includes all materials that actually come into contact with food. Examples include the inside surfaces of containers, films or wraps, trays, and all other parts of the package that are in direct contact with the food itself. Any substance that migrates from these materials into food must be carefully evaluated for safety.
What Counts as Indirect Contact
Indirect contact can be defined as materials that are not in direct contact with food, or with a barrier intervening between the material and the food. Indirect contact materials may include outer cartons, printing inks on the outside layer, or structural components of packaging.
Even if it’s part of an indirect-contact layer, if it can migrate or diffuse through a barrier into the food, then it’s subject to the FCS rules. That is, the manufacturer has to consider not just the immediate surface but the whole stack-up of materials in contact or near contact with food.
FDA Regulations Applying to Each Category
The FCS that migrates to direct-contact articles must be covered by an effective FCN, GRAS status, or a pertinent regulation under 21 CFR. Parts 174 through 179 are examples of this.
Indirect-contact materials: Though the material does not directly contact food, FCS is subject to approval if it is likely to migrate under conditions of use. Same pathways above apply: FCN, GRAS, and prior sanctio.n
Real-world examples: pizza boxes, inner liners, bottle caps
Pizza boxes. The inside of the cardboard can be coated with a grease-repellent coating, an FCS, which prevents oil from soaking through. That coating must meet FDA migration/safety criteria.
Inner liners of containers: For example, the inner coating in a food-contacting metal can or film on a plastic tray must be FDA-approved.
Bottle caps: Plastic caps that come into contact with the drink, or seal liners within caps, can contain FCSs that may migrate into the liquid; hence, these are often subject to regulatory scrutiny.
Migration Testing of Packaging Materials
The most important safety tests on food-contact materials are the migration tests, which determine how much of a chemical can migrate from the package into food under specified conditions.
Why Migration Testing Is Required
The goal of migration testing is to ensure that any chemical that could migrate from the package into food under conditions of heat, long storage, and pressure that are realistic or worse does not exceed safe levels. FDA needs such data to estimate exposure to be within a margin of safety in a Food Contact Notification.
There is no scientific ground for the safety of food packaging over time, without data on migration, which would result in toxicological risk or rejection of the notification.
FDA Guidelines on Chemical Migration
The FDA estimates migration by using models of exposure coupled with toxicological data. It calculates the probable level of migration of a chemical into food under worst-case conditions and compares that level against levels considered safe based on toxicity studies.
FDA has developed an expectation, in developing its guidance for Food Contact Substance notifications, that both chemistry-that is, how much of a substance may migrate-and toxicology-that is, is that amount safe-are demonstrated.
Types of Migration Tests (Overall, Specific, NIAS)
Migration testing in general measures the overall migration into a food simulant of all the substances that are not volatile. This gives a general overview of the risk of migration.
If the test is one of migration, then the target will often be a selection of individual compounds relevant because of their toxicity; that is, the amount migrating from each of the monomers, additives, or impurities will be tested.
NIAS: These are substances that are not intentionally added to the FCS. Examples include impurities and reaction by-products. FDA does consider NIAS in its safety assessments; to the extent such substances can be detected, potential migration and risk need to be assessed.
These tests provide the data necessary to confirm that substances remain within safe limits of exposure.
Guidelines on Risk Assessment
Considering the data on the migration, FDA compares estimates of consumer exposure based on assumptions about consumption and migration values with toxicological benchmarks, such as the No Observed Adverse Effect Level or other reference doses. In setting this safety standard, the FDA requires “reasonable certainty of no harm” under the conditions of intended use.
For very low exposures, the Threshold of Regulation (TOR) exemption under 21 CFR 170.39 may be considered. This approach assumes that the degree of migration is so low as to be of negligible risk.
Selection of Safe Packaging Material for FDA-Approved Custom Packaging
Regulatory status, functional performance, and chemical risk are important factors to be considered in the use of safe custom packaging materials in food-contact applications.
Selection of FDA-Approved Materials
First, it has to be ensured that all the constituents of the proposed packaging—polymers, coatings, adhesives, inks, laminates—have a regulatory status named under FDA regulations. FDA policy in respect of food-contact materials has been that any substance expected to migrate into food should be subject to one of the following: a regulation in 21 CFR (Parts 174–179); a generally recognized as safe designation; an exemption authorized by the Threshold of Regulation rule; or an effective Food Contact Substance Notification.
It is very important during the sourcing of material to request that the supplier provide a Letter of Guarantee. The letter provides assurance that the substance is to the exact specification covered under the specific FCN involved or other authorization and is traceable to the notifier.
Another very important verification involves checking the supplier’s FCN or other documentation to match up the intended use with the conditions of use, which are contained in the notification. Conditions of use generally include such factors as temperature, food type, and contact duration.
Commonly Used Materials for Food-Safe Packaging
Due to their regulatory history, performance, and safety, applications of the following materials are common in food-contact packaging:
Plastics such as PET, PP, and HDPE are very common, and many of their constituent polymers or monomers are well-known FCSs.
Paper and paperboard, many with grease-resistant or moisture-barrier coatings.
Coatings on can interiors, or on paper, to impart protection against grease or moisture. Adhesives and laminates: these are applied for bonding different films or board layers in multilayer packaging. Inks: printing colorants, usually formulated using FDA-approved FCSs that are non-toxic to contact foods. Compliance will be considerably facilitated, and unknown migration risks can be avoided by making use of materials whose regulatory history is documented.
Selecting Adhesives, Inks, Laminates, and Coatings
Adhesives, inks, and coatings can be chemically more complicated than base polymers because of the frequent inclusion of low-molecular-weight substances that are more apt to migrate. All substances associated with these components should be verified as authorized under FDA food-contact regulations via FCN, GRAS, or TOR. Full disclosure by the supplier should be required for migrating substances, purity specifications, and migration data when considering adhesives or coatings. Designers and quality teams should ensure that any specified use-e.g., dry foods versus fatty foods, hot fill-is consistent with the intended use of the packaging.
Inks, too, should be no different: colorants and solvents should be FCSs, and their conditions of use should be compatible with the application. This will ensure regulatory safety with minimal risk of chemical migration.
BPA, PFAS, Heavy Metals: How to Avoid Harmful Chemicals
Some classes of chemicals have a higher associated risk and, hence, regulatory scrutiny. For example, PFASs, per- and polyfluoroalkyl substances, have been used historically for grease proofing but, due to safety concerns and migration risk, have been phased out for many of those uses by the FDA.
Authorized uses of PFAS are disappearing. Indeed, as of early 2024, the FDA announced that many PFAS-containing FCNs for greaseproofing paperboard are no longer effective because manufacturers have discontinued these uses.
Most critical risk factors are bisphenols like BPA and heavy metals such as lead and cadmium; in this kind of contamination, the materials must be tested or excluded on purpose. Suppliers should provide test certificates and guarantee low migration levels.
The avoidance of these substances supports not only safety but also emerging state-level restrictions, including PFAS bans.
FDA Filings Required for Food Contact-Packaging
Good recordkeeping is vital to regulatory compliance. The following are the principal types of FDA-related paperwork and records for food-contact packaging.
Food Contact Notifications (FCN)
A food contact notification is a premarket submission to the FDA under Section 409(h) of the FD&C Act. It includes the scientific and technical data-chemistry plus toxicology-showing that the substance is safe under its intended conditions of use in contact with food.
Each FCN is limited to a manufacturer and precise conditions of use: temperature, food type, and duration of contact.
Therefore, the basis of legal compliance when it comes to selecting substances is checking that the manufacturer possesses a relevant, effective FCN.
Threshold of Regulation (TOR) Exemptions
Other substances whose migration risk is considered extremely low, i.e., below defined thresholds, may be exempt under 21 CFR 170.39, so-called Threshold of Regulation.
When available, a supplier can rely on a TOR and not submit a full FCN, but the documentation-public exemption listing + assurance from the supplier is key. The
FDA has exempted, for example, metal carbides used as coatings on processing equipment from TORs on the basis of negligible migration.
GRAS Materials in Packaging
Rather than being an FCN, some food-contact substances are considered “Generally Recognized As Safe” (GRAS). The regulatory status is based on prior or existing GRAS notices and regulations.
In such cases, documentation supporting the GRAS status should be compiled and archived for audits, including a GRAS notice, supporting studies, and purity data.
Letters of Guarantee from Suppliers
A LOG from a supplier shall confirm the supplied substance is the same as the exact FCN, TOR, or GRAS authorization, including specification, purity, and permitted conditions of use.
This letter provides critical traceability and helps any downstream user, whether a packager or a brand, defend its compliance in case of an inspection.
Traceability & Compliance Documentation
Besides authorization, for packaging compliance, traceability is called for: batch records, COAs, LOGs, and migration/test reports shall be maintained.
Anytime a building block changes-new supplier, a new batch, or a change in process-documentation must be revised to reflect those changes and confirm compliance under the same regulatory conditions.
Common Violations & Recent FDA Actions
Still, even with the clarity of regulations, violations abound. Understanding recent trends can help manufacturers make safer choices.
Abuse of the Term “FDA-Approved Materials”
One frequent violation is misusing or exaggerating the phrase “FDA-approved.” FCNs are proprietary to a manufacturer, so not all users of a substance benefit automatically from an FCN.
Packaging marketers or designers that make broad claims of “FDA-approved” without first ensuring their supplier holds a relevant FCN risk misleading consumers and the FDA.
Packaging Contamination Warnings
The contamination violations occur where applicants/brand owners have not tested for impurities, by-products of unknown reactions, or degradants. These include residual monomers, stabilizers, or catalysts not explicitly considered in an FCN.
Outdated or incomplete migration testing can also fail to find the presence of substances added non-intentionally, which again can lead to enforcement if those substances are found at hazardous levels.
PFAS-Related Actions in Food Packaging
PFASs added to food-contact articles have recently been under increased regulatory scrutiny. While certain uses of PFASs were allowed historically, the FDA has now determined that many grease-proofing FCNs for paper and paperboard are no longer effective because companies have abandoned those uses.
Meanwhile, states have started taking matters into their own hands. California barred the use of PFAS in many paper-based food packaging products, starting on January 1, 2023.
Real-World Enforcement Examples
The FDA periodically updates its Constituent Updates and has recently revoked FCNs or issued guidance about previously authorized substances. For example, the recent revocation of PFAS grease-proofing FCNs illustrates how the regulation has shifted due to health concerns.
Manufacturers that continue to use such materials without proper documentation or their substitutes without proper evaluation may have certain compliance or enforcement issues.
Other US Regulations Affecting Food-Safe Materials
Apart from FDA sector-specific regulation, food-contact material choices are influenced by various other U.S. legislations and state-level regulations.
USDA Requirements for Certain Food Categories
Packaging of food in USDA-regulated foods, such as meats, poultry, and eggs, requires the packaging material to comply not just with FDA rules on food-contact, but also additional labeling and safety criteria of the USDA through the inspection process. Generally speaking, USDA does not regulate FCS directly, although specific types of processed products may be required to support cross-agency compliance.
California PFAS Bans
California has led the nation in efforts to curb PFAS in food packaging. AB 1200 prohibits food packaging made of paper-based materials containing intentionally added PFAS or more than 100 ppm total organic fluorine.
Suppliers and brands alike must familiarize themselves with local laws, since these state bans can become far more limiting compared to the existing federal authorizations.
USDA Organic Packaging Compatibility
Components of packaging that come in direct contact with the product, like inks and adhesives, for products labeled as USDA Organic are generally required to meet requirements of organic system plans, not contain prohibited substances, and not contaminate the product. USDA does not chemically regulate all materials, but its organic certification may impact material choices-particularly in cases of biodegradable or “green” packaging.
FTC Rules on Environmental and Recycling Claims
Marketing claims such as “recyclable,” “compostable,” or “sustainable” fall under the Federal Trade Commission Green Guides, which require that environmental claims be truthful, clear, and substantiated. If the package contains a recycled resin, the percentage of the recyclate needs to be able to be verified; if a material is compostable, valid testing under recognized standards needs to be available. Deceptive green claims can lead to enforcement from the FTC, regardless of FDA compliance.
Buyer’s Guide: How U.S. Brands Can Verify Food-Safe Materials
Verification is one aspect of a proper procedure for the clearance of food packaging. All materials, coatings, inks, and adhesives in contact with food shall be compliant with the U.S. FDA specifications for contact foods under Title 21 of the Code of Federal Regulations. Recordkeeping reduces risks to compliance and prevents errors that may lead to contamination.
How to Check If a Material Is FDA Compliant
The regulatory status of any food-contact material can be verified via one of the following four pathways:
A regulation listed in 21 CFR Parts 174–179
A Food Contact Notification (FCN)
A Threshold of Regulation (TOR) exemption
A GRAS determination
FDA distinguishes these categories quite clearly in its guidance on determining the regulatory status of food-contact materials. Source:
Matching intended use conditions of temperature, food type, and duration of contact are important because FCNs and listings in the CFR apply only under those conditions.
Steps for Supplier Verification
The final compliance is directly influenced by the reliability of the supplier. Authentic documentation would usually contain:
A Letter of Guarantee that the material meets its FCN or CFR citation
A Certificate of Analysis for purity and contaminants
Coating, ink, or adhesive migration or extractables testing
Traceability documents showing the manufacturer and batch history
FDA urges buyers to request written assurance that confirms compliance. Source:
Basically, one must always be wary of suppliers that refuse to supply documentation.
Food Contact Substance Databases Review
The FDA keeps several publicly accessible databases that help verify a food-contact substance’s legal status:
Food Contact Substance Notification Inventory (FCN Inventory) – Lists effective and discontinued FCNs
Threshold of Regulation Inventory
GRAS Notices Inventory
These databases are checked for the validity of the authorization and whether or not the material has been withdrawn or discontinued.
Identifying Red Flags
There are common warning signs that often surround a compliance risk.
Vague claims of “FDA-approved material” without citing the exact CFR section or FCN number
No willingness to give Letters of Guarantee
Lack of supporting test data about inks, coatings, and adhesives
Use of materials whose use is under regulatory scrutiny without documented justification (e.g., various DFAS)
FAQ Section
Are all packaging materials FDA-approved?
No. Only materials listed in CFR, covered under an FCN, GRAS, or TOR exemption are legally allowable.
How would one know if packaging was food safe?
The material shall be of a specific FDA clearance and its indication for use conditions, accompanied by documentation from the supplier.
Are PLA and biodegradable packaging FDA-compliant?
PLA will only be food-safe if the exact grade appears in an FDA authorization for food contact; in other words, it needs to be checked individually for each biodegradable material.
Does printing ink need FDA approval?
Yes. All of the components-colorants, solvents, and additives must be permitted under an FDA food-contact regulation or FCN.
Must custom boxes have food-contact certification?
Provided the product comes into direct or indirect contact with the food. In case of direct contact, the substrate, coatings, and inks must be in compliance with the rules for food-contact.
Conclusion
Food-contact safety is predicated on the accurate verification of materials, proper documentation, and compliance with FDA use conditions. CFR citations, FCNs, TOR exemptions, and GRAS notices are central to the basic framework.
Continuous compliance can be ensured through periodic checks of documentation, auditing of suppliers, updating, migration testing, and monitoring changes in regulations.
The regulatory trends promise a future with PFAS-free, low migration, and sustainably engineered packaging. Considering the further evolving material science, a greater reliance can be placed on FDA pathways and state-level restrictions to shape the makeup of food-safe systems in the future.
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