What does FDA Food Contact Rules (21 CFR) require and does it protect your family?
The U.S. regulatory framework governing every material that can touch your food - from nonstick coatings on air fryer baskets to plastic containers, packaging films, and can linings. Codified in Title 21 of the Code of Federal Regulations (21 CFR), Parts 170-199, these rules define which substances are permitted in food contact applications, what migration limits apply, and how manufacturers prove compliance. Critically, FDA does not pre-approve finished cookware - meaning that "FDA compliant" on a product label is a manufacturer's self-declaration, not a government stamp of approval.
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Every time you cook in an air fryer, pack a lunch box, or open a can of tomatoes, you're interacting with materials that FDA has - in one form or another - reviewed for safety. That regulatory framework lives in Title 21 of the Code of Federal Regulations, specifically Parts 170-199. It's dense, technical, and genuinely important to understand if you care about what migrates from surfaces into the food your family eats.
But here's the thing most parents don't know: the FDA doesn't approve your specific air fryer. It doesn't inspect the nonstick basket before it ships from a factory in Guangdong. What FDA does is maintain a list of approved substances and define the conditions under which those substances are safe for food contact. Whether any given product actually uses only those approved substances - and uses them within the allowed limits - is largely on the manufacturer to verify and self-declare.
That distinction matters enormously when you're reading product marketing.
Title 21, Subchapter B is the core of FDA's food contact regulatory framework. Here's a map of the relevant territory:
Part 170 - Food Additives (General Provisions) establishes the foundational definitions, petition processes, and safety standards. It defines what a food additive is and sets the statutory framework that everything else builds on.
Part 174 - Indirect Food Additives: General is where the food contact story really begins. Part 174 establishes that substances used in the manufacture of food packaging and contact materials are regulated as indirect food additives - meaning they're not intentionally added to food, but they may migrate into it. The general provisions here apply across all the indirect additive categories.
Part 175 - Indirect Food Additives: Adhesives and Components of Coatings is directly relevant to cookware and air fryer baskets. This part lists the approved substances for use in adhesives and resinous or polymeric coatings intended for food contact. Section 175.300 is the key provision for nonstick coatings - it specifies the conditions under which resinous and polymeric coatings may be used in contact with food, including a 0.5 mg per square inch limit on chloroform-soluble extractives. PTFE is authorized under Part 175 for food contact coatings when manufactured and used within the conditions specified.
Part 176 - Indirect Food Additives: Paper and Paperboard Components governs materials used in paper food packaging - fast food wrappers, microwave popcorn bags, bakery boxes, food-grade kraft paper. This is the part under which PFAS-containing grease-proofing agents were previously authorized through Food Contact Notifications, and from which those authorizations were subsequently voided.
Part 177 - Indirect Food Additives: Polymers covers the plastics used in food contact applications - polyethylene, polypropylene, nylon, and hundreds of other polymer formulations. Part 177 is what governs most plastic food containers, storage bags, and the plastic components of cookware and appliances.
Part 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers covers the processing chemicals and sanitizers that may come into contact with food during manufacturing.
Part 189 - Substances Prohibited From Use in Human Food is a shorter but important list - substances explicitly banned from food use.
Beyond these core sections, Parts 182-186 cover GRAS (Generally Recognized as Safe) substances for both direct and indirect food uses, and Part 181 covers prior-sanctioned ingredients that were approved before the 1958 Food Additives Amendment.
Not every approved food contact substance has been codified as a 21 CFR listing. Many are authorized through FDA's Food Contact Substance Notification (FCN) program, established by the FDA Modernization Act of 1997 as a faster alternative to the full food additive petition process.
Here's how it works: a manufacturer or supplier who wants to use a substance in food contact applications submits a notification to FDA describing the substance's identity, the intended use, migration data, and safety evidence including estimated dietary exposure. FDA then has 120 days to conduct a scientific review. If FDA doesn't object, the notification becomes effective and the substance is authorized for use.
There's an important nuance to FCN authorizations: they are proprietary. An FCN is effective only for the specific manufacturer or supplier named in the notification. If Company B wants to use the same substance in the same application, they can't rely on Company A's FCN - they need their own. This creates a system where the safety authorization is tied to specific supply chains, not just chemical identities.
Alternatively, substances may be used if they qualify as GRAS (Generally Recognized as Safe) - meaning there's expert scientific consensus that the substance is safe at its intended use level. Or they may qualify for a Threshold of Regulation (TOR) exemption, which allows use of a substance whose migration into food is so low (typically below 0.5 parts per billion) that it doesn't raise safety concerns regardless of its chemical properties.
FDA maintains public databases for all three pathways: the Inventory of Effective Food Contact Substance Notifications, the GRAS Notice Inventory, and the Threshold of Regulation Exemptions list. These are your verification tools when a manufacturer makes compliance claims.
This is the part that surprises most families: there is no FDA pre-market approval process for finished cookware or household appliances.
FDA regulates the individual substances that go into food contact materials. It does not approve the assembled product. When a cookware brand says its air fryer is "FDA compliant" or "FDA safe," that's a manufacturer self-declaration - it means the brand is asserting that the materials used comply with relevant 21 CFR provisions. FDA has not independently verified that claim.
This is meaningfully different from how drugs, medical devices, or food additives work. A new drug requires FDA pre-market approval before it can be sold. A new food contact substance can be authorized through the FCN program, GRAS, or TOR. But the assembled cookware product goes to market on the manufacturer's own declaration of compliance.
Migration testing - the process of exposing a material to food simulants and measuring what chemicals transfer - is the technical backbone of compliance demonstration. But there's no mandatory reporting requirement that makes those test results available to consumers. A manufacturer can conduct internal migration testing that shows compliance and never disclose the data publicly.
For parents trying to evaluate products, this means the regulatory signal is weaker than the labeling often implies. "FDA compliant" is necessary-but-not-sufficient. Third-party certifications like NSF/ANSI 51 exist precisely to fill this gap - they require independent verification of the same compliance claims that manufacturers would otherwise self-declare.
The story of PFAS in FDA-regulated food contact materials is a case study in how slowly regulatory action can move relative to the accumulation of scientific evidence.
For decades, certain PFAS compounds were authorized through Food Contact Notifications for use as grease-proofing agents in paper food packaging - the coatings that keep burger wrappers, microwave popcorn bags, and fast food containers from getting soggy. Three major manufacturers had FCN authorizations for short-chain PFAS compounds in these applications.
In July 2020, those three manufacturers voluntarily agreed to phase out their sales of PFAS-containing grease-proofing agents for food packaging in the U.S. market, with a three-year phase-out period beginning January 2021. The voluntary phase-out reflected pressure from scientific research, state-level legislation, and advocacy campaigns - not an FDA mandate.
FDA formalized the end of the phase-out in January 2025, issuing a Federal Register notice that 35 Food Contact Notifications related to PFAS in paper and paperboard food packaging are no longer effective. A compliance date of June 30, 2025 was established to allow manufacturers time to exhaust existing stocks of packaging produced before January 6, 2025.
What this means in practice: as of mid-2025, PFAS-containing grease-proofing agents are no longer supposed to be in use for paper food packaging in the United States. The paper wrappers at fast food restaurants, the microwave popcorn bag, the bakery box should no longer contain intentionally added PFAS for moisture resistance.
What this does NOT cover: PFAS in cookware coatings (which fall under Part 175, not Part 176), PFAS in non-paper packaging, or PFAS that may be present as background contamination rather than intentionally added.
PTFE - polytetrafluoroethylene, marketed as Teflon and used in the vast majority of nonstick cookware and air fryer basket coatings - is explicitly authorized for food contact use under 21 CFR 175.300. FDA's current position, based on available scientific evidence, is that cured PTFE polymer does not migrate into food at meaningful levels during normal use.
The key caveat is "cured" and "normal use." PTFE coatings that are properly cured at manufacturing temperatures do not break down under normal cooking conditions. The concern with PTFE arises at extremely high temperatures (above approximately 500 degrees Fahrenheit) where the polymer can begin to degrade and release fumes - a hazard to pet birds and, at very high exposures, humans. Standard air fryer cooking temperatures (typically 300-400 degrees Fahrenheit) do not reach the PTFE decomposition threshold under normal use.
FDA has not initiated any regulatory action to restrict PTFE in cookware. This contrasts with the European Union, where the broader category of PFAS is under active regulatory review as part of the REACH restriction process, with potential restrictions on PFAS in food contact materials being assessed.
The parent-relevant nuance: PTFE is a PFAS chemically speaking (it's a fluoropolymer), but it behaves very differently from the short-chain PFAS that contaminate drinking water and bioaccumulate in human tissue. PTFE is a high-molecular-weight polymer that - when intact - doesn't meaningfully migrate. The health concern with PFAS in cookware is more specifically about PFOA (the processing aid historically used to apply PTFE coatings, now phased out globally) and other coating additives, not the PTFE polymer itself.
BPA (bisphenol A) is an instructive case study in the limits of FDA's food contact framework.
In July 2012, FDA amended its regulations to prohibit BPA-based polycarbonate resins in baby bottles and sippy cups. In July 2013, FDA followed with a ban on BPA-based epoxy resin coatings in packaging for infant formula. These actions came in response to food additive petitions filed by industry trade groups, not from FDA-initiated rulemaking - the petitions cited that manufacturers had already abandoned BPA in these applications, making the ban largely a formalization of market reality.
For food cans, however, BPA remains technically permitted under FDA regulations. FDA's current stated position is that BPA is safe at the levels occurring in foods based on available evidence. Practically speaking, the market has moved substantially away from BPA can linings even without a regulatory mandate - the Can Manufacturers Institute reports approximately 95% of food cans in the U.S. are now produced with BPA-free linings. But consumers buying canned food cannot assume BPA-free on the basis of FDA prohibition alone.
This gap between what science suggests and what the regulatory framework requires is a recurring feature of FDA's food contact system. The standard for regulatory action is "not safe" - not "optimally safe" or "precautionary." Substances remain authorized until evidence crosses a threshold sufficient to trigger rulemaking, a process that can take years to decades.
Families who research product safety often encounter EU standards and wonder how they compare to the U.S. system. The differences are meaningful.
EU food contact materials are governed by Framework Regulation (EC) No 1935/2004, which establishes that all food contact materials must be safe, inert, and not transfer substances to food in quantities that could endanger human health or change food composition, taste, or odor. The Framework Regulation applies to 17 categories of materials, including plastics, paper, metals, ceramics, glass, and rubber - a broader scope than U.S. regulations.
For plastics specifically, EU Regulation (EU) No 10/2011 establishes a positive list of authorized monomers, additives, and other starting substances, with specific migration limits expressed in milligrams per kilogram of food. Manufacturers must provide a Declaration of Compliance (DoC) confirming their product meets applicable EU regulations - a documented declaration with supporting test data.
Key differences from the U.S. approach:
For parents: a product meeting EU food contact standards is generally held to a more comprehensive and precautionary standard than one meeting only U.S. requirements. This doesn't mean U.S.-compliant products are unsafe - it means the standard of evidence for restriction is higher in the U.S.
For the specific category of air fryers and nonstick cookware, the FDA framework creates a specific gap that parents should understand:
What FDA regulates: The chemical identity and permitted use conditions for coating materials. PTFE is authorized under 21 CFR 175.300. Ceramic-based coatings must use substances from the approved lists or authorized through FCN/GRAS.
What FDA does not regulate: Whether any specific air fryer's coating actually complies. The manufacturing quality of applied coatings. The durability of coatings over time (a worn or scratched coating may behave differently than the virgin coating that passed testing). The presence of impurities in coating materials that weren't part of the original formulation review.
The migration testing gap: Migration testing at the substance level confirms that approved ingredients don't migrate above threshold levels under defined test conditions. But consumer use conditions - repeated high-heat cycles, abrasion from metal utensils, dishwasher exposure - can change migration behavior. There's no ongoing post-market surveillance requirement that monitors real-world migration from consumer products.
For families who want stronger assurance: - Third-party certification to NSF/ANSI 51 means materials have been independently verified against 21 CFR requirements rather than self-declared - California AB 1200 requires cookware brands selling in California to disclose intentionally added chemicals from a designated list, including PFAS, providing transparency FDA doesn't require - Choosing uncoated stainless steel or cast iron eliminates coating-related migration concerns entirely - Air fryer baskets specifically: stainless steel mesh baskets are increasingly available as alternatives to PTFE-coated aluminum baskets
Most air fryer baskets use PTFE nonstick coatings authorized under 21 CFR 175.300. FDA permits these coatings and considers them safe for normal cooking use. However, FDA does not independently verify that any specific air fryer's coating actually complies - that's the manufacturer's self-declaration. For stronger assurance, look for NSF/ANSI 51 certification or choose baskets made from uncoated stainless steel, which require no coating compliance claims at all.
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What this does NOT cover
21 CFR Parts 170-199 do not cover the safety of finished cookware or appliances as assembled products - only the individual substances used in their construction. FDA has no specific regulations for stainless steel or ceramic materials in food contact applications. The rules do not require post-market surveillance or ongoing monitoring of products already in consumer use. PFAS in cookware coatings (governed by Part 175) are not subject to the 2025 phase-out that applies to paper packaging under Part 176. And the system does not require manufacturers to publish migration test data - compliance is verified internally and self-declared unless a third-party certification is sought.
How to verify
For FDA food contact substance authorizations, search the Inventory of Effective Food Contact Substance Notifications at fda.gov for FCN-based approvals. For 21 CFR-listed substances, the eCFR database at ecfr.gov is the authoritative public source. For independent verification of a manufacturer's compliance claims, check the NSF certified food equipment database at listings.nsf.org for NSF/ANSI 51 certification. For California-sold cookware, check the brand's website for California AB 1200 disclosures listing intentionally added chemicals in food-contact surfaces. For PFAS specifically, the Environmental Working Group's food packaging database cross-references brand claims against available testing data.
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It means the manufacturer is self-declaring that the materials used in their product comply with relevant 21 CFR food contact regulations. FDA does not pre-approve finished cookware or appliances - there's no FDA inspector reviewing the product before it goes to market. The claim reflects the manufacturer's assessment of their own compliance, not an independent government verification. For stronger assurance, look for third-party certification from NSF International (NSF/ANSI 51) which independently verifies those same compliance claims.
The primary section is 21 CFR Part 175, specifically Section 175.300 on resinous and polymeric coatings intended for food contact. This is where PTFE (Teflon) and other coating polymers are authorized, with conditions including a 0.5 mg per square inch limit on chloroform-soluble extractives. Part 177 covers the plastic components of appliances. Part 174 provides the overarching general requirements for all indirect food additives. For PFAS specifically in paper packaging, Part 176 applied - and the 35 FCN authorizations under Part 176 for PFAS grease-proofing agents are now voided.
Yes. PTFE is explicitly authorized for food contact coatings under 21 CFR 175.300. FDA's current position is that properly cured PTFE polymer does not migrate into food at meaningful levels during normal cooking use. The concern with PTFE coatings is less about the PTFE polymer itself and more about historical processing aids like PFOA (now phased out globally) and potential degradation at very high temperatures above 500 degrees Fahrenheit. Standard air fryer temperatures (300-400 degrees) don't reach the PTFE decomposition threshold under normal use.
FDA effectively ended PFAS use in paper food packaging grease-proofing agents as of June 2025. Three major manufacturers voluntarily agreed in 2020 to phase out their PFAS-containing products for this use, and FDA issued a January 2025 notice that 35 Food Contact Notifications for PFAS in paper and paperboard packaging are no longer effective - with a June 30, 2025 compliance date for exhausting existing stocks. However, this action covers PFAS in paper packaging only - it does not restrict PFAS in cookware coatings, plastic food contact materials, or other applications.
Partially. FDA banned BPA-based polycarbonate resins in baby bottles and sippy cups in 2012, and in infant formula packaging in 2013. For adult food packaging including metal can linings, BPA technically remains FDA-permitted. FDA's current stated position is that BPA is safe at the levels found in foods. In practice, roughly 95% of food cans in the U.S. now use BPA-free can linings voluntarily - not because of a regulatory mandate. If BPA-free cans matter to you, check brand-specific claims rather than assuming FDA prohibition.
The EU system under Framework Regulation EC 1935/2004 is broader in scope (it explicitly covers stainless steel and ceramics, which FDA doesn't specifically regulate), operates more from positive lists (if it's not listed, it's not permitted), requires formal Declarations of Compliance with documented test data, and formally incorporates the precautionary principle. The U.S. system requires evidence of harm before restriction - substances remain authorized until FDA determines they're 'not safe.' A product complying with EU food contact standards is generally held to a more comprehensive standard, particularly around PFAS, where the EU is pursuing broad restrictions that the U.S. has not matched.
The FCN program is how FDA authorizes new food contact substances that aren't already listed in 21 CFR. A manufacturer or supplier submits a notification to FDA with safety data including the substance's identity, intended use, migration testing results, and estimated dietary exposure. FDA has 120 days to review and object. If no objection is filed, the notification becomes effective. Importantly, FCN authorizations are proprietary - they apply only to the specific manufacturer or supplier named in the notification. Another company using the same substance for the same purpose needs their own FCN. FDA maintains a public database of effective FCNs at the Inventory of Effective Food Contact Substance Notifications.
Migration testing measures how much of a material's chemical components transfer into food under defined conditions. The standard approach involves exposing the material to food simulants - solutions that mimic acidic, fatty, or aqueous foods - at representative temperatures for representative contact times. The resulting concentration of chemical migrants is then compared against limits in 21 CFR or the applicable FCN. For cookware, migration testing matters because coatings that are technically compliant with approved ingredient lists can still fail if their total extractables exceed migration limits under use conditions. The gap is that migration testing is done on new, pristine samples - not on worn, scratched, or repeatedly heat-cycled coatings as they actually exist in your kitchen after months of use.
A family of 10,000+ synthetic chemicals with an unbreakable carbon-fluorine bond. Found in nonstick cookware, air fryer baskets, food packaging, and drinking water. Called "forever chemicals" because they accumulate in the body and never break down — with links to cancer, immune suppression, and hormone disruption.