FDA indirect food contact regulations treat almost any substance that could migrate from packaging, processing equipment, or storage materials into food as a food additive, which means it needs either an existing regulation covering its use, a recognized exemption, or a company-specific Food Contact Notification before the product can legally be sold. The rule reaches further than most manufacturers expect: the polymer in a yogurt cup, the adhesive on a cereal box, the coating inside a beverage can, and the lubricant on a conveyor belt all fall inside it. The burden of proving safety sits with the manufacturer or supplier of the substance, not with the FDA.
What Counts as Indirect Food Contact
An indirect food contact substance is any component of a material that holds, processes, or transports food where the substance is not meant to have a technical effect on the food itself. Nobody intends for it to end up in what people eat. The concern is migration: the gradual transfer of chemical components from the contact surface into the food over time, driven by temperature, contact duration, and the chemistry of both the food and the material.
Migration is measured in parts per billion, and even trace amounts can trigger regulatory review because the FDA looks at cumulative dietary exposure across everything a person eats and drinks. Fatty, acidic, and aqueous foods behave differently against the same material, which is why the regulatory framework is built around specific conditions of use rather than blanket approvals.
Why the Legal Stakes Reach the Food Company, Not Just the Packaging Supplier
The Federal Food, Drug, and Cosmetic Act defines “food additive” broadly. Under 21 U.S.C. § 321(s), any substance whose intended use may reasonably be expected to result in it becoming a component of food, whether directly or indirectly, is a food additive unless it falls into a specific exemption.1Legal Information Institute. 21 USC 321 – Definitions A food additive is “unsafe” unless its use conforms to an exemption, a regulation prescribing safe conditions of use, or an effective food contact notification.2Office of the Law Revision Counsel. 21 USC 348 – Food Additives
Under 21 U.S.C. § 342, food containing any additive deemed unsafe under § 348 is legally adulterated.3Office of the Law Revision Counsel. 21 USC 342 – Adulterated Food Introducing adulterated food into interstate commerce is a prohibited act under 21 U.S.C. § 331, which can lead to product seizure, injunctions, and criminal prosecution.4Office of the Law Revision Counsel. 21 USC 331 – Prohibited Acts The practical effect: if a food company uses packaging containing an uncleared substance, the food itself becomes adulterated, not just the packaging. Compliance is a supply-chain problem, and food manufacturers have every reason to demand documentation from their packaging and equipment suppliers.
Check First Whether the Substance Is Already Cleared
Before filing anything with FDA, look at whether the substance is already authorized. Several parts of Title 21 catalog substances that have already gone through the clearance process and can be used by anyone within the specified conditions:
- Part 174 sets general provisions applicable to all indirect food additives, including good manufacturing practice requirements.5eCFR. 21 CFR Part 174 – Indirect Food Additives: General
- Part 175 covers adhesives, coatings, and components of coatings.
- Part 176 covers paper and paperboard components, including resins, coatings, and processing chemicals used in paper manufacture.6eCFR. 21 CFR Part 176 – Indirect Food Additives: Paper and Paperboard Components
- Part 177 covers polymers used in food packaging and food-processing equipment.
- Part 178 covers adjuvants, production aids, and sanitizers used in food manufacturing.
Each regulation specifies the substance, the permitted conditions of use, any concentration limits, and which food types the substance may contact. When the intended use fits, no notification or petition is needed.
Two other categories can also apply without a fresh clearance. A substance qualifies as Generally Recognized as Safe (GRAS) if qualified experts, working from scientific procedures or a documented history of common use before January 1, 1958, conclude it is safe for its intended purpose.7eCFR. 21 CFR 570.30 – Eligibility for Classification as Generally Recognized as Safe (GRAS) The exemption is procedural; the safety bar is the same as for any food additive. Prior-sanctioned substances, cataloged in 21 CFR Part 181, are those the FDA or USDA formally approved for specific food contact uses before the 1958 Food Additives Amendment.8eCFR. 21 CFR Part 181 – Prior-Sanctioned Food Ingredients A prior sanction is limited to the specific use approved before 1958; a new use requires a fresh safety determination.
Three Pathways to Market for a New Substance
When a substance is not already covered, three routes exist. Choosing wrong wastes time and money, so the differences matter.
Food Contact Notification
The Food Contact Notification (FCN) program, established in 1997, is now the primary mechanism for clearing new food contact substances.9U.S. Food and Drug Administration. How FDA Regulates Substances That Come Into Contact With Food The manufacturer submits data demonstrating the substance is safe for its intended use.10U.S. Food and Drug Administration. How to Submit a Food Contact Substance Notification FDA has 120 days to review. If the agency does not object within that window, the notification becomes effective and the substance can be legally marketed.11U.S. Food and Drug Administration. About the FCS Review Program
An FCN is proprietary. It authorizes only the specific manufacturer or supplier named in the notification, for the specific substance and conditions of use described.11U.S. Food and Drug Administration. About the FCS Review Program A competitor who wants to sell the same substance must file its own. Downstream customers of the notifier can rely on the FCN for their packaging operations, but the authorization does not extend to other suppliers. If the notifier is acquired or renamed, the notification can be transferred by notifying FDA and providing documentation of the legal basis, though no formal transfer procedure exists in the regulations. FDA retains authority to rescind an effective FCN if new information indicates the substance is unsafe, following a notice-and-response process.
Food Additive Petition
A food additive petition (FAP) was the only route to market before FCNs existed. The petition process results in a published regulation authorizing the substance, so any manufacturer can use it under the specified conditions rather than just the filer. FDA still has discretion to require a petition instead of an FCN when it determines the petition process is more appropriate for evaluating the safety data.9U.S. Food and Drug Administration. How FDA Regulates Substances That Come Into Contact With Food Petitions take significantly longer because they go through notice-and-comment rulemaking, but the resulting regulation benefits the entire industry.
Threshold of Regulation Exemption
The Threshold of Regulation (TOR) exemption offers a faster path for substances that migrate at very low levels. A substance qualifies if it meets all four criteria: no evidence of being a carcinogen in humans or animals, dietary concentration at or below 0.5 parts per billion (equivalent to 1.5 micrograms per person per day), no technical effect on the food, and no significant adverse environmental impact.12eCFR. 21 CFR 170.39 – Threshold of Regulation for Substances Used in Food-Contact Articles A TOR exemption is not proprietary; once granted, any manufacturer can use the substance under the specified conditions.9U.S. Food and Drug Administration. How FDA Regulates Substances That Come Into Contact With Food
The submission requires the chemical identity, proposed conditions of use, migration data or residual-level information sufficient for FDA to estimate dietary concentration, and a review of the toxicological literature. When the manufacturer can only provide residual levels in the contact material rather than direct migration data, FDA assumes 100 percent migration as a worst case.12eCFR. 21 CFR 170.39 – Threshold of Regulation for Substances Used in Food-Contact Articles Many companies get tripped up here: without validated migration data showing low transfer, the worst-case calculation can push the estimated exposure above the 0.5 ppb threshold and disqualify the substance.
What an FCN Has to Prove
The core of any FCN is showing the substance is safe at the exposure levels consumers will actually encounter.
The submission must include the full chemical identity of the substance, including impurities. It must include migration testing data showing how much of the substance transfers into food under the intended conditions of use. FDA does not accept theoretical estimates alone for most substances; it wants validated laboratory data using standardized food simulants matched to the type of food the packaging will contact. The agency uses 10% ethanol for aqueous and acidic foods, food oil such as corn oil for fatty foods, and either the actual ethanol concentration or 50% ethanol for alcoholic beverages, with separate water and 3% acetic acid extractions when acidity could drive higher migration.13U.S. Food and Drug Administration. Chemistry Recommendations for Submissions of Food Contact Substances
Temperature and contact time matter as much as chemistry. FDA categorizes conditions of use from high-temperature sterilization above 250°F down through boiling, hot-fill, room temperature, refrigerated, and frozen storage.14U.S. Food and Drug Administration. Food Types and Conditions of Use for Food Contact Substances The notification must specify which conditions apply, and the migration testing must match.
The migration data feeds an estimated daily intake calculation based on a reference diet of 3,000 grams per day. That figure determines how much toxicological data FDA expects. Low-exposure substances may need only a basic toxicology review; higher-exposure substances require more extensive testing. The legal standard is “reasonable certainty of no harm” over a lifetime of exposure.
Recycled Plastics Are Handled Separately
Post-consumer recycled plastic raises a distinct concern: the recycled feedstock may carry contaminants from its previous life. A plastic bottle that held motor oil or cleaning solution could enter the recycled stream and contaminate packaging intended for food. FDA evaluates recycled plastics case by case and issues letters of opinion on whether a particular recycling process produces material of suitable purity.15U.S. Food and Drug Administration. Recycled Plastics in Food Packaging
The manufacturer must submit a complete description of the recycling process, source controls used to ensure only food-grade plastic enters the recycled stream, and results of surrogate contaminant testing showing the process reduces incidental contaminants to a dietary concentration below 0.5 ppb.15U.S. Food and Drug Administration. Recycled Plastics in Food Packaging That threshold mirrors the TOR standard.
One exception matters. FDA no longer requires surrogate contaminant testing for recycled PET or PEN plastic produced through tertiary (chemical) recycling processes. The agency has determined that these processes inherently produce material of suitable purity for food contact and no longer issues individual opinion letters for them.15U.S. Food and Drug Administration. Recycled Plastics in Food Packaging Mechanical recycling of PET still requires the full evaluation.
Staying Compliant After Clearance
An effective FCN or a matching existing regulation is not the end of the obligation. The manufacturer must stay within every limitation in the authorization: maximum concentration in the contact material, temperature ceiling, permitted food types. Drift outside those parameters and the substance is no longer covered, which means any food it touches becomes adulterated.
Current Good Manufacturing Practice requirements under 21 CFR Part 117 apply to food facilities generally, covering plant design, sanitation, equipment maintenance, and production controls.16eCFR. 21 CFR Part 117 Subpart B – Current Good Manufacturing Practice For food contact substance manufacturers, good manufacturing practice means ensuring the substance consistently meets the purity specifications and performance characteristics that formed the basis of the safety assessment. The general provisions in 21 CFR Part 174 reinforce this by conditioning the safe use of all indirect food additives on compliance with good manufacturing practice.5eCFR. 21 CFR Part 174 – Indirect Food Additives: General
Detailed records and functioning quality controls are not optional. When FDA questions whether a substance still meets its authorized specifications, the documentation is what answers. Companies that treat the FCN filing as a one-time event and neglect ongoing verification are the ones most exposed when a downstream problem surfaces.