Authorized Uses of PFAS in Food Contact Applications
<< Per and Polyfluoroalkyl Substances (PFAS)
Since the 1960s, the FDA has authorized specific types of substances that contain PFAS for use in food contact applications. Substances that contain PFAS are used for their non-stick and grease, oil, and water-resistant properties. PFAS authorized for use in contact with food generally fall into four application categories: Nonstick coating applications; sealing gaskets for food processing equipment; manufacturing aids; and grease-proof agents for paper food packaging. Of these uses, current data available to the FDA indicate that only paper and paperboard agents would result in dietary exposure to PFAS that may result in a potential safety concern (see “assessing dietary exposure” section below). In February 2024, the FDA announced that substances containing PFAS used as grease-proofing agents on paper and paperboard for food contact use are no longer being sold by manufacturers into the U.S. market.
To obtain FDA authorization, manufacturers must submit data and information to the FDA demonstrating that there is a reasonable certainty of no harm from the intended use. Since 1999 these authorizations come to the FDA in the form of Food Contact Notifications which are specific to each manufacturer. If another manufacturer wants to use the same substance, they must submit their own application to the FDA.
After a substance has been authorized, the FDA reviews new scientific information on the authorized uses of food contact substances to ensure that these uses continue to be safe. When the FDA identifies potential safety concerns, the agency ensures that these concerns are addressed or that these substances are no longer used in food contact applications.
For More Information, please visit: Understanding How the FDA Regulates Substances that Come into Contact with Food and FDA Announcements on PFAS and Other U.S. Government Information.
Assessing Dietary Exposure to Food Contact Substances Containing PFAS
The FDA evaluates the safety of food contact substances by evaluating the expected consumer dietary exposure to the food contact substance and their components from each intended use. To estimate dietary exposure, the FDA evaluates the potential for the food contact substance and its minor components to transfer, or migrate, into the food. If a food contact substance has more than one authorized use, the FDA considers the potential health impact of all of the dietary exposures.
The extent to which food contact substances, including those that contain PFAS, migrate to food depends on the authorized and intended use, molecular structure of the substance, how the final product is manufactured.
Authorized Uses of Food Contact Substances that Contain PFAS and Potential for Migration
| Authorized & Intended Use | Molecular Structure of Substance & Product Manufacturing Process | Migration Potential Description |
|---|---|---|
| Non-stick applications on pots & pans | PFAS molecules are polymerized* (i.e., joined together to form large molecules) and are then applied to the surface of the cookware at very high temperatures, which tightly binds the polymer coating to the cookware. | The manufacturing process vaporizes off virtually all the smaller (i.e., migratable) PFAS molecules. The result is a highly polymerized coating bound to the surface of the cookware. Studies show negligible amounts of PFAS in this coating can migrate to food. |
| Rubber O-rings & gaskets used in food processing equipment | PFAS molecules are polymerized* and the resultant large molecules are further joined together (i.e., “crosslinked”) to create a resin that is formed into parts such as sealing gaskets and O-rings, typically used in food processing equipment. | This process removes virtually all the smaller (i.e., migratable) PFAS molecules, resulting in negligible amounts of PFAS capable of migrating to food. |
| Manufacturing aids added to other food contact polymers | PFAS molecules may or may not be polymerized but are large molecules. | The amount of PFAS used as aids in the manufacture of other food contact polymers is so small that only negligible amounts can migrate to food from this use. |
| Grease-Proofers applied to fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags. Note: As of January 2024, substances containing PFAS are no longer being sold into the U.S. market for food contact use as grease-proofers. | PFAS molecules are not polymerized, but rather are attached to other non-PFAS polymerized molecules as smaller “sidechains” to form the final grease-proofing agent that is applied to the paper packaging. Grease-proofing agents are applied to paper/paperboard packaging at lower temperatures, which are not high enough to remove residual smaller (i.e., migratable) PFAS molecules. | Under certain conditions, the smaller PFAS “sidechain” can detach from the polymerized molecule. As a result, there is potential for PFAS to migrate to food at levels that may result in a potential safety concern. |
*Polymerized or large molecule PFAS are not absorbed by the human body when ingested.
PFAS may also occur in food packing as an impurity or a contaminant. An impurity can form during the processing of other chemicals. PFAS can occur as a contaminant if, for example, water used in manufacturing food packaging contains PFAS from environmental contamination. These occurrences of PFAS are not specifically authorized by the FDA and are considered contaminants. For this reason, highly sensitive testing methods may detect the presence of PFAS in food packaging even if PFAS are not intentionally used in the packaging’s manufacture or are present at such low levels that they would not be of concern for human health. In addition, certain general detection methods, such as total fluorine analysis, only analyze for fluorine in a product and cannot discern between the presence of PFAS or the presence of other non-concerning fluorine containing substances. For scientific articles from FDA researchers on PFAS migration from food packaging to food, please see the Scientific Articles section below.
Grease-proofers are substances applied to paper and paperboard packing to prevent leaking of grease or oil.
In the spring of 2020, the FDA published findings from our scientific review and analysis of newly available data on a subset of PFAS that contain 6:2 fluorotelomer alcohol (6:2 FTOH). Our findings raised safety questions for exposure to 6:2 FTOH from the use of this subset of PFAS as grease-proofers in paper food packaging. As a result, the FDA worked with industry to reach voluntary market phase-out agreements for all grease-proofers that contain 6:2 FTOH. This work, combined with FDA’s efforts in the 2010s pertaining to another subset of PFAS substances known as “long-chain” PFAS, removes all PFAS grease-proofers with known safety concerns from the market. In addition, manufacturers of the remaining PFAS containing grease-proofers authorized for food-contact use have voluntarily stopped selling them for non-safety reasons. As a result, PFAS containing substances are no longer sold for use as grease-proof coatings on paper food packaging. This completion of the phase-out eliminates the primary source of exposure to PFAS from authorized food contact uses.
For more information and to access the commitment letters, please see: Market Phase Out of Grease-Proofing Substances Containing PFAS.
Substances Containing Short-Chain PFAS
- Evaluating the toxicokinetics of some metabolites of a C6 polyfluorinated compound, 6:2 fluorotelomer alcohol in pregnant and nonpregnant rats after oral exposure to the parent compound (2024)
- Comparative analysis of the toxicological databases for 6:2 fluorotelomer alcohol (6:2 FTOH) and perfluorohexanoic acid (PFHxA) (2020)
- Characterizing Biopersistence Potential of the Metabolite 5:3 Fluorotelomer Carboxylic Acid After Repeated Oral Exposure to the 6:2 Fluorotelomer Alcohol (2020)
- Internal exposure-based pharmacokinetic evaluation of potential for biopersistence of 6:2 fluorotelomer alcohol (FTOH) and its metabolites (2018)
- C6-Perfluorianted Compounds: The New Greaseproofing Agents in Food Packaging (2015)