Authorized Uses of PFAS in Food Contact Applications

<< Per and Polyfluoroalkyl Substances (PFAS)

Since the 1960s, the FDA has authorized specific PFAS for use in specific food contact applications. Some PFAS are used in cookware, food packaging, and in food processing for their non-stick and grease, oil, and water-resistant properties. To ensure food contact substances are safe for their intended use, the FDA conducts a rigorous scientific review before they are authorized for the market.

PFAS that are authorized for use in contact with food generally fall into four application categories:

Non-stick cookware: PFAS may be used as a coating to make cookware non-stick.
Gaskets, O-Rings, and other parts used in food processing equipment: PFAS may be used as a resin in forming certain parts used in food processing equipment that require chemical and physical durability.
Processing aids: PFAS may be used as processing aids for manufacturing other food contact polymers to reduce build-up on manufacturing equipment.
Paper/paperboard food packaging: PFAS may be used as grease-proofing agents in fast-food wrappers, microwave popcorn bags, take-out paperboard containers, and pet food bags to prevent oil and grease from foods from leaking through the packaging.

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. The FDA can work with industry to reach voluntary market phase-out agreements for such food contact substances. The FDA can also revoke food contact authorizations when the agency determines that there is no longer a reasonable certainty of no harm from the authorized use of a food contact substance.

FDA Regulation of Food Contact Substances

The FDA conducts a rigorous scientific review before a food contact substance is authorized for market entry to ensure that it is safe for its intended use. This includes reviewing data on migration of the food contact substance into food from its intended use, expected consumer exposure to the food contact substance from its intended use and other sources of dietary exposure including other uses authorized by FDA, and considers the potential health impact from this estimated cumulative exposure. The authorization for the use of a food contact substance requires that available data and information demonstrate a reasonable certainty of no harm for its intended use. The FDA reviews new scientific information post-authorization on food contact substances, as it becomes available, to ensure that these uses continue to be safe.

Food contact substances are generally regulated by the FDA as food additives because of their potential to migrate into food. All food additives require premarket authorization. Prior to 2000, the FDA authorized the use of food contact substances through the food additive petition process. This resulted in the publishing of regulations establishing safe conditions of use in Title 21 of the Code of Federal Regulations. Since 2000, the Food Contact Notification (FCN) program is the primary method by which the FDA authorizes the use of food contact substances.

The Inventory of Effective Food Contact Substance (FCS) Notifications is a publicly available database of all uses of food contact substances authorized through the FCN program.

Assessing PFAS Migration Potential from Food Contact Applications

The extent to which PFAS authorized for use in food contact applications migrate to food depends on the molecular structure of the substance, how the final consumer product is manufactured, and its intended use.

Non-stick cookware: PFAS molecules are polymerized (i.e., joined together to form large molecules) and then applied to the surface of the cookware at very high temperatures, which tightly binds the polymer coating to the cookware. This 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 that this coating contains a negligible amount of PFAS capable of migrating to food.
Gaskets, O-Rings, and other parts 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 a negligible amount of PFAS capable of migrating to food.
Processing aids: PFAS molecules may or may not be polymerized. However, the amount of PFAS used as processing aids in the manufacture of other food contact polymers is so small that a negligible amount of PFAS is capable of migrating to food from this use.
Paper and paperboard food packaging: 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 may be potential for PFAS migration to food from this use.

For scientific articles from FDA researchers on PFAS migration from food packaging to food, please see the Scientific Articles section below.

Market Phase-Out of Certain Short-Chain PFAS

Short-chain PFAS have 7 or less carbons (typically 6 carbons). This type of PFAS emerged to replace long-chain PFAS after they stopped being sold in the United States due to safety concerns in 2011. The FDA has authorized the use of certain short-chain PFAS as grease-proofing agents on food contact paper and paperboard packaging.

In the spring of 2020, the FDA published findings from our scientific review and analysis of newly available data on short-chain PFAS that contain 6:2 fluorotelomer alcohol (6:2 FTOH). Our findings raised safety questions for exposure to 6:2 (FTOH) from some authorized uses of short-chain PFAS. Four manufacturers hold 15 Food Contact Notifications (FCNs) for 11 short-chain PFAS compounds that may contain 6:2 fluorotelomer alcohol (6:2 FTOH). One of the manufacturers had already informed the FDA in 2019 that it had stopped sales of its food contact substances that may contain 6:2 FTOH in the U.S. market. The three other manufacturers voluntarily agreed in July 2020 to a 3-year phase-out of their sales of these compounds for use in food contact applications in the United States, beginning in January 2021. After the 3-year period, it is anticipated that it may take up to 18 months to exhaust existing stocks of products containing these food contact substances.

As part of their commitment, they also agreed to provide the FDA with annual updates on their progress of the phase-out. One of the manufacturers informed the FDA in its first annual update that it has permanently ceased all sales of its food contact substances that may contain 6:2 FTOH.

The commitment letters from industry, the FDA acknowledgement letters, and the manufacturers’ first annual updates are available here:

Archroma Management

AGC Chemicals Americas, Inc.

Daikin America, Inc.

The Chemours Company

Information on the Scientific Analysis of Short-Chain PFAS with 6:2 FTOH

In the spring of 2020, the FDA published findings from our scientific review and analysis of data on 6:2 fluorotelomer alcohol (6:2 FTOH). The data raised questions about the potential human health risks from dietary exposure resulting from the authorized uses of short-chain PFAS that contain 6:2 FTOH.

The manufacturers of these short-chain grease-proofing agents had previously obtained authorization for the use of these substances in food contact paper packaging applications through the FDA’s Food Contact Notification (FCN) process. At the time the FCNs for short-chain PFAS became effective, the scientific data available to the FDA showed they were a safe alternative to long-chain PFAS and did not indicate any potential for biopersistence. Subsequent studies on short-chain PFAS continued to be conducted after the FCNs became effective, and the FDA continued its analysis of these data as they became available.

The two papers published by FDA researchers in 2020 pertained to additional available information on 6:2 FTOH. The first paper described the biopersistence of 6:2 FTOH in rodents. The second paper reviewed the available data in rodents, comparing the toxicity and biopersistence of 6:2 FTOH and another short-chain -PFAS, perfluorohexanoic acid (PFHxA). PFHxA has been proposed in the scientific literature as a representative substance when assessing toxicity for some short-chain PFAS. However, many short-chain -PFAS contain 6:2 FTOH either as a constituent or an impurity or may be metabolized or converted to 6:2 FTOH. FDA’s review found that 6:2 FTOH in rodents biopersists, whereas PFHxA does not, and that 6:2 FTOH is more toxic than PFHxA. As a result, the FDA concluded that 6:2 FTOH is a more representative substance in evaluating the safety of certain short-chain PFAS that contain 6:2 FTOH.

Because the data showed biopersistence of 6:2 FTOH and a higher level of toxicity compared to other types of short-chain PFAS, and because of the scientific data-gap for long-term studies on the safety of these substances, the FDA contacted the manufacturers of these substances to discuss questions on the potential human health risks. Based on the FDA’s scientific review of the data and dialogue with manufacturers, there was an agreement to phase-out these short-chain 6:2 FTOH substances from the market.

For scientific articles from FDA researchers on short-chain PFAS please see the Scientific Articles section.

Market Phase-Out and Revocation of Authorization of Long-Chain PFAS

In the early 2000s, new scientific studies raised safety questions with the types of PFAS that contain 8 or more carbon atoms in length, commonly referred to as “C8 compounds” or “long-chain” compounds. The most common types are perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS). The studies indicated that these C8 compounds persist in the environment and animal tissue and have toxic effects on humans and animals. Following FDA’s analysis of these studies, the FDA worked with several manufacturers to voluntarily stop their sales of grease-proofing agents containing C8 compounds for use in food contact applications in the U.S. market.

In 2016, the FDA revoked the regulations authorizing the remaining uses of these long-chain PFAS in food packaging (see 81 FR 5, January 4, 2016 and 81 FR 83672, November 22, 2016). As of November 2016, long-chain PFAS are no longer used in food contact applications sold in the United States.

The commitment letters from industry and the FDA acknowledgement letters are available here:

BASF Corporation

E.I. DuPont de Nemours & Co

Clariant Corporation

Scientific Articles from FDA researchers

Short-Chain PFAS

PFAS Migration from Packaging to Food