Market Phase-Out of Grease-Proofing Substances Containing PFAS

<< Authorized Uses of PFAS in Food Contact Applications

Food contact substances containing different types of PFAS have been used for grease-proofing. Grease-proofing agents are substances applied to paper and paperboard packaging to prevent leaking of grease, oil, or water. This type of use can result in dietary exposure to the substance from the transfer or migration into the food. This is due to the molecular structure of the substance and the way it is applied to the surface. For more information, please see the section: Assessing Dietary Exposure to Food Contact Substances Containing PFAS.

In February 2024, the FDA announced that substances containing PFAS were no longer being sold into the U.S. market for use as grease-proofing agents on paper food packaging. This is result of the fulfillment of the voluntary market phase-out commitments made by manufacturers, as well as previous FDA regulatory actions and the decision by manufacturers to stop selling the remaining grease-proofing agents (containing a different type of PFAS). This phase-out is eliminating the primary source of exposure to PFAS from authorized food contact uses.

The FDA first raised safety concerns with certain PFAS substances in the early 2000s as part of a post-market assessment. Through a combination of voluntary market withdrawals and FDA revocations of authorizations, grease-proofing agents that contained a class of PFAS commonly referred to as “C8 compounds” or “long-chain” compounds stopped being used for food contact use in the U.S. market between 2011 and 2016. At that time, industry used as a replacement, substances that contained “short-chain” PFAS that had been authorized for this use. The data and information submitted at the time of application for the substances containing short-chain PFAS, demonstrated a reasonable certainty of no harm from the intended use of these types of PFAS.

In 2020, after data became available to the FDA that raised potential safety concerns about a subset of the substances that contained a specific short-chain PFAS known as 6:2 fluorotelomer alcohol (6:2 FTOH), the FDA obtained market-phase-out commitment letters from each of the manufacturers of PFAS grease-proofing agents that contain this substance.

In 2023, the FDA received confirmation from manufacturers of all remaining authorized grease-proofing substances containing different types of PFAS that those manufacturers had ceased to produce and sell those products for business reasons unrelated to safety.

Market Phase-Out and Revocation of Authorization of Grease-Proofing Substances Containing Long-Chain PFAS

In the early 2000s, new scientific studies raised safety questions on 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

Market Phase-Out of Grease-proofing Substances Containing 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. This authorization was based on the data and information available to the FDA at the time of authorization that supported the safety of these types of PFAS.

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) components. 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). The Chemours Company 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. It is anticipated that it may take until June 2025 to exhaust existing stocks of products containing these food contact substances.

As part of their commitment, the manufacturers agreed to provide the FDA with annual updates on their progress on the phase-out, as well as a mid-year update for the third and final year. In their first annual update (January 2022), Archroma Management GmbH informed the FDA that they permanently ceased all sales of food contact substances that may contain 6:2 FTOH.

The commitment letters from industry, the FDA acknowledgement letters, and the manufacturers’ 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 safety concerns. 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 how 6:2 FTOH remained in the tissues of rodents. The second paper reviewed the available data in rodents, comparing the toxicity and the 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.

Notification of Cessation of Sales of Remaining Grease-Proofing Substances Containing PFAS

In addition to efforts related to grease-proofing agents containing long-chain PFAS and 6:2 fluorotelomer alcohol (6:2 FTOH), the FDA received confirmation in 2023 that manufacturers of all remaining authorized grease-proofing substances containing PFAS had ceased to sell those products for food contact use in the U.S. market. These manufacturers stopped selling these products for business reasons; these products were not included in the 2020 market-phase-out commitments as FDA did not have safety concerns for their use.