Authorized Uses of PFAS in Food Contact Applications
<< Per and Polyfluoroalkyl Substances (PFAS)
Since the 1960s, the FDA has authorized several broad classes of PFAS for use in food contact substances due to their non-stick and grease, oil, and water-resistant properties. The authorization of the use of a food contact substance requires that available data and information demonstrate that there is a reasonable certainty of no harm for that use. To ensure food contact substances are safe for their intended use, the FDA conducts a rigorous review of scientific data prior to their authorization for market entry. This includes reviewing data on migration of the food contact substance into food, expected consumer exposure to the food contact substance from this and other uses in food, and potential health impact from this exposure.
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.
Food contact substances, because of their potential to migrate into food, are generally regulated by FDA as food additives. All food additives, including those identified as food contact substances, require premarket authorization by FDA. Prior to 2000, the FDA authorized the use of food contact substances through the food additive petition process, which 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 FDA reviews the use of food additives that are food contact substances and by which such uses are authorized.
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.
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.
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 substances for use as grease-proofing agents on food contact paper and paperboard packaging that can lead to potential short-chain PFAS migration to food.
In the spring of 2020, the FDA published findings from a post-market scientific review and analysis of data from rodent studies on 6:2 fluorotelomer alcohol (6:2 FTOH), which is found in certain short-chain PFAS that are authorized for use in food contact applications. The data raise questions about the potential human health risks from dietary exposure resulting from these authorized uses of short-chain PFAS that contain 6:2 FTOH. Four manufacturers hold 15 Food Contact Notifications (FCNs) for 11 compounds that may contain 6:2 FTOH. Because the data showed biopersistence of 6:2 FTOH in rodents and a higher level of toxicity compared to other types of short-chain PFAS, along with a lack of long-term data on the safety of these substances, the FDA contacted the manufacturers of these substances to discuss questions on the potential human health risks from these authorized food contact uses.
In July 2020, three manufacturers voluntarily agreed 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. The fourth manufacturer informed the FDA in August of 2019 that it had stopped sales of its food contact substances that may contain 6:2 FTOH for food contact use in the U.S. market.
To read the commitment letters from industry, please visit:
- Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020) (PDF: 380KB)
- AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020) (PDF: 324KB)
- Daikin America, Inc Commitment Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2020) (PDF: 470KB)
- The Chemours Company Commitment Letter Regarding FCN No. 940 (August 2019) (PDF: 126KB)
- The Chemours Company Commitment Letter Regarding FCN Nos. 885 and 1027 (August 2019) (PDF: 129KB)
To read the FDA’s letters to industry acknowledging receipt of industry commitment letters, please visit:
- Acknowledgement Receipt to Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020) (PDF: 57KB)
- Acknowledgement Receipt to AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020) (PDF: 69KB)
- Acknowledgement Receipt to Daikin America, Inc Commitment Letter Regarding FCN Nos. 820, 827, 888, 933, 1044, 1360, and 1451 (July 2020) (PDF: 85KB)
- Acknowledgement Receipt to The Chemours Company Commitment Letter Regarding FCN Nos. 940, 885 and 1027 (July 2020) (PDF: 68KB)
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.
For scientific articles from FDA researchers on short-chain PFAS please see the Scientific Articles section.
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.
To read the commitment letters from industry, please visit:
- BASF Corporation Commitment Letter Regarding FCN Nos. 59 and 255 (November 2011)
- E. I. DuPont de Nemours & Co Commitment Letter Regarding FCN Nos. 206, 311, 338, and 646 (November 2011)
- Clariant Corporation Commitment Letter Regarding FCN No. 628 (November 2011)
To read the FDA’s letters to industry acknowledging receipt of industry commitment letters, please visit:
- Acknowledgement Receipt to BASF Corporation Commitment Letter Regarding FCN Nos. 59 and 255 (June 2012)
- Acknowledgement Receipt to E. I. DuPont de Nemours & Co Commitment Letter Regarding FCN Nos. 206, 311, 338, and 646 (June 2012)
- Acknowledgement Receipt to Clariant Corporation Commitment Letter Regarding FCN No. 628 (June 2012)
Short-Chain PFAS
- 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)
PFAS Migration from Packaging to Food