July 31, 2020
The U.S. Food and Drug Administration (FDA) is announcing the voluntary phase-out of a certain type of short-chain per- and poly-fluoroalkyl substances (PFAS), that contain 6:2 fluorotelomer alcohol (6:2 FTOH), which may be found in certain food contact substances used as grease-proofing agents on paper and paperboard food packaging.
Today’s announcement follows an FDA post-market scientific review and analysis of data from rodent studies finding biopersistence of 6:2 FTOH. While the findings were in rodents, the data point to the potential that 6:2 FTOH may also persist in humans following dietary exposure. Further scientific studies are needed to better understand the potential human health risks from dietary exposure resulting from authorized food contact substances for short-chain PFAS that contain 6:2 FTOH. This phased market removal balances uncertainty about the potential for public health risks with minimizing potential market disruptions during the COVID-19 public health emergency.
Three manufacturers have agreed to a 3-year phase-out of their sales of compounds that contain 6:2 FTOH for use as food contact substances in the U.S. marketplace, beginning in 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 from the market. The fourth manufacturer informed the FDA in 2019 that they had already stopped sales of their food contact substances that may contain 6:2 FTOH for use in the U.S. market.
Manufacturers of these short-chain grease-proofing agents obtained authorization for the use of these substances in food contact paper packaging applications through the FDA’s Food Contact Notification (FCN) process. This pre-market scientific review ensures food contact materials that contain or are made of food contact substances are safe for their intended use, based on the scientific data that is available at the time of submission.
There are 15 Food Contact Notifications held by the four manufacturers that contain 6:2 FTOH. These compounds are replacements for the long-chain PFAS that are no longer in use in food contact applications through voluntary agreements with manufacturers in 2011 and through FDA regulatory action. At the time the FCNs for short-chain PFAS became effective, the available scientific data showed they were a safe alternative to the long-chain PFAS and did not indicate any potential for biopersistence.
The commitments made by the manufacturers that hold FCNs that contain 6:2 FTOH is noted on FDA's Inventory of Effective Food Contact Substance (FCS) Notifications. This inventory is the main mechanism by which the FDA informs both the public and industry of substances authorized through the FCN program. The FDA will monitor the progress of the phase-out of the FCNs using annual updates provided by the three manufacturers. Additionally, these manufacturers have agreed to supply FDA samples of each of the authorized food contact substances in case future analysis is needed.
For additional background information, correspondence between the FDA and industry, and other resources, see Per and Polyfluoroalkyl Substances (PFAS).