The U.S. Food and Drug Administration is announcing a voluntary phase-out of certain types of grease-proofing agents on paper and paperboard food packaging. This phase-out comes after an FDA post-market scientific review and analysis from rodent studies found biopersistence of the grease-proofing substances.
Though the findings were in rodents, the FDA believes these substances — short-chain per- and poly-fluoroalkyl substances (PFAS), that contain 6:2 fluorotelomer alcohol (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 food contact substances for short-chain PFAS that contain 6:2 FTOH, according to the report.
The FDA is opting for a phased market removal because it 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 phase-out their sales of compounds that contain 6:2 FTOH for use as food contact substances in the U.S. marketplace over three years starting in 2021.
The FDA says that after the 3-year period, it could take up to 18 months for existing stocks of products containing these substances to get off the market.
A 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 had obtained authorization for the use of these substances in food contact paper packaging applications of these short-chain grease-proofing agents through the FDA’s Food Contact Notification (FCN) process. This pre-market process 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.
The FDA will monitor the progress of the phase-out using annual updates provided by the three manufacturers.
For additional background information, correspondence between the FDA and industry, and other resources, see Per and Polyfluoroalkyl Substances (PFAS).
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