July 19, 2022
Today, the U.S. Food and Drug Administration (FDA) issued a request for information on the food contact uses of fluorinated polyethylene. Fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS) and this request is part of our continued work to ensure that authorized food contact uses are safe. The FDA is seeking scientific data and information on the current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and safety information on substances that may migrate from fluorinated polyethylene food containers.
Fluorination of polyethylene containers improves chemical barrier properties. The FDA authorized fluorinated polyethylene for general use in contact with food in 1983 (21 CFR 177.1615). This regulation requires specific manufacturing conditions that must be in place during the fluorination process. Last year, testing by the Environmental Protection Agency (EPA) noted the migration of perfluorooctanoic acid (PFOA), a type of PFAS, from fluorinated polyethylene containers used to hold pesticides. In conjunction with EPA’s testing, the FDA became aware of different fluorination processes used in containers for holding pesticides, which are not approved for food contact. To help ensure these alternative fluorination processes are not used in the production of food-contact articles, we issued a letter to industry reminding them that it is the responsibility of the manufacturer of a Food Contact Substance (FCS) to ensure that food contact materials comply with the specifications and limitations in all applicable authorizations.
The FDA monitors new scientific information on FCSs as it becomes available. This includes reviewing scientific literature and studies from other regulatory and health agencies in the United States and in other countries. Considering recent developments, the FDA is seeking additional information on current practices to ensure the safe use of fluorinated polyethylene in contact with food.
To ensure comments regarding “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information” are considered, please submit written or electronic comments within 90 days of publication in the Federal Register.
Submit comments electronically on Regulations.gov to docket number FDA-2022-N-1526.
Submit written/paper submissions to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All submissions received must include the Docket No. FDA-2022-N-1526 for “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information.”