The U.S. Food and Drug Administration (FDA) has 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).
Specifically, 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. FDA’s request is part the agency’s effort to ensure that authorized food contact uses are safe.
Fluorination of polyethylene containers improves chemical barrier properties. FDA authorized fluorinated polyethylene for general use in contact with food in 1983, requiring specific manufacturing conditions to be in place during the fluorination process. In 2021, testing by the Environmental Protection Agency (EPA) observed the migration of perfluorooctanoic acid (PFOA), a type of PFAS, from fluorinated polyethylene containers used to hold pesticides. FDA also became aware of different fluorination processes used in containers for holding pesticides that are not approved for food contact. To help ensure that alternative fluorination processes are not used in the production of food-contact articles, FDA issued a letter to industry regarding manufacturers’ responsibility to ensure that food contact materials comply with regulatory specifications and limitations in all applicable authorizations.
FDA monitors new scientific information on food contact substances as it becomes available. Considering recent developments, the agency 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, FDA asks that stakeholders 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 must include the Docket No. FDA-2022-N-1526 for “Fluorinated Polyethylene Containers for Food Contact Use; Request for Information.”