The U.S. Food and Drug Administration (FDA) is directing this letter to manufacturers, distributors, and food manufacturers that use fluorinated polyethylene food contact articles as a reminder that only certain fluorinated polyethylene containers are authorized for food contact use. Specifically, FDA’s regulation authorizing the use of fluorinated polyethylene in contact with food is listed in Title 21 of the Code of Federal Regulations Part 177.1615 (21 CFR 177.1615).1 This regulation stipulates that fluorinated polyethylene containers for food contact use may only be manufactured by modifying the surface of the molded container using fluorine gas in combination with gaseous nitrogen as an inert diluent. The regulation does not authorize fluorination in the presence of water, oxygen, or gases other than nitrogen.
Available information indicates that some manufacturers of fluorinated polyethylene produce articles via alternative manufacturing methods from that stipulated in FDA’s regulation. For example, fluorination of polyethylene for non-food uses may occur during the fabrication or molding of the container2 or involve the use of fluorine gas in combination with other inert diluents such as carbon dioxide, helium, or argon.3,4 Oxygen can also be incorporated into the fluorinating mixture to modify the properties of the final container.3, 5 These alternative processes for fluorination of polyethylene are not compliant with 21 CFR 177.1615, and are not lawful for use in food contact articles. It is the responsibility of food packaging manufacturers and distributors to only market fluorinated polyethylene containers that are manufactured in compliance with FDA’s regulations.
Recently, based on testing performed by the Environmental Protection Agency (EPA),6 FDA has become aware that certain per- and polyfluoroalkyl substances (PFAS) can form and migrate from some fluorinated high-density polyethylene (HDPE – a type of polyethylene) containers.7 EPA’s testing was conducted on containers that are not regulated by FDA (containers intended to hold mosquitocontrolling pesticides not approved for direct use on food crops). However, we are concerned that such containers could also be used in contact with food. The specific PFAS detected in EPA’s testing are perfluoroalkyl carboxylic acids (PFCAs). Several of these PFCAs are either known or suspected to.
If you have any questions concerning this matter, please do not hesitate to contact us at premarkt@fda.hhs.gov.
U.S. Food and Drug Administration Center for Food Safety & Applied Nutrition 5001 Campus Drive College Park, MD 20740 www.fda.gov
