FDA Announces FCNs for 35 PFAS Are No Longer Effective
On January 3, 2025, the U.S. Food and Drug Administration (FDA) announced its determination that 35 food-contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) are no longer effective due to abandonment. The food-contact substances (FCSs) were authorized for use in grease-proofing coatings applied to paper and paperboard packaging. The Agency also announced that it has developed a screening method to detect grease-proofing agents containing PFAS in paper and paperboard packaging.
By way of background, FDA announced on February 28, 2024, that PFAS were no longer being sold for use in grease-proofing agents for food packaging in the U.S. market. (For more information on that announcement, see the packaginglaw.com article, FDA Announces PFAS Used in Grease-Proofing Agents for Food Packaging Are No Longer Sold in the U.S.) Following that announcement, FDA conducted a surveillance sampling assignment to monitor the presence of PFAS in grease-proof food contact paper and packaging.
In the Federal Register notice announcing that the FCNs are no longer effective, FDA provides two tables identifying the FCNs that are no longer effective. The compliance date for the FCSs listed in Table 1 was January 6, 2025, as FDA stated that it expected any existing stocks of those FCSs to have already been exhausted from the U.S. market based on the end of sales dates provided by their manufacturers. The FCSs listed in the FCNs in Table 2 have a compliance date of June 20, 2025.
FDA also announced that it has established an Inventory of FCNs that are no longer effective on its website.