In a recent Federal Register announcement, the U.S. Food and Drug Administration (FDA) plans to withdraw 35 Food Contact Substance Notifications (FCNs) associated with perfluoroalkyl and polyfluoroalkyl substances (PFAS). These FCNs initially endorsed oil-resistant coatings for paper and cardboard packaging, a practice some manufacturers or suppliers have already discontinued.
According to FDA's update, these 35 FCNs will be nullified starting January 6, 2025. Acknowledging real-world market dynamics, FDA has established a transition period. This allows food contact substance manufacturers or suppliers ample time to deplete existing inventories, such as paper food packaging. Consequently, for food paper packaging produced, supplied, or used before January 6, 2025, the compliance deadline extends to June 30, 2025.
The latest Inventory of Effective Food Contact Substance (FCS) Notifications can be queried through the Global Food Contact Materials Regulatory Database on Chemradar.
Table 1 Food Contact Notifications (FCNs) No Longer Effective as of January 6, 2025
|
FCN No. |
FCS |
|
59 |
Glycine, N,N-bis[2-hydroxy-3-(2-propenyloxy)propyl]-, monosodium salt, reaction products with ammonium hydroxide and pentafluoroiodoethane-tetrafluoroethylene telomer (CAS Reg. No.220459-70-1) |
|
187 |
Fluorinated polyurethane anionic resin (CAS Reg. No.328389-91-9) prepared by reacting perfluoropolyether diol (CAS Reg. No.88645-29-8), isophorone diisocyanate (CAS Reg. No.4098-71-9), 2,2-dimethylolpropionic acid (CAS Reg. No.4767-03-7), and triethylamine (CAS Reg. No.121-44-8) |
|
195 |
Diphosphoric acid, polymers with ethoxylated reduced Me esters of reduced polymerized oxidized tetrafluoroethylene (CAS Reg. No.200013-65-6). This substance is also known as: phosphate esters of ethoxylated perfluoroether, prepared by reaction of ethoxylated perfluoroether diol (CAS Reg. No.162492-15-1) with phosphorous pentoxide (CAS Reg. No.1314-56-3) or pyrophosphoric acid (CAS Reg. No.2466-09-3) |
|
206 |
Copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate |
|
255 |
3-cyclohexane-1-carboxylic acid, 6-((di-2-propenylamino)carbonyl)-,(1R,6R), reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts |
|
311 |
Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate |
|
314 |
2-Propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No.464178-90-3) |
|
338 |
Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate |
|
398 |
Perfluoropolyether dicarboxylic acid (CAS Reg. No.69991-62-4), ammonium salt |
|
416 |
Diphosphoric acid, polymers with ethoxylated reduced methyl esters of reduced polymerized oxidized tetrafluoroethylene (CAS Reg. No.200013-65-6). This substance is also known as phosphate esters of ethoxylated perfluoroether, prepared by reaction of ethoxylated perfluoroether diol (CAS Reg. No.162492-15-1) with phosphorous pentoxide (CAS Reg. No.1314-56-3) or pyrophosphoric acid (CAS Reg. No.2466-09-3) |
|
487 |
2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No.464178-90-3) |
|
518 |
2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178-90-3) |
|
538 |
Perfluoropolyether dicarboxylic acid (CAS Reg. No.69991-62-4), ammonium salt |
|
542 |
2-propen-1-ol, reaction products with 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-6-iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No.464178-94-7) |
|
628 |
Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No.479029-28-2) |
|
646 |
Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid (CAS Reg. No.870465-08-0) |
|
746 |
2-propen-1-ol, reaction products with 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-6-iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No.464178-94-7) as manufactured in accordance with the description in the FCN |
|
783 |
2-propen-1-ol, reaction products with 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-6-iodohexane, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No.464178-94-7) as manufactured in accordance with the description in the FCN |
|
820 |
2-Propenoic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl ester, polymer with α-(1-oxo-2-propen-1-yl)-ω-hydroxypoly(oxy-1,2-ethanediyl) |
|
827 |
2-propenoic acid, 2-hydroxyethyl ester, polymer with α-(1-oxo-2-propen-1-yl)-ω-hydroxypoly(oxy-1,2-ethanediyl), α-(1-oxo-2-propen-1-yl)-ω-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate (CAS Reg. No.1012783-70-8) |
|
885 |
2-propenoic acid, 2-methyl-, polymer with 2-(diethylamino)ethyl 2-methyl-2-propenoate, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, acetate (CAS Reg. No.1071022-26-8) |
|
888 |
2-propenoic acid, 2-hydroxyethyl ester, polymer with α-(1-oxo-2-propen-1-yl)-ω-hydroxypoly(oxy-1,2-ethanediyl), α-(1-oxo-2-propen-1-yl)-ω-[(1-oxo-2-propen-1-yl)oxy]poly(oxy-1,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate (CAS Reg. No.1012783-70-8) |
|
933 |
2-propenoic acid, 2-methyl-, polymer with 2-hydroxyethyl 2-methyl-2-propenoate, α-(1-oxo-2-propen-1-yl)-ω-hydroxypoly(oxy-1,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate sodium salt (CAS Reg. No.1158951-86-0) |
|
940 |
Hexane, 1,6-diisocyanato-, homopolymer, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanol-blocked (CAS Reg. No.357624-15-8) |
|
962 |
Diphosphoric acid, polymers with ethoxylated reduced methyl esters of reduced polymerized oxidized tetrafluoroethylene (CAS Reg. No.200013-65-6). This substance is also known as phosphate esters of ethoxylated perfluoroether, prepared by reaction of ethoxylated perfluoroether diol (CAS Reg. No.162492-15-1) with phosphorous pentoxide (CAS Reg. No.1314-56-3) or pyrophosphoric acid (CAS Reg. No.2466-09-3) |
|
1027 |
2-propenoic acid, 2-methyl-, polymer with 2-(diethylamino)ethyl 2-methyl-2-propenoate, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, acetate (CAS Reg. No.1071022-26-8) |
|
1044 |
2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester polymer with 1-ethyenyl-2-pyrrolidinone, 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate sodium salt (CAS Reg. No.1206450-10-3) |
|
1097 |
Hexane, 1,6-diisocyanato-, homopolymer, α-[1-[[[3-[[3 (dimethylamino)propyl]amino]propyl]amino]carbonyl]-1,2,2,2-tetrafluoroethyl]-ω-(1,1,2,2,3,3,3-heptafluoropropoxy)poly[oxy[trifluoro(trifluoromethyl)-1,2-ethanediyl]]-blocked (CAS Reg. No.1279108-20-1) |
|
1360 |
2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymer with 1-ethenyl-2-pyrrolidinone and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, acetate (CAS Reg. No.1334473-84-5) |
|
1451 |
2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymer with 1-ethenyl-2-pyrrolidinone and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate, acetate (CAS Reg. No.1334473-84-5) |
|
1493 |
Copolymer of 2-(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, N-oxide, acetate (CAS Reg. 1440528-04-0) |
Table 2 Food Contact Notifications (FCNs) No Longer Effective as of January 6, 2025 With a Compliance Date of June 30, 2025
|
FCN No. |
FCS |
|
599 |
Copolymer of perfluorohexylethyl methacrylate, 2-N,N-diethylaminoethyl methacrylate, 2-hydroxyethyl methacrylate, and 2,2'-ethylenedioxydiethyl dimethacrylate, acetic acid salt (CAS Reg. No.863408-20-2) or malic acid salt (CAS Reg. No.1225273-44-8) |
|
604 |
Copolymer of perfluorohexylethyl methacrylate, 2-N,N-diethylaminoethyl methacrylate, 2-hydroxyethyl methacrylate, and 2,2'-ethylenedioxydiethyl dimethacrylate, acetic acid salt (CAS Reg. No.863408-20-2) or malic acid salt (CAS Reg. No.1225273-44-8) |
|
1186 |
Butanedioic acid, 2-methylene-, polymer with 2-hydroxyethyl, 2-methyl-2-propenoate, 2-methyl-2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, sodium salt (CAS Reg. No.1345817-52-8) |
|
1676
|
2-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, sodium salt (CAS Reg. No.1878204-24-0) |
Food Contact Substances (FCS)
FCS are materials that may interact with food during production, packaging, transportation, or storage. These include antioxidants, stabilizers, and additives in plastics or paper, which don't technically alter the food.
Food Contact Substance Notifications (FCNs)
Under Section 409 of the U.S. Federal Food, Drug, and Cosmetic Act, FDA strictly regulates FCS via the FCN process. This procedure requires substantial scientific evidence, including chemical analysis and toxicology studies, to confirm FCS safety in intended uses.
Background on PFAS Restrictions in Food Contact Materials
FDA began addressing PFAS-related issues in the early 2000s. In July 2020, a voluntary agreement was reached with FCS manufacturers or suppliers to phase out the sale of PFAS-containing oil-resistant materials. By February 2024, these materials were no longer used for food contact in the U.S. market.
In addition to declaring that PFAS-containing oil-resistant substances are not authorized for use in paper and cardboard food packaging, FDA has developed a screening method to detect these substances. This method will help FDA effectively monitor FCS in the paper food packaging market.
