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U.S. FDA Declares 35 PFAS Food Contact Notifications Ineffective

by Rose Hong Jan 10, 2025
The U.S. Food and Drug Administration (FDA) announced that 35 Food Contact Notifications (FCNs) for per- and polyfluoroalkyl substances (PFAS) are no longer effective.

On January 3, 2025, the U.S. Food and Drug Administration (FDA) issued a notice regarding Food Contact Notifications That Are No Longer Effective. In this notice, the FDA determined that 35 food contact notifications (FCNs) related to per- and polyfluoroalkyl substances (PFAS) are no longer effective, following notifications from manufacturers that they have ceased the production, supply, or use of the listed food contact substances (FCSs) in the United States. These substances were previously used for grease-proofing coatings applied to paper and paperboard packaging to prevent leaking of oil and water.

This determination for the FCNs listed in Table 1 and Table 2 will be effective on January 6, 2025. Manufacturers must comply by June 30, 2025, for FCSs listed in Table 2 produced, supplied, or used prior to this determination's effective date.

Table 1—Food Contact Notifications (FCNs) No Longer Effective as of January 6, 2025

FCN No.Food contact substances (FCSs)
59Glycine, 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)
187Fluorinated 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)
195Diphosphoric 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)
206Copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate
2553-cyclohexane-1-carboxylic acid, 6-((di-2-propenylamino)carbonyl)-,(1R,6R), reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts
311Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate
3142-Propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3)
338Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate
398Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt
416Diphosphoric 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)
4872-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3)
5182-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178-90-3)
538Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt
5422-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)
628Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029-28-2)
646Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid (CAS Reg. No. 870465-08-0)
7462-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
7832-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
8202-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)
8272-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)
8852-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)
8882-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)
9332-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)
940Hexane, 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)
962Diphosphoric 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)
10272-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)
10442-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)
1097Hexane, 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)
13602-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)
14512-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)
1493Copolymer 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.Food contact substances (FCSs)
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)
604Copolymer 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)
1186Butanedioic 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)
16762-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)


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Rose Hong
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