2024-31692. Food Contact Notifications That Are No Longer Effective  

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

    FCN No. FCS Manufacturer/supplier
    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) BASF Corporation.
    ( print page 654)
    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) Solvay Specialty Polymers Italy S.p.A.
    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) Solvay Specialty Polymers Italy S.p.A.
    206 Copolymer of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate DuPont Chemical Solutions Enterprise.
    255 3-cyclohexane-1-carboxylic acid, 6-((di-2-propenylamino)carbonyl)-,(1R,6R), reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, ammonium salts BASF Corporation.
    311 Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate DuPont Chemical Solutions Enterprise.
    314 2-Propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3) Solenis LLC.
    338 Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, and glycidyl methacrylate DuPont Chemical Solutions Enterprise.
    398 Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt Solvay Specialty Polymers Italy S.p.A.
    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) Solvay Specialty Polymers Italy S.p.A.
    487 2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No. 464178-90-3) Solenis LLC.
    518 2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178-90-3) Solenis LLC.
    538 Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt Solvay Specialty Polymers Italy S.p.A.
    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) Solenis LLC.
    628 Copolymer of 2-perfluoroalkylethyl acrylate, 2-(dimethylamino)ethyl methacrylate, and oxidized 2-(dimethylamino)ethyl methacrylate (CAS Reg. No. 479029-28-2) Clariant Corporation.
    646 Copolymers of 2-perfluoroalkylethyl acrylate, 2-N,N-diethylaminoethyl methacrylate, glycidyl methacrylate, acrylic acid, and methacrylic acid (CAS Reg. No. 870465-08-0) Dupont Chemical Solutions Enterprise.
    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 Solenis LLC.
    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 Solenis LLC.
    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) Daikin America, Inc.
    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) Daikin America, Inc.
    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) The Chemours Company FC, LLC.
    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) Daikin America, Inc.
    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) Daikin America, Inc.
    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) The Chemours Company FC, LLC.
    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) Solvay Specialty Polymers USA, LLC.
    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) The Chemours Company FC, LLC.
    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) Daikin America, Inc.
    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) Archroma U.S., Inc.
    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) Daikin America, Inc.
    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) Daikin America, Inc.
    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) Archroma Management GmbH.
    ( print page 655)

    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 Manufacturer/supplier
    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) Asahi Glass Co., Ltd. (Manufacturer) and AGC Chemicals Americas, Incorporated.
    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) Asahi Glass Co., Ltd. (Manufacturer) and AGC Chemicals Americas, Incorporated.
    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) Asahi Glass Co., Ltd. AGC Chemicals Americas, Inc.
    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) Asahi Glass Co., Ltd. AGC Chemicals Americas, Inc.

Document Information

Effective Date:
1/6/2025
Published:
01/06/2025
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2024-31692
Dates:
Applicable date: This determination for the FCNs listed in table 1 and table 2 is effective January 6, 2025.
Pages:
653-655 (3 pages)
Docket Numbers:
Docket No. FDA-2021-N-0403
PDF File:
2024-31692.pdf
Supporting Documents:
» NEPA CatEx Memorandum (Notice 2024)
» Reference 1 - Food Additives: Food Contact Substance Notification That Is No Longer Effective, Final Regulatory Impact Analysis, Regulatory Flexibility Analysis
» FCN PRIA 4-8-2022 - Food Additives: Food Contact Substance Notification That Is No Longer Effective RE Food Additives: Food Contact Substance Notification That Is No Longer Effective