Inventory of Effective Food Contact Substance (FCS) Notifications
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The database lists effective premarket notifications for food contact substances that have been demonstrated to be safe for their intended use. The list includes the food contact substance (FCS), the notifier, the manufacturer of the FCS, the intended use, the limitations on the conditions of use for the FCS and its specifications, the effective date, and its environmental decision. Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348 (h)(2)(C)) a food contact substance notification (FCN) is only effective for the manufacturer or supplier identified in the notification. Persons who market a FCS based on an effective notification must be able to demonstrate that the notification is effective for their food contact substance. All persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification. Additional information about Food Contact Substances and the definitions of Food Types and Conditions of Use are available on the FCS Program page.
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| FCN No. | Food Contact Substance | Manufacturer/Supplier | Effective Date |
|---|---|---|---|
| 2-Propenoic acid, 2-cyano-3,3-diphenyl-, 2,2-bis[[(2-cyano-1-oxo-3, 3-diphenyl-2-propenyl)oxy]methyl]-1,3-propanediyl ester (CAS Reg. No. 178671-58-4). | BASF Aktiengesellschaft | Jan 21, 2003 | |
| Hexanedioic acid, polymer with N-(2-aminoethyl)-1,2-ethanediamine, N-acetyl derivative, epichlorohydrin quaternized (CAS Reg. No. 344612-00-6). | Solenis LLC | Nov 20, 2002 | |
| Silver-magnesium-sodium-boron-phosphate glass (silver glass). | Ishizuka Glass Company, Ltd. (manufacturer); Kanebo Chemical Industries, Ltd. (supplier) | Jan 3, 2003 | |
| 2-Naphthalenesulfonic acid, 6-hydroxy-5((4-methoxy-2-sulfophenyl)azo)-, strontium salt (1:1) (CAS Reg. No. 380304-86-9; C.I. Pigment Violet 52). | Colors and Effects USA LLC | Nov 14, 2002 | |
| 2-Propen-1-aminium, N,N-dimethyl-N-2-propenyl-, chloride, polymer with 2-propenoic acid and N-2-propen-1-amine hydrochloride, 2,2'-azobis(2-methylpropanimidamide) dihydrochloride- initiated. (CAS Reg. No. 343837-39-8). | Solenis LLC | Nov 13, 2002 | |
| A silver-zinc-sodium aluminosilicate zeolite containing up to 2.9 percent by weight of silver and 19 percent by weight of zinc. The finished zeolite will also contain small amounts of calcium metaphosphate, zinc oxide and silica. | Kanebo Chemical Industries, Ltd. | Dec 18, 2002 | |
| Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). | Addivant | Oct 18, 2002 | |
| A mixture of: 1) imidazolium compounds, 2-(C17 and C17 unsaturated alkyl)-1-(2-(C18 and C18 unsaturated amido)ethyl)-1-ethyl-4,5-dihydro-, ethyl sulfates (CAS Reg. No. 91053-16-6); and 2) amides, C18 and C18-unsaturated, N-(2-(2-(C17 and C17-unsaturated alkyl)-4,5-dihydro-1H-imidazol-1-yl)ethyl) (CAS Reg. No. 71808-32-7). | Solenis LLC | Oct 18, 2002 | |
| Pyrrolo(3,4-c)pyrrole-1,4-dione,2,5-dihydro-3,6-bis(4-(octadecylthio)phenyl)- (CAS Reg. No. 247089-62-9). | Colors and Effects USA LLC | Nov 26, 2002 | |
| Nylon 6/69 (CAS Reg. No. 51995-62-1), manufactured by the condensation of 49.5+ 0.5 weight percent epsilon-caprolactam, 19.4+0.2 weight percent hexamethylenediamine, and 31.2+0.3 weight percent azelaic acid. | EMS Chemie AG | Oct 11, 2002 | |
| Tetrafluoroethylene-hexafluoropropylene-vinylidene fluoride copolymers (CAS Reg. No. 25190-89-0). | Dyneon LLC | Oct 3, 2002 | |
| C.I. Pigment Yellow 189 (Nickel titanium tungsten oxide)(CAS Reg. No. 69011-05-8). | Colors and Effects USA LLC | Oct 25, 2002 | |
| α-sulfo-ω-(dodecyloxy)poly(oxyethylene) sodium salt (CAS Reg. No. 9004-82-4). The FCS is also known as sodium lauryl ether sulfate. | Stepan Company | Nov 30, 2002 | |
| N,N,N',N'-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4). | EMS Chemie AG/EMS Primid | Oct 19, 2002 | |
| Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether terpolymer, aminolyzed with dimethylaminopropylamine and partially quaternized with methyl chloride. (CAS Reg. No. 65997-24-2). | DDP Specialty Electronic Materials US 5, LLC | Aug 31, 2002 | |
| Iso-butylene/maleic anhydride copolymer, sodium salt (CAS Reg. No. 39612-00-5) cross-linked with 1.9 percent by weight glycerol and 1.25 percent by weight 1,4-butanediol. | Camelot Technologies, Ltd. | Aug 28, 2002 | |
| Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg. No. 25718-70-1), meeting the specifications in 21 CFR 177.1500(b) item 10.2, when tested by the method given in 21 CFR 177.1500(c). The FCS is also known as Nylon MXD-6. | FCS: Mitsubishi Gas Chemical Company, Inc., Tokyo, Japan; Polymers modified with the FCS: Gruppo Mossi & Ghisolfi | Aug 24, 2002 | |
| Poly(N-vinylformamide), 20-100 percent hydrolyzed, chloride or sulfate salts. The FCS is specifically known as one of the following: a) formamide, N-ethenyl-, polymer with ethanamine, hydrochloride (CAS Reg. No. 111616-55-8); b) formamide, N-ethenyl-, polymer with ethanamine, sulfate (CAS Reg. No. 117985-59-8); and c) formamide, ethenyl-, homopolymer, hydrolyzed, hydrochlorides, (CAS Reg. No. 183815-54-5). | BASF AG/BASF Corporation | Oct 5, 2002 | |
| Silver zinc glass, of nominal composition silver (0.47 percent +/- 0.1 percent)-zinc (21 percent +/- 2.0 percent)-aluminum-boron phosphate (=/> 76.4 percent) glass. | Kanebo Chemical Industries, Ltd. | Aug 16, 2002 | |
| A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoro-2,5-dimethyl-3,6-dioxanonane vinyl ether (CAS Reg. No. 2599-84-0), and perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexene (CAS Reg. No. 106108-22-9), and subsequent curing of the terpolymer (CAS Reg. No. 106108-23-0) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7). | Greene, Tweed and Company, Inc. | Aug 13, 2002 | |
| Fluorocarbon cured elastomer produced by copolymerizing tetrafluoroethylene (CAS Reg. No. 116-14-3) and propylene (CAS Reg. No. 115-07-01) and subsequent curing of the copolymer (CAS Reg. No. 27029-05-6) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,2'-bis(tert-butylperoxy)diisopropylbenzene (CAS Reg. No. 25155-25-3). | Greene, Tweed and Company, Inc. | Aug 13, 2002 | |
| A perfluorocarbon cured elastomer (PCE) produced by terpolymerizing tetrafluoroethylene, (CAS Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No. 1187-93-5), and perfluoro-6,6-dihydro-6-iodo-3-oxa-1-hexane (CAS Reg. No. 106108-22-9), and subsequent curing of the terpolymer (CAS Reg. No. 193018-53-0) with triallylisocyanurate (CAS Reg. No. 1025-15-6) and 2,5-dimethyl-2,5-di(t-butylperoxy)hexane (CAS Reg. No. 78-63-7). | Greene, Tweed and Company, Inc. | Aug 13, 2002 | |
| Styrene/butadiene/acrylonitrile copolymers (SBA) (CAS Reg. No., exclusive of minor monomers: 9003-56-9) containing no more than 30 weight percent acrylonitrile and no more than 10 weight percent of total polymer units from one or more of the following monomers: acrylic acid, 2-hydroxyethyl acrylate, itaconic acid, and methacrylic acid. | Synthomer Inc. | Sep 26, 2002 | |
| A mixture consisting of 63-72 percent oxidized bis(hydrogenated tallow alkyl)amines, 12-15 percent bis(hydrogenated tallow alkyl)amines, 4-8 percent (hydrogenated tallow alkyl)nitrones, and 5-12 percent (hydrogenated tallow alkyl)oximes. | BASF Corporation | Jul 31, 2002 | |
| Diethylene glycol monobenzoate (CAS Reg. No. 20587-61-5). | Velsicol Chemical Corp. | Jul 31, 2002 | |
| Quino(2,3-b)acridine-7,14-dione,5,12-dihydro-,(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivatives (CAS Reg. No. 332142-67-3). This FCS is a mixture of phthalimidomethyl derivatives of quinacridone. | Colors and Effects USA LLC | Jul 26, 2002 | |
| Poly(1,4-cyclohexylenedimethylene-1,4-cyclohexanedicarboxylate) (CAS Reg. No. 219566-57-1). | SABIC Innovative Plastics | Jul 19, 2002 | |
| Tin antimony oxide (CAS Reg. No. 12673-86-8). The food contact substance is also known as tin antimony gray cassiterite. | Colors and Effects USA LLC | Sep 12, 2002 | |
| Phenol,2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)- (CAS Reg. No. 103597-45-1). | Asahi Denka Kogyo K.K. | Jul 16, 2002 | |
| 2-propenoic acid, homopolymer, calcium sodium salt (CAS Reg. No. 35830-10-5). | Polacryl, Inc. | Aug 23, 2002 | |
| Phosphorous acid, bis(2,4-bis(1,1-dimethylethyl)-6-methylphenyl)ethyl ester (CAS Reg. No. 145650-60-8). The FCS is also known as bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphite. REPLACES FCN 51. | BASF Corporation | Jul 10, 2002 | |
| Styrene-acrylic copolymers. | BASF Corporation | Jun 25, 2002 | |
| Trilauryl phosphite (CAS Reg. No. 3076-63-9). | General Electric | Aug 16, 2002 | |
| Silaneamine, 1,1,1-trimethyl-N-(trimethylsylyl)-, hydrolysis products with silica (CAS Reg. No. 68909-20-6) or Silica ((dimethylvinylsilyl)oxy)- and ((trimethylsily)oxy)-modified (CAS Reg. No. 68988-89-6). | Wacker Silicones Corp. | Jun 12, 2002 | |
| 2,2,4-Trimethyl-1,3-pentanediol diisobutyrate (TXIB) (CAS Reg. No. 6846-50-0). | Eastman Chemical Co. | Jun 7, 2002 | |
| 1,5-Cyclooctadiene (CAS Reg. No. 111-78-4). | Degussa-Huls Corp. | Jun 1, 2002 | |
| An approximately 1:1 mixture of hydroxymethyl-5,5-dimethylhydantoin (MMDMH)(CAS Reg. No. 27636-82-4) and 1,3-bis(hydroxymethyl)-5,5-dimethylhydantoin (DMDMH), (CAS Reg. No. 6440-58-0), containing up to 8.5 percent by weight residual 5,5-dimethylhydantoin on a dry basis (DMH)(CAS Reg. No. 77-71-4) or up to 5.5 percent in the formulated product. | Arxada, LLC | May 24, 2002 | |
| Methyl methacrylate-trimethylolpropane trimethacrylate copolymers (CAS Reg. No. 28931-67-1). | Nippon Shokubai Ltd. | Jun 4, 2002 | |
| 2-Cyano-3,3-diphenyl-2-propenoic acid 2-ethylhexyl ester (CAS Reg. No. 6197-30-4). | BASF Aktiengesellschaft | May 3, 2002 | |
| Poly(ethylene-methyl acrylate-cyclohexenylmethyl acrylate) (CAS Reg. No. 223503-47-7). | Cryovac, Inc. | Apr 30, 2002 | |
| 2-Cyano-3,3-diphenyl-2-propenoic acid ethyl ester (CAS Reg. No. 5232-99-5). | BASF Aktiengesellschaft | Apr 26, 2002 | |
| Isophthalic acid (CAS Reg. No. 121-91-5). | Eastman Chemical Company | May 25, 2002 | |
| Acetic acid ethenyl ester, polymer with ethenol and dimethyl maleate (DMM). This material is equivalent to poly(vinyl acetate-vinyl alcohol) (CAS Reg. No. 25213-24-5), polymerized with DMM (CAS Reg. No. 624-48-6)). | Synthomer (UK) Ltd. | Apr 3, 2002 | |
| A mixture of the lithium salts of stearic acid (69.5 weight percent), palmitic acid (25.8 weight percent), myristic acid (1.6 weight percent), arachidonic acid (1 weight percent), and other carboxylic acids (2.1 weight percent). | Asahi Denka Kogyo K.K. | May 28, 2002 | |
| Acetic acid ethenyl ester, polymer with α-hydro-ω-hydroxypoly(oxy-1,2-ethanediyl), hydrolyzed. | Synthomer (UK) Ltd. | May 24, 2002 | |
| Aluminum, hydroxybis(2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzol(d,g)(1,3,2)dioxaphosphocin 6-oxidato)-, (CAS Reg. No. 151841-65-5). The FCS will be manufactured and characterized as described in the notification. | Asahi Denka Kogyo K.K. | May 4, 2002 | |
| 2H-benzimidazole-2-thione, 1,3-dihydro-, 4(or 5)-methyl-, zinc salt(2:1) containing up to 4 percent by weight petroleum process oil. | Vanderbilt Chemicals, LLC | May 30, 2002 | |
| Pyromellitic dianhydride (CAS Reg. No. 89-32-7). | Nippon Shokubai Co. Ltd. Gruppo Mossi & Ghisolfi | Mar 20, 2002 | |
| A mixture of imidazolium and imidazoline compounds, 9-Octadecenoic acid (9Z)-, reaction products wirh diethylenetriamine, cyclized, diethyl sulfate quaternized (CAS Reg. No. 68511-92-2) and Amides, C18 and C18-unsaturated, N-(2-(2-(C17 and C17-unsaturated alkyl)-4,5-dihydro-1H-imidazol-1-yl)ethyl)- (CAS Reg. No. 71808-32-7). | Solenis LLC | Apr 20, 2002 | |
| A copolymer of dimethyl terephthalate (CAS Reg. No. 120-61-6), 1,3-dimethyl-5-sulfo-1,3-benzenedicarboxylate, sodium salt (CAS Reg. No. 3965-55-7), and 1,6-hexanediol (CAS Reg. No. 629-11-8). | Teijin Ltd. | Mar 13, 2002 |
| FCN No. | Food Contact Substance | Manufacturer/Supplier | Effective Date |
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