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. | Manufacturer/Supplier | Effective Date | Food Contact Substance |
|---|---|---|---|
| Solenis LLC | Apr 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). | |
| Teijin Ltd. | Mar 13, 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). | |
| UCB Films PLC | Mar 8, 2002 | Copolymers (polyurethanes) produced from 4,4'-methylenebis(cyclohexylisocyanate), polytetramethylene glycol, and polyethylene glycol (CAS Reg. No. 375387-19-2). | |
| Wacker Chemie/Wacker Silicones | May 14, 2002 | 1-Dodecene (CAS Reg. No. 112-41-4). | |
| Pergan Marshall LLC | Mar 6, 2002 | Di-tert-amyl peroxide (CAS Reg. No. 10508-09-5). | |
| Kanebo Chemical Industries, Ltd. | Mar 6, 2002 | Silver zinc zeolite, a mixture of silver-magnesium-zinc-calcium phosphate sodium alumino silicate, zinc oxide (CAS Reg. No. 1314-13-2), and hydrotalcite (CAS Reg. No. 12304-65-3). | |
| Asahi Denka Kogyo K.K. | Feb 27, 2002 | 12H-dibenzol(d,g)(1,3,2)dioxaphosphocin, 2,4,8,10-tetrakis(1,1-dimethylethyl)-6-((2-ethylhexyl)oxy)- (CAS Reg. No. 126050-54-2). | |
| Wacker Chemie/Wacker Silicones | Apr 20, 2002 | Hydrolized tetraethyl silicate (CAS Reg. No. 68412-37-3) | |
| SABIC Innovative Plastics | Feb 16, 2002 | Copolymers of methyl methacrylate, acrylonitrile, butadiene and styrene (CAS Reg. No. 9010-94-0). The polymers will be manufactured and characterized as described in the notification. | |
| BASF Corporation | May 24, 2002 | Di-(para-methylbenzylidene)sorbitol (CAS Reg. No. 54686-97-4, 197809-37-3 and 81541-12-0) containing up to 1 percent triisopropanolamine. | |
| Milliken Chemical, Division of Milliken & Co. | Jan 30, 2002 | Cis-endo-bicyclo(2.2.1)heptane-2,3-dicarboxylic acid, disodium salt (CAS Reg. No. 351870-33-2). | |
| Mitsubishi Shoji Plastics Corp. | Jan 29, 2002 | Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a radio-frequency plasma as described in the notification. | |
| BASF Corporation | Jan 26, 2002 | Phenol, 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)- (CAS Reg. No. 70321-86-7). | |
| BASF Corporation | Jan 26, 2002 | Butanedioic acid, dimethyl ester, polymer with 4-hydroxy-2,2,6,6-tetramethyl-1-piperidineethanol (CAS Reg. No. 65447-77-0). | |
| BASF AG/BASF Corporation | Jan 17, 2002 | Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared by reacting hexanedioic acid, 1,2-ethanediamine, N-(2-aminoethyl)-1,3-propanediamine, N,N''-1,2-ethanediylbis-1,3-propanediamine, (chloromethyl)oxirane, ethyleneimine(aziridine), and polyethylene glycol, and partly neutralized with sulfuric acid (CAS Reg. No. 167678-43-5) or formic acid (CAS Reg. No. 114133-44-7). | |
| BASF Corporation | Jan 15, 2002 | Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-,octadecyl ester (CAS Reg. No. 2082-79-3). The FCS is also known as octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate. | |
| 3V, Inc. | Mar 6, 2002 | Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1,3,5-triazin -2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9). | |
| Eastman Chemical Company | Jan 3, 2002 | Copolymers and polymers made from the reaction of dimethyl terephthalate or terephthalic acid with a mixture containing 99 to 0 mole percent of ethylene glycol and 1 to 100 mole percent of 1,4-cyclohexanedimethanol (70 percent trans isomer, 30 percent cis isomer). The FCS is further identified as follows: Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25640-14-6), manufactured from dimethylterephthalate (DMT), ethylene glycol (EG), and 1,4-cyclohexanedimethanol (CHDM). Ethylene-1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25038-91-9), manufactured from terephthalic acid (TPA), EG, and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25135-20-0), manufactured with DMT and CHDM. 1,4-cyclohexylenedimethylene terephthalate copolymers (CAS Reg. No. 25037-99-4), manufactured with TPA and CHDM. | |
| NatureWorks LLC | Jan 3, 2002 | Polylactide polymers (CAS Reg. No. 9051-89-2). The polymers will be manufactured and characterized as described in the notification. | |
| Mizusawa Industrial Chemicals, Ltd., Tokyo, Japan | Feb 19, 2002 | Aluminum lithium carbonate hydroxide trihydrate (CAS Reg. No. 150607-28-6). | |
| Sumitomo Chemical Company, Ltd. | Dec 27, 2001 | Phenol, 2-(1,1-dimethylethyl)-6-methyl-4-(3-((2,4,8,10-tetrakis(1,1-dimethylethyl)dibenzo(d,f)(1,3,2)dioxaphosphepin-6-yl)oxy)propyl)- (CAS Reg. No. 203255-81-6). | |
| Arch Chemicals, Inc. | Feb 7, 2002 | 2-Pyridinethiol-1-oxide, sodium salt (CAS Reg. No. 3811-73-2). | |
| Polyplastics | Dec 20, 2001 | Copolymers produced by the polymerization of 6-hydroxy-2-naphthoic acid and 4-hydroxybenzoic acid. The copolymers have the CAS name 2-naphthalenecarboxylic acid, 6-hydroxy-, polymer with 4-hydroxybenzoic acid (CAS Reg. No. 81843-52-9). The copolymers should be manufactured and characterized as described in the notification. | |
| Lubrizol Advanced Materials | Feb 16, 2002 | Polyacrylic acid homopolymer, or copolymer of acrylic acid and up to 10 percent alkyl (C10-C30) methacrylate, crosslinked with either allyl sucrose (CAS Reg. No. 68784-14-5) or allyl pentaerythritol (CAS Reg. No. 91648-24-7); optionally contains up to 7 percent block copolymer surfactant of fatty acid (C12-C18) and polyethylene glycol. | |
| BASF Corporation | Dec 11, 2001 | 5,7-bis(1,1-dimethylethyl)-3-hydroxy-2(3H)-benzofuranone, reaction products with o-xylene (CAS Reg. No. 181314-48-7). | |
| Arxada, LLC | Nov 28, 2001 | An approximately 1:1 ratio 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 dimethylhydantoin. | |
| Arakawa Chemical Industries, Ltd. | Nov 13, 2001 | Aromatic petroleum hydrocarbon resin, hydrogenated (CAS Reg. No. 88526-47-0), produced by the catalytic polymerization of aromatic substituted olefins from low boiling distillates of cracked petroleum stocks with a boiling point no greater than 220°C (428°F), and the subsequent catalytic reduction of the resulting aromatic petroleum hydrocarbon resin. | |
| Polyplastics and Kureha | Oct 16, 2001 | Polyphenylene sulfide (CAS Reg. No. 25212-74-2 or 26125-40-6). | |
| BASF Corporation | Oct 16, 2001 | Phenol, 2-(5-chloro-2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylethyl)- (CAS Reg. No. 3864-99-1). | |
| Arxada, LLC | Oct 11, 2001 | A mixture of ca. 49 percent by weight of polyethylene glycol (400) monooleate and ca. 34 percent by weight of polyethylene glycol (400) dioleate. | |
| Evonik Corporation | Oct 4, 2001 | 2-Propenoic acid, methyl ester, telomer with 1-dodecanethiol, C16-C18 alkyl esters (CAS Reg. No. 174254-23-0). | |
| Total Petrochemicals & Refining USA, Inc. | Oct 2, 2001 | Piperylene/2-methyl-2-butene copolymer resins (CAS Reg. No. 26813-14-9) and Piperylene/2-methyl-2-butene/α-methylstyrene terpolymer resins (CAS Reg. No. 62258-49-5), and as further described in the identity and manufacturing sections of the notification. | |
| Invitrogen Corporation | Sep 13, 2001 | 1. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl 2-hydroxypropyl ether, (CAS Reg. No. 343845-30-7) (High Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (High Capacity). 2. Cellulose, regenerated, polymer with epichlorohydrin, 2-(diethylamino) ethyl ether, (CAS Reg. No. 343846-01-5) (Medium Capacity). The FCS is also referred to as diethylaminoethyl (DEAE) ion exchange cellulose resin (Medium Capacity). | |
| Invitrogen Corporation | Sep 4, 2001 | Cellulose, regenerated polymer with epichlorohydrin, carboxymethyl 2-hydroxypropyl ether (CAS Reg. No. 343844-23-5). The FCS is also referred to as carboxymethyl (CM) ion exchange cellulose resin. | |
| Tetra Pak, Inc. | Aug 31, 2001 | Silicon dioxide (CAS Reg. No. 7631-86-9). | |
| Gruppo Mossi & Ghisolfi | Aug 29, 2001 | Pyromellitic dianhydride (CAS Reg. No. 89-32-7). | |
| Colors and Effects USA LLC, BASF Corporation | Aug 24, 2001 | Quinacridone red (Alternate names: (1) Quino(2,3-b)acridine-7,14-dione, 5, 12-dihydro- and (2) C.I. Pigment violet 19, C.I. 73900) (CAS Reg. No. 1047-16-1). | |
| Lubrizol Corporation | Aug 7, 2001 | 2-Acrylamido-2-methylpropanesulfonic acid, in its free acid form (CAS Reg. No. 15214-89-8), and its sodium (CAS Reg. No. 5165-97-9), calcium (CAS Reg. No. 95176-15-1), potassium (CAS Reg. No. 52825-28-2), ammonium (CAS Reg. No. 58374-69-9), and lithium (CAS Reg. No. 77817-87-9) salts. | |
| ColorMatrix Group Inc. | Aug 4, 2001 | Ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3, 177.1637 and FCN numbers 4, 13, 14, 135 and 145 modified with polybutadienediol (PBD) (CAS Reg. Name: 1,3-Butadiene, homopolymer, hydroxy-terminated) (CAS Reg. No. 69102-90-5). | |
| Basell Polyolefins N.V. | Aug 2, 2001 | Poly-1-butene polymers (CAS Reg. No. 009003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7) as identified in 21 CFR 177.1570(a). | |
| ColorMatrix Group Inc. | Jul 31, 2001 | Ethylene phthalate polymers identified in 21 CFR 177.1630(e)(4)(i) and 177.1630(e)(4)(ii), items 2 and 3, 177.1637 and FCN numbers 4, 13, 14, and 135 modified with 1,2,4,5-benzenetetracarboxylic dianhydride (pyromellitic dianhydride (PMDA)) (CAS Reg. No. 89-32-7). | |
| Eastman Chemical Company | Jul 25, 2001 | 5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt (CAS Reg. No. 6362-79-4). | |
| BASF Corporation | Jul 20, 2001 | Octadecanoic acid, methyl ester, reaction products with 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinol (CAS Reg. No. 300711-92-6). | |
| Dow Silicones Corporation | Jul 19, 2001 | Silicones and siloxanes, dimethyl, methylhydrogen, reaction products with polyethylene glycol monoallyl ether acetate (CAS Reg. No. 70914-12-4). | |
| Gordon Burns and Robert Ellsworth | Jul 10, 2001 | Cross-linked terpolymer of 1-vinylimidazole,1-vinylpyrrolidone and 1,3-divinylimidazolidinone (CAS Reg. No. 87865-40-5). The FCS is also known as Polyvinylimidazol. | |
| REPLACED BY FCN 2046 | |||
| Coca-Cola Co., ColorMatrix Corp. and KoSa | Jun 6, 2001 | Anthranilamide. The Chemical Abstracts Service (CAS) name is 2-aminobenzamide (CAS Reg. No. 88-68-6). | |
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Indorama Ventures Xylenes & PTA LLC |
May 30, 2001 | Dimethyl 2,6-naphthalenedicarboxylate (NDC, CAS Reg. No. 840-65-3) or 2,6-naphthalenedicarboxylic acid (NDA, CAS Reg. No. 1141-38-4). | |
| PQ Corporation | May 30, 2001 | Sodium zeolite A (CAS Reg. No. 68989-22-0). | |
| Warwick International, Ltd. | May 30, 2001 | Bis-1,2-((N,N-diacetyl)amino)ethane (CAS Reg. No. 10543-57-4). |
| FCN No. | Manufacturer/Supplier | Effective Date | Food Contact Substance |
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