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U.S. Department of Health and Human Services

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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  • Select the FCN number below to view the record details, including its intended use, limitations, specifications, and the Final Environmental Impact Decisions.
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Records Found: 16 Page 1 of 1
FCN No.
(sorted Z-A)
Food Contact Substance Manufacturer/Supplier Effective Date
1761 Polycaprolactone (CAS Reg. No. 24980-41-4). Ingevity Jul 5, 2017
1538 Ethylene-propylene copolymers (CAS Reg. No. 9010-79-1) Pinnacle Polymers Jun 9, 2015
1531 Polyester-urethane adhesive formulated from:
  1. Polyester resin prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 2,2-dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7), and glycerol polyoxypropylene triol (CAS Reg. No. 25791-96-2).
  2. Urethane cross-linking agent comprising not more than 40 percent by weight of the cured adhesive and formulated from 1,6-hexanediisocyanate (CAS Reg. No. 822-06-0) adducted with isobutanol (CAS Reg. No. 78-83-1) and the reaction with the polyester resin and 1,3-bis(isocyanatomethyl) benzene (CAS Reg. No. 3634-83-1) and/or 3-isocyanatomethyl-3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-0).
  3. Optional trimethoxysilane coupling agents containing amino, epoxy, ether, and/or mercapto groups not to exceed 3 percent by weight of the cured adhesive.
Mitsui Chemicals, Inc. Jul 2, 2015
853 Copolymer of styrene (CAS Reg. No. 100-42-5), methyl methacrylate (CAS Reg. No. 80-62-6), and glycidyl methacrylate (CAS Reg. No. 106-91-2). BASF SE Jan 20, 2009
851 Hexanedioic acid, polymer with 1,3-benzenedimethanamine (CAS Reg. No. 25718-70-1). Far Eastern New Century Corporation APG Polytech LLC Jan 8, 2009
850 1,3-butadiene, 2-methyl-, homopolymer, of cis-1,4-configuration, cyclized (CAS Reg. No. 68441-13-4). Zeon Corporation Dec 31, 2008
846 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5). DDP Specialty Electronic Materials US, Inc. Jan 10, 2009
845 Styrene/butadiene copolymers (CAS Reg. No., exclusive of minor monomers, is 9003-55-8), produced by copolymerizing styrene and butadiene with one or more of the monomers methacrylic acid, 2-hydroxyethyl acrylate, itaconic acid, acrylic acid, fumaric acid, N-methylol methacrylamide, and methacrylamide, such that the total of methacrylic acid, 2-hydroxyethyl acrylate, itaconic acid, acrylic acid, and fumaric acid does not exceed 10 percent by weight, and the methacrylamide and N-methylol methacrylamide do not exceed 2 percent and 3 percent by weight, respectively. OMNOVA Solutions, Inc. Dec 10, 2008
802 Benzoic acid, 2-hydroxy-, monosodium salt (CAS Reg. No. 54-21-7). PeroxyChem, LLC May 1, 2008
772 A mixture of one or more of tripropylene glycol diacrylate (CAS Reg. No. 42978-66-5), trimethylolpropane triacrylate (CAS Reg. No. 15625-89-5), trimethylolpropane ethoxylate triacrylate (CAS Reg. No. 28961-43-5), and bisphenol A diglycidyl ether diacrylate (CAS Reg. No. 4687-94-9, 53814-24-7, 55127-80-5, 55818-57-0 or 37625-93-7), and optionally the difunctional α-hydroxy ketone described in the notification as a photoinitiator. The mixture will be cured by either ultraviolet (UV) or electron beam (EB) irradiation. Alcan Packaging, Alcoa, Inc., Allnex, Amgraph Packaging, Inc., Ashland Specialty Chemical Company, Bayer Polymers LLC, Bostik-Findley, Bryce Corporation, Coating and Adhesives Corporation, Crown Cork & Seal, Dart Container, Dixie Packaging, Energy Sciences Inc., Fujihunt, Fusion UV Systems, Inc., Gidue SpA, Graphic Packaging Inc., H.B Fuller Company, IGM Resins, INX International Ink Co., Lamberti, s.p.a., Liofol, MeadWestvaco, Nordson Corporation, Petroferm Inc., Pliant Corp., PPG Industries, Inc., Printpack Inc., Rahn USA Corporation, Rock-Tenn Company, Rohm and Haas Company, Sartomer Company, Sealed Air, Siegwerk Group, Sherwin-Williams Company Mar 8, 2008
733 Polyester-polyurethane adhesive formulated from the following:
  1. Urethane cross-linking agent, comprising not more than 75 percent by weight of the cured adhesive, prepared by the reaction of a mixture of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, homopolymer (CAS Reg. No. 53880-05-0) and 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4), and a polyester prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300(b)(3)(vii),
  2. Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300(b)(3)(vii). Additionally, 1,6-hexanediol may be used as an alcohol reactant.
  3. Optional use, in either the urethane cross-linking agent or polyester resin portions of the resin, of: 1) acid anhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione (CAS Reg. No. 73003-90-4), comprising not more than 3 percent by weight of the cured adhesive, and/or 2) trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive.
Dainippon Ink and Chemicals, Inc. Oct 3, 2007
673 D,L-Aspartic acid, N-(1,2-dicarboxyethyl)-, tetrasodium salt (CAS Reg. No. 144538-83-0). LANXESS Deutschland GmbH Mar 21, 2007
538 Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt. Solvay Specialty Polymers Italy S.p.A. Nov 19, 2005
448 Polyester-polyurethane resin formulated from:
  1. (1) Polyester-polyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 1,6-hexanediol (CAS Reg. No. 629-11-8), dimethylolbutanoic acid (CAS Reg. No. 10097-02-6), 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg No. 4098-71-9), and/or 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4). The FCS will be manufactured and characterized as described in the notification. (2) An optional trimethoxysilane coupling agent containing an epoxy group, as described in the notification, not to exceed 3 percent by weight of the cured adhesive.
  2. Urethane cross-linking agent comprising not more than 20 percent by weight of the cured adhesive, and formulated from trimethylolpropane (CAS Reg. No. 77-99-6) adduct of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate and/or trimethylolpropane adduct of 1,3-bis(isocyanatomethyl)benzene and/or 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-0). The content of the 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate shall not exceed 14 percent by weight of the cured adhesive.
Perstorp Polyols, Inc. Rock Paint Co., Ltd. Oct 15, 2004
197 Copolymers (polyurethanes) produced from 4,4'-methylenebis(cyclohexylisocyanate), polytetramethylene glycol, and polyethylene glycol (CAS Reg. No. 375387-19-2). UCB Films PLC Mar 8, 2002
75 Ethylene-2-norbornene copolymer (CAS Reg. No. 26007-43-2). The CAS nomenclature is bicyclo{2.2.1} hept-2-ene, polymer with ethene. TOPAS Advanced Polymers, GmbH
Polyplastics USA, Inc., and
Polyplastics Co., Ltd.
Aug 22, 2000

FCN No.
(sorted Z-A)
Food Contact Substance Manufacturer/Supplier Effective Date

679661  

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