Inventory of Effective Food Contact Substance (FCS) Notifications
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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|Food Contact Substance||Manufacturer||Effective Date|
|1592||Copolymers of acrylamide, diallyldimethylammonium chloride, 2-methylenebutanedioic acid and propenoic acid||Plasmine Technology, Inc./Harima Chemicals, Inc.||Dec 9, 2015|
|1590||Chromium Nitride (CAS Reg. No. 24094-93-7)||Euclid Refinishing Inc. DBA Surftech Inc.||Nov 25, 2015|
|1589||2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs. (CAS Reg. No. 68784-12-3)||Omya International AG and its affiliates||Nov 24, 2015|
|1588||Diphosphoric acid, copper (2+) salt, hydrate (1:2:x) (CAS Reg. No. 16570-28-8) (Note: where x is unspecified, therefore this submission can cover both the anhydrous and hydrated versions of copper pyrophosphate.)||Chemische Fabrik Budenheim KG||Nov 19, 2015|
|1582||Microfibrillated cellulose pulp||Imerys Minerals, Inc.||Nov 6, 2015|
|1579||Benzoic acid, 4-[(4-chlorobenzoyl)amino]-, sodium salt (1:1) (CAS Reg. No. 1489170-67-3)||Milliken & Company||Nov 3, 2015|
|1576||Pentaerythritol tetra(3-dodecylthiopropionate) (CAS Reg. No. 29598-76-3).||Addivant||Oct 30, 2015|
|1573||Poly[imino-1,4-butanediylimino(1,10-dioxo-1,10-decanediyl)] (CAS Reg. No. 26247-06-3)||DSM Engineering Plastics B.V.||Dec 11, 2015|
|1570||Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a radio-frequency plasma as described in the notification.||Mitsubishi Corporation Plastics Ltd.||Oct 16, 2015|
|1569||A solution of silver dihydrogen citrate stabilized with sodium lauryl sulfate and citric acid||Pure Bioscience, Inc.||Dec 18, 2015|
|1560||Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. No. 9011-17-0).||Arkema, Inc.||Sep 18, 2015|
|1558||An aqueous mixture of hydrogen peroxide (HP; CAS Reg. No. 7722-84-1), percitric acid (CAS Reg. No. 127542-88-5), perlactic acid (CAS Reg. No. 75033-25-9), citric acid (CAS Reg. No. 77-92-9), and lactic acid (CAS Reg. No. 79-33-4), manufactured and characterized as further described in the notification.||Mantrose-Haeuser Co., Inc.||Aug 26, 2015|
|1557||Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).REPLACES FCN 1206||BASF Schweiz AG||Aug 26, 2015|
|1556||Terephthalic acid polymer with 1,4:3,6-dianhydro-D-glucitol, 1,4-cyclohexanedimethanol and 1,2-ethanediol (CAS Reg. No. 1038843-64-9).||SK Chemicals||Nov 6, 2015|
|1554||An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 02809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).||BioSafe Systems, LLC||Oct 27, 2015|
|1553||2-Propen-1-aminium, N,N-dimethyl-N-2-propen-1-yl-, chloride (1:1), polymer with ethanedial and 2-propenamide (CAS Reg. No. 32555-39-8).||BASF Corporation||Oct 9, 2015|
|1548||2-Propenoic acid, polymer with sodium 2-hydroxy-3-(2-propen-1-yloxy)-1-propanesulfonate (1:1) and α-sulfo-ω-(2-propen-1-yloxy)poly(oxy-1,2-ethanediyl) ammonium salt (1:1), sodium salt (CAS Reg. No. 903573-39-7).||GE Water & Process Technologies||Sep 2, 2015|
|1545||Phosphorous acid, triphenyl ester, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2- ethanediyl)], C10-16 alkyl esters (CAS Reg. No. 1227937-46-3). REPLACES FCN 1429||Dover Chemical Corporation||Jul 7, 2015|
|1544||Phosphorous acid, mixed 2,4-bis(1,1-dimethylpropyl)phenyl and 4-(1,1-dimethylpropyl)phenyl triesters (CAS Reg. No. 939402-02-5)||Addivant||Jul 1, 2015|
|1539||Ethylene/hexene copolymers containing up to 50 weight percent polymer units derived from hexene (CAS Reg. No. 25213-02-9).||The Dow Chemical Company||Jun 19, 2015|
|1538||Ethylene-propylene copolymers (CAS Reg. No. 9010-79-1)||Pinnacle Polymers||Jun 9, 2015|
|1535||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).||Paramount Minerals and Chemicals Limited||Jun 4, 2015|
|1534||1,3-Benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid and 4,4′-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 62694-40-0)||EMS-Chemie AG||May 26, 2015|
Cross-linked 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7)
REPLACES FCN 1388
|McAirlaid's Inc.||May 23, 2015|
|1532||Acetic acid ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone (CAS Reg. No. 25086-89-9)||Nestlé Infant Nutrition and Sartorius Stedim Biotech GmbH||May 15, 2015|
Polyester-urethane adhesive formulated from:
(a) 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).
(b) 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).
(c) 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|
|1529||Silanediol, 1,1-dimethyl-, polymer with ethene, triblock (CAS Reg. No. 837387-70-9)||Mitsui Fine Chemicals, Inc.||May 5, 2015|
|1528||Polymers composed of a 50-60 weight-percent ethyl acrylate (CAS Reg. No. 140-88-5), 36-40 weight-percent methacrylic acid (CAS Reg. No. 79-41-4), and up to 10 weight-percent mixture of poly(oxy-1,3-ethanediyl), α-(2-methyl-1-oxo-2-propen-1-yl)-ω-hydoxy-, C16-18-alkyl ethers (CAS Reg. No. 70879-51-5) and/or poly(oxy-1,3-ethanediyl), α-(2-methyl-1-oxo-2-propen-1-yl)-ω-hydoxy-, C12-14-alkyl ethers (CAS Reg. No. 72275-82-2).||The Dow Chemical Company||Jun 27, 2015|
|1525||2-Propenoic acid, butyl ester, polymer with 1,3-butadiene, ethenylbenzene and 2-propenenitrile (CAS Reg. No. 26657-42-1).||Trinseo LLC||Apr 18, 2015|
|1522||An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), dipicolinic acid (DPA, CAS Reg. No. 499-83-2) and sulfuric acid (CAS Reg. No. 7664-93-9)||Evonik Corporation||May 28, 2015|
|1515||A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, optionally stabilized with magnesium or sodium nitrate and further stabilized with 0.15% copper (II) nitrate.||Thor GmbH||Mar 6, 2015|
|1514||An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), sulfuric acid (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4)||Valley Chemical Solutions||May 21, 2015|
|1513||Polyacrylic acid, partially neutralized sodium salt, polymer (CAS Reg. No. 68479-09-4).||Ecolab Inc.||Apr 28, 2015|
|1512||Polyacrylic acid, neutralized sodium salt, polymer (CAS Reg. No. 292842-03-6)||Ecolab Inc.||May 8, 2015|
|1511||Polymaleic acid, homopolymer (CAS Reg. No. 26099-09-2).||Ecolab Inc.||Apr 29, 2015|
|1510||Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of dimethyl terephthalate or terephthalic acid and ethylene glycol with one or more of the following: dimethyl isophthalate, isophthalic acid, and diethylene glycol.||Nan Ya Plastics Corporation, America||Feb 26, 2015|
|1509||Copolymer of polyethylene glycol dimethacrylate, trimethylolpropane trimethacrylate and 2-hydroxyethyl methacrylate.||Pall Corporation||Feb 19, 2015|
|1508||2-propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, butyl 2-propenoate and ethenylbenzene (CAS Reg. No. 25101-28-4).||Kaneka Belgium NV||Feb 19, 2015|
|1507||Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4).||
Kuraray Co., Ltd.
Kuraray America, Inc.
Kuraray Europe GmbH
|Feb 18, 2015|
|1505||Polyester-polyurethane adhesive formulated from the following: (a) Polyurethane component, comprising not more than 63% percent by weight of the cured adhesive, prepared by the reaction of allophonate modified methane diphenyl diisocyanate (CAS Reg. No. 201615-11-4), 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), polypropylene glycol, toluene diisocyanate (CAS Reg. No. 26471-62-5), hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and (b) Polyester/polyol component, a mixture of polyesters and polyether polyols prepared by the reaction of adipic acid, 1,3-benzenedicarboxylic acid, gallic acid, diethylene glycol, 1,2-propanediol, methyloxirane polymer, 1,1,1-tris(hydroxymethyl)propane, and 1,2,3-propanetriol.||Henkel, Inc.||Feb 5, 2015|
|1503||1-hydroxy-4-(p-toluidino)anthraquinone (CAS Reg. No. 81-48-1).||Americas Styrenics, LLC||Feb 3, 2015|
N,N,N’,N’-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5).
REPLACES FCN 1245
|The Dow Chemical Company||Jan 29, 2015|
|1501||An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).||Arkema Inc. and Biosafe Systems||Mar 21, 2015|
|1500||2-Propenoic acid, polymer with butyl 2-propenoate, ethenylbenzene, N-(hydroxymethyl)-2-methyl-2-propenamide and 2-methyl-2-propenamide (CAS Reg. No. 71477-85-5)||BASF SE||May 5, 2015|
|1499||2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,3-butadiene, diethenylbenzene, ethenylbenzene and ethyl 2-propenoate (CAS Reg. No. 59858-50-3).||The Dow Chemical Company||Apr 2, 2015|
|1498||Copolymer of ethylene glycol dimethacrylate, butyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 133396-60-8).||Alcresta Inc.||Jan 20, 2015|
|1497||2-oxiranone, 3-methylene, homopolymer (CAS Reg. No. 56385-15-0).||Kemira Oyj||Apr 4, 2015|
|1496||Pyrophyllite (CAS Reg. No. 12269-78-2)||Trinity Resources Ltd.||Mar 6, 2015|
|1495||An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), and 1-hydroxyethylidene-1,1- diphosphonic acid (CAS Reg. No. 2809-21-4).||Ecolab Inc.||Feb 20, 2015|
|1494||1-Naphthalenamine, N-phenyl-ar-(1,1,3,3-tetramethylbutyl)- (CAS Reg. No. 68259-36-9) (paraisomer).||Vanderbilt Chemicals, LLC||Jan 6, 2015|
|Food Contact Substance||Manufacturer||Effective Date|