FDA Adds 11 New Substances to its Inventory of Effective FCS Noti

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FDA Adds 11 New Substances to its Inventory of Effective FCS Notifications

by: Packaging Law at Keller and Heckman of Keller and Heckman LLP - Packaging Law Blog at Keller and Heckman

Thursday, September 28, 2017

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The U.S. Food and Drug Administration (FDA) recently added 11 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.

FCN No. (sorted Z-A)	Food Contact Substance	Manufacturer/Supplier	Effective Date
1797	Copolymers of acrylamide, diallyldimethylammonium chloride, 2-methylenebutanedioic acid and propenoic acid. REPLACES FCN 1592	Harima Chemicals, Inc. Plasmine Technology, Inc.	Aug 30, 2017
1794	N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5). REPLACES FCNs 1353 and 1502	The Dow Chemical Company	Aug 23, 2017
1756	Ethanol, 2-amino- (CAS Reg. No. 141-43-5).	Omya International AG and its Affiliates	Aug 5, 2017
1790	Phosphoric acid, iron (2+) salt, (2:3:x) (CAS Reg. No. 14940-41-1 (anhydrous); (CAS Reg. No. 10028-23-6) (octahydrate).	Chemische Fabrik Budenheim KG, Germany Budenheim Ibérica S.L.U., Spain Budenheim USA Inc.	Aug 3, 2017
1767	The FCS is a reaction product of three polymers: 2-propenoic acid, 2-methyl-, methyl ester, polymer with 4,5-dihydro-2-(1-methylethenyl)oxazole and ethyl 2-propenoate (CAS Reg. No. 57460-65-8); methyl methacrylate, ethyl acrylate, methacrylic acid, butanoic acid 3-oxo- 2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester,3-(trimethoxysilyl)propyl methacrylate with poly(oxy-1,2-ethanediyl), alpha-sulfo-omega-[4-nonyl-2-(1-propen-1-yl)phenoxy]-, branched, ammonium salts copolymer; and 1,3-benzenedicarboxylic acid, polymer with 2-[(2-aminoethyl)amino]ethanol, 1,3-bis(isocyanatomethyl)cyclohexane, decanedioic acid, 1,3-diisocyanatomethylbenzene, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, compd. with 1,1',1''-nitrilotris[2-propanol] (CAS Reg. No. 1239020-50-8).	TOYOBO Co., Ltd.	Aug 3, 2017
1764	Chlorine dioxide (CAS Reg. No. 10049-04-4).	Selective Micro Technologies, LLC	Aug 2, 2017
1754	Butanoic acid, 3-hydroxy-, (R)-, homopolymer (CAS Reg. No. 29435-48-1).	Newlight Technologies, Inc.	Jul 22, 2017
1787	Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2).	BASF SE	Jul 18, 2017
1739	Benzene, diethenyl-, polymer with ethenylbenzene and ethenylethylbenzene, chloromethylated (CAS Reg. No. 69011-14-9).	Dow Chemical Company	Jul 11, 2017
1733	2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4).	LANXESS Corporation	Jul 7, 2017
1751	Carbonic dichloride, polymer with 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-1-H-isoindol-1-one and 4,4’-(1-methylethylidene)bis[phenol], bis[4-(1-methyl-1-phenylethyl)phenyl] ester (CAS Reg. No. 503834-43-3).	SABIC Innovative Plastics	Jul 7, 2017

The Food and Drug Administration Modernization Act of 1997 amended the Federal Food, Drug, and Cosmetic Act to provide for the submission of food-contact notifications (FCNs). Under the FCN system, a manufacturer or supplier of a food-contact material may submit an FCN to FDA regarding the identity and use of a new food-contact substance (FCS), along with information supporting the conclusion that the substance is safe for the intended use.

If FDA does not object in writing within 120 days to the substance's use based on safety grounds, the submitter and its customers may market the substance. Once the notification becomes effective, FDA will add it to its Inventory of Effective FCS Notifications.