FDA Adds Nine New Substances to its Inventory of Effective FCS No

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FDA Adds Nine 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

Tuesday, February 21, 2017

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

FCN No.	Food Contact Substance	Manufacturer/Supplier	Effective Date
1724	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).	Dover Chemical Corporation	Jan 24, 2017
1723	1-hexene, 3,3,4,4,5,5,6,6,6-nonafluoro-, polymer with 1,1,2,2-tetrafluoroethene (CAS Reg. No. 82606-24-4). REPLACES FCN 1065	Asahi Glass Co., Ltd. AGC Chemicals Europe AGC Chemicals Americas, Inc.	Jan 13, 2017
1720	A mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CIT; CAS Reg. No. 26172-55-4) and 2-methyl-4-isothiazolin-3-one (MIT; CAS Reg. No. 2682-20-4) at a ratio of 3 parts to 1 part by weight, optionally stabilized with magnesium nitrate or sodium nitrate and optionally further stabilized with 0.15 percent copper (II) nitrate.	Lonza, Inc.	Jan 5, 2017
1713	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).	Brainerd Chemical Company, Inc.	Dec 13, 2016
1712	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).	Arkema	Dec 13, 2016
1704	Dimethyl ether (CAS Reg. No. 115-10-6).	Akzo Nobel Industrial Chemicals, b.v.	Jan 17, 2017
1701	Chromium metal, chromium (III) oxide, chromium (III) hydroxide and chromium carbide material obtained by electrodeposition onto low carbon mild steel.	Tata Steel IJmuiden B.V.; Tata Steel UK Ltd; thyssenkrupp Rasselstein GmbH	Jan 10, 2017
1692	Polyester-polyurethane adhesive formulated as follows: polyurethane component prepared from isophthalic acid, diethylene glycol, adipic acid, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8) and hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2); and Polyester-polyol component prepared from isophthalic acid, diethylene glycol, castor oil, propoxylated glycerol, propoxylated trimethylolpropane and caprolactam.	Henkel, Inc.	Dec 17, 2016
1686	1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5).	Shanghai Miken Biotech Co., Ltd.	Dec 1, 2016

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.