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FDA Adds 20 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 13, 2018

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The U.S. Food and Drug Administration (FDA) recently added 20 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
1834	Hydroquinone (CAS Reg. No. 123-31-9). REPLACES FCNs 1246 and 1306	The Valspar Corporation	Dec 15, 2017
1833	Sorbic Acid (CAS Reg. No. 110-44-1). REPLACES FCN 1305	The Valspar Corporation	Dec 15, 2017
1832	Diethylene glycol (CAS Reg. No. 111-46-6).	Anderson Development Company	Dec 13, 2017
1831	Tripropylene glycol (CAS Reg. No. 24800-44-0).	Anderson Development Company	Dec 13, 2017
1830	Dipropylene glycol (CAS Reg. No. 25265-71-8).	Anderson Development Company	Dec 13, 2017
1825	Siloxanes and silicones, methyl-phenyl, methyl-3,3,3-trifluoropropyl (CAS Reg. No. 1643944-25-5).	Dow Corning Corporation	Dec 1, 2017
1824	Poly-1-butene polymers (CAS Reg. No. 9003-28-5) and butene/ethylene copolymers (CAS Reg. No. 25087-34-7).	LyondellBasell Industries	Dec 1, 2017
1823	An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (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) and dipicolinic acid (DPA) (CAS Reg. No. 449-83-2).	Brainerd Chemical Company, Inc.	Nov 29, 2017
1821	Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-(4-morpholinyl)-6-(phenylamino)-1,3,5-triazin-2-yl]amino]-, sodium salt (CAS Reg. No. 16090-02-1).	Zhejiang Hongda Chemicals Co. Ltd.	Nov 21, 2017
1820	Styrene-isobutylene block copolymer (CAS Reg. No. 9011-12-5).	Kaneka North America, LLC	Nov 15, 2017
1819	A mixture of 1-decene, polymer with sulfur dioxide (CAS Reg. No. 33990-98-6); 1,3-propanediamine, N1-(9Z)-9-octadecen-1-yl-, polymer with 2-(chloromethyl)oxirane (CAS Reg. No. 1010121-89-7); and dodecylbenzenesulfonic acid (CAS Reg. No. 27176-87-0).	Innospec Ltd.	Nov 7, 2017
1818	Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid. REPLACES FCN 1643	PTT MCC Biochem Company Ltd.	Dec 23, 2017
1817	Poly(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. REPLACES FCN 1574	PTT MCC Biochem Company Ltd.	Dec 23, 2017
1815	An aqueous solution of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), with oxalic acid (CAS Reg. No. 144-62-7) and/or maleic acid (CAS Reg. No. 110-16-7).	PeroxyChem, LLC	Dec 29, 2017
1810	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-disphosphonic acid (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 766-93-9).	BioSafe Systems LLC	Nov 30, 2017
1809	Maleic anhydride-grafted polyethylene (CAS Reg. No. 9006-26-2).	The Dow Chemical Company	Dec 29, 2017
1808	1,2,4,5,7,8-Hexoxonane, 3,6,9-trimethyl-, 3,6,9-tris(Et and Pr) derivs. (CAS Reg. No. 1613243-54-1)	Akzo Nobel Functional Chemicals, LLC S.A. Akzo Nobel Chemicals N.V.	Dec 8, 2017
1805	A polymer produced from tetrafluoroethylene (CAS Reg. No. 116-14-3) and 1,1,2,2-tetrafluoro-2-((1,2,2-trifluoroethenyl)oxy)ethanesulfonyl fluoride (CAS Reg. No. 29514-94-1). The polymer is hydrolyzed and may optionally be further neutralized to its ammonium salt.	Solvay Specialty Polymers USA, LLC	Dec 20, 2017
1804	Chlorine dioxide (CAS Reg. No. 10049-04-4).	Selective Micro Technologies	Dec 6, 2017
1803	Maleic anhydride, polymer with ethene and 1-hexene (CAS Reg. No. 86286-09-1).	The Dow Chemical Company	Dec 29, 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.