Food Contact Substances List Expands by 10 Substances

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FDA Adds Ten 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

Friday, February 22, 2019

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The U.S. Food and Drug Administration (FDA) recently added ten 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
1941	N,N,N',N',-tetrakis(2-hydroxyethyl)hexanediamide (CAS Reg. No. 6334-25-4).	SIR Industriale S.p.A.	Jan 9, 2019
1937	Copolymer of vinyl acetate (CAS Reg No. 108-05-4), butyl acrylate (CAS Reg No 141-32-2), glycidyl methacrylate (CAS Reg. No. 106-91-2), itaconic acid (CAS Reg. No. 97-65-4), and sodium vinylsulfonate (CAS Reg. No. 3039-83-6).	BASF Corporation	Dec 26, 2018
1936	An aqueous mixture containing 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-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4), dipicolinic acid (DPA, CAS Reg. No. 499-83-2), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).	Diversey Inc.	Dec 26, 2018
1934	Isononanoic and 2-ethylhexanoic acid esters with pentaerythritol	Performance Fluids, Ltd.	Dec 21, 2018
1933	Isononanoic acid esters with dipentaerythritol	Performance Fluids, Ltd.	Dec 21, 2018
1928	Fatty acids, C18-unsatd., dimers, polymers with caprolactam and hexamethylenediamine [Nylon 6/6.36] (CAS Reg. No 2068097-08-3).	BASF SE	Dec 5, 2018
1922	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).	SNF SAS SNF Inc.	Jan 23, 2019
1919	2,6-Pyridinedicarboxylic acid (dipicolinic acid) (CAS Reg. No. 499-83-2).	Enviro Tech Chemical Services, Inc.	Dec 28, 2018
1914	Tetrafluoroethylene-ethylene-3,3,4,4,5,5,6,6,6-nonafluoro-1-hexene terpolymer (CAS Reg. No. 68258-85-5).	Asahi Glass Co., Ltd. AGC Chemicals Europe	Dec 13, 2018
1911	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-hydroxyethane 1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, sulfuric acid (CAS Reg. No. 7664-93-9).	Xgenex, LLC	Dec 6, 2018

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.