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

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The U.S. Food and Drug Administration (FDA) recently added eight 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 SubstanceManufacturer/SupplierEffective Date
1682Polycyclooctene (PCOE; CAS Reg. No. 25267-51-0) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0). REPLACES FCN 1432Kuraray Company, Ltd.Sep 20, 2016
1681N,N'''-l,2-Ethanediylbis[N-[3-[[4,6-bis[butyl(1,2,2,6,6-pentamethyl-4-piperidinyl)amino]-1,3,5-triazin-2-yl]amino]propyl]-N',N''-dibutyl-N',N''-bis(1,2,2,6,6-pentamethyl-4-piperidinyl)-1,3,5-triazine-2,4,6-triamine] (CAS Reg. No. 106990-43-6).BASF CorporationSep 20, 2016
16762-propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 2-propenoic acid and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-methyl-2-propenoate, sodium salt (CAS Reg. No. 1878204-24-0).Asahi Glass Co., Ltd.
AGC Chemicals Americas, Inc.
Sep 21, 2016
16742,4,4'-Trifluorobenzophenone (TFBP) (CAS Reg. No. 80512-44-3).Victrex PlcSep 2, 2016
1664An aqueous mixture of peroxyacetic acid (CAS Reg. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).CraftChem, Inc.Sep 21, 2016
1662An 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), dipicolinic acid (DPA, CAS Reg. No. 499-83-2) and sulfuric acid (CAS Reg. No. 7664-93-9).Evonik CorporationSep 29, 2016
1658Polyphenylene sulfide (CAS Reg. No. 25212-74-2).SK Chemicals Co., Ltd.
INITZ Co., Ltd.
Sep 29, 2016
1650An aqueous mixture containing 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-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9).Alex C. Fergusson, LLC (AFCO)Sep 15, 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. For more background on submission of FCNs, please see the PackagingLaw.com article, "What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?"