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

FDA Building

The U.S. Food and Drug Administration (FDA) recently added five 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
2265 Polyurethane resin produced by reacting 2,4-toluene diisocyanate (TDI; CAS Reg. No. 584-84-9) with polyoxyethylene-polyoxypropylene glyceryl ether (CAS Reg. No. 9082-00-2). FabriRes - Produtos Quimicos S.A. April 20, 2023
2277 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1,3,5-triazin-2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9). Hebei Sanchuan Chemical Co., Ltd. April 13, 2023
2278 2-Methyl-4,6-bis[(octylthio)methyl]phenol (CAS Reg. No. 110553-27-0). BASF April 13, 2023
2276 2-Propenoic acid, 2-cyano-3-(3,4-dimethoxyphenyl)-, 1,1'-[2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2,2-dimethyl-2,1-ethanediyl)] ester, (2E,2'E)- (CAS Reg. No. 2233585-18-5). Chitec Technology Co., Ltd. April 8, 2023
2274 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), optionally, sulfuric acid (CAS Reg. No. 7664-93-9), and optionally, 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4) and/or optionally dipicolinic acid (DPA) (CAS Reg. No. 499-83-2). REPLACES FCNS 1872, 1897, and 2070 Hydrite Chemical Co. April 7, 2023

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 article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?