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

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The U.S. Food and Drug Administration (FDA) recently added six 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
2258 Copolyesters of terephthalic acid with ethylene glycol, neopentyl glycol, 1,4-cyclohexanedimethanol, and diethylene glycol (CAS Reg. No. 208755-39-9). Eastman Chemical Company February 17, 2023
2255 Copolymer of 1,3-benzenedicarboxylic acid, azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid, and 4,4'-methylenebis[2-methylcyclohexanamine] (CAS Reg. No. 2080394-29-0). EMS-CHEMIE AG, Business Unit EMS-GRIVORY Europe February 9, 2023
2253 Ethanaminium, N,N,N- trimethyl-2-[(1-oxo-2-propen-1-yl)oxy]-, chloride (1:1), polymer with 2-propenamide (CAS Reg. No. 69418-26-4) modified with up to 2.0 % by weight of propenoic acid (CAS Reg. No. 79-10-7). Nalco Water, An Ecolab Company January 29, 2023
2247 2-Propenoic acid, 2-methyl-, 1,1-(1,2-ethanediyl) ester, polymer with phenylmethyl 2-methyl-2-propenoate (CAS Reg. No. 126969-53-7). Amano Enzyme U.S.A. Co., Ltd. January 25, 2023
2251 Ethylene/octene copolymers containing up to 30 weight percent polymer units derived from 1-octene (CAS Reg. No. 26221-73-8). NOVA Chemicals Corporation January 24, 2023
2248 Naphthalenesulfonic acid, C8-C10, C9-rich alkylderivatives, calcium salts, primarily calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate) (CAS Reg. No. 1474044-79-5). King Industries, Inc. January 19, 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?