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

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The U.S. Food and Drug Administration (FDA) recently added seven 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
2233 2(3H)-Benzofuranone, 5,7-bis(1,1-dimethylethyl)-3-[3,5-dimethyl-4-[[2,4,8,10-tetrakis(1,1-dimethylethyl)-12-methyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin-6-yl]oxy]phenyl]- (CAS Reg. No. 1893088-15-4). BASF Corporation August 26, 2022
2231 Dipentaerythritol, hexaesters with 3,5,5-trimethylhexanoic, decanoic, heptanoic, and octanoic acids (CAS Reg. No. 2640167-40-2). Nyco August 19, 2022
2230 Pentaerythritol (CAS Reg. No. 115-77-5). REPLACES FCN 2116 Meredian, Inc. July 29, 2022
2228 Cross-linked 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7). Novipax July 14, 2022
2217 Poly-1-butene homopolymer (CAS Reg. No. 9003-28-5) LyondellBasell Industries July 6, 2022
2226 Poly(ethyl acrylate-co-glycidyl methacrylate-co-methacrylic acid-co-methyl methacrylate-co-styrene) (CAS Reg. No. 29437-40-9). REPLACES FCN 1213 PPG Industries, Inc. July 6, 2022
2216 Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7). The Dow Chemical Company July 5, 2022

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?