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

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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
2296 Ethene, polymer with 2-propenenitrile and ethenylbenzene (CAS Reg. No. 106826-13-5), and methacrylic acid-2-[(tert-butylperoxycarbonyl)oxy]ethyl ester (CAS Reg. No. 41892-41-5), graft; also known as Ethene, polymer with 2-propenenitrile, ethenylbenzene, and methacrylic acid-2- [(tertbutylperoxycarbonyl)oxy]ethyl ester, graft (CAS Reg. No. 118497-28-2). NOF Corporation August 30, 2023
2297 Hypochlorous acid (CAS Reg. No. 7790‐92‐3). REPLACES FCN 2161 Ecolab, Inc. August 30, 2023
2287 Ethylene propylene copolymer (CAS Reg. No. 9010-79-1) Exxon Mobil Corporation August 4, 2023
2292 Triphenyl phosphite, polymer with 1,4-cyclohexanedimethanol and polypropylene glycol,C10-16 alkyl esters (CAS Reg. No. 1821217-71-3). REPLACES FCN 001998 Dover Chemical Corporation August 1, 2023
2293 2-Propenoic acid, 2-methyl-, methyl ester, polymer with 1,1-dichloroethene, 2-hydroxyethyl 2-propenoate, methyl 2-propenoate, and 2-propenenitrile (CAS Reg. No. 794518-17-5). Unitika Ltd.
Asahi Kasei Corporation
August 1, 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?