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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 substance and the manufacturer is listed below.

FCN No. Food Contact Substance Manufacturer/ Supplier Effective Date
2359 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs. (CAS Reg. No. 68784-12-3). Omya International AG and its affiliates May 31, 2024
2356 A copolymer of methyltrimethoxysilane (CAS Reg. No. 1185-55-3), trimethoxyphenylsilane (CAS Reg. No. 2996-92-1), and silica (CAS Reg. No. 7631-86-9). PPG Industries, Inc. May 28, 2024
2354 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 4-hydroxybutyl acrylate, acetate (salts) (CAS Reg. No. 2374117-56-1). REPLACES FCN 2191 Daikin America, Inc. May 25, 2024
2340 Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). Rianlon Corporation May 22, 2024
2350 Methacrylic acid, polymer with N-(butoxymethyl)acrylamide, ethyl acrylate, styrene, and vinylphosphonic acid. PPG Industries, Inc. May 8, 2024

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?