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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
2307 Polyphenylene sulfide (CAS Reg. No. 26125-40-6 or 25212-74-2). Zhejiang NHU Special Materials Co., Ltd. November 29, 2023
2316 Hypochlorous Acid (CAS Reg. No. 7790-92-3). REPLACES FCN 2186 Clarentis Technologies, LLC November 23, 2023
2315 Ethylene/1-butene copolymer (CAS Reg. No. 25087-34-7). Formosa Plastics Corporation, USA November 18, 2023
2299 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). SNF SA, SNF Inc. November 15, 2023
2308 Industrial starch modified by treatment with greater than 5 percent and not more than 21 percent 2,3-epoxypropyltrimethylammonium chloride (CAS Reg. No. 56780-58-6). Chemigate Oy November 3, 2023
2313 2,5-Dihydro-3,6-bis(4-methylphenyl)pyrrolo[3,4-c]pyrrole-1,4-dione (CAS Reg. No. 84632-66-6). Sun Chemical Corporation November 2, 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?