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

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The U.S. Food and Drug Administration (FDA) recently added eight 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
2161 Hypochlorous acid (CAS Reg. No. 7790-92-3). Ecolab, Inc. September 29, 2021
2160 2-propenoic acid, polymer with sodium phosphinate (1:1), neutralized with calcium and sodium (CAS Reg. No. 2144395-83-3). BASF September 18, 2021
2158 Quino[2,3-b]acridine-7,14-dione, 5,12-dihydro-2,9-dimethyl-, also known as 2,9-dimethylquinacridone and C.I. Pigment Red 122 (CAS Reg. No. 980-26-7). Trust Chem Co., Ltd. September 14, 2021
2157 Decanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, isooctadecanoate (CAS Reg. No. 2294927-19-6). OLEON NV September 10, 2021
2149 Alcohols, C16-18, ethoxylated (CAS Reg. No. 68439-49-6). Cytec Industries Inc. September 29, 2021
2141 Poly(2-ethyl-2-oxazoline) (CAS Reg. No. 25805-17-8). Solenis LLC August 21, 2021
2135 1,4-butanediol-polytetramethylene glycol-dimethyl terephthalate block copolymer (CAS Reg. No. 106465-17-2), reaction products with maleic anhydride. Mitsubishi Chemical Corporation September 4, 2021
2131 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. NOF Corporation August 21, 2021

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?