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

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The U.S. Food and Drug Administration (FDA) recently added ten 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
2259 Oxirane, 2-methyl-, polymer with oxirane, ether with 1,2,3-propanetriol (3:1), polymer with 1,3-diisocyanato-2-methylbenzene and 2,4-diisocyanato-1-methylbenzene (CAS Reg. No. 68227-13-4). Diam Bouchage SAS Dec. 21, 2022
2245 A hydrogen peroxide solution (CAS Reg. No. 7722-84-1). Perfect Day, Inc. Dec. 9, 2022
2254 1,4-Benzenedicarboxylic acid, polymer with 1,2-ethanediol and β,β,β′,β′,-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS Reg. No. 102070-64-4). Perstorp AB Dec. 2, 2022
2252 Titanium nitride (CAS Reg. No. 25583-20-4). REPLACES FCN 818 Avient Corporation and its stewarded global affiliates Nov. 26, 2022
2249 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). Guangxi State Farms Mingyang Development Co., Ltd. Nov. 24, 2022
2241 Rice bran wax, oxidized (CAS Reg. No. 1883583-80-9) and its calcium salt (CAS Reg. No. 1850357-57-1) or sodium salt (CAS Reg. No. 2759532-87-9). Clariant Corporation Nov. 23, 2022
2236 An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally, octanoic acid (CAS Reg. No. 124-07-2) and peroxyoctanoic acid (CAS Reg. No. 33734-57-5). LPR Technologies & Safe Foods Corporation Nov. 16, 2022
2246 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). Shandong Huabao Pigment Co. Ltd. Oct. 27, 2022
2244 Oleic acid, mono ester with oxybis(propanediol) (CAS Reg. No. 49553-76-6). Palsgaard A/S Oct. 7, 2022
2243 Pentaerythritol (CAS Reg. No. 115-77-5). REPLACES FCN 2069 Kaneka North America Oct. 4, 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?