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

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The U.S. Food and Drug Administration (FDA) recently added 11 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
2209 Butanedioic acid, hydroxy-, polymer with butanedioic acid, 1,4-butanediol and 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (CAS Reg. No. 864132-20-7), optionally reacted with 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0). Chang Chun Plastics Company, Ltd. March 24, 2022
2181 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS Reg. No. 28628-75-3). Mitsubishi Gas Chemical Co., Inc. March 23, 2022
2207 1-Decene, homopolymer, hydrogenated (CAS Reg. No. 68037-01-4). BYK-Chemie GmbH March 17, 2022
2184 Siloxane and Silicones, di-Me, Me hydrogen polymers with di-Me, Me vinyl siloxanes, 1,1’-(1-methylethylidene)bis[4-(2-propen-1-yloxy)benzene]-2,4,6,8-tetramethylcyclotetrasiloxane reaction products, vinyl group-terminated di-Me siloxanes and hydrogen-terminated di-Me siloxanes. Shin-Etsu Chemical Co., Ltd. March 15, 2022
2206 Chromium iron oxide (C.I. Pigment Brown 29; CAS Reg. No. 109414-04-2 and CAS Reg. No. 12737-27-8). The Shepherd Color Company March 12, 2022
2183 Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS. Reg. No. 13170-05-3). Shandong Rainwell New Materials Technology Company, Ltd. March 10, 2022
2201 Glycidyl methacrylate (CAS Reg. No. 106-91-2). Akzo Nobel Coatings Inc. March 2, 2022
2199 Ethylene propylene copolymer (CAS Reg. No. 9010-79-1). ExxonMobil Chemical Company and its stewarded affiliates around the world February 25, 2022
2200 Ethylene propylene copolymer (CAS Reg. No. 9010-79-1). ExxonMobil Chemical Company and its stewarded affiliates around the world February 25, 2022
2197 N,N'-dioleoylethylenediamine (CAS. Reg. No. 110-31-6). SK Functional Polymer S.A.S. February 19, 2022
2191 2-Propenoic acid, 2-methyl-, 2-(dimethylamino)ethyl ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and 4-hydroxybutyl acrylate, acetates (salts) (CAS Reg. No. 2374117-56-1). Daikin America, Inc. February 1, 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?