FDA Adds Eleven New Substances to its Inventory of Effective FCS Notifications
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 packaginglaw.com article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?