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

March 4, 2021

The U.S. Food and Drug Administration (FDA) recently added eleven 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
2088 1H-Azepine-1-carboxamide, N,N',N''-[(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)]]tris[hexahydro-2-oxo- (CAS Reg. No. 68975-83-7) PPG Industries, Inc. January 30, 2021
2082 Aluminum oxide (CAS Reg. No. 1344-28-1) Merck KGaA, Darmstadt, Germany and its affiliated companies December 23, 2020
2081 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) LANXESS Corporation January 7, 2021
2055 Ethylene glycol dipalmitate (CAS Reg. No. 624-03-3) Emery Oleochemicals GmbH October 9, 2020
2051 Bis(4-tert-butylbenzoate-O)hydroxyl aluminum (CAS. Reg. No. 13170-05-3) Shanghai Xinxin Chemical Co., Ltd. July 29, 2020
2046 An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and/or dipicolinic acid (DPA) (CAS Reg. No. 499-83-2), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9). REPLACES FCNs 1968, 1745, 1495, 1236, 1096, 921 and 140 Ecolab Inc. July 21, 2020
2044 Siloxanes 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 and vinyl group-terminated di-Me siloxanes (CAS Reg. No. 2305613-79-8) Shin-Etsu Chemical Co., Ltd. July 30, 2020
2035 Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3) BASF Corporation April 2, 2020
2032 1,4-benzenedicarboxylic acid, (or dimethyl ester) polymer with 1,4-butanediol, adipic or sebacic acid, hexamethylene diisocyanate and further reacted with no more than 1 percent by weight of the polyhydric alcohol described in the notification. REPLACES FCN 907 and FCN 916 BASF SE May 29, 2020
2029 REPLACED BY FCN 2106 - -
2027 Silicic acid, aluminum magnesium sodium salt, (CAS Reg. No. 12040-43-6) W. R. Grace & Co.-Conn. May 13, 2020

 

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?