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