FDA Adds Thirteen New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added thirteen 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|
|2079||Ethanol, 2-amino- (CAS Reg. No. 141-43-5). REPLACES FCN 1756||Omya International AG and its Affiliates||October 20, 2020|
|2076||Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. No. 31570-04-4). REPLACES FCN 524||BASF Corporation||August 19, 2020|
|2075||Glass-based pearlescent pigments.||Merck KGaA, Darmstadt, Germany and its affiliated companies||October 1, 2020|
|2071||Amorphous hydrogenated carbon coating produced from acetylene as the carbon source in a radio-frequency plasma as described in the notification.||Fuji WPC Co., Ltd.||September 25, 2020|
|2070||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-hydroxyethylidene-1,1- diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9).||Hydrite Chemical Co.||September 18, 2020|
|2069||Pentaerythritol (CAS Reg. No. 115-77-5).||Kaneka North America LLC||September 15, 2020|
|2068||Alcohols, C10-14-branched, C11-rich, reaction products with ethylene oxide, [(2-propenyloxy)methyl]oxirane and sulfamic acid (CAS Reg. No. 905843-50-7). The FCS is comprised primarily of poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-(hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich, C10-14-branched alkyl ethers, ammonium salts (CAS Reg. No. 403983-53-9). REPLACES FCN 1945||Adeka Corporation||September 5, 2020|
|2067||Tricyclodecanedimethanol (CAS Reg. Nos. 26896-48-0 and 26160-83-8).||Akzo Nobel Coatings Inc.||September 1, 2020|
|2066||Copolymers of terephthalic acid (CAS Reg. No.100-21-0), ethylene glycol (CAS Reg. No. 107-21-1), diethylene glycol (CAS Reg. No. 111-46-6), and 1,4-cyclohexanedimethanol (CAS Reg. No. 105-08-8), optionally branched with trimellitic anhydride (CAS Reg. No. 552-30-7).||SK Chemicals Co., Ltd.||September 1, 2020|
|2065||lcohols, C10-14-branched, C11-rich, reaction products with polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane (CAS Reg. No. 403983-11-9 and 1000866-04-5). REPLACES FCN 1944||Adeka Corporation||August 26, 2020|
|2064||Fatty acids, C18-unsaturated, dimers, hydrogenated, polymers with caprolactam and hexamethylenediamine (CAS Reg. No.475994-94-6)||Nylon Corporation of America, Inc. (NYCOA)||August 19, 2020|
|2063||Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4)||TSRC Corporation||October 14, 2020|
|2062||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), sulfuric acid (SA) (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4)||Agri-Neo Inc.||August 6, 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?