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

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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 article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?