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

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The U.S. Food and Drug Administration (FDA) recently added five 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
2178 1,4-Benzenedicarboxylic acid, polymer with 1,2-ethanediol and octahydro-4,7-methano-1H-indene5,?-dimethanol (CAS Reg. No. 106127-84-8), optionally cross-linked with ≤0.15 wt.-% glycerin. Chang Chun Plastics Co., Ltd October 13, 2021
2169 1,6-hexanediol (CAS Reg. No. 629-11-8). National Coatings, Inc. October 26, 2021
2168 An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg No 79-21-0), hydrogen peroxide (HP) (CAS Reg No 7722-84-1), acetic acid (CAS Reg No 64-19-7), dipicolinic acid (DPA) (CAS Reg No 499-83-2), and optionally sulfuric acid (CAS Reg No 7664-93-9). Enviro Tech Chemical Services, Inc. October 19, 2021
2165 An aqueous solution of hydrogen peroxide (CAS Reg. No. 7722-84-1). Cargill, Inc. October 8, 2021
2164 Niobium-doped titanium dioxide, coated with calcium titanate Merck KGaA, Darmstadt, Germany and its affiliated companies October 6, 2021

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?