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

October 5, 2020

The U.S. Food and Drug Administration (FDA) recently added seven 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
2074 Tungsten carbide containing up to 15 percent nickel with up to 1.5 percent chromium carbide EXTRAMET AG July 16, 2020
2061 Fatty acids, C14-C20, esters with pentaerythritol (CAS Reg. Nos. 68440-28-8 and 85116-93-4) INEOS Styrolution Group GmbH July 16, 2020
2060 An aqueous mixture containing peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4), and, optionally, sulfuric acid (CAS Reg. No. 7664-93-9) Alex C. Fergusson, LLC (AFCO) July 10, 2020
2059 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) Hydrite Chemical Co. July 28, 2020
2058 Poly(ethylene furandicarboxylate) (CAS Reg. No. 52733-28-5) DuPont Industrial Biosciences LLC July 28, 2020
2057 Poly(ethylene furandicarboxylate) (CAS Reg. No. 52733-28-5) DuPont Industrial Biosciences LLC July 28, 2020
2056 1-Decene, homopolymer, hydrogenated (CAS Reg. No. 68037-01-4) The Sherwin-Williams Company July 25, 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?