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

July 21, 2020

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
2054 Chromium(3+) iron(3+) trioxidandiide (C.I. Pigment Brown 29; CAS Reg. No. 109414-04-2 and CAS Reg No. 12737-27-8) Ferro Corporation June 30, 2020
2053 Manganese ferrite black hematite (C.I. Pigment Black 33, CAS Reg. No. 188735-18-4) Ferro Corporation June 30, 2020
2052 Tricyclodecanedimethanol (CAS Reg. No. 26896-48-0 and 26160-83-8) Dairen Chemical Corporation
Chang Chun Plastics Co., Ltd
June 20, 2020
2050 Copolymer of acrylamide, 2-methacryloxyethyltrimethylammonium chloride, itaconic acid, and N,N'-methylenebis(acrylamide) (CAS Reg. No. 214495-32-6) Harima Chemicals, Inc.
Plasmine Technology, Inc.
June 17, 2020
2047 Hydrogenated castor oil monoglycerides, acetylated (CAS Reg. No. 736150-63-3) DuPont Nutrition & Biosciences ApS and DuPont de Nemours, Inc. June 4, 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?