Skip to main content

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

FDA Building

The U.S. Food and Drug Administration (FDA) recently added eight 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
2116 Pentaerythritol (CAS Reg. No. 115-77-5). Meredian, Inc. March 24, 2021
2115 Ethylene-vinyl acetate-vinyl alcohol (EVOH) copolymers modified with up to 8 mol% 1,2-epoxypropane (CAS Reg. No. 482589-30-0). Kuraray Co., Ltd. March 12, 2021
2114 Chromium(3+) iron(3+) trioxidandiide (C.I. Pigment Brown 29; CAS Reg. No. 109414-04-2 and CAS Reg No. 12737-27-8). Al-Farben, S.A. March 5, 2021
2112 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), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No. 2809-21-4). Diversey, Inc. February 20, 2021
2105 Alkyl(C10-16)benzenesulfonic acid (CAS Reg. No. 68584-22-5). CHEP March 19, 2021
2102 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5). Lanxess Corporation March 10, 2021
2101 1,2-Benzisothiazolin-3-one (CAS Reg. No. 2634-33-5). Lanxess Corporation March 10, 2021
2098 Phosphoric acid, zirconium(4+) salt (2:1) (CAS Reg. No. 13772-29-7). Jinda Nano Tech. (Xiamen) Co., Ltd. March 10, 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?