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

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The U.S. Food and Drug Administration (FDA) recently added three 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
2242 An aqueous mixture of peroxycitric acid (PCA) (CAS Reg. No. 127542-89-6), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), citric acid (CAS Reg. No. 77-92-9), lactic acid (CAS Reg. No. 50-21-5), acetic acid (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). Evonik Active Oxygens, LLC September 28, 2022
2238 A copolyester made from dimethyl terephthalate (DMT), ethylene glycol (EG), and 2,2,4,4-tetramethyl-1,3-cyclobutanediol (TMCD) (CAS Reg. No. 185625-67-6). REPLACES FCN 1878 Eastman Chemical Company September 16, 2022
2235 Glass-based pearlescent pigments Merck KGaA, Darmstadt, Germany, and its affiliated companies September 3, 2022

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?