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FDA Adds Two New Substances to Its Inventory of Effective FCS Notifications

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The U.S. Food and Drug Administration (FDA) recently added two 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
2302 Calcium hydride (CAS Reg. No. 7789-78-8) used in conjunction with platinum oxide (CAS Reg. No. 1314-15-4) or zeolite encapsulated platinum (CAS Reg. Nos. 63231-69-6 and 20634-12-2). Avient Corporation and its stewarded global affiliates September 16, 2023
2298 1,4-Benzenedicarboxylic acid, polymer with 1,2-ethanediol and β,β,β’,β’-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS Reg. No. 102070-64-4). REPLACES FCN 2254 Perstorp AB September 1, 2023

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?