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

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The U.S. Food and Drug Administration (FDA) recently added four 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
2283 2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[3-chloro-5-(octadecylthio)phenyl) and 4-chloro-phenyl] derivatives (CAS Reg. No. 2142611-43-4). CINIC Chemicals America, LLC May 23, 2023
2282 Pyrophyllite (CAS Reg. No. 12269-78-2). Trinity Resources Ltd.
Trinity Performance Minerals
May 20, 2023
2270 2-[4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5-(octyloxy)phenol (CAS Reg. No. 2725-22-6). Rianlon Corporation May 13, 2023
2281 Butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid (CAS Reg. No. 125495-90-1), containing from 25 to 35 weight percent 4-hydroxybutanoic acid. CJ CheilJedang Corporation May 3, 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?