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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
2280 Bis(2,4,4-trimethylpentyl)phosphinic acid-modified titanium dioxide (produced by chemically reacting bis(2,4,4-trimethylpentyl)phosphinic acid (bis) with titanium dioxide to achieve a treatment level of up to 0.6% bis by weight of the pigment) Tronox Holdings plc June 28, 2023
2288 Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2) UBE Corporation
UBE Corporation Europe, S.A.U.
UBE Chemicals (ASIA) Public Company Limited
June 22, 2023
2279 n-Octyl phosphonic acid (NOPA)-modified titanium dioxide (produced by chemically reacting NOPA (CAS Reg. No.4724-48-5) with titanium dioxide to achieve a treatment level of 0.85% by weight of NOPA on the pigment) Cinkarna Celje June 17, 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?