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

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The U.S. Food and Drug Administration (FDA) recently added five 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
2325 Subtilisin from Alkalihalobacillus clausii produced by a genetically modified strain of Bacillus licheniformis. Carbios S.A. and its affiliates February 29, 2024
2333 Quino[2,3-b]acridine-7,14-dione, 5,12-dihydro- (C.I. Pigment Violet 19; CAS Reg. No. 1047-16-1). Sun Chemical Corporation February 17, 2024
2322 An aqueous solution of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), sulfuric acid (CAS Reg. No. 7664-93-9), and 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP, CAS Reg. No. 2809-21-4). REPLACES FCN 2100 Agri-Neo Inc. February 15, 2024
2352 An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg. No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), sodium acetate (CAS Reg. No. 127-09-3), and glycerol (CAS Reg. No. 56-81-5). Clean Chemistry Inc. February 14, 2024
2332 Poly(2-ethyl-2-oxazoline) (CAS Reg. No. 25805-17-8). 3M Purification Inc.
3M Healthcare US Opco LLC
February 9, 2024

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?