FDA Adds Four New Substances to its Inventory of Effective FCS Notifications
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 |
|---|---|---|---|
| 2285 | 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs. (CAS Reg. No. 68784-12-3). | Omya International AG and its affiliates | July 27, 2023 |
| 2291 | An aqueous mixture of peroxyacetic acid (PAA) (CAS Reg No. 79-21-0), hydrogen peroxide (HP) (CAS Reg. No. 7722-84-1), acetic acid (AA) (CAS Reg. No. 64-19-7), 1-hydroxyethylidene-1,1-diphosphonic acid (HEDP) (CAS Reg. No.2809-21-4), and optionally sulfuric acid (SA) (CAS Reg. No. 7664-93-9). REPLACES FCNs 887, 1132, 1738, and 1806 | Enviro Tech Chemical Services, Inc. | July 25, 2023 |
| 2290 | 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine (CAS Reg. No. 32687-78-8) | Rianlon Corporation | July 22, 2023 |
| 2289 | Glycidyl methacrylate (CAS Reg. No. 106-91-2) | PPG Industries, Inc. | July 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 Packaginglaw.com article, What is the Best Approach to Obtaining FDA Clearance for Food Contact Substances?