FDA Adds Five New Substances to its Inventory of Effective FCS Notifications
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 substance and the manufacturer are listed below.
FCN No. | Food Contact Substance | Manufacturer/ Supplier | Effective Date |
|---|---|---|---|
| 2440 | 5-[[[cis-4-(1,1-Dimethylethyl)cyclohexyl]carbonyl]amino]-N1,N3-bis[cis-4-(1-methylethyl)cyclohexyl]-1,3-benzenedicarboxamide (CAS Reg. No. 2649373-38-4). | Milliken Chemical | July 31, 2025 |
| 2438 | 2,4-Bis[(dodecylthio)methyl]-6-methylphenol (CAS Reg. No. 110675-26-8). | Rianlon Corporation | July 26, 2025 |
| 2434 | 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4). | Henkel Corporation | June 25, 2025 |
| 2431 | Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-[[4-[bis(2-hydroxyethyl)amino]-6-[(4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-, tetrasodium salt (CAS Reg. No. 16470-24-9). | Bann Química Ltda | June 20, 2025 |
| 2424 | Poly((R)-3-hydroxybutyric acid-co-(R)-3-hydroxyvaleric acid) (CAS Reg. No. 92267-82-8). | Ningbo Tianan Biologic Material Co., Ltd. | June 18, 2025 |
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?