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The U.S. Food and Drug Administration (FDA) recently added 5 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.
| FCM 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 |
| 2428 | 5,5-Dimethylhydantoin (DMH) (CAS Reg. No. 77-71-4) | Solenis LLC | May 13, 2025 |
Understanding FCS Notifications
Pursuant to the Food and Drug Administration Modernization Act (FDAMA) amended the Federal Food, Drug, and Cosmetic Act, a food contact substance notification (FCN) allows manufacturers or suppliers to market a substance for food contact use only if it has been demonstrated to be safe for its intended application. Companies that wish to use FCS must submit FCN to the FDA prior to marketing the product.
The FDA has a mandated 120-day time period to review that submission. If the agency does not express any objections about the safety of the substance in that time period, then the company can legally market the product. Once the notification becomes effective, the FDA will add it to its Inventory of Effective FCS Notifications.
An effective FCN applies only to the food contact substance that is the subject of the FCN and is applicable to the manufacturer/supplier listed within the notification.
