US FDA Adds 5 Substances to Inventory of Effective FCS Notifications

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

In pursuant to the Food and Drug Administration Modernization Act (FDAMA) amended the 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 who wish to use FCS must submit FCN to 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, 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.