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US FDA Adds 9 Substances to Inventory of Effective FCS Notifications

A food contact substance notification (FCN) is only effective for the manufacturer or supplier identified in the notification.

The U.S. Food and Drug Administration (FDA) recently added 9 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 SubstanceManufacturer/SupplierEffective Date
2395Chlorine dioxide (CAS Reg. No. 10049-04-4).Energis SolutionsFeb 25, 2025
2414Dimethyl dicarbonate (CAS Reg. No. 4525-33-1).LANXESS CorporationFeb 19, 2025
2413Microfibrillated cellulose pulp (CAS Reg. No.: 65996-61-4). REPLACES FCN 2022Fiberlean Technologies LimitedFeb 12, 2025
2412Microfibrillated cellulose pulp (CAS Reg. No.: 65996-61-4).Borregaard ASFeb 12, 2025
2411Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4).Evergreen Packaging LLCFeb 8, 2025
2410Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4).Sappi Biochemtech BV
Sappi Papier Holding GmbH
Feb 8, 2025
2409Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4).Stora Enso OyjFeb 8, 2025
2408Tricyclodecanedimethanol (CAS Reg. No. 26160-83-8 and 26896-48-0).Metlac S.p.A. and its stewarded affiliates around the worldFeb 4, 2025
2407Fluorphlogopite-based pearlescent pigments.NIHON KOKEN KOGYO Co., LTD.Feb 4, 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.

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