U.S. FDA Adds New Substances to Inventory of Effective Food Contact Substance (FCS) Notifications

"The U.S. Food and Drug Administration (FDA) has added multiple substances to its Inventory of Effective Food Contact Substance (FCS) Notifications in early 2025. This inventory lists FCSs that have been demonstrated to be safe for their intended use through premarket notifications. Each entry in the database includes details such as the food contact substance, notifier, manufacturer, intended use, usage limitations, specifications, effective date, and the corresponding environmental decision. According to section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(h)(2)(C)), an FCS notification is effective only for the manufacturer or supplier identified in the notification. Any party marketing an FCS based on an effective notification must be able to demonstrate its applicability. Entities purchasing a food contact substance from an approved manufacturer or supplier may legally market or use it, provided they adhere to the intended use and any specified limitations. The following FCS notifications have been made effective in 2025: 1.Chlorine dioxide (CAS Reg. No. 10049-04-4) -Effective date: Feb 25, 2025 (Manufacturer- Energis Solutions) 2.Dimethyl dicarbonate (CAS Reg. No. 4525-33-1)- Effective date: Feb 19, 2025 (Manufacturer-LANXESS Corporation) 3.Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) – Effective date: Feb 12, 2025 (Manufacturer-Borregaard AS 4.Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) – Effective date: Feb 12, 2025 (Manufacturer-Fiberlean Technologies Limited) 5.Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) – Effective date: Feb 8, 2025 (Manufacturer-Stora Enso Oyj) 6.Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) – Effective date: Feb 8, 2025 (Manufacturer-Sappi Biochemtech BV Sappi Papier Holding GmbH) 7.Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4) – Effective date: Feb 8, 2025 (Manufacturer-Evergreen Packaging LLC) 8.Fluorphlogopite-based pearlescent pigments – Effective date: Feb 4, 2025 (Manufacturer-NIHON KOKEN KOGYO Co., LTD) 9.Tricyclodecanedimethanol (CAS Reg. Nos. 26160-83-8 and 26896-48-0) – Effective date: Feb 4, 2025 (Manufacturer--Metlac S.p.A. and its stewarded affiliates around the world) 10.Fatty acids, C16-18, [9-(acetyloxy)-3,8,10-triethyl-7,8,10-trimethyl-1,5-dioxa-9-azaspiro[5.5]undec-3-yl]methyl esters (CAS Reg. No. 1422729-07-4) – Effective date: Jan 28, 2025 (Manufacturer- BASF) 11.Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of terephthalic acid and isophthalic acid with ethylene glycol – Effective date: Jan 7, 2025 (Manufacturer-Unitika LTD)"