FDA Adds Ten New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added the 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 |
|---|---|---|---|
| 2391 | 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). | BASF | Jan. 28, 2025 |
| 2935 | Chlorine dioxide (CAS Reg. No. 10049-04-4). | Energis Solutions | Feb. 25, 2025 |
| 2407 | Fluorphlogopite-based pearlescent pigments. | NIHON KOKEN KOGYO Co., LTD. | Feb. 4, 2025 |
| 2408 | Tricyclodecanedimethanol (CAS Reg. No. 26160 83-8 and 26896-48-0). | Metlac S.p.A. and its stewarded affiliates around the world | Feb. 4, 2025 |
| 2409 | Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4). | Stora Enso Oyj | Feb. 8, 2025 |
| 2410 | Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4). | Sappi Biochemtech BV Sappi Papier Holding GmbH | Feb. 8, 2025 |
| 2411 | Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4). | Evergreen Packaging LLC | Feb. 8, 2025 |
| 2412 | Microfibrillated cellulose pulp (CAS Reg. No.: 65996-61-4). | Borregaard AS | Feb. 12, 2025 |
| 2413 | Microfibrillated cellulose pulp (CAS Reg. No.: 65996-61-4). FCN 2413 replaces FCN 2022. | Fiberlean Technologies Limited | Feb. 12, 2025 |
| 2414 | Dimethyl dicarbonate (CAS Reg. No. 4525-33-1). | LANXESS Corporation | Feb. 19, 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?