FDA Adds Ten New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added ten 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 |
|---|---|---|---|
| 2419 | 2-Methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4) | Dalian Bio-Chem Company Ltd. Bester Trading Co., Ltd. | May 24, 2025 |
| 2428 | 5,5-Dimethylhydantoin (DMH) (CAS Reg. No. 77-71-4) | Solenis LLC | May 13, 2025 |
| 2427 | Polyphenylene sulfide (CAS Reg. No. 26125-40-6 or 25212-74-2). REPLACES FCN 1180 | Toray Industries, Inc. Toray Advanced Materials Korea Inc. | April 25, 2025 |
| 2406 | [4-tert-butyl-2-(5-tert-butyl-2-oxo-3H-benzofuran-3-yl)phenyl] 3,5-ditertbutyl-4-hydroxy-benzoate (CAS Reg. No. 1261240-30-5). REPLACES FCNs 1254 and 1433 | Chitec Technology Co., Ltd. Double Bond Chemical Ind. Co., Ltd. FDC, Lees Co., Ltd. | April 8, 2025 |
| 2423 | Poly(oxy(1,1'-biphenyl)-4,4'-diyloxy-1,4-phenylenesulfonyl-1,4-phenylene) (CAS Reg. No. 25839-81-0 and 25608-64-4). | Sumitomo Chemical Co., Ltd. | April 8, 2025 |
| 2422 | 2-Propenoic acid, 2-cyano-3-(3,4-dimethoxyphenyl)-, 1,1'-[2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diylbis(2,2-dimethyl-2,1-ethanediyl)] ester, (2E,2'E)- (CAS Reg. No. 2233585-18-5). REPLACES FCN 2276 | Chitec Technology Co., Ltd. | April 1, 2025 |
| 2404 | Styrene block polymer with 1,3-butadiene, hydrogenated (CAS Reg. No. 66070-58-4). | LCY GRIT Corporation | March 22, 2025 |
| 2403 | Sodium sulfate salt of ethoxylated (7 moles of ethylene oxide) n‐ and isoundecyl alcohol (C11) (CAS Reg. No. 219756‐63‐5). | KLK Kolb Specialties B.V., KLK Tensachem S.A. | March 19, 2025 |
| 2420 | Carbon Black (Thermal Carbon Black or Thermal Black) (CAS Reg. No. 1333-86-4). | Cancarb Limited | March 15, 2025 |
| 2401 | Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate (Type 1, containing fluorine) (CAS Reg. No. 85085-18-3), lithium magnesium sodium silicate (Type 2, without fluorine) (CAS Reg. No. 53320-86-8). | BYK-Chemie GmbH | March 12, 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?