FDA Adds Six New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added six new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substance and the manufacturer is 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 |
| 2402 | Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of terephthalic acid and isophthalic acid with ethylene glycol. | Unitika LTD | Jan. 7, 2025 |
| 2400 | 2,2,4,4-tetramethylcyclobutane-1,3-diol. | Eastman Chemical Co. | Dec. 27, 2024 |
| 2397 | Fatty acids, C18-unsat., dimers, polymers with dodecanedioic acid, isophthalic acid, 4,4’-methylenebis[2-methylcyclohexanamine], and terephthalic acid (CAS Reg. No. 2014364-77-1). | EMS-CHEMIE AG | Dec. 18, 2024 |
| 2384 | Polylactide (Polylactic acid; PLA) optionally containing up to 16 weight percent D-lactic acid polymer units (CAS Reg. No. 9051-89-2). | Ingenia Polymers Corp. | Dec. 13, 2024 |
| 2396 | Crosslinked 2-propenoic acid, homopolymer, sodium salt (CAS Reg. No. 9003-04-7). | Formosa Plastics Corp. | Dec. 13, 2024 |
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?