FDA Adds 11 New Substances to its Inventory of Effective FCS Notifications
The U.S. Food and Drug Administration (FDA) recently added 11 new substances to its Inventory of Effective Food Contact Substances (FCS) Notifications. The newly listed substances and the manufacturers are listed below.
| FCN No. (sorted Z-A) | Food Contact Substance | Manufacturer/Supplier | Effective Date |
|---|---|---|---|
| 1797 | Copolymers of acrylamide, diallyldimethylammonium chloride, 2-methylenebutanedioic acid and propenoic acid. REPLACES FCN 1592 | Harima Chemicals, Inc. Plasmine Technology, Inc. | Aug 30, 2017 |
| 1794 | N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide (CAS Reg. No. 57843-53-5). REPLACES FCNs 1353 and 1502 | The Dow Chemical Company | Aug 23, 2017 |
| 1756 | Ethanol, 2-amino- (CAS Reg. No. 141-43-5). | Omya International AG and its Affiliates | Aug 5, 2017 |
| 1790 | Phosphoric acid, iron (2+) salt, (2:3:x) (CAS Reg. No. 14940-41-1 (anhydrous); (CAS Reg. No. 10028-23-6) (octahydrate). | Chemische Fabrik Budenheim KG, Germany Budenheim Ibérica S.L.U., Spain Budenheim USA Inc. | Aug 3, 2017 |
| 1767 | The FCS is a reaction product of three polymers:
| TOYOBO Co., Ltd. | Aug 3, 2017 |
| 1764 | Chlorine dioxide (CAS Reg. No. 10049-04-4). | Selective Micro Technologies, LLC | Aug 2, 2017 |
| 1754 | Butanoic acid, 3-hydroxy-, (R)-, homopolymer (CAS Reg. No. 29435-48-1). | Newlight Technologies, Inc. | Jul 22, 2017 |
| 1787 | Hexanedioic acid, polymer with hexahydro-2H-azepin-2-one and 1,6-hexanediamine (CAS Reg. No. 24993-04-2). | BASF SE | Jul 18, 2017 |
| 1739 | Benzene, diethenyl-, polymer with ethenylbenzene and ethenylethylbenzene, chloromethylated (CAS Reg. No. 69011-14-9). | Dow Chemical Company | Jul 11, 2017 |
| 1733 | 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682-20-4). | LANXESS Corporation | Jul 7, 2017 |
| 1751 | Carbonic dichloride, polymer with 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-1-H-isoindol-1-one and 4,4’-(1-methylethylidene)bis[phenol], bis[4-(1-methyl-1-phenylethyl)phenyl] ester (CAS Reg. No. 503834-43-3). | SABIC Innovative Plastics | Jul 7, 2017 |
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?