Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 2391
BASF
According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.
| Food Contact Substance: | 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). |
|---|---|
| Notifier: | BASF |
| Manufacturer/Supplier: | BASF |
| Intended Use: | As a rheology modifier in the production of single and repeat use polyolefins, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be used at a level not to exceed 0.1 percent by weight of the polyolefin polymers. Food contact articles manufactured with polyolefin polymers modified with the FCS may be used in contact with all types of food under conditions of use A through H as described in Tables 1 and 2, unless restricted by applicable regulations for the polyolefin polymers. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Jan 28, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 140 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 239 kB) |
-
