Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 2280
Tronox Holdings plc
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: | Bis(2,4,4-trimethylpentyl)phosphinic acid-modified titanium dioxide (produced by chemically reacting bis(2,4,4-trimethylpentyl)phosphinic acid (bis) with titanium dioxide to achieve a treatment level of up to 0.6% bis by weight of the pigment). |
|---|---|
| Notifier: | Tronox Holdings plc |
| Manufacturer/Supplier: | Tronox Holdings plc |
| Intended Use: | As a colorant in all types of food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be used as colorant for polymers at levels up to 20% by weight of polymers. Finished polymers containing the FCS are intended to contact all food types, under Conditions of Use A through H as described in Tables 1 and 2. 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: | Jun 28, 2023 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 861 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 202 kB) |
-
