Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2362
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: | A mixture of alcohols, C12-C16, with a degree of ethoxylation between 2.5 - < 40 moles ethylene oxide. |
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| Notifier: | Tronox Holdings plc |
| Manufacturer/Supplier: | Tronox Holdings plc |
| Intended Use: | As an emulsifier for a surface-treated titanium dioxide pigment used as a colorant in polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be used at levels not to exceed 532 parts per million (ppm) with surface-treated titanium dioxide pigment, which will not exceed 15% by weight of the polymer in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The finished food contact articles will not be used in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Jun 7, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 330 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 174 kB) |
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