Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications
  • Print
  • Share
  • E-mail
-

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.
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)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
-
-