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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1953

Tronox LLC

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: Trimethylolpropane (CAS Reg. No. 77-99-6).
Notifier: Tronox LLC
Manufacturer/Supplier: Tronox LLC
Intended Use: As a milling aid and dispersant for pigments used as components of food-contact articles, 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 0.45 percent by weight of pigment. The pigmented article may contact all food types under Conditions of Use A through H, as described in Table 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: May 5, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 594 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 144 kB)
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