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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. 2121

Anhui Gold Star Titanium Dioxide (Group) Co., Ltd.

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: Octyltriethoxysilane-modified titanium dioxide.
Notifier: Anhui Gold Star Titanium Dioxide (Group) Co., Ltd.
Manufacturer/Supplier: Anhui Gold Star Titanium Dioxide (Group) Co., Ltd.
Intended Use: As a pigment in food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The silane-modified component will not exceed 1.6 percent by weight of the pigment. The FCS will be used at levels not to exceed 25 percent by weight of the food-contact article 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: Jun 26, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 247 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 143 kB)

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