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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. 38

Huntsman Tioxide

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: n-Octyl phosphonic acid (NOPA)-modified titanium dioxide (produced by chemically reacting NOPA (CAS Reg. No. 4724-48-5) with titanium dioxide to achieve a treatment level of 0.85 percent by weight of NOPA on the pigment).
Notifier: Huntsman Tioxide
Manufacturer: Huntsman Tioxide
Intended Use: As a colorant in all types of food-contact polymers.
Limitations/Specifications*: Maximum use level of 30 percent by weight of the polymer. The finished polymers are intended to contact all types of food under Condition of Use C, as described in Table 2, or less severe conditions. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.
Effective Date: Jun 3, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (468 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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