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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. 419

Huntsman Tioxide/Tioxide Europe S.A.S./Tioxide Europe S.L.

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% by weight of NOPA on the pigment).
Notifier: Huntsman Tioxide/Tioxide Europe S.A.S./Tioxide Europe S.L.
Manufacturer: Huntsman Tioxide/Tioxide Europe S.A.S./Tioxide Europe S.L.
Intended Use: For use as a colorant in all types of food-contact polymers.
Limitations/Specifications*: The FCS is for use at a maximum level of up to 20 percent by weight of the polymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H described in Table 2. (In accordance with effective FCN 000038, the FCS may be used at levels up to 30 percent when used under Conditions of Use C and less severe conditions.) Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297.
Effective Date: Jul 31, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (365 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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