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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. 527

Tioxide Group, Unlimited

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: 1,3-Propanediol, 2-ethyl-2-(hydroxymethyl) (CAS Reg. No. 77-99-6).
Notifier: Tioxide Group, Unlimited
Manufacturer: Tioxide Group, Unlimited
Intended Use: As a dispersant for pigments. 1) At levels up to 0.6 percent by weight of the pigment when the pigment is used as a colorant for all types of polymers complying with 21 CFR 178.3297. 2) At levels up to 1.0 percent by weight of the pigment when the pigment is used in inks that may come into contact with food.
Limitations/Specifications*: The finished polymers and inks may contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Oct 20, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32 (i) and (j)
FDA Decision: Categorical Exclusion Memo