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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. 1252

Rockwood Pigments NA, Inc.

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: Rutile Tin Zinc - doped with either potassium, sodium, or calcium (CAS Reg. No.: 207691-99-4, 389623-07-8, 389623-01-2, respectively).
Notifier: Rockwood Pigments NA, Inc.
Manufacturer/Supplier: Rockwood Pigments NA, Inc.
Intended Use: As a colorant in polymers and in printing ink.
Limitations/Specifications: At levels not to exceed 5 percent by weight in food-contact polymers and not to exceed 30 percent by weight in printing inks, for all food types under all temperature conditions as described in Tables 1 and 2.
Effective Date: Apr 3, 2013
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 384 kB)
FDA Decision: Finding of No Significant Impact (FONSI)