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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. 431

EMD Chemicals 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: Tin(IV) Oxide (CAS Reg. No. 18282-10-5).
Notifier: EMD Chemicals Inc.
Manufacturer: EMD Chemicals Inc.
Intended Use: For use in combination with silicon dioxide and titanium dioxide as a colorant for food-contact polymers, paper and paperboard, coatings, and in printing inks applied to non-food-contact surfaces of food-contact articles.
Limitations/Specifications*: The FCS will be used at a level not to exceed 6 percent of the total colorant weight. The finished food-contact articles may contact all food types with no temperature limitation.
Effective Date: Sep 8, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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