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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. 1253

Nippon Steel & Sumitomo Metal Corporation

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: Zirconium Oxide (CAS. Reg. No. 1314-23-4) and Tin(II) Phosphate (CAS. Reg. No. 15578-32-2) and Tin(II) Fluoride (CAS Reg. No. 7783-47-3).
Notifier: Nippon Steel & Sumitomo Metal Corporation
Manufacturer: Nippon Steel & Sumitomo Metal Corporation
Intended Use: As a conversion coating on the interior of tinplated steel containers (cans) with or without a polymeric topcoat.
Limitations/Specifications*: The coating may be applied to the food-contact surface of tinplated steel containers at a maximum coating weight of 9 mg/m2. The finished coating may contact (1) all food types, except infant formula, under Conditions of Use A through H, as described in Tables 1 and 2, respectively, and (2) powdered infant formula (i.e., excluding ready-to-consume infant formula and infant formula concentrate) under room temperature conditions and below.
Effective Date: Jun 8, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 23.32(i)
FDA Decision: Categorical Exclusion Memo
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