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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. 549

Toyo Seikan Kaisha, Ltd.

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: Silicon Dioxide (CAS Reg. No. 7631-86-9), with a topcoat of a polymer of hexamethyldisiloxane (CAS Reg. No. 26298-61-3).
Notifier: Toyo Seikan Kaisha, Ltd.
Manufacturer: Toyo Seikan Kaisha, Ltd.
Intended Use: To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PET food packaging articles.
Limitations/Specifications*: The maximum thickness of the three layered coating shall not exceed 60 nm. The coating may contact all types of food under Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Dec 21, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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