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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. 904

KHS Plasmax GmbH

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: KHS Plasmax GmbH
Manufacturer: KHS Plasmax GmbH
Intended Use: To be used as a barrier coating on the food-contact surface of polyethylene terephthalate (PET) articles.
Limitations/Specifications*: The maximum thickness of the triple layered coating shall not exceed 200 nm. The FCS may be used in contact with all food types under Conditions of Use C through G.
Effective Date: Sep 16, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo