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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. 1073

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: Silicone Dioxide (CAS Reg. No. 7631-86-9).
Notifier: KHS Plasmax GmbH
Manufacturer/Supplier: KHS Plasmax GmbH
Intended Use: To be used as an amorphous plasma-deposited silicon barrier coating on the food-contact surface of PLA and HDPE food packaging articles.
Limitations/Specifications: The maximum thickness of the double layered coating shall not exceed 100 nm. The coating may contact all food types under Conditions of Use C through G as described in Tables 1 and 2.
Effective Date: Jun 3, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo