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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. 1159

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).
Notifier: KHS Plasmax GmbH
Manufacturer/Supplier: KHS Plasmax GmbH
Intended Use: As a barrier coating on the surfaces of polyethylene terephthalate (PET) articles that may contact food.
Limitations/Specifications: The maximum thickness of the triple layered coating shall not exceed 200 nm. The FCS will be used in contact with all food types under Conditions of Use A through H as described in Table 2.
Effective Date: May 23, 2012
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo