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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. 1644

Nissei ASB Machine Co., 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: High-frequency plasma polymerized hexamethyldisiloxane.
Notifier: Nissei ASB Machine Co., Ltd
Manufacturer/Supplier: Nissei ASB Machine Co., Ltd
Intended Use: As a barrier coating on the food-contact surface of polyethylene terephthalate (PET) articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use at a thickness not to exceed 80 nm in contact with all food types under Conditions of Use A through H. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 18, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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