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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. 1860

Kirin Company, 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: Amorphous SiOC coating applied by catalytic chemical vapor deposition, utilizing vinylsilane (CAS Reg. No. 7291-09-0) as the starting material.
Notifier: Kirin Company, Ltd.
Manufacturer/Supplier: Kirin Company, Ltd.
Intended Use: As a barrier for polyethylene terephthalate (PET), polyethylene (PE), and polypropylene (PP) bottles intended for single-use in contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at a maximum thickness of 0.1 micrometers. The finished bottles may contact all food types under Conditions of Use A through H as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 31, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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