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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. 890

Idemitsu Kosan 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: Hydrocarbons, C6-20, polymer, hydrogenated (CASRN 69430-35-9)
Notifier: Idemitsu Kosan Co., Ltd
Manufacturer: Idemitsu Kosan Co., Ltd
Intended Use: Used in polypropylene (PP) film to improve the transparency and in ethylene vinyl acetate (EVA) film to improve the adhesive strength.
Limitations/Specifications*: The FCS will be used in single use PP at levels not to exceed 20 wt% in the finished film that may contact Food Types I, II, IVB, VIA, VIB, VIC, and VIIB under Conditions of Use B through G and Food Types III, IVA, V, VIIA, and IX under Conditions of Use D through G, as identified in Table 1 and 2. The FCS will also be used in single use EVA at levels not to exceed 25 wt% in the finished film that may contact Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC, VIIA, VIIB, and IX under Conditions of Use D through G. The thickness of film will not exceed 100 micron.
Effective Date: Jul 21, 2009
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (417 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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