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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. 1671

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: Polypropylene (CAS Reg. No. 9003-07-0).
Notifier: Idemitsu Kosan Co., Ltd.
Manufacturer/Supplier: Idemitsu Kosan Co., Ltd.
Intended Use: As an additive to single-use polyolefin films in contact with foods, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The melting point of the FCS is between 70 and 80°C, and the softening point is between 85 and 105°C as determined by the ring and ball method. The FCS may be used at a level not to exceed 50 weight percent in polyolefin films complying with 21 CFR 177.1520. The finished film will have a thickness of no more than 500 µm (0.02 inches) and may be used in contact with food types I, II, IV-B, VI-A, VI-B, VII-B, and VIII, except for infant formula and breast milk, under Conditions of Use A through H. 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: Oct 26, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 660 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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