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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. 1912

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 in single-use polyolefin food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The melting point of the FCS is between 65 80°C, and the softening point is between 85 120°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 food contact articles complying with 21 CFR 177.1520. The finished article containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and/or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Sep 21, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 836 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 153 kB)