Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 1717
Japan Polyethylene Corporation
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: | Ethene, polymer with 1-hexene and 1-propene (CAS Reg. No. 25895-46-9). |
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| Notifier: | Japan Polyethylene Corporation |
| Manufacturer/Supplier: | Japan Polyethylene Corporation |
| Intended Use: | As a component of polyolefin film, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will consist of a minimum of 75 weight% ethene, up to 15 weight% propene, and 15 weight% hexene, with the combined weight% of propene and hexene not exceeding 25 weight%. The finished polyolefin film will consist of no more than 80 weight% of the FCS. The maximum thickness of the polyolefin film containing the FCS is 100 μm. The FCS may be used in contact with all foods 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 human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Apr 13, 2017 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 2.3 MB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) and EA Revision Sheet |
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