Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2327
Mitsui Chemicals, Incorporated
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: | 2,5-Furandione, polymer with 1-propene (CAS Reg. No. 25722-45-6). REPLACES FCN 631 |
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| Notifier: | Mitsui Chemicals, Incorporated |
| Manufacturer/Supplier: | Mitsui Chemicals, Incorporated |
| Intended Use: | As a component in blends with polyolefins intended for use as an adhesive tie-layer in multilayered food-contact packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS is intended to contact all food types under Conditions of Use A through H. The FCS is used such that the level of the FCS (fraction by weight of polyolefin) multiplied by the thickness of the polyolefin layer containing the FCS in micrometers (µm) does not exceed the value of 6.35. 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: | Jan 10, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 174 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 134 kB) |
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