Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2449
Mitsubishi Chemical 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: | Boric Acid (CAS Reg. No. 10043-35-3). |
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| Notifier: | Mitsubishi Chemical Corporation |
| Manufacturer/Supplier: | Mitsubishi Chemical Corporation |
| Intended Use: | As a stabilizer and melt flow regulator in ethylene-vinyl acetate-vinyl alcohol (EVOH) and modified EVOH copolymers, except for use in infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at levels not to exceed 0.24 weight percent of the finished polymer with a maximum thickness of 180 microns in contact with all food types, except those containing more than 8% alcohol, under Conditions of Use B 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: | Sep 20, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
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