Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2432
Arkema, Inc.
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: | Hexanedioic acid, polymer with azacyclotridecan-2-one and α-hydro-ω-hydroxypoly(oxy-1,2-ethanediyl) (CAS Reg. No. 70290-02-7). |
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| Notifier: | Arkema, Inc. |
| Manufacturer/Supplier: | Arkema, Inc. |
| Intended Use: | As a processing aid in olefin polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be used at levels not to exceed 1050 ppm by weight in finished olefin polymers in contact with 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 human milk. Such uses were not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Aug 27, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 323 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 206 kB) |
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