Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2502
Cargill, 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: | Fatty acids, C18-unsaturated, dimers, hydrogenated, polymers with hexamethylenediamine (CAS Reg. No. 800392-64-7) |
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| Notifier: | Cargill, Incorporated |
| Manufacturer/Supplier: | Cargill, Incorporated |
| Intended Use: | As a processing aid in the production of polyethylene films, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used in food packaging at levels not to exceed 2000 ppm by weight in finished polyethylene films with a thickness not to exceed 6 mil, or at levels not to exceed 1000 ppm by weight in finished polyethylene films with a thickness not to exceed 12 mil, 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: | Jul 4, 2026 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
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