Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2387
Songwon International-Americas, 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: | Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3). |
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| Notifier: | Songwon International-Americas, Inc. |
| Manufacturer/Supplier: | Songwon International-Americas, Inc. |
| Intended Use: | As an antioxidant/stabilizer in ethylene-methyl acrylate copolymer resins complying with 21 CFR 177.1340 for use as a component of food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at levels not to exceed 0.1 percent by weight of the finished article in contact with all food types under Conditions of Use A through H as described in Table 2. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN. |
| Effective Date: | Oct 22, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 194 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 249 kB) |
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