Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2484
WACKER Chemie AG
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: | Dodecanoic acid, ethenyl ester, polymer with chloroethene and ethenyl acetate (CAS Reg. No. 25155-88-8), and, optionally, less than 1% by weight of glycidyl methacrylate (CAS Reg. No. 106-91-2). |
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| Notifier: | Wacker Chemical Corporation |
| Manufacturer/Supplier: | WACKER Chemie AG |
| Intended Use: | The FCS is intended for use as a coating for single-use food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be applied at a maximum dry weight application rate of 15 g/m2. Finished articles containing the FCS may contact 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: | Mar 13, 2026 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) |
| FDA Decision: | Categorical Exclusion Memo |
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