Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2414
LANXESS 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: | Dimethyl dicarbonate (CAS Reg. No. 4525-33-1). |
|---|---|
| Notifier: | LANXESS Corporation |
| Manufacturer/Supplier: | LANXESS Corporation |
| Intended Use: | As a microbial control agent in ready-to-drink 1) hard seltzer and shandy with no more than 8% alcohol by volume (ABV) and 2) cocktails, i.e., distilled spirit-based mixed alcoholic beverages, with no more than 15% ABV. |
| Limitations/Specifications: | The FCS may be used at a maximum level of 250 ppm (0.025%) by weight of the beverage. The FCS will also comply with the requirements listed in 21 CFR 172.133(a) and (c). The beverages must be produced under good manufacturing conditions and their microbial load must first be reduced by current technologies such as heat treatment, filtration, etc. prior to the addition of the FCS. |
| Effective Date: | Feb 19, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
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