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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 483

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 (DMDC)
Notifier: Lanxess Corporation
Manufacturer/Supplier: Lanxess Corporation
Intended Use: As a microbial control agent in carbonated beverages containing up to and including 100 percent juice and flavored water beverages (carbonated and non-carbonated) that contain low levels of juice or artificial or natural flavors.
Limitations/Specifications: For use only at levels not to exceed 250 ppm of DMDC. The DMDC complies 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: Apr 5, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(k)
FDA Decision: Categorical Exclusion Memo