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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. 35

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
Notifier: LANXESS Corporation
Manufacturer: LANXESS Corporation
Intended Use: As a microbial control agent in non-carbonated juice beverages containing up to and including 100 percent juice.
Limitations/Specifications*: No more than 250 ppm of DMDC may be added to non-carbonated juice beverages containing up to and including 100 percent juice. 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 DMDC.
Effective Date: Jun 9, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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