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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. 1970

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: 2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52-51-7).
Notifier: The Dow Chemical Company
Manufacturer/Supplier: LANXESS Corporation
Intended Use: As a preservative in wet-end paper additives, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a maximum level of 500 ppm in wet-end paper additives. The total use level of the FCS in finished paper may not exceed 54 g of the FCS per metric ton of dry weight fiber. 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: Aug 1, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 672 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 170 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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