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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. 2241

Clariant 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: Rice bran wax, oxidized (CAS Reg. No. 1883583-80-9) and its calcium salt (CAS Reg. No. 1850357-57-1) or sodium salt (CAS Reg. No. 2759532-87-9).
Notifier: Clariant Corporation
Manufacturer/Supplier: Clariant Corporation
Intended Use: As a processing aid, lubricant, release agent, and/or slip additive in food-contact polyesters, including infant formula and human milk.
Limitations/Specifications: For use at levels not to exceed 0.5% in food-contact polyesters that contact all food types, including infant formula and human milk, under Conditions of Use C through H, as described in Tables 1 and 2, respectively, at 21 CFR 176.170.
Effective Date: Nov 23, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 880 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 183 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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