Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2473
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) |
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| Notifier: | Clariant Corporation |
| Manufacturer/Supplier: | Clariant Corporation |
| Intended Use: | As a processing aid, lubricant, release agent, and/or slip additive in single- and repeat-use rigid polyvinyl chloride, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | For use at levels not to exceed 0.5% in rigid polyvinyl chloride that contacts all food types at temperatures up to 80°C. 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: | May 7, 2026 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 146 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 184 kB) |
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