Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2279
Cinkarna Celje
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: | n-Octyl phosphonic acid (NOPA)-modified titanium dioxide (produced by chemically reacting NOPA (CAS Reg. No.4724-48-5) with titanium dioxide to achieve a treatment level of 0.85% by weight of NOPA on the pigment) |
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| Notifier: | Cinkarna Celje |
| Manufacturer/Supplier: | Cinkarna Celje |
| Intended Use: | For use as a colorant in food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS is for use at a maximum level of 20 percent by weight of finished polymers in contact with all food types under Conditions of Use A, B, and H; and a maximum use level of 30 percent by weight of finished polymers that are used in contact with all food types under Conditions of Use C-G. Use of the colorant is subject to the provisions and definitions set forth in 21 CFR 178.3297. 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: | Jun 17, 2023 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 817 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 241 kB) |
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