Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2283
CINIC Chemicals America, LLC
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: | 2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[3-chloro-5-(octadecylthio)phenyl) and 4-chloro-phenyl] derivatives (CAS Reg. No. 2142611-43-4). |
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| Notifier: | CINIC Chemicals America, LLC |
| Manufacturer/Supplier: | CINIC Chemicals America, LLC |
| Intended Use: | For use as a colorant in food-contact high density polyethylene (HDPE), except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS may be used at levels not to exceed 0.01 percent by weight of the finished polymers. The finished polymers may contact all food types under conditions of use B though H as described in Tables 1 and 2. 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 23, 2023 |
| National Environmental Policy Act (NEPA)** Submission: | Categorical Exclusion 25.32(i) and (j) |
| FDA Decision: | Categorical Exclusion Memo |
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