Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2335
Galata Chemicals
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: | Triisotridecyl phosphite (CAS Reg. No. 77745-66-5). |
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| Notifier: | Galata Chemicals |
| Manufacturer/Supplier: | Galata Chemicals |
| Intended Use: | As an antioxidant in vinyl chloride polymers and linear low-density polyethylene, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: |
1. For use at levels not to exceed 1 percent by weight of finished vinyl chloride polymers in contact with all food types under Conditions of Use B through H, as described in Table 2. 2. For use at levels not to exceed 0.25 percent by weight in linear low-density polyethylene complying with 21 CFR 177.1520(c), items 3.1 and 3.2, where the density of the polymer is not greater than 0.94 grams per cubic centimeter. Linear low density polyethylene articles containing the FCS may be used in contact with dry (with no free surface fat or oil), aqueous, acidic, and alcoholic food (up to 15 percent alcohol), under Conditions of Use B through H, as described in Table 2. The FCS may contain no more than 1 percent by weight triisopropanolamine (CAS Reg. No. 122-20-3). 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: | Mar 5, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 130 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 178 kB) |
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