Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2402
Unitika LTD
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: | Polyethylene terephthalate copolyesters (diethylene glycol-isophthalate modified) prepared by the condensation of terephthalic acid and isophthalic acid with ethylene glycol. |
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| Notifier: | Unitika LTD |
| Manufacturer/Supplier: | Unitika LTD |
| Intended Use: | For use as films intended for contact with aqueous, acidic, fatty, alcoholic foods (containing up to 50 percent alcohol by volume), and dry foods under Conditions of Use A through H as described in Table 2, and for use in contact with alcoholic foods containing more than 50 percent alcohol by volume under Conditions of Use E through G, as described in Table 2, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The finished polymer shall contain a total of not more than 13 mole-percent of diethylene glycol and isophthalate units, with the diethylene glycol content expressed as a mole-percent of the total glycol units and the isophthalate content expressed as a mole-percent of the total isophthalate/terephthalate units. The finished food-contact film shall have a maximum thickness of 50 µm and must meet any applicable specifications and is subject to all applicable conditions of use cited in 21 CFR 177.1630(f), (g), and/or (j). Adjuvant substances permitted for use in polymers complying with 21 CFR 177.1630 may be used in the copolyesters that are the subject of this notification, subject to any applicable limitations. 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: | Jan 7, 2025 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 285 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 280 kB) |
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