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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 2089

SK Chemicals Co., 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: Terephthalic acid polymer with 1,4:3,6-dianhydro-D-glucitol, 1,4-cyclohexanedimethanol and 1,2-ethanediol (CAS Reg. No. 1038843-64-9) and optionally prepared with trimellitic anhydride (CAS Reg. No. 552-30-7) as a branching agent. REPLACES FCNs 1075, 1444 and 1556
Notifier: SK Chemicals Co., Ltd.
Manufacturer/Supplier: SK Chemicals Co., Ltd.
Intended Use: As a component of articles in contact with food, including infant formula and human milk.
Limitations/Specifications: The FCS may be used in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS may be used in repeat-use articles in contact with infant formula and human milk.
Effective Date: Nov 28, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 184 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 269 kB)

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