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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. 1840

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: 1,4-Benzenedicarboxylic acid, polymer with 1,4-cyclohexanedimethanol, 1,2-ethanediol,[4-(hydroxymethyl) cyclohexyl]methyl 4-(hydroxymethyl)cyclohexanecarboxylate, 2,2'-oxybis[ethanol] and 4,4'-[oxybis(methylene)]bis[cyclohexanemethanol] (CAS Reg. No. 1632972-01-0).
Notifier: SK Chemicals Co., Ltd.
Manufacturer/Supplier: SK Chemicals Co., Ltd.
Intended Use: As a polymeric component of food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The polymer will be used under Conditions of Use C through G in contact with all types of food. 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 9, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 387 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 94 kB)

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