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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. 1898

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-Cyclohexanedimethanol (CAS Reg. No. 105-08-8).
Notifier: SK Chemicals Co., Ltd.
Manufacturer/Supplier: SK Chemicals Co., Ltd.
Intended Use: For use as a polyhydric alcohol for use in the manufacture of polyester resins intended for use in coatings complying with 21 CFR 175.300(b)(3)(vii)(c), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2. Polyester resins manufactured from the FCS are subject to the applicable limitations/specifications in and crossed references to 21 CFR 175.300 as appropriate for their intended use. The FCS is not for use in contact with infant formula and human milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Jul 24, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo