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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. 1966

Kuraray Company, 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 2-methyl-1,8-octanediamine and 1,9-nonanediamine, reaction products with benzoic acid (CAS Reg. No. 1310362-57-2).
Notifier: Kuraray Company, Ltd.
Manufacturer/Supplier: Kuraray Company, Ltd.
Intended Use: As a base polymer in the production of food contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The finished food-contact article may contact all food types and may be used under Conditions of Use A through H, as described in Tables 1 and 2. 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: May 28, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

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