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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. 1647

Sumitomo Chemical 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: Copolymer of 4-hydroxybenzoic acid, 4,4'-dihydroxybiphenyl, terephthalic acid, and isophthalic acid (CAS Reg. No. 60088-52-0), manufactured as described in the notification.
Notifier: Sumitomo Chemical Co., Ltd.
Manufacturer/Supplier: Sumitomo Chemical Co., Ltd.
Intended Use: As a component of articles used in contact with all types of food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use as a component of articles in contact with all foods under Conditions of Use A through H and J, as described in Table 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: Aug 6, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 1 MB)
FDA Decision: Finding of No Significant Impact (FONSI)

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