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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. 1818

PTT MCC Biochem 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: Poly[(butylenesuccinate)-co-adipate] cross-linked with malic acid. REPLACES FCN 1643
Notifier: PTT MCC Biochem Company Ltd.
Manufacturer/Supplier: PTT MCC Biochem Company Ltd.
Intended Use: The FCS is intended for use in coatings, films, molded articles, and thermoformed articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all food types, except alcoholic foods, under Conditions of Use C (Hot filled or pasteurized above 150°F) through G (Frozen storage (no thermal treatment in the container) as defined 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: Dec 23, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 74 kB)
FDA Decision: Finding of No Significant Impact (FONSI)