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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. 1817

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(1,4-butylene glycol-co-succinic acid), cross-linked with malic acid. REPLACES FCN 1574
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*: For contact with all food types, except alcoholic foods, under Conditions of Use B (Boiling water sterilized) through H (Frozen or refrigerated storage: Ready-prepared foods intended to be reheated in container at time of use) 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: Dec 23, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (73 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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