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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. 574

Kureha Corporation

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: Polyglycolic acid (CAS Reg. No. 26124-68-5).
Notifier: Kureha Corporation
Manufacturer: Kureha Corporation
Intended Use: As the non food-contact layer of multi-layer, polyethylene terephthalate (PET) beverage bottles.
Limitations/Specifications*: The FCS shall be no more than 28 um thick and separated from food by a layer of PET having a thickness of at least 90 um, which will contact non-fatty food types (i.e., I, II, IV-B, VI-A, VI-B, VI-C (up to 15 percent alcohol content) VIIB, and VIII under Conditions of Use C through G, as described in Table 2.
Effective Date: Apr 14, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (516 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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