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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. 958

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: (1) As an internal nonfood-contact layer separated from food by one or more polyethylene terephthalate (PET) layers in PET food contact articles, or by one or more polylactic acid (PLA) layers in PLA food contact articles. (2) In blends with PET.
Limitations/Specifications*: (1) The maximum thickness of the FCS layer, in relationship to the minimum thickness of the PET or PLA food-contact layer, shall follow the relationship: y=0.1802e0.1493x, where y is the PGA thickness in μm and x is the PET or PLA thickness in μm. The finished food-contact articles may be used in contact with Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC (up to 15 percent alcohol), VIIA, VIIB, VIII, and IX under Conditions of Use C through G as described in Tables 1 and 2, except that when PLA is the food-contact layer the finished food-contact articles will be used at temperatures no greater than 60oC. (2) The FCS may be used at levels up to 2.5 percent by weight of the blend with PET, provided that the difference in the measured haze is no greater than a value of 2.5, when determined on PET samples containing PGA and the same grade of PET without PGA, with both samples in the same physical form, using ASTM D 1003. The finished food-contact articles may be used in contact with Food Types I, II, III, IVA, IVB, V, VIA, VIB, VIC (up to 15 percent alcohol), VIIA, VIIB, VIII, and IX under Conditions of Use C through G as described in Tables 1 and 2.
Effective Date: Jun 2, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i), (j) and Environmental Assessment (in PDF) (2.17 MB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)
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