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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. 63

Kuraray America, Inc., Kuraray Co., Ltd., Kuraray Europe, GmbH, and SEPTON Company of America

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: Styrene block polymers with 2-methyl-1,3-butadiene and 1,3-butadiene, hydrogenated (CAS Reg. No.132778-07-5) in food contact applications.
Notifier: Kuraray America, Inc., Kuraray Co., Ltd., Kuraray Europe, GmbH, and SEPTON Company of America
Manufacturer/Supplier: Kuraray America, Inc., Kuraray Co., Ltd., Kuraray Europe, GmbH, and SEPTON Company of America
Intended Use: For use as a basic resin in food-contact articles.
Limitations/Specifications: For use in contact with food of Types I, II, IVB, VIA, VIB, VIIB, and VIII identified in Table 1 under conditions of use B, C, D, E, F, G, and H as described in Table 2, and food of Types III, IVA, V, VIC, VIIA, and IX under conditions of use D, E, F, and G. The finished resin must comply with the following specifications: Molecular weight (minimum): 68,000 (as the minimum number average molecular weight); Solubility: Completely soluble in toluene. Glass transition points: -57°C (-70°F) to -51°C(-59.8°F) and 91°C(195.8°F) to 102°C(215°F). Maximum extractable fraction in distilled water at specified temperatures, times, and thicknesses: 0.001 mg/cm2(0.01 mg/in2) of surface at reflux temperature for 2 hr on a 0.1 cm (0.04 in) thick sample. Maximum extractable fraction in 50% ethanol at specified temperatures, times, and thicknesses 0.001 mg/cm2(0.01 mg/in2) of surface at 66°C (150° F) for 2 hr on a 0.1 cm (0.04 in) thick sample.
Effective Date: Jul 22, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 349 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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