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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. 321

Septon Company of America Kuraray America, Inc. Kuraray Co., Ltd. Kuraray Europe, GmbH

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 polymer with 2-methyl-1,3-butadiene, hydrogenated (CAS Reg. No. 68648-89-5).
Notifier: Septon Company of America Kuraray America, Inc. Kuraray Co., Ltd. Kuraray Europe, GmbH
Manufacturer/Supplier: Septon Company of America Kuraray America, Inc. Kuraray Co., Ltd. Kuraray Europe, GmbH
Intended Use: As an article or component of articles intended to contact food.
Limitations/Specifications: The FCS may contact food types I, II, IVB, VIA, VIB and VIII under Conditions of Use A through H as described in Tables 1 and 2, and all other food types under Conditions of Use D through G, as described in Tables 1 and 2. The FCS may include adjuvant substances permitted for use in styrene block polymers in accordance with applicable food additive regulations and effective notifications.
Effective Date: Jul 1, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 409 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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