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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. 650

Toyo Seikan Kaisha, 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: Hydrogenated styrene butadiene (15 percent styrene to 85 percent butadiene, 67 percent styrene to 33 percent butadiene, or both grades in combination) (CAS Reg. No. 66070-58-4) used in conjunction with cobalt stearate (CAS Reg. No. 13586-84-0).
Notifier: Toyo Seikan Kaisha, Ltd.
Manufacturer: Toyo Seikan Kaisha, Ltd.
Intended Use: The FCS is intended for use as a component of a linear low-density polyethylene (LLDPE) oxygen scavenging barrier layer, which is used as a non-food contact layer in multilayer LDPE bottles.
Limitations/Specifications*: The non-food contact oxygen scavenging LLDPE layer will contain hydrogenated styrene butadiene at a level not to exceed 5 weight percent and cobalt stearate at a level not to exceed 250 ppm and will be used in multilayer LDPE bottles for contact with all food types under the Conditions of Use C through G, as described in Tables 1 and 2.
Effective Date: Oct 5, 2006
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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