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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. 514

Asahi Denka Co., 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: Lithium 12-hydroxystearate
Notifier: Asahi Denka Co., Ltd.
Manufacturer/Supplier: Asahi Denka Co., Ltd.
Intended Use: As a stabilizing agent in polypropylene homo and copolymer.
Limitations/Specifications: At levels not to exceed 0.2 percent by weight of polypropylene homo and copolymer. The finished polymers are intended to contact all types of food under Conditions of Use A through H.
Effective Date: Aug 23, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo