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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. 515

Asahi Denka, Company, 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: 12H-Dibenzo[d,g][1,3,2]dioxaphosphocin, 2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-,6-oxide, lithium salt (CAS Reg. No. 85209-93-4).
Notifier: Asahi Denka, Company, Ltd.
Manufacturer: Asahi Denka, Company, Ltd.
Intended Use: For use as a clarifying and nucleating agent in polypropylene polymers and copolymers complying with 21 CFR 177.1520(c) items 1.1, 3.1, and 3.2.
Limitations/Specifications*: At levels not to exceed 0.3% by weight of the finished polymer under Conditions of Use A through H as defined in Table 2. The finished polymer may be used with all food types.
Effective Date: Aug 23, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo