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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. 202

Asahi Denka Kogyo K.K.

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: Aluminum, hydroxybis(2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hydroxy-12H-dibenzol(d,g)(1,3,2)dioxaphosphocin 6-oxidato)-, (CAS Reg. No. 151841-65-5). The FCS will be manufactured and characterized as described in the notification.
Notifier: Asahi Denka Kogyo K.K.
Manufacturer/Supplier: Asahi Denka Kogyo K.K.
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: Maximum use level of 0.18 percent by weight of the finished polypropylene polymers and copolymers (as described above) in contact with alcoholic and fatty food (Food Types III, IVA, V, VIA, VIC, VIIA and IX) under Conditions of Use B through H, as described in Tables 1 and 2, respectively.
Effective Date: May 4, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo