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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. 860

New Japan Chemical 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: N,N',N''-Tris(2-methylcyclohexyl)-1,2,3-propanetricarboxamide (CAS Reg. No. 160535-46-6).
Notifier: New Japan Chemical Co., Ltd.
Manufacturer: New Japan Chemical Co., Ltd.
Intended Use: As a clarifier/nucleator for polypropylene homo- and copolymers.
Limitations/Specifications*: At levels not to exceed 0.25 percent by weight of the finished polymer for direct contact with all food types, under the Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Jan 30, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32 (i) and (j)
FDA Decision: Categorical Exclusion Memo