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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. 1257

Dai-Ichi Kogyo Seiyaku 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: Octadecanamide, N,N'-1,2-ethanediylbis[12-hydroxy- (CAS Reg. No. 123-26-2).
Notifier: Dai-Ichi Kogyo Seiyaku Co., Ltd.
Manufacturer/Supplier: Dai-Ichi Kogyo Seiyaku Co., Ltd.
Intended Use: As a slip and nucleating agent in polylactic acid polymers that may contact food.
Limitations/Specifications: The FCS will be used at levels not to exceed 1 percent by weight in polylactic acid polymer materials that may contact all food types under Conditions of Use C through G as described in Table 2.
Effective Date: Apr 18, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo