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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. 1059

Nippon Kasei Chemical Co., Ltd.
Sumitomo Chemical Co., Ltd.
Prime Polymer Co., Ltd.
Japan Polyethylene Corp.

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: The reaction products of mixed fatty acids (predominantly oleic acid) and ethylenediamine, of which the major component is N,N'-dioleoylethylenediamine (CAS Reg. No. 110-31-6).
Notifier: Nippon Kasei Chemical Co., Ltd.
Sumitomo Chemical Co., Ltd.
Prime Polymer Co., Ltd.
Japan Polyethylene Corp.
Manufacturer: Nippon Kasei Chemical Co., Ltd.
Sumitomo Chemical Co., Ltd.
Prime Polymer Co., Ltd.
Japan Polyethylene Corp.
Intended Use: For use as a slip and antiblocking agent in linear low-density polyethylene (LLDPE).
Limitations/Specifications*: The FCS will be used at levels not to exceed 0.14 percent by weight in LLDPE with a maximum thickness of 120 μm, which may contact all food types under Conditions of Use A through H, as described in Table 2.
Effective Date: Apr 19, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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