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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. 766

Nippon Polyurethane Industry 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: Polyester-urethane adhesive formulated from: 1) Polyester-urethanediol resins described in 21 CFR 177.1390(c)(2)(iv)(a). In addition, 2,2-bis(hydroxymethyl) butanoic acid (CAS Reg. No. 10097-02-6) may be used as an optional polyhydric alcohol, and 2,2-dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7) may be used as a polyhydric alcohol in structures that are intended to contact alcoholic foods containing up to 8 percent ethyl alcohol. 2) Urethane cross-linking agent consisting of 1,3-butanediol reaction products with 1,6-diisocyanatohexane (CAS Reg. No. 187852-79-5).
Notifier: Nippon Polyurethane Industry Co., Ltd.
Manufacturer: Nippon Polyurethane Industry Co., Ltd.
Intended Use: The FCS will be used as an adhesive in laminate structures that are intended for use at retort temperatures.
Limitations/Specifications*: The finished FCS will be used only in the manufacture of retort pouches at temperatures up to 275oF and in contact with all food types, except those containing more than 8 percent alcohol.
Effective Date: Apr 4, 2008
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (917 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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