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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. 733

Dainippon Ink and Chemicals, Inc.

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-polyurethane adhesive formulated from the following: (a) Urethane cross-linking agent, comprising not more than 75 percent by weight of the cured adhesive, prepared by the reaction of a mixture of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, homopolymer (CAS Reg. No. 53880-05-0) and 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4), and a polyester prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300(b)(3)(vii), (b) Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii). Additionally, 1,6-hexanediol may be used as an alcohol reactant. (c) Optional use, in either the urethane cross-linking agent or polyester resin portions of the resin, of: 1) acid anhydride formulated from 3a, 4, 5, 7a-tetrahydro-7-methyl-5- (tetrahydro-2,5-dioxo-3-furanyl) -1,3-isobenzofurandione (CAS Reg. No. 73003-90-4), comprising not more than 3 percent by weight of the cured adhesive, and/or 2) trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive.
Notifier: Dainippon Ink and Chemicals, Inc.
Manufacturer: Dainippon Ink and Chemicals, Inc.
Intended Use: For use as an adhesive in laminate structures that are intended for use at retort temperatures.
Limitations/Specifications*: For use only in retort pouches intended for use in contact with all food types at temperatures not to exceed 135oC (275oF).
Effective Date: Oct 3, 2007
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (336 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement
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