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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. 413

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 resin-acid dianhydride adhesives.
Notifier: Dainippon Ink and Chemicals, Inc.
Manufacturer/Supplier: 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 in finished food-contact articles in contact with all food types at temperatures not to exceed 135°C (275°F). The food contact substance may be fabricated from the following: 1) Polyesterpolyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 C.F.R. 175.300(b)(3)(vii) and 3- isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg No. 4098-71-9). Additionally, 1,6-hexanediol may be used as a polybasic alcohol reactant. 2) Optional trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups not in excess of 3 percent by weight of the cured adhesive. 3) Urethane cross-linking agent, comprising not more than 12 percent by weight of the cured adhesive, and formulated from 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate and/or trimethylol propane (CAS Reg. No. 77-99-6 ) adduct of 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4). 4) Optional use of acid dianhydride 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 1 percent by weight of the cured adhesive.
Effective Date: Jul 6, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 438 kB)
FDA Decision: Finding of No Significant Impact (FONSI)