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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. 349

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 adhesive as described at 21 CFR 177.1390(c)(2)(vii).
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 in contact with all food types at temperatures not to exceed 121°C (250°F). This notification extends the present regulated use of the adhesive per 21 CFR 177.1390(c)(2)(vii) to include use in laminates in contact with fatty foods described as Food Types III, IV A and B, V, VII A, and IX in Table 1.
Effective Date: Nov 25, 2003
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (270 kB)
FDA Decision: Finding of No Significant Impact (FONSI)