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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. 123

Toyo-Morton, Limited

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-epoxy-urethane adhesives formulated from: 1. Polyester resins described in 21 CFR 177.1390(c)(2)(v)(a). 1,6-Hexanediol may also be used as an optional polyhydric alcohol. 2. Optional epoxy resin listed in 21 CFR 175.300(b)(3)(viii)(a) and comprising up to 30 percent by weight of the cured adhesive. 3. Urethane cross-linking agent, as described in 21 CFR 177.1390(c)(2)(v)(c). 4. Optional trimethoxysilane coupling agents containing epoxy and/or ether groups not to exceed 3 percent by weight of the cured adhesive.
Notifier: Toyo-Morton, Limited
Manufacturer: Toyo-Morton, Limited
Intended Use: The FCS may be used as an adhesive for laminate constructions intended for packaging all food types, except those containing more than 8 percent alcohol. The FCS may be used only for construction of retort pouches intended for use at a maximum temperature 135°C (275°F). The FCS may also be used as permitted by other regulatory clearances which incorporate by reference, materials cleared in 21 CFR 177.1390 provided such use is in retort pouch applications.
Limitations/Specifications*: The FCS will meet the test specifications outlined in 21 CFR 177.1390(c)(3)(i)(b)(2) and 21 CFR 177.1390(c)(3)(ii).
Effective Date: Apr 11, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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