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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. 448

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Food Contact Substance:  Polyester-polyurethane resin formulated from: (a)(1) Polyester-polyurethanediol resins prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 1,6-hexanediol (CAS Reg. No. 629-11-8), dimethylolbutanoic acid (CAS Reg. No. 10097-02-6), 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg No. 4098-71-9), and/or 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4). The FCS will be manufactured and characterized as described in the notification. (2) An optional trimethoxysilane coupling agent containing an epoxy group, as described in the notification, not to exceed 3 percent by weight of the cured adhesive. (b) Urethane cross-linking agent comprising not more than 20 percent by weight of the cured adhesive, and formulated from trimethylolpropane (CAS Reg. No. 77-99-6) adduct of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate and/or trimethylolpropane adduct of 1,3-bis(isocyanatomethyl)benzene and/or 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-0). The content of the 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate cyanurate shall not exceed 14 percent by weight of the cured adhesive.
Notifier:  Perstorp Polyols, Inc. Rock Paint Co., Ltd.
Manufacturer:  Perstorp Polyols, Inc. Rock Paint Co., Ltd.
Intended Use:  For use as an adhesive in laminate structures that are intended for use at retort temperatures.
Effective Date:  10/15/2004
Limitations/Specifications:  For use in contact with all types of food, except those containing more than 8 percent alcohol, under retort packaging conditions at temperatures not to exceed 275°F. Laminate structures containing the FCS will meet all applicable provisions and test specifications in 21 CFR 177.1390, including 177.1390(c)(3)(i)(b)(3) and 177.1390(c)(3)(ii).
Environmental Impact Decisions:  Environmental Decisions Site