FCN No. 448

Perstorp Polyols, Inc. Rock Paint Co., Ltd.

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 formulated from:
  1. (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.
  2. 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/Supplier: 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.
• 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).
• Effective Date: Oct 15, 2004
• National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
• FDA Decision: Categorical Exclusion Memo

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*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.

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