FCN No. 448
| Food Contact Substance: |
Polyester-polyurethane resin formulated from: - (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.
- 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.
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| Environmental Assessment NEPA Submission: |
Categorical Exclusion 25.32(i)
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| FDA Decision: |
Categorical Exclusion Memo
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| FCN Premarket Authorization Issued: |
FCN description
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