FCN No. 733
| Food Contact Substance: |
Polyester-polyurethane adhesive formulated from the following: - Urethane cross-linking agent, comprising not more than 75 percent by weight of the cured adhesive, prepared by the reaction of a mixture of 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, homopolymer (CAS Reg. No. 53880-05-0) and 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No. 25854-16-4), and a polyester prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300(b)(3)(vii),
- Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300(b)(3)(vii). Additionally, 1,6-hexanediol may be used as an alcohol reactant.
- Optional use, in either the urethane cross-linking agent or polyester resin portions of the resin, of: 1) acid anhydride formulated from 3a,4,5,7a-tetrahydro-7-methyl-5-(tetrahydro-2,5-dioxo-3-furanyl)-1,3-isobenzofurandione (CAS Reg. No. 73003-90-4), comprising not more than 3 percent by weight of the cured adhesive, and/or 2) trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive.
|
| Environmental Assessment NEPA Submission: |
Environmental Assessment (in PDF, 336 kB)
|
| FDA Decision: |
Finding of No Significant Impact (FONSI)/EA Supplement
|
| FCN Premarket Authorization Issued: |
FCN description
|
