FCN No. 1718
| Food Contact Substance: |
Polyurethane adhesive formulated from:- Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii);
- Isocyanate hardeners consisting of one or more of the following
- m-xylylene diisocyanate (CAS Reg. No. 3634-83-1),
- m-xylylene diisocyanate-trimethylol propane prepolymer (CAS Reg. No. 51852-81-4),
- 2-ethyl-1-hexanol reaction products with 1,6-diisocyanatohexane,
- 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0), and
- prepolymers of them.
- Optional use, in either the urethane hardener or polyester resin portions of the resin, of trimethoxysilane coupling agents containing amino, epoxy, ether, or mercapto groups comprising not more than 3 percent by weight of the cured adhesive and/or the triethoxysilane coupling agent described in the notification.
- An inorganic filler must be included in the adhesive as described in the notification.
|
| Environmental Assessment NEPA Submission: |
Environmental Assessment (in PDF, 595 kB)
|
| FDA Decision: |
Finding of No Significant Impact (FONSI)
|
| FCN Premarket Authorization Issued: |
FCN description
|
