FCN No. 1718

DIC Corporation

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: Polyurethane adhesive formulated from:
  1. Polyester resins prepared by the reaction of a mixture of acids and alcohols listed in 21 CFR 175.300 (b)(3)(vii);
  2. Isocyanate hardeners consisting of one or more of the following
     1. m-xylylene diisocyanate (CAS Reg. No. 3634-83-1),
     2. m-xylylene diisocyanate-trimethylol propane prepolymer (CAS Reg. No. 51852-81-4),
     3. 2-ethyl-1-hexanol reaction products with 1,6-diisocyanatohexane,
     4. 1,6-diisocyanatohexane (CAS Reg. No. 822-06-0), and
     5. prepolymers of them.
  3. 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.
  4. An inorganic filler must be included in the adhesive as described in the notification.
• Notifier: DIC Corporation
• Manufacturer/Supplier: DIC Corporation
• Intended Use: For use as an adhesive and oxygen barrier in laminate structures that are intended for use in contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
• Limitations/Specifications: The adhesive may be used at levels up to 5 g/m² for conventional films, and up to 3.5 g/m² for metalized films. A food-contact layer consisting of co-polymer polypropylene with a minimum thickness of 70 μm or another material with equivalent or greater barrier properties will separate the adhesive from food. The finished article may contact all types of food under Conditions of Use A through H. The finished food contact articles containing the FCS are not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
• Effective Date: Feb 22, 2017
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 595 kB)
• FDA Decision: Finding of No Significant Impact (FONSI)

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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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