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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 1531

Mitsui Chemicals, Inc.

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-urethane adhesive formulated from:
  1. Polyester resin prepared by the reaction of a mixture of polybasic acids and polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii) and 2,2-dimethyl-1,3-propanediol (CAS Reg. No. 126-30-7), and glycerol polyoxypropylene triol (CAS Reg. No. 25791-96-2).
  2. Urethane cross-linking agent comprising not more than 40 percent by weight of the cured adhesive and formulated from 1,6-hexanediisocyanate (CAS Reg. No. 822-06-0) adducted with isobutanol (CAS Reg. No. 78-83-1) and the reaction with the polyester resin and 1,3-bis(isocyanatomethyl) benzene (CAS Reg. No. 3634-83-1) and/or 3-isocyanatomethyl-3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS Reg. No. 53880-05-0).
  3. Optional trimethoxysilane coupling agents containing amino, epoxy, ether, and/or mercapto groups not to exceed 3 percent by weight of the cured adhesive.
Notifier: Mitsui Chemicals, Inc.
Manufacturer/Supplier: Mitsui Chemicals, Inc.
Intended Use: The FCS will be used as an adhesive in laminate structures that are intended for use at retort temperatures, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The polyester-urethane adhesive will be used only in the manufacture of retort pouches at temperatures up to 275°F and in contact with all food types. The maximum adhesive application rate will be 3.5 g/m2 as a non-food contact layer, and will be separated from food by at least 60 μm (0.0024 in or 2.4 mil) of polypropylene, or one or more authorized polymers having equivalent or better barrier properties. The FCS is not for use in contact with infant formula or breast milk. Such use was not included as part of the intended use of the substance in the FCN. Laminate structures containing the FCS will meet all applicable provisions and test specifications in 177.1390, including 177.1390(c)(3)(i)(b)(1) and 177.1390(c)(3)(ii). Additives and adjuvants with appropriate regulatory statuses may be optionally used in the manufacture of the FCS.
Effective Date: Jul 2, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 5.5 Mb)
FDA Decision: Finding of No Significant Impact (FONSI)

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