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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. 1692

Henkel, 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-polyurethane adhesive formulated as follows:
  1. polyurethane component prepared from isophthalic acid, diethylene glycol, adipic acid, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8) and hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2); and
  2. Polyester-polyol component prepared from isophthalic acid, diethylene glycol, castor oil, propoxylated glycerol, propoxylated trimethylolpropane and caprolactam.
Notifier: Henkel, Inc.
Manufacturer/Supplier: Henkel, Inc.
Intended Use: As an adhesive in laminate structures for use at high temperatures, including microwave reheating, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The adhesive may be applied at a maximum rate of 2.5 pounds per 3000 square feet of food-contact surface. A food-contact layer will separate the adhesive from food and will consist of low density polyethylene with a minimum thickness of 1 mil or another material with equivalent or greater barrier properties under the intended conditions of use. Laminate structures using the FCS as an adhesive may be used in contact with all food types under Conditions of Use B through H as described in Tables 1 and 2. The FCS is 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: Dec 17, 2016
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 523 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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