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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. 1505

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 from the following:
  1. Polyurethane component prepared by the reaction of allophonate modified methane diphenyl diisocyanate (CAS Reg. No. 201615-11-4), 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), polypropylene glycol, toluene diisocyanate (CAS Reg. No. 26471-62-5), hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2) and
  2. Polyester/polyol component, a mixture of polyesters and polyether polyols prepared by the reaction of adipic acid, 1,3-benzenedicarboxylic acid, gallic acid, diethylene glycol, 1,2-propanediol, methyloxirane polymer, 1,1,1-tris(hydroxymethyl)propane, and 1,2,3-propanetriol.
Notifier: Henkel, Inc.
Manufacturer/Supplier: Henkel, Inc.
Intended Use: As an adhesive in laminate structures intended for contact with food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The adhesive may be applied at a maximum rate of 1.5 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 other 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 breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 5, 2015
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 755 kb)
FDA Decision: Finding of No Significant Impact (FONSI)