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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. 1746

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 from allophanate-modified methane diphenyl diisocyanate, 4,4'-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2), and hexamethylene diisocyanate (CAS Reg. No. 822-06-0) and
  2. Polyester/polyether/polyol component prepared from adipic acid (CAS Reg. No. 124-04-0), 1,3-benzenedicarboxylic acid (CAS Reg. No. 121-91-5), diethylene glycol (CAS Reg. No. 111-46-6), 1,2-propanediol (CAS Reg. No. 57-55-6), polypropylene glycol (CAS Reg. No. 25322-69-4), and 1,2,3-propanetriol (CAS Reg. No. 56-81-5).
Notifier: Henkel, Inc.
Manufacturer/Supplier: Henkel, Inc.
Intended Use: The FCS Is intended to be used as an adhesive in laminate structures intended for contact with food, 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 1.25 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, respectively. 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: Apr 15, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo