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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. 1434

Ashland 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: Reaction product of hexamethylene diisocyanate trimer (CAS Reg. No. 3779-63-3) with poly[di(ethylene glycol)adipate] (CAS Reg. No. 9010-89-3).
Notifier: Ashland Inc.
Manufacturer/Supplier: Ashland Inc.
Intended Use: The FCS will be used as an adhesive in multi-laminate structures, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS 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 will be separated from food by at least 1 mil of linear low density polyethylene (LLDPE), or one or more authorized polymers having equivalent or better barrier properties. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the food contact substance in the FCN.
Effective Date: Jul 16, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 5 Mb)
FDA Decision: Finding of No Significant Impact (FONSI)