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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. 1105

Kemira 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: A reaction product of 9-octadecenoic acid (9Z)- with diethylenetriamine, cyclized, diethyl sulfate quaternized (CAS Reg. No. 68511-92-2). The reaction product contains a mixture of (1) 1-H-imidazolium, 1-ethyl-2-(8Z)-8-heptadecen-1-yl-4,5-dihydro-1-[2-[[(9Z)-1-oxo-9-octadecen-1-yl]amino]ethyl]-, ethyl sulfate (1:1) (CAS Reg. No. 67846-14-4); and (2) 9-octadecenamide, N-[2-[2-(8Z)-8 heptadecen-1-yl-4,5-dihydro-1H-imidazol-1-yl]ethyl]-, (9Z)-(CAS Reg. No. 63441-26-9).
Notifier: Kemira Chemicals, Inc.
Manufacturer: Kemira Chemicals, Inc.
Intended Use: As a debonding agent and softener employed during the manufacture of food-contact paper and paperboard.
Limitations/Specifications*: The FCS may be used at a level not to exceed 0.5% by weight of dry paper and paperboard. The finished product is intended for use in contact with all food types under Conditions of Use B through H as described in Tables 1 and 2.
Effective Date: Sep 28, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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