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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. 1303

ChemStone, 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: ChemStone, Inc.
Manufacturer: ChemStone, Inc.
Intended Use: As a debonding agent and softener in food-contact paper and paperboard.
Limitations/Specifications*: At levels not to exceed 0.5 weight percent of dry paper and paperboard in contact with all food types under Conditions of Use B through H, as described in Table 2.
Effective Date: Sep 20, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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