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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. 389

Evonik Corporation

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 mixture of imidazolium and imidazoline compounds, 1H-imidazolium, 1-ethyl-2-(8Z)-8-heptadecenyl-4,5-dihydro-1-[2-[[(9Z)-1-oxo-9-octadecenyl]amino]ethyl]-, ethyl sulfate (CAS Reg. No. 67846-14-4) and 9-octadecenamide, N-[2-[2-(8Z)-8-heptadecenyl-4,5-dihydro-1H-imidazol-1-yl]ethyl]-, (9Z)- (CAS Reg. No. 63441-26-9).
Notifier: Goldschmidt Chemical Corporation
Manufacturer: Evonik Corporation
Intended Use: The FCS may be used as a debonding agent in food-contact paper and paperboard at levels not to exceed 0.5 percent by weight of the dry paper and paperboard.
Limitations/Specifications*: The FCS may be used at levels not to exceed 0.5 weight percent in paper and paperboard in contact with all food types under Conditions of Use B through H, as described in Tables 1 and 2, respectively.
Effective Date: Feb 4, 2004
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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