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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. 199

Solenis LLC

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, 9-Octadecenoic acid (9Z)-, reaction products wirh diethylenetriamine, cyclized, diethyl sulfate quaternized (CAS Reg. No. 68511-92-2) and Amides, C18 and C18-unsaturated, N-(2-(2-(C17 and C17-unsaturated alkyl)-4,5-dihydro-1H-imidazol-1-yl)ethyl)- (CAS Reg. No. 71808-32-7).
Notifier: Hercules Inc.
Manufacturer/Supplier: Solenis LLC
Intended Use: As a debonding agent in food-contact paper and paperboard at levels up to 0.5 percent by weight of the dry paper and paperboard. The FCS may also be used in accordance with food additive regulations and effective notifications which incorporate by reference materials cleared in 21 CFR 176.170 and 176.180.
Limitations/Specifications: The FCS may be used in contact with all food types as described in Table 1.
Effective Date: Apr 20, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo