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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. 267

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: 1) imidazolium compounds, 2-(C17 and C17 unsaturated alkyl)-1-(2-(C18 and C18 unsaturated amido)ethyl)-1-ethyl-4,5-dihydro-, ethyl sulfates (CAS Reg. No. 91053-16-6); and 2) 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 uncoated food-contact paper and paperboard at levels up to 0.25 percent by weight of the dry paper and paperboard.
Limitations/Specifications: The FCS may be used in contact with all food types, as described in Table 1.
Effective Date: Oct 18, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo