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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. 1097

Archroma U.S., 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: Hexane, 1,6-diisocyanato-, homopolymer, α-[1-[[[3-[[3 (dimethylamino)propyl]amino]propyl]amino]carbonyl]-1,2,2,2-tetrafluoroethyl]-ω-(1,1,2,2,3,3,3-heptafluoropropoxy)poly[oxy[trifluoro(trifluoromethyl)-1,2-ethanediyl]]-blocked (CAS Reg. No. 1279108-20-1).
Notifier: Archroma U.S., Inc.
Manufacturer/Supplier: Archroma U.S., Inc.
Intended Use: As a grease resistant treatment for paper and paperboard employed either prior to or after the sheet forming operation.
Limitations/Specifications: The FCS may be used at a level not to exceed 0.6 percent by weight (on a polymer basis) of dry paper and paperboard. The finished product is intended for use in contact with all food types, except foods containing greater than 15 percent alcohol, under Conditions of Use B through H as described in Tables 1 and 2.
Effective Date: Aug 24, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo