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U.S. Department of Health and Human Services

Inventory of Environmental Impact Decisions for Food Contact Substance Notifications

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FCN No. 1105

Food Contact Substance: 9-octadecanoic acid (9 Z)- with diethylenetriamine, cyclized, diethyl sulfate quaternized, reaction product of, containing 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) and (2) 9-octadecenamide, N-[2-[2-(8Z)-8-heptadecen-1-yl-4,5-dihydro-1H-imidazol-1-yl]ethyl]-, (9Z)-
National Environmental Policy Act (NEPA) Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
FCN Premarket Authorization Issued: FCN 1105 description