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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. 1929

NALCO Water, an Ecolab Company

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: Ethanaminium, N,N,N-trimethyl-2-[(1-oxo-2-propen-1-yl)oxy]-, chloride (1:1), polymer with 2-propenamide (CAS Reg. No. 69418-26-4) with up to 0.06 mol % of poly(oxy-1,2-ethanediyl), alpha-(2-methyl-1-oxo-2-propen-1-yl)-omega-hydroxy-, C16-18-alkyl ethers (CAS Reg. No. 70879-51-5).
Notifier: NALCO Water, an Ecolab Company
Manufacturer/Supplier: NALCO Water, an Ecolab Company
Intended Use: As a flocculant, dry strength agent, and retention and/or drainage aid in the manufacture of food contact paper and paperboard except for use in contact with infant formula and/or human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended for use at levels not to exceed 0.5% by weight of coated and uncoated paper and paperboard. The finished article containing the FCS may contact all food types under Conditions of Use A through H, and J, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and/or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Mar 11, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo