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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. 1945

ADEKA Corporation

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: Alcohols, C10-14-branched, C11-rich, reaction products with ethylene oxide, [(2-propenyloxy)methyl]oxirane and sulfamic acid (CAS Reg. No. 905843-50-7). The FCS is comprised primarily of poly(oxy-1,2-ethanediyl), α-sulfo-ω-[1-(hydroxymethyl)-2-(2-propen-1-yloxy)ethoxy]-, C11-rich, C10-14-branched alkyl ethers, ammonium salts (CAS Reg. No. 403983-53-9).
Notifier: ADEKA Corporation
Manufacturer/Supplier: ADEKA Corporation
Intended Use: As a reactive emulsifier in emulsion polymerization processes of water-based polymers that are intended to be used in the manufacture of adhesives, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: The FCS may be used at levels up to 1% by weight of total monomers in adhesive polymers complying with 21 CFR 175.105 and 21 CFR 175.125. The finished food contact articles containing the FCS are not for use in contact with infant formula and breast milk.
Effective Date: May 5, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

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