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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. 442

Lubrizol Advanced Materials

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: Alcohol ethoxylate in which the alcohol contains from 12 to 22 carbon atoms and the ethoxylate chain contains from 4 to 20 repeating ethoxylate units.
Notifier: Lubrizol Advanced Materials
Manufacturer: Lubrizol Advanced Materials
Intended Use: For use as a component of a mixture intended for use as a thickener for hand sanitizers used in food service establishments.
Limitations/Specifications*: The FCS is to be included at up to 7 percent by weight in a mixture containing 1) a polyacrylic acid homopolymer or the copolymer of acrylic acid and up to 10 percent by weight alkyl (C10-C30) methacrylate, crosslinked with either allyl sucrose or allyl pentaerythritol, and (2) optionally containing up to 7 percent by weight of a block copolymer surfactant of fatty acid (C12-C18) and polyethylene glycol. The mixture will be used at levels no greater than 0.5 percent by weight in hand sanitizer formulations.
Effective Date: Nov 23, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (380 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement