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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. 173

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: Polyacrylic acid homopolymer, or copolymer of acrylic acid and up to 10 percent alkyl (C10-C30) methacrylate, crosslinked with either allyl sucrose (CAS Reg. No. 68784-14-5) or allyl pentaerythritol (CAS Reg. No. 91648-24-7); optionally contains up to 7 percent block copolymer surfactant of fatty acid (C12-C18) and polyethylene glycol.
Notifier: Lubrizol Advanced Materials
Manufacturer: Lubrizol Advanced Materials
Intended Use: As a thickener for hand sanitizers intended for use in food service establishments.
Limitations/Specifications*: The crosslinked polymers may be used at levels no greater than 0.5 percent in hand sanitizer formulations.
Effective Date: Feb 16, 2002
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (121 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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