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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. 105

Nalco Chemical 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: Sodium acrylate/styrene sulfonate copolymer.
Notifier: Nalco Chemical Company
Manufacturer/Supplier: Nalco Chemical Company
Intended Use: As an antiscalant boiler water treatment where steam from treated boilers may contact food.
Limitations/Specifications*: The polymer must be used at levels not to exceed 20 ppm in the feed water. The polymer must not be used at pressures above 1,000 pounds per square inch gauge (psig). The polymer has a molecular weight range of 7,500 to 15, 000. The polymer comprises at least 99 mole percent acrylic acid and 1 mole percent sodium styrene sulfonate. Specific substances permitted for use as boiler water additives complying with 21 CFR 173.310 may be used in the subject boiler water additives subject to any limitations in the authorizing regulation or notification. The finished boiler water additive must meet any applicable specifications prescribed in 21 CFR 173.310.
Effective Date: Feb 3, 2001
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (275 kB)
FDA Decision: Finding of No Significant Impact (FONSI)