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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. 18

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 food contact substance contains not more than 15% styrene sulfonate and has a molecular weight greater than 20,000 and a polydispersity of 2.0 - 3.3, as measured by a method entitled "Molecular Weight Distribution of Aqueous Anionic Polymers by Size Exclusion Chromatography (SEC) Using Synchropak GPC Columns". The substance must not exceed 20 ppm in feed water, must not be used in boilers at pressures above 1000 pounds per square inch gauge (psig), and must meet any applicable specifications prescribed in 21 CFR 173.310.
Effective Date: Apr 7, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (69 kB)
FDA Decision: Finding of No Significant Impact (FONSI)/EA Supplement