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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. 97

BetzDearborn, Inc.

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: Polyethylene glycol (400) monooleate (CAS Reg. No. 9004-96-0).
Notifier: BetzDearborn, Inc.
Manufacturer/Supplier: BetzDearborn, Inc.
Intended Use: As an anti-corrosive agent in the steam header and steam lines of boiler systems in which the steam will contact food.
Limitations/Specifications*: The FCS is to be continuously added into the steam header to maintain a maximum concentration of 2 ppm in the steam. The FCS shall contain no more than 100 ppm and 800 ppm residual ethylene oxide and 1,4-dioxane, respectively, and must meet any applicable specifications prescribed in 21 CFR 173.310.
Effective Date: Nov 23, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (558 kB)
FDA Decision: Finding of No Significant Impact (FONSI)